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Archive for the ‘Pharmaceuticall R&D Informatics’ Category


Applying Pharmacology to New Drug Discovery, April 22, 2016 in San Diego, CA by CHI

Reporter: Aviva Lev-Ari, PhD, RN

 

Applying Pharmacology to New Drug Discovery, April 22, 2016 in San Diego, CA by CHI

The system-independent quantification of molecular drug properties for prediction of therapeutic utility

April 22, 2016

Over the past 6 six years, the primary cause of new drug candidate failures (50%) has been failure of therapeutic efficacy. Put another way, drug discovery programs do everything right, get the defined candidate molecule, only to have it fail in therapeutic trials. Among the most prevalent reasons proposed for this shortcoming is the lack of translation of in vitro and recombinant drug activity to therapeutic in vivo whole systems. Drug activity in complete systems can be characterized with the application of pharmacological principles which translate drug behaviors in various organs with molecular scales of affinity and efficacy.

Pharmacological techniques are unique in that they can convert descriptive data (what we see, potency, activity in a given system) to predictive data (molecular scales of activity that can be used to predict activity in all systems including the therapeutic one, i.e. affinity, efficacy). The predicted outcome of this process is a far lower failure rate as molecules are progressed toward clinical testing.

Instructor

Terry Kenakin presently is a Professor of Pharmacology in the Department of Pharmacology, University of North Carolina School of Medicine. The course is taught from the perspective of industrial drug discovery; Dr. Kenakin has worked in drug industry for 32 years (7 at Burroughs-Wellcome, RTP, NC and 25 at GlaxoSmithKline, RTP. NC). He is Editor-in-Chief of the Journal of Receptors and Signal Transduction and Co-Editor-in-Chief of Current Opinion in Pharmacology and is on numerous journal Editorial Boards. In addition, he has authored over 200 peer reviewed papers and reviews and has written 10 books on Pharmacology.

Course Material

Summary sheets, exercises with answers, relevant papers are included as well as a pdf of all slides. The course is based on the book A Pharmacology Primer: Techniques for More Effective and Strategic Drug Discovery. 4th Edition, Elsevier/Academic Press, 2014.

This course will describe pharmacological principles and procedures to quantify affinity, efficacy, biased signaling and allostery to better screen for new drugs and characterize drug candidates in lead optimization assays.

1. Assay Formats/Experimental Design

  • Binding
  • Functional Assays
  • Null Method Assays

2. Agonism

  • Agonist Affinity/Efficacy
  • Black/Leff Operational model

3. Biased Signaling (Agonism)

  • Mechanism of Biased Signaling
  • Quantifying Biased Agonism
  • Therapeutic application(s)

4. Orthosteric Antagonism (I)

  • Competitive
  • Non-Competitive/Irreversible

5. Orthosteric Antagonism (II)

  • Partial Agonism
  • Inverse Agonism

6. Allosteric Modulation (I)

  • Functional Allosteric Model
  • Negative Allosteric Modulators (NAMs)

7. Allosteric Modulation (II)

  • Positive Allosteric Modulators (PAMs)
  • Allosteric Agonism

8. Drug-Receptor Kinetics

  • Measuring Target Coverage
  • Allosteric Proof-of-Concept
  • Application of Real-Time Kinetics

9. Drug Screening

  • Design of Screening Assays
  • Screening for Allosteric Modulators

Cambridge Healthtech Institute’s Eleventh Annual Drug Discovery Chemistry is a dynamic conference for medicinal chemists working in pharma and biotech. Focused on discovery and optimization challenges of small molecule drug candidates, this event provides many exciting opportunities for scientists to create a unique program by going back and forth between concurrent meeting tracks to hear presentations most suited to one’s personal interests. New for 2016 is the addition of three symposia on Friday covering the blood-brain barrier, biophysical approaches for drug discovery, and antivirals.

Plenary Keynotes

 

A New Model for Academic Translational Research

Peter G. Schultz, Ph.D., The Scripps Research Institute

Cell-Penetrating Miniproteins

Gregory L. Verdine, Ph.D., Harvard University

April 19-20

April 20-21

April 22

Inflammation Inhibitors

Kinase Inhibitor Chemistry

Brain Penetrant Inhibitors

Protein-Protein Interactions

Macrocyclics & Constrained Peptides

Biophysical Approaches

Epigenetic Inhibitor Discovery

Fragment-Based Drug Discovery

Antivirals

Short Courses

Make the most of your time in San Diego by adding on one or more short courses*. Topics include trends in physical properties, GPCRs, peptide therapeutics, immunology, phenotypic screening, crystallography, ligand-receptor molecular interactions, inhibitor design, macrocycles, FBDD, and covalent inhibitors.

* separate registration required for short courses

SOURCE

From: Deborah Shear <pete@healthtech.com>

Date: Friday, January 8, 2016 at 11:42 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Training Seminar: Applying Pharmacology to New Drug Discovery

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J.P. Morgan 34th Annual Healthcare Conference & Biotech Showcase™ January 11 – 15, 2016 in San Francisco

Reporter: Aviva Lev-Ari, PhD, RN

J.P. Morgan 34th Annual Healthcare Conference

When:

January 11, 2016 – January 14, 2016 (all-day)

Where:

San Francisco, CA, USA

Conference AGENDA

http://jpmorgan.metameetings.com/confbook/healthcare16/agenda.php 

 

UPDATED on 1/10/2016

The definitive guide to the J.P. Morgan Healthcare Conference

Image SOURCE

[Image courtesy of Flickr user Ryan McDonald]

http://medcitynews.com/2016/01/the-definitive-guide-to-the-j-p-morgan-healthcare-conference/

 

MAJOR BioTech Conferences in San Francisco –

The CAPITAL of BioTech for 2nd week in January 2016

 

  • Festival Start up Health

http://festival.startuphealth.com/

  • Biotech Showcase 2016

http://www.ebdgroup.com/bts/media/about_conf.php

  • JP Morgan HealthCare Conference

http://globalbiodefense.com/2015/12/28/jp_morgan_healthcare_2016/#sthash.IhPw1DcA.dpuf

AGENDA

#JPM16

http://jpmorgan.metameetings.com/confbook/healthcare16/agenda.php

  • The 9th Annual OneMedForum, San Francisco 2016 – A Private Investment Conference for OneMed Research Clients

http://www.onemedconferences.com/

 

  • RESI@JPM — Redefining Early Stage Investments – Life Science Nation (LSN)

http://www.resiconference.com/

 

Venture Valkyrie (and capitalist) Lisa Suennen rightly pointed out that JPM is typically a male-dominated affair, which is why she’s written “JP Morgan: Where the Boys are… And not the Girls.”

