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The Top 10 Drug launches of 2017 following FDA green light to 22 drugs in 2016

Reporter: Aviva Lev-Ari, PhD, RN

 

After an unusually slow year for new drug approvals—the FDA green lighted just 22 meds in 2016—it remains to be seen whether drugmakers can do much better in 2017. One thing’s for sure, though: No matter what total the industry tallies up this year, the crop will bring some would-be blockbusters and market disrupters.

At the top of the list, according to EP Vantage’s 2017 preview, which ranks the year’s rollouts by 2022 sales, is Ocrevus (ocrelizumab), the Roche multiple sclerosis drug that’s promising to shake things up in more ways than one. In clinical trials, the candidate bested Merck KGaA’s standard therapy Rebif, and it’s also gone where no other MS drug has gone before, posting positive data in patients with the primary progressive form of the disease. Those data will put the heat on other meds—and invite payers to pile pressure onto the segment, too.

The top 10 drug launches of 2017

The top 10 drug launches of 2017

SOURCE

http://www.fiercepharma.com/special-report/top-10-drug-launches-2017

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What's The Big Data?

cbinsights_race_for_aiCB Insights:

Nearly 140 private companies working to advance artificial intelligence technologies have been acquired since 2011, with over 40 acquisitions taking place in 2016 alone (as of 10/7/2016). Corporate giants like Google, IBM, Yahoo, Intel, Apple and Salesforce, are competing in the race to acquire private AI companies, with Samsung emerging as a new entrant this month with its acquisition of startup Viv Labs, which is developing a Siri-like AI assistant.

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BioGENEius GenePool Competition – the “nature and nurture” SHARK TANK®

at Bio International Convention, June 19-22, 2017 | San Diego, CA

Reporter: Aviva Lev-Ari, PhD, RN

http://www.convention.bio.org/2017/

 

AGENDA

BIO 2017 Schedule

Arrive Sunday and Stay Until Friday!

Take full advantage of BIO 2017! Partnering and Education kick off on Monday afternoon, and the BIO Exhibition opens Tuesday morning following our first keynote.

2017 view in mybio button

*Schedule as of June 13, 2017 and subject to change.


Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

Reporter: Aviva Lev-Ari, PhD, RN

 

  • by Nicole Lou, Reporter, MedPage Today/CRTonline.org June 21, 2017

Action Points

  • Off-label transcatheter aortic valve replacement (TAVR) was associated with higher in-hospital, 30-day, and 1-year mortality rates compared with on-label TAVR use, but after adjustment, 1-year mortality was similar in the two groups.
  • Note that approximately one in 10 TAVR patients in the United States have received the procedure for an off-label indication.

Three-quarters of off-label indications were deemed so due to presence of severe aortic or mitral regurgitation or both; one-fifth were off-label because of bicuspid valves.

Successful device implantation was slightly less likely with off-label TAVR (92.9% versus 93.0%, P=0.02). But in-hospital outcomes were the bigger issue for off- versus on-label TAVR:

  • Mortality (6.3% versus 4.7%, P<0.001)
  • Cardiac arrest (6.6% versus 4.8%, P<0.001)
  • Transient ischemic attack (0.5% versus 0.2%, P=0.007)
  • Moderate-to-severe perivalvular leaks (12.4% versus 7.6%, P<0.001)

Mortality was most likely for patients with severe mitral regurgitation as the only off-label indication for TAVR. The authors suggested this is owing to secondary mitral regurgitation caused by left ventricular dilatation.

SOURCE

1 in 10 TAVR Procedures Done Off-Label Despite early risks vs on-label use, ‘acceptable results’ cited from registry

https://www.medpagetoday.com/Cardiology/CHF/66173?xid=nl_mpt_DHE_2017-06-22&eun=g99985d0r&pos=1

Other related TAVR articles published in this Open Access Online Scientific Journal included the following 64 articles:

https://pharmaceuticalintelligence.com/?s=TAVR

 

 


The BioPharma Industry’s Unrealized Wealth of Data, by Ben Szekely, Vice President, Cambridge Semantics

Reporter: Aviva Lev-Ari, PhD, RN

 

 

The BioPharma Industry’s Unrealized Wealth of Data

by Ben Szekely, Vice President of Solutions and Pre-sales, Cambridge Semantics

 

Solving the great medical challenges of our time reside within patient data. Clinical trial data, real-world evidence, patient feedback, genetic data, wearables data and adverse event reports contain signals to target medicines at the right patient populations, improve overall safety, and uncover the next blockbuster therapy for unmet medical needs.