In a field where women hold many senior positions in actual US healthcare corporations, they are drowned out at this conference by the advancing horde of finance guys in red ties and the CEOs that love them.

http://medcitynews.com/2016/01/the-definitive-guide-to-the-j-p-morgan-healthcare-conference/?rf=1

Signal Podcast on STAT

Listen to Episode 5: By LUKE TIMMERMANandMEG TIRRELL

https://soundcloud.com/stat-signal-podcast/episode-5-san-francisco-in-january-is-where-new-medicines-get-made

San Francisco 2016

Union Square: Maps & Resources by MacDougall Biomedical Communications.

http://macb.io/jpm2016/

Biotech Showcase™ 2016 Program Overview

Sunday, January 10, 2016
1:00–5:00 pm
Additional Program
Biotech Showcase™ pre-event

This workshop is focused on delivering results and securing funding at All Levels: Boards, Angels, VCs, Corporate Partners and Other Sources of Funds, with four hours of intensive and interactive discussion, on-your-feet sessions, war stories and insights aimed at folks looking for financing. It is designed to accelerate your funding activities and eliminate unnecessary noise.

Preregistration is required, more information can be found here.

3:00–6:00 pm
Level 4, Cyril Magnin Foyer

All Biotech Showcase attendees are invited to pick up name badges prior to the beginning of the conference on Monday.

Monday, January 11, 2016
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–8:55 am
Workshops
8:00 am–6:00 pm
One-to-one Meetings ►

Hilton Union Square
333 O’Farrell Street
Level 2, Ballroom

8:00–9:50 am

Regenerative Medicine and Advanced Therapies State of the Industry Briefing

8:00 am–12:00 pm

Company Presentations ►

Private Biotech
Public Biotech

12:00–1:30 pm

Lunch Plenary

1:45–5:30 pm

Company Presentations ►

Private Biotech
Public Biotech

Tuesday, January 12, 2016
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–8:55 am
Workshops
8:00 am–6:00 pm
One-to-one Meetings ►

Hilton Union Square
333 O’Farrell Street
Level 2, Ballroom

8:00–9:15 am

Medtech Showcase State of the Industry Report

8:00 am–12:00 pm

Company Presentations ►

Private Biotech
Public Biotech

12:00–1:30 pm

Lunch Plenary

1:45–5:30 pm

Company Presentations ►

Private Biotech
Public Biotech

4:30–5:30 pm

Medtech Showcase Workshop

 

Wednesday, January 13, 2016
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–8:55 am

Workshops
8:00 am–5:00 pm
One-to-one Meetings ►

Hilton Union Square
333 O’Farrell Street
Level 2, Ballroom

8:00–9:00 am

Digital Health Showcase State of the Industry Report

8:00 am–12:00 pm

Company Presentations ►

Private Biotech
Public Biotech

10:00–11:00 am

Digital Health Showcase Workshop

11:00–11:45 am

11:45 am–12:15 pm

Digital Health Showcase Discussion

12:00–1:30 pm

Lunch Plenary

1:00–1:45 pm

Digital Health Showcase Workshop

4:00–5:00 pm

Digital Health Showcase Workshop

1:45–5:00 pm

Company Presentations ►

Private Biotech
Public Biotech

5:00–6:00 pm

Level 4, Cyril Magnin Foyer
Closing Reception

 

SOURCE

http://www.ebdgroup.com/bts/program/index.php

About Biotech Showcase™ 2016

Previous conferences ►

Biotech Showcase™ 2016
January 11–13, 2016, San Francisco

Biotech Showcase™ 2015 Highlights

  • 232 company presentations
  • 2,100 attendees
  • 1,276 companies
  • 37 countries represented
  • 4,277 one-to-one meetings
  • 14 workshops and panels

Photos of Biotech Showcase 2015 ►

Biotech Showcase™ is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and potential strategics in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this critical week which is widely viewed as setting the tone for the coming year.

Now in its eighth year, this rapidly growing conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings.

Biotech Showcase delegates include investors in private and public companies, sector analysts, bankers and industry professionals, as well as biopharmaceutical and life science company executives.

Biotech Showcase is produced by Demy Colton Life Science Advisors and EBD Group. Both organizations have a long history of producing high quality programs that support the biotechnology and broader life sciences industry.

http://www.ebdgroup.com/bts/media/about_conf.php

Biotech Showcase™ 2016 Press Releases

J.P. Morgan 34th Annual Healthcare Conference

When:

January 11, 2016 – January 14, 2016 (all-day)

Where:

San Francisco, CA, USA

Conference AGENDA

http://jpmorgan.metameetings.com/confbook/healthcare16/agenda.php 

 

J.P. MORGAN HEALTHCARE CONFERENCE 2016 SURVIVAL GUIDE

 

Whether you’re a conference veteran or a rookie, we hope this light-hearted guide helps you survive the week of life science mayhem in San Fransisco. At Chempetitive Group, we have a deep passion for everything life science—its people, its processes and its promise for the future. As life science marketers, this passion takes us to the industry’s biggest events every year, including the J.P. Morgan Healthcare Conference and related conferences each January. Over the years, we’ve learned our way around San Francisco’s Union Square—places we like to frequent.

 

January 11-14 San Francisco RAMP UP

Over 12,000 attendees

Over 15,000 meetings

Over 1,500 companies presenting

http://www.ebdgroup.com/bts/presenters/prs_comps.php

Over 40 countries represented Projected value of this year’s deals: unlimited

Surviving the J.P. Morgan Healthcare Conference [Plus Insider’s Guide]

POSTED BY:

Each January, the J.P. Morgan Healthcare Conference – perhaps the life science industry’s largest and most frenzied conference of the year – reliably draws thousands of investors and executives across the healthcare sector to San Francisco’s Union Square neighborhood as hundreds of companies present their latest innovations and dreams in an attempt to pique the interest of venture capitalists and potential partners. In addition to J.P. Morgan, parallel events Biotech Showcase, OneMedForum and RESI Conference ensure that there is a high density of biotech brainpower and capital in the City by the Bay.

The conference week is a mix of long days of presentations and lively evenings of cocktail parties and networking events. With more than 50 networking receptions, days of sessions, and still a volume of work to manage while away from the office, you might need some guidance on where to take your client or potential partner for a meeting, where to refuel or caffeinate, or simply where to hide from the chaos. For these reasons, we decided to let you into our world by creating this simple guide to surviving the 2016 J.P. Morgan Healthcare Conference week.

Download it and, if you happen to find yourself in one of our favorite spots, let us know with a direct message on Twitter at @chempetitive. Safe travels, have fun, and get some deals done.

JP Morgan 2016 Healthcare Conference Participants

The following organizations have released announcements of their participation in the 34th Annual JP Morgan Healthcare Conference:

http://globalbiodefense.com/2015/12/28/jp_morgan_healthcare_2016/#sthash.IhPw1DcA.dpuf

SOURCE

http://info.chempetitive.com/hubfs/jp-morgan-infographic.pdf?__hssc=206009548.1.1452199074195&__hstc=206009548.1433c7a0bae9903565d9225ff3a2e21a.1452199074194.1452199074194.1452199074194.1&hsCtaTracking=4f124550-2dd0-4834-b2e3-1bcf78ce32bc%7C8020c5d5-e8f4-4e7e-95df-a299dd5dffbc

 

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Genomics’ Proprietary Statistical Analysis Tools and Integrated Multi-Phenotype Database to be used to Support Research and Development at Vertex Pharmaceuticals

Reporter: Aviva Lev-Ari, PhD, RN

 

 

Press release

04 January 2016

Genomics and Vertex Collaborate to Identify Target Therapeutic Pathways

 

Genomics’ Proprietary Statistical Analysis Tools and Integrated Multi-Phenotype Database to be used to Support Research and Development at Vertex Pharmaceuticals

 

Oxford, UK, 04 January 2016: Genomics plc (“Genomics”), a leading analysis company developing algorithms, data resources, and software solutions to uncover the relationships between genetic variation and human disease, today announced that Vertex Pharmaceuticals will use Genomics’ integrated database and state-of-the-art analysis tools to inform its drug research and development.  These tools aim to provide confidence in the rationale for targeting Vertex’s pathways of interest for the treatment of certain diseases and to identify potential safety concerns and repositioning opportunities.

 

Genomics has developed a unique analytical platform for genome analysis and interpretation. The platform combines proprietary algorithms and software with the Company’s integrated genome-phenome database and analytical expertise to learn about human biology.  Genomics has several existing partnerships with large pharmaceutical companies, and in clinical genomics is a Platform Partner for Genomics England, the company undertaking the 100,000 Genomes Project in the UK.

 

John Colenutt, CEO, Genomics plc, said: “Pharmaceutical and biotech companies are increasingly using human genetic data in research to increase the chance of success in drug development.  We are excited that Vertex has chosen to use Genomics’ proprietary technology, integrated database and tools to support them in this aim.”

 

Paul de Bakker, Ph.D., Head of Computational Genomics for Vertex said: “Vertex is focused on advancing research programs where disease mechanisms are validated by human biology.  Our collaboration with Genomics is aimed at obtaining insights into the genetic underpinnings of specific targets and diseases to help predict which potential medicines may have success moving from discovery research toward patients.”

 

ENDS

 

Photo: John Colenutt, CEO, Genomics plc. For a high resolution image please contact lorna.cuddon@zymecommunications.com

 

For further information please contact:

 

Zyme Communications

Lorna Cuddon

Tel: +44 (0)7811996942

Email: lorna.cuddon@zymecommunications.com

 

About Genomics plc http://www.genomicsplc.com/

Genomics was founded by four leading Oxford academics, including Professor Peter Donnelly, Director of The Wellcome Trust Centre for Human Genetics, and Professor Gil McVean, Director of The Big Data Institute. The Company has developed a unique platform for genomic sequence data analysis and interpretation which combines world-leading expertise in statistical analysis and data mining with a unique integrated database linking genotypes and phenotypes. Genomics England, the company running the UK project to undertake whole genome sequencing of 100,000 patients in the National Health Service, has appointed Genomics plc as a Platform Partner and has also awarded the Company three SBRI grants. Genomics plc is also working with four major pharmaceutical companies to bring the benefits of genomic analysis to their drug development processes. The Company is supported by major investors, including IP Group, Invesco Perpetual, Woodford Investment Management and Lansdowne Partners.

SOURCE

From: Lorna Cuddon <lorna.cuddon@zymecommunications.com>

Reply-To: <lorna.cuddon@zymecommunications.com>

Date: Monday, January 4, 2016 at 4:11 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Genomics and Vertex Collaborate to Identify Target Therapeutic Pathways

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Top Seven big Pharma in Thomson Reuters 2015 Top 100 Global Innovators

Reporter: Aviva Lev-Ari, PhD, RN

 

NAME COUNTRY PREVIOUS WINNER PREVIOUS WINNER PREVIOUS WINNER
Abbott USA

2014

2013
Bayer GERMANY

2011

Boehringer

Ingelheim

GERMANY
Brinstol-Myers Squibb USA

2011

J&J USA

2014

2013

Novartis Switzerland

2014

Roche Switzerland

2014

2013

2012, 2011

SOURCE

http://images.info.science.thomsonreuters.biz/Web/ThomsonReutersScience/%7Beb621c66-e238-4994-b1b5-9f5f9f897a75%7D_Thomson_Reuters_Top100_Global_Innovators_final.pdf

Introducing the Thomson Reuters 2015 Top 100 Global Innovators Organization Country Industry Previous Winners

New in 2015:

Top Bay Area Innovators For the first time, Thomson Reuters analysts studied Silicon Valley, known as the technology and innovation corridor in the US, to see which companies are leading there. Following a methodology similar to that of the Top 100 Global Innovators, except for the Volume criteria, all companies headquartered or with a major subsidiary in that region were investigated. The Top Bay Area Innovators list can be found on page 19. There are 11 companies that overlap with the Top 100 Global Innovators; meaning 31 percent of the leading US innovators and 11 percent of the world’s top innovators are located in the Bay Area.

Absentees:

The United Kingdom is absent from the list yet again this year. Innovation incentives introduced in the UK, such as Patent Box legislation, do not have enough legacy yet to have had an impact. Additionally, the UK spends much less on R&D as a percentage of Gross Domestic Product (GERD) than the Top 100 Global Innovator countries do. The UK’s GERDis 1.63 percent, whereas, for example, Japan’s is 3.47 percent.5 The region’s underuse of its patent system and lack of significant commercialization keep the UK from making the list once again.

China is also absent from the 2015 list. It joined the innovation-leader ranks in 2014, for the first time, via Huawei, however wasn’t able to replicate that performance to join again in 2015. A big factor contributing to China’s shortcoming is the fact that most of its innovation is domestic and therefore is not realized outside of its borders. In fact, only about six percent of China’s innovation activity is protected, and commercialized, outside of China. In order for China to see more organizations join this prestigious group, it will need to think more internationally and look to bring its inventions to market around the world. There are 27 companies that dropped from the prior year (see Table 1 on page 12), including AT&T, IBM, Siemens and Xerox. While these companies are still innovating at noteworthy levels, their respective scores across all of the metrics did not advance them to the Top 100. It’s expected that we will see them again in the future.

Patent Reform

There’s been some influential intellectual property legislation that is shaping how companies innovate, where they seek protection and when. Some of these initiatives include the America Invents Act and the Patent Trial & Appeal Board; the European unitary patent and unified patent court; the UK’s Patent Box legislation; and impactful court rulings, such as Alice 101 in the US. The landscape is ripe with reform as patent offices and filers grapple with how best to implement these changes given their goals and needs. Despite these changes, one thing remains certain: the patent system is vital to protecting innovation and to the economic wellbeing of organizations, nations and our world. OECD statistics confirm that nations with higher GDPs have similarly high patent filing rates (aka strong patent infrastructures), whereas the converse holds equally true. One way for developing nations to propel their economies forward is to invest in innovation and building a reliable intellectual property infrastructure.

Methodology

The Thomson Reuters Top 100 Global Innovator methodology analyzes patent and citation data across four main criteria:

  • volume,
  • success,
  • globalization and
  • influence

using Thomson Reuters solutions including Derwent World Patents Index (DWPI), Thomson Innovation and Derwent Patent Citations Index (PCI).

Volume

Volume is the first criteria. An organization must have at least 100 unique inventions protected by a granted patent over the most recent five year period to advance for further analysis. A unique invention is defined as one instance of a published application or granted patent for an idea for which protection is sought. In DWPI, these are called “basic” patents. DWPI provides access to 50 patentissuing authorities. Subsequent filings for the same invention are recorded as equivalents and collated into patent families which, for this analysis, were not included. Once an organization passes the volume stage gate, it is measured across the next three criteria: success, globalization and influence.

Success

The success metric covers the ratio of inventions described in published applications (those patents which are filed and publicly published by the patent office but not yet granted) to inventions protected with granted patents over the most recent five years. Not all patent applications pass through the examination process and are granted.

Globalization

Globalization has to do with the value an organization places on an invention by protecting it across the major world markets. The premise being that inventions protected in all four of the Thomson Reuters Quadrilateral Patent Index authorities: the Chinese Patent Office, the European Patent Office, the Japanese Patent Office and the United States Patent & Trademark Office, are deemed to be of significant value to the organization. A ratio is created of the inventions protected across the Quadrilateral Patent Index authorities versus the total volume for that period. Influence Finally,

Influence

influence is the downstream impact of an invention, measured by how often it is cited by other organizations. Via the Derwent Patent Citation Index, citations to an organization’s patents are counted over the most recent five years, excluding self citations. Scores for each of these areas are tallied and combined to produce the Top 100 Global Innovator list.

Top 100 Global Innovator list

3M Company USA Chemical 2011, 2012, 2013, 2014

Abbott Laboratories USA Pharmaceutical 2013, 2014

Advanced Micro Devices USA Semiconductor & Electronic Components 2011, 2012, 2013, 2014

Air Products USA Chemical 2013

Aisin Seiki Japan Automotive 2014

Alcatel-Lucent France Telecommunication & Equipment 2011, 2012, 2013, 2014

Alstom France Electrical Power

Amazon USA Media Internet Search & Navigation Systems

Analog Devices USA Semiconductor & Electronic Components 2011, 2012, 2013

Apple USA Telecommunication & Equipment 2011, 2012, 2013, 2014

Arkema France Chemical 2011, 2012, 2013, 2014

Avago Technologies (previously LSI) USA Semiconductor & Electronic Components 2011,2012, 2013, 2014

BASF Germany Chemical 2011, 2014

Bayer Germany Pharmaceutical 2011

Becton Dickinson USA Medical Devices

Blackberry Canada Telecommunication & Equipment 2013, 2014

Boehringer Ingelheim Germany Pharmaceutical

Boeing USA Aerospace 2011, 2012, 2013, 2014

Bridgestone Japan Automotive

Bristol-Myers Squibb USA Pharmaceutical 2011

Canon Japan Imaging 2011, 2012, 2013, 2014

Casio Computer Japan Computer Hardware 2014

Chevron USA Oil & Gas 2011, 2012, 2013

CNRS, The French National Center for Scientific Research France Scientific Research 2011, 2012, 2013, 2014

CEA–The French Alternative Energies and Atomic Energy Commission France Scientific Research 2011, 2012, 2013, 2014

Daikin Industries Japan Industrial 2011, 2014

Dow Chemical Company USA Chemical 2011, 2012, 2013, 2014

DuPont USA Chemical 2011, 2012, 2013, 2014

Emerson Electric USA Electrical Products 2012, 2013, 2014

Ericsson Sweden Telecommunication & Equipment 2011, 2012, 2013, 2014

Exxon Mobil USA Oil & Gas 2011, 2012, 2013

Fraunhofer Germany Scientific Research 2013, 2014

Freescale Semiconductor USA Semiconductor & Electronic Components 2013, 2014

Fujifilm Japan Imaging 2012, 2013, 2014

Fujitsu Japan Computer Hardware 2011, 2012, 2013, 2014

Furukawa Electric Japan Electrical Products 2014

General Electric USA Consumer Products 2011, 2012, 2013, 2014

Google (now Alphabet Inc.) USA Media Internet Search & Navigation Systems 2012, 2013, 2014

Hitachi Japan Computer Hardware 2011, 2012, 2013, 2014

Honda Motor Japan Automotive 2011, 2012, 2013, 2014

Honeywell International USA Electrical Products 2011, 2012, 2013, 2014

Idemitsu Kosan Japan Oil & Gas

IFP Energies Nouvelles France Scientific Research 2011, 2012, 2013, 2014

Intel USA Semiconductor & Electronic Components 2011, 2012, 2013, 2014

InterDigital USA Telecommunication & Equipment

Japan Science and Technology Agency (JST) Japan Scientific Research

Johnson & Johnson USA Pharmaceutical 2013, 2014

Johnson Controls USA Automotive

JTEKT Japan Automotive Kawasaki Heavy Industries Japan Industrial

Kobe Steel Japan Primary Metals 2014

Komatsu Japan Industrial 2014

Kyocera Japan Electrical Products 2014

LG Electronics S Korea Consumer Products 2011, 2012, 2013, 2014

Lockheed Martin USA Transportation Equipment 2012, 2013, 2014

LSIS S Korea Electrical Power 2011, 2012, 2013, 2014

Makita Corporation Japan Machinery

Marvell USA Semiconductor & Electronic Components 2012, 2013, 2014

MediaTek Taiwan Semiconductor & Electronic Components 2014

Medtronic USA Medical Devices 2014

Micron USA Semiconductor & Electronic Components 2012, 2013, 2014

Microsoft USA Computer Software 2011, 2012, 2013, 2014

Mitsubishi Electric Japan Electrical Products 2011, 2012, 2013, 2014

Mitsubishi Heavy Industries Japan Machinery 2012, 2013, 2014

Mitsui Chemicals Japan Chemical NEC Japan Computer Hardware 2011, 2012, 2013, 2014

Nike USA Consumer Products 2012, 2013, 2014

Nippon Steel & Sumitomo Metal Japan Primary Metals 2012, 2013, 2014

Nissan Motor Japan Automotive 2013, 2014

Nitto Denko Japan Chemical 2011, 2012, 2013, 2014

Novartis Switzerland Pharmaceutical 2014 2015

NTT Japan Telecommunication & Equipment 2011, 2012, 2013, 2014

Olympus Japan Healthcare Products 2011, 2012, 2013, 2014

Oracle USA Computer Software 2013, 2014

Panasonic Japan Consumer Products 2011, 2012, 2013, 2014

Philips Netherlands Electrical Products 2011, 2013, 2014

Qualcomm USA Semiconductor & Electronic Components 2011, 2012, 2013, 2014

Roche Switzerland Pharmaceutical 2011,2012,2013, 2014

Safran France Transportation Equipment 2013, 2014

Saint-Gobain France Industrial 2011, 2012, 2013, 2014

Samsung Electronics S Korea Semiconductor & Electronic Components 2011, 2012, 2013, 2014

Seagate USA Computer Hardware 2012, 2013, 2014

Seiko Epson Japan Imaging 2011, 2012, 2013, 2014

Shin-Etsu Chemical Japan Chemical 2011, 2012, 2013, 2014

Showa Denko Japan Chemical

Solvay Belgium Chemical 2012

Sony Japan Consumer Products 2011, 2012, 2013, 2014

Sumitomo Electric Japan Industrial 2011, 2013, 2014

Symantec USA Computer Software 2011, 2012, 2013, 2014

TE Connectivity Switzerland Semiconductor & Electronic Components 2011, 2012, 2013, 2014

Thales France Transportation Equipment 2012, 2013

Toray Japan Chemical

Toshiba Japan Computer Hardware 2011, 2012, 2013, 2014

Toyota Motor Japan Automotive 2011, 2012, 2013, 2014

Valeo France Automotive 2012, 2013

Xilinx USA Semiconductor & Electronic Components 2012, 2013, 2014

Yamaha Japan Consumer Products 2011, 2014

Yamaha Motor Japan Automotive

Yaskawa Electric Japan Industrial

Yazaki Japan Automotive

 

SOURCE

http://images.info.science.thomsonreuters.biz/Web/ThomsonReutersScience/%7Beb621c66-e238-4994-b1b5-9f5f9f897a75%7D_Thomson_Reuters_Top100_Global_Innovators_final.pdf

 

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FDA Drug Approvals in 2014: Drug Indication, Approval Date, Pharma, Agent Type and Drug Name

Curator: Stephen J Williams, PhD

Summary of 2014 FDA Approvals

Small Molecules versus Biologics

Below is a summary of the 2014 FDA Approvals with respect to their classification as small molecule or biologic. Data is taken from the FDA website https://www.centerwatch.com/drug-information/fda-approved-drugs/year/2014

In molecular biology and pharmacology, a small molecule is a low molecular weight (<900 daltons) organic compound that may help regulate a biological process, with a size on the order of 10−9 m. Most drugs are small molecules.

From the FDA Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include:
• vaccines
• blood and blood products for transfusion and/or manufacturing into other products
• allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
• human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
• gene therapies
• cellular therapies
• tests to screen potential blood donors for infectious agents such as HIV

CONCLUSIONS:

As shown there were 106 small molecules approved and 59 biologics approved in 2014.

  • Sales figures were or their anticipated market size as well as cost/benefit analysis.   This was mentioned as a very important requirement in drug development by JNJ. The pharmacy benefit managers, insurers and the pharma companies said they were talked early in the drug development process using cost/benefit analysis as a criteria of go/ no go decision point.
  • The insurers are very cost conscious as well as the PBMs. There are some classes that had mainly biologics and this was not oncology. In addition inflammation had lots more small molecule. The breakdown seems to be more meaningful than the totals and there are many reformulations and double indications.
Cardiology/Vascular Diseases (2 small molecules)
Drug Indication Pharma drug type Drug Name Approval Date
For the treatment of severe hypertriglyceridemia AstraZeneca small molecule Epanova (omega-3-carboxylic acids) May-14
For the reduction of thrombotic cardiovascular events Merck small molecule Zontivity (vorapaxar); May-14
Dermatology 7 small molecules 2 biologics
For the treatment of acute bacterial skin and skin structure infections Durata Therapeutics synthetic small molecule Dalvance (dalbavancin); May-14
For the treatment of onychomycosis of the toenails Valeant Pharmaceuticals synthetic small molecule Jublia (efinaconazole) 10% topical gel Jun-14
For the treatment of onychomycosis of the toenails Anacor synthetic small molecule Kerydin (tavaborole) Jul-14
For the treatment of unresectable or metastatic melanoma Merck biologic Keytruda (pembrolizumab) Sep-14
For the treatment of unresectable or metastatic melanoma Bristol-Myers Squibb biologic Opdivo (nivolumab) Dec-14
For the treatment of acute bacterial skin and skin structure infections The Medicines Company semisynthetic small molecule Orbactiv (oritavancin) Aug-14
For the treatment of moderate to severe plaque psoriasis Celgene small molecule Otezla (apremilast) Sep-14
For the treatment of acute bacterial skin and skin structure infections Cubist Pharmaceuticals small molecule Sivextro (tedizolid phosphate) Jun-14
For the treatment of inflammatory lesions of rosacea Galderma Labs semisynthetic small molecule Soolantra (ivermectin) cream, 1% Dec-14
Endocrinology 6 small molecules 4 biologics
For the treatment of diabetes mellitus Mannkind biologic Afrezza (insulin human) Inhalation Powder Jun-14
For the treatment of hypogonadism Endo Pharmaceuticals small molecule Aveed (testosterone undecanoate) injection Mar-14
For the treatment of type II diabetes Bristol-Myers Squibb small molecule Farxiga (dapagliflozin) Jan-14
For the treatment of type II diabetes Boehringer Ingelheim small molecule Jardiance (empagliflozin) Aug-14
For the treatment of deficiency or absence of endogenous testosterone Trimel Pharmaceuticals small molecule Natesto, (testosterone) nasal gel May-14
For the treatment of acromegaly Novartis biologic Signifor LAR (pasireotide) Dec-14
For the treatment of type II diabetes mellitus GlaxoSmithKline biologic Tanzeum (albiglutide) Apr-14
To improve glycemic control in type II diabetics Eli Lilly biologic Trulicity (dulaglutide) Sep-14
For males with a deficiency or absence of endogenous testosterone Upsher-Smith synthetic small molecule Vogelxo (testosterone) gel Jun-14
For glycemic control in adults with type II diabetes AstraZeneca small molecule Xigduo XR (dapagliflozin + metformin hydrochloride) Oct-14
Family Medicine 21 small molecules 11 biologics
For the treatment of diabetes mellitus Mannkind biologic Afrezza (insulin human) Inhalation Powder; Jun-14
For the treatment of hemophilia B Biogen Idec biologic Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] Mar-14
For the treatment of asthma, GlaxoSmithKline small molecule Arnuity Ellipta (fluticasone furoate inhalation powder) Aug-14
For the treatment of hypogonadism Endo Pharmaceuticals small molecule Aveed (testosterone undecanoate) injection; Mar-14
For the treatment of insomnia Merck small molecule Belsomra (suvorexant) Aug-14
For the maintenance treatment of opioid dependence BioDelivery Sciences small molecule Bunavail (buprenorphine and naloxone) Jun-14
For chronic weight management Takeda Pharmaceuticals U.S.A small molecule Contrave (naltrexone HCl and bupropion HCl) Sep-14
For the treatment of acute bacterial skin and skin structure infections Durata Therapeutics semisynthetic small molecule Dalvance (dalbavancin) May-14
For the management of mild, moderate or severe pain Hospira small molecule Dyloject (diclofenac sodium) Injection Dec-14
For the treatment of adults with ulcerative colitis and Crohn’s disease Millenium Pharmaceuticals biologic Entyvio (vedolizumab) May-14
For the treatment of type II diabetes Bristol-Myers Squibb small molecule Farxiga (dapagliflozin) Jan-14
For the treatment of grass pollen-induced allergic rhinitis Merck biologic Grastek (Timothy Grass Pollen Allergen Extract) Apr-14
For the treatment of type II diabetes Boehringer Ingelheim small molecule Jardiance (empagliflozin) Aug-14
For the treatment of onychomycosis of the toenails Anacor small molecule Kerydin (tavaborole) Jul-14
For the treatment of bacterial vaginosis Actavis, Inc semisynthetic small molecule Metronidazole 1.3% Vaginal Gel Apr-14
For the treatment of congenital or acquired generalized lipodystrophy Bristol-Myers Squibb biologic Myalept (metreleptin for injection) Feb-14
For the treatment of deficiency or absence of endogenous testosterone Trimel Pharmaceuticals semisynthetic small molecule Natesto, (testosterone) nasal gel; May-14
For the treatment of neurogenic orthostatic hypotension Chelsea Therapeutics synthetic small molecule Northera (droxidopa) Feb-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
For the treatment of moderate to severe plaque psoriasis Celgene small molecule Otezla (apremilast) Sep-14
For the treatment of relapsing multiple sclerosis Biogen Idec biologic Plegridy (peginterferon beta-1a) Aug-14
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome Upsher-Smith Laboratories small molecule Qudexy XR (topiramate) Mar-14
For the treatment of short ragweed pollen-induced allergic rhinitis Merck biologic Ragwitek (Short Ragweed Pollen Allergen Extract) Apr-14
For the treatment of acute uncomplicated influenza in adults Biocryst small molecule Rapivab (peramivir injection) Dec-14
For chronic weight management Novo Nordisk biologic Saxenda (liraglutide [rDNA origin] injection) Dec-14
For the treatment of type II diabetes mellitus GlaxoSmithKline biologic Tanzeum (albiglutide) Apr-14
For the management of severe chronic pain Purdue Pharma small molecule Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets Jul-14
For the treatment of acute pain Iroko Pharmaceuticals small molecule Tivorbex (indomethacin) Feb-14
To improve glycemic control in type II diabetics Eli Lilly biologic Trulicity (dulaglutide) Sep-14
For the management of acute pain Mallinckrodt Pharmaceuticals small molecule Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release Mar-14
For the treatment of acute otitis externa Alcon small molecule Xtoro (finafloxacin otic suspension) 0.3%; Dec-14
For the treatment of complicated intra-abdominal and urinary tract infections Cubist Pharmaceuticals small molecule Zerbaxa (ceftolozane + tazobactam) Dec-14
Gastroenterology 3 small molecules 2 biologics
For the prevention of chemotherapy-induced nausea and vomiting, Helsinn small molecule Akynzeo (netupitant and palonosetron) Oct-14
For the treatment of gastric cancer Eli Lilly biologic Cyramza (ramucirumab); Apr-14
For the treatment of adults with ulcerative colitis and Crohn’s disease, Millenium Pharmaceuticals biologic Entyvio (vedolizumab) May-14
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain AstraZeneca small molecule Movantik (naloxegol) Sep-14
For the treatment of complicated intra-abdominal and urinary tract infections Cubist Pharmaceuticals small molecule Zerbaxa (ceftolozane + tazobactam) Dec-14
Genetic Disease 2 small molecule 2 biologic
For the treatment of hemophilia B Biogen Idec biologic Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Mar-14
For the treatment of certain adult patients with Gaucher disease type 1 Genzyme small molecule Cerdelga (eliglustat) Aug-14
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome Upsher-Smith Laboratories small molecule Qudexy XR (topiramate) Mar-14
For the treatment of Mucopolysaccharidosis type IVA BioMarin biologic Vimizim (elosulfase alfa) Feb-14
Healthy Volunteers 1 biologic
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
Hematology 4 small molecule 6 biologics
For the treatment of hemophilia B Biogen Idec biologic Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Mar-14
For the treatment of relapsed or refractory peripheral T-cell lymphoma Spectrum Pharmaceuticals small molecule Beleodaq (belinostat) Jul-14
For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia Amgen biologic Blincyto (blinatumomab) Dec-14
For the treatment of hemophillia A Biogen Idec biologic Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ; Jun-14
For the treatment of chronic lymphocytic leukemia Pharmacyclics small molecule Imbruvica (ibrutinib) Feb-14
For the treatment of acquired hemophilia A Baxter biologic Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] Oct-14
For the treatment of hereditary angioedema Pharming Group biologic Ruconest (C1 esterase inhibitor [recombinant]) Jul-14
For the treatment of multicentric Castleman’s disease Janssen Biotech biologic Sylvant (siltuximab); Apr-14
For the reduction of thrombotic cardiovascular events Merck small molecule Zontivity (vorapaxar) May-14
For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma Gilead small molecule Zydelig (idelalisib) Jul-14
Immunology 3 small molecules 9 biologics
For the treatment of adults with ulcerative colitis and Crohn’s disease Millenium Pharmaceuticals biologic Entyvio (vedolizumab) May-14
For the treatment of grass pollen-induced allergic rhinitis Merck biologic Grastek (Timothy Grass Pollen Allergen Extract); Apr-14
For the treatment of Primary Immunodeficiency Baxter biologic HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Sep-14
For the treatment of chronic obstructive pulmonary disease GlaxoSmithKline small molecule Incruse Ellipta (umeclidinium inhalation powder); May-14
For the treatment of congenital or acquired generalized lipodystrophy Bristol-Myers Squibb biologic Myalept (metreleptin for injection) Feb-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
For the treatment of moderate to severe plaque psoriasis Celgene small molecule Otezla (apremilast) Sep-14
For the treatment of relapsing multiple sclerosis Biogen Idec biologic Plegridy (peginterferon beta-1a) Aug-14
For the treatment of short ragweed pollen-induced allergic rhinitis Merck biologic Ragwitek (Short Ragweed Pollen Allergen Extract) Apr-14
For the treatment of multicentric Castleman’s disease Janssen Biotech biologic Sylvant (siltuximab) Apr-14
For the treatment of HIV-1 ViiV HealthCare biologic Triumeq (abacavir, dolutegravir, and lamivudine); Aug-14
Infections and Infectious Diseases 13 small molecules 0 biologics
For the treatment of acute bacterial skin and skin structure infections Durata Therapeutics semisynthetic small molecule Dalvance (dalbavancin) May-14
For the treatment of hepatitis C, Gilead small molecule Harvoni (ledipasvir and sofosbuvir) Oct-14
For the treatment of visceral, cutaneous and mucosal leishmaniasis Knight Therapeutics small molecule Impavido (miltefosine) Mar-14
For the treatment of onychomycosis of the toenails Valeant Pharmaceuticals small molecule Jublia (efinaconazole) 10% topical gel Jun-14
For the treatment of onychomycosis of the toenails Anacor small molecule Kerydin (tavaborole) Jul-14
For the treatment of bacterial vaginosis Actavis, Inc small molecule Metronidazole 1.3% Vaginal Gel Apr-14
For the treatment of acute bacterial skin and skin structure infections The Medicines Company semisynthetic small molecule Orbactiv (oritavancin) Aug-14
For the treatment of acute uncomplicated influenza in adults Biocryst small molecule Rapivab (peramivir injection) Dec-14
For the treatment of acute bacterial skin and skin structure infections Cubist Pharmaceuticals small molecule Sivextro (tedizolid phosphate) Jun-14
For the treatment of HIV-1 ViiV HealthCare small molecule Triumeq (abacavir, dolutegravir, and lamivudine) Aug-14
; For the treatment of genotype 1 chronic hepatitis C virus Abbvie small molecule Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Dec-14
For the treatment of acute otitis externa Alcon small molecule Xtoro (finafloxacin otic suspension) 0.3% Dec-14
For the treatment of complicated intra-abdominal and urinary tract infections Cubist Pharmaceuticals small molecule Zerbaxa (ceftolozane + tazobactam) Dec-14
Internal Medicine 1 small molecule
For the treatment of certain adult patients with Gaucher disease type 1, Genzyme small molecule Cerdelga (eliglustat); Aug-14
Musculoskeletal 2 small molecule 3 biologic
For the treatment of relapsing multiple sclerosis Genzyme biologic Lemtrada (alemtuzumab) Nov-14
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
For the treatment of relapsing multiple sclerosis Biogen Idec biologic Plegridy (peginterferon beta-1a) Aug-14
For the management of severe chronic pain Purdue Pharma small molecule Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets Jul-14
For the treatment of Mucopolysaccharidosis type IVA BioMarin biologic Vimizim (elosulfase alfa) Feb-14
Nephrology 3 small molecule
For the treatment of hyperphosphatemia in patients with chronic kidney disease Keryx Biopharma small molecule Auryxia (Ferric citrate) Sep-14
For the treatment of hepatitis C Gilead small molecule Harvoni (ledipasvir and sofosbuvir) Oct-14
For the treatment of genotype 1 chronic hepatitis C virus Abbvie small molecule Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets Dec-14
Neurology 10 small molecules 2 biologics
For the treatment of insomnia Merck small molecule Belsomra (suvorexant) Aug-14
For the management of mild, moderate or severe pain Hospira small molecule Dyloject (diclofenac sodium) Injection Dec-14
For the treatment of non-24-hour sleep-wake disorder in the totally blind Vanda Pharmaceuticals small molecule Hetlioz (tasimelteon) Jan-14
For the treatment of relapsing multiple sclerosis Genzyme biologic Lemtrada (alemtuzumab) Nov-14
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain AstraZeneca small molecule Movantik (naloxegol) Sep-14
For the treatment of moderate to severe dementia of the Alzheimer’s type Forest Laboratories small molecule Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride) Dec-14
For the treatment of neurogenic orthostatic hypotension Chelsea Therapeutics small molecule Northera (droxidopa) Feb-14
For the treatment of relapsing multiple sclerosis Biogen IDEC biologic Plegridy (peginterferon beta-1a) Aug-14
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome Upsher-Smith Laboratories small molecule Qudexy XR (topiramate) Mar-14
For the management of severe chronic pain Purdue Pharma small molecule Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets Jul-14
For the treatment of acute pain Iroko Pharmaceuticals small molecule Tivorbex (indomethacin) Feb-14
For the management of acute pain Mallinckrodt Pharmaceuticals small molecule Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release Mar-14
Nutrition and Weight Loss 2 small molecule 3 biologics
For chronic weight management Takeda Pharmaceuticals U.S.A small molecule Contrave (naltrexone HCl and bupropion HCl) Sep-14
For the treatment of type II diabetes Boehringer Ingelheim small molecule Jardiance (empagliflozin) Aug-14
For chronic weight management Novo Nordisk biologic Saxenda (liraglutide [rDNA origin] injection) Dec-14
For the treatment of type II diabetes mellitus GlaxoSmithKline biologic Tanzeum (albiglutide) Apr-14
To improve glycemic control in type II diabetics Eli Lilly biologic Trulicity (dulaglutide) Sep-14
Obstetrics/Gynecology (Women’s Health) 2 small molecule
For the treatment of previously treated BRCA mutated advanced ovarian cancer, AstraZeneca small molecule Lynparza (olaparib) Dec-14
For the treatment of bacterial vaginosis Actavis, Inc small molecule Metronidazole 1.3% Vaginal Gel Apr-14
Oncology 6 small molecules 4 biologics
For the prevention of chemotherapy-induced nausea and vomiting Helsinn small molecule Akynzeo (netupitant and palonosetron) Oct-14
For the treatment of relapsed or refractory peripheral T-cell lymphoma Spectrum Pharmaceuticals small molecule Beleodaq (belinostat) Jul-14
For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia Amgen biologic Blincyto (blinatumomab) Dec-14
For the treatment of gastric cancer Eli Lilly biologic Cyramza (ramucirumab) Apr-14
For the treatment of chronic lymphocytic leukemia Pharmacyclics small molecule Imbruvica (ibrutinib) Feb-14
For the treatment of unresectable or metastatic melanoma Merck biologic Keytruda (pembrolizumab) Sep-14
For the treatment of previously treated BRCA mutated advanced ovarian cancer AstraZeneca small molecule Lynparza (olaparib) Dec-14
For the treatment of unresectable or metastatic melanoma Bristol-Myers Squibb biologic Opdivo (nivolumab) Dec-15
For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma Gilead small molecule Zydelig (idelalisib) Jul-14
For the treatment of ALK+ metastatic non-small cell lung cancer Novartis small molecule Zykadia (ceritinib) Apr-14
Ophthalmology 2 small molecule 1 biologic
For the treatment of non-24-hour sleep-wake disorder in the totally blind Vanda Pharmaceuticals small molecule Hetlioz (tasimelteon) Jan-14
For use during eye surgery to prevent intraoperative miosis and reduce post-operative pain Omeros small molecule Omidria (phenylephrine and ketorolac injection) Jun-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
Orthopedics/Orthopedic Surgery 1 small molecule
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
Otolaryngology (Ear, Nose, Throat) 1 small molecule 3 biologic
For the treatment of grass pollen-induced allergic rhinitis Merck biologic Grastek (Timothy Grass Pollen Allergen Extract) Apr-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) 14-Apr
For the treatment of short ragweed pollen-induced allergic rhinitis Merck biologic Ragwitek (Short Ragweed Pollen Allergen Extract) Apr-14
For the treatment of acute otitis externa Alcon small molecule Xtoro (finafloxacin otic suspension) 0.3% Dec-14
Pediatrics/Neonatology 2 small molecule 2 biologics
; For the treatment of hemophilia B Biogen Idec biologic Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] Mar-14
For the treatment of asthma GlaxoSmithKline small molecule Arnuity Ellipta (fluticasone furoate inhalation powder) Aug-14
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome Upsher-Smith Laboratories small molecule Qudexy XR (topiramate) Mar-14
For the treatment of Mucopolysaccharidosis type IVA BioMarin biologic Vimizim (elosulfase alfa) Feb-14
Pharmacology/Toxicology 3 small molecule 1 biologic
For the prevention of chemotherapy-induced nausea and vomiting Helsinn small molecule Akynzeo (netupitant and palonosetron) Oct-14
For the maintenance treatment of opioid dependence BioDelivery Sciences small molecule Bunavail (buprenorphine and naloxone) Jun-14
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain AstraZeneca small molecule Movantik (naloxegol) Sep-14
For the treatment of congenital or acquired generalized lipodystrophy Bristol-Myers Squibb biologic Myalept (metreleptin for injection) Feb-14
Psychiatry/Psychology 1 small molecule
For the maintenance treatment of opioid dependence BioDelivery Sciences small molecule Bunavail (buprenorphine and naloxone) Jun-14
Pulmonary/Respiratory Diseases 6 small molecule 3 biologic
For the treatment of asthma GlaxoSmithKline small molecule Arnuity Ellipta (fluticasone furoate inhalation powder) Aug-14
For the treatment of idiopathic pulmonary fibrosis InterMune small molecule Esbriet (pirfenidone) Oct-14
For the treatment of grass pollen-induced allergic rhinitis Merck biologic Grastek (Timothy Grass Pollen Allergen Extract) Apr-14
For the treatment of chronic obstructive pulmonary disease GlaxoSmithKline small molecule Incruse Ellipta (umeclidinium inhalation powder) May-14
For the treatment of idiopathic pulmonary fibrosis Boehringer Ingelheim small molecule Ofev (nintedanib) Oct-14
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis Greer Labs biologic Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) Apr-14
For the treatment of short ragweed pollen-induced allergic rhinitis Merck biologic Ragwitek (Short Ragweed Pollen Allergen Extract) Apr-14
For the treatment of chronic obstructive pulmonary disease Boehringer Ingelheim small molecule Striverdi Respimat (olodaterol) Jul-14
For the treatment of ALK+ metastatic non-small cell lung cancer Novartis small molecule Zykadia (ceritinib) Apr-14
Rheumatology 1 small molecule
For the treatment of adults with active psoriatic arthritis Celgene small molecule Otezla (apremilast) Mar-14
Sleep 1 small molecule
For the treatment of non-24-hour sleep-wake disorder in the totally blind Vanda Pharmaceuticals small molecule Hetlioz (tasimelteon) Jan-14
Urology 1 small molecule
For the treatment of complicated intra-abdominal and urinary tract infections Cubist Pharmaceuticals small molecule Zerbaxa (ceftolozane + tazobactam) Dec-14

 

SOURCE

https://www.centerwatch.com/drug-information/fda-approved-drugs/year/2014

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Hyper Innovations in Pharma 2015

Reporter : Gérard Henri Loiseau, ESQ

 

Bio Pharma 2015: Soaring to New Heights

Pharmaceutical Manufacturing, Steven E. Kuehn, Nov 10 2015

 

Growth Statistics

Bio Pharma is an “evolving accelerating science” (John J. Castellani, PhRMA).

R&D spending which was

$2 billion in 1980 is estimated

$51,6 billion in 2013,

it represents 1 in every 5 dollars spent on domestic R&D in the US.

90% is spent on Clinical Trials,

6199 Clinical Trials in 2013.

>$2.6 billion is the cost estimated to develop and bring a new drug on the market

In 2014 FDA approved 44 drugs, so a good year both for NCEs and NBEs, Forbes Magazine, Bernard Munos

 

Hyper Innovation

According to Mr. Munos the main players are

  • Novartis
  • J&J
  • GSK
  • AstraZeneca

Deloitte’s report “Advanced Biopharmaceutical Manufacturing: An Evolution, Underway” identifies several targets:

  • Continuous manufacturing
  • New process analytical tools
  • Single-use systems
  • Alternative downstream processing technique

Amgen vice president Jim Thomas points out:

  • A more competitive business environment
  • A more challenging reimbursement environment
  • A more conservative regulatory environment

There is a necessity for the highest quality manufacturing environments.

“Design the molecule. Design the Process. Design the plant,” is his credo, which generates its “transforming Biotechnology Manufacturing” initiative

  • Trends in analytical tools will support operational excellence
  • Bio therapeutics manufacturing will be centered on cell-based systems
  • A greater productivity within a smaller footprint will be allowed
  • Flexibility is the goal thanks to standardized processes across all stages

These are the keys to operational excellence.

 

Process Analytical Technology (PAT)

FDA’s perspective is that ”quality cannot be tested into products; it should be built-in or should be by design”

Deloitte estimates that PAT can promote fewer recalls and less scrap inventory.

 

Towards a continuous future?

A recognized potential for small molecule drugs, and some companies have developed this continuous technology.

Deloitte’s study says that FDA views continuous manufacturing as consistent with the FDA’s quality by design efforts.

How to define a batch in case of product recall is a true challenge, which means that new measurements methods are needed.

Continuous manufacturing opposed to efficient, well-planned and engineered facilities, which is the vision developed by Amgen and others innovative players.

SOURCE

http://www.pharmamanufacturing.com/articles/2015/bio-pharma-2015/

 

 

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Pharmacy International Conference

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

 

3rd Nirma Institute of Pharmacy International Conference
NIPiCON – 2016
January 21 – 23, 2016 ………….http://www.nipicon.org/.

Anthony Melvin Crasto   https://www.facebook.com/groups/worlddrugtracker/permalink/1170816792946389/

The pharmaceutical sciences is a dynamic and interdisciplinary field that combines a broad range of scientific disciplines that are critical to the discovery and development of new drugs and therapies. Over the years, pharmaceutical scientists have been instrumental in discovering and developing innovative drugs that save people’s lives and improve the quality of life.

NIPiCON was initiated in a year 2013 to offer a common platform for academicians, researchers, industrialists, clinical practitioners and young budding pharmacists to share their ideas and research work and finally emerge with new concepts, innovations and novel strategies for various challenges in the pharmaceutical field.

The 3 International Conference, NIPiCON 2016 aims to provide a knowledge sharing experience in the area of “Global Challenges in Drug Discovery, Development and Regulatory Affairs”.

Pharmaceutical innovation is a complex creative process that harnesses the application of knowledge and creativity for discovering, developing and bringing to clinical use, new medicinal products that extend or improve the lives of patients.A successful pharmaceutical R&D process is one that minimizes the time and cost needed to bring a compound from the scientific ‘idea’, through discovery and clinical development, to final regulatory approval and delivery to the patient. This conference will provide an open forum for the academicians, researchers, clinicians and professionals of pharmaceutical industry to enrich their knowledge in the area of drug discovery, development and its regulatory requirements.

The conference features plenary sessions which will be delivered by eminent national and international speakers from different disciplines of pharmaceutical field. In addition, there will be invited lectures and sessions delivered by distinguished and young researchers in their respective fields during parallel technical sessions. The conference willalso provide the opportunity to scientists and research scholars from various organizations to put forth their innovative ideas and research findings by means of deliberations, discussions and poster presentations.

 

NIPiCON was initiated in a year 2013 to offer a common platform for academicians, researchers, industrialists, clinical practitioners and young budding pharmacists to share their ideas and research work and finally emerge with new concepts, innovations and novel strategies for various challenges in the pharmaceutical field.

The 3 International Conference, NIPiCON 2016 aims to provide a knowledge sharing experience in the area of “Global Challenges in Drug Discovery, Development and Regulatory Affairs”.

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