However, data sources are large, diverse, multi-structured, messy and highly regulated presenting numerous challenges. As result, extracting value from data are slow to come and require manual work or long-poll dependencies on IT and Data Science teams.

Fortunately, there are new ways being adopted to take better advantage of the ever-growing volumes of patient data.  Called ‘Smart’ Patient Data Lakes (SPDL), these tools create an Enterprise Knowledge Graph built upon foundational and open Semantic Web technology standards, providing rich descriptions of data and flexibility end-to-end.  With the SPDL, biopharma researchers can:

  • Quickly on-board new data without requiring up-front modeling or mapping, ingesting data from any source versus months or weeks of preparation
  • Dynamically map and prepare data at analytics time
  • Horizontally scale in cloud or on-prem infrastructure to 100’s of nodes – allowing billions of facts to be analyzed, queried and explored in real-time   

The world’s BioPharma and research institutions are sitting on a wealth of highly differentiating and life-saving data and should begin to realize its value via Smart Patient Data Lakes (SPDL).

 

 

CONTACT: Nadia Haidar

Global Results Communications ∙ 949-278-7328 ∙ nhaidar@globalresultspr.com

 


Personalized Medicine been Positively affected by FDA Drug Approval Record

Reporter: Aviva Lev-Ari, PhD, RN

FDA to Clear Path for Drugs Aimed at Cancer-Causing Genes

By Anna Edney and Michelle Cortez

June 20, 2017, 10:41 AM EDT June 20, 2017, 3:02 PM EDT

https://www.bloomberg.com/news/articles/2017-06-20/fda-moves-to-clear-path-for-drugs-aimed-at-cancer-causing-genes

 

 

‘Landmark FDA approval bolsters personalized medicine’

PMC – An Op-Ed in STAT News

by Edward Abrahams

June 21, 2017

Our understanding of cancer has been morphing from a tissue-specific disease — think lung cancer or breast cancer — to a disease characterized more by specific genes or biomarkers than by location. A recent FDA decision underscores that transition and further opens the door to personalized medicine.

Two years ago, the director of the FDA’s Office of Hematology and Oncology Products told the Associated Press that there was no precedent for the agency to approve a drug aimed at treating tumors that generate a specific biomarker no matter where the cancer is in the body. Such a drug had long been seen as the epitome of personalized medicine. But with the rapid pace of progress in the field, director Dr. Richard Pazdur said, such an approval could one day be possible.

That day has arrived.

In a milestone decision for personalized medicine, the FDA approved Merck’s pembrolizumab (Keytruda) late last month for the treatment of tumors that express one of two biomarkers regardless of where in the body the tumors are located. The decision marks the first time FDA has approved a cancer drug for an indication based on the expression of specific biomarkers rather than the tumor’s location in the body.

Keytruda is designed to help the immune system recognize and destroy cancer cells by targeting a specific cellular pathway. The FDA notes that the two biomarkers — microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) — affect the proper repair of DNA inside cells.

The approval represents an important first for the field of personalized medicine, which anticipates an era in which physicians use molecular tests to classify different forms of cancer based on the biomarkers they express, then choose the right treatment for it. In contrast to standard cancer treatments, which are given to large populations of patients even though only a fraction of them will benefit, Keytruda was approved only for the 4 percent of cancer patients whose tumors exhibit MSI-H or dMMR mutations. That may help the health system save money by focusing resources only on patients who are likely to benefit from Keytruda.

Such “personalized” strategies now dominate the landscape for cancer drug development. Personalized medicines account for nearly 1 of every 4 FDA approvals from 2014 to 2016, and the Tufts Center for the Study of Drug Development estimates that more than 70 percent of cancer drugs now in development are personalized medicines.

While this is encouraging, the U.S. research, regulatory, and reimbursement systems aren’t aligned to stimulate the development of personalized medicines, and may even deter progress.

The Trump administration’s proposal to cut biomedical research spending at the National Institutes of Health by 18 percent in fiscal year 2018, for example, would undermine its ability to fund more studies like the National Cancer Institute’s Molecular Analysis for Therapy Choice (MATCH) trial, which is designed to test targeted therapies across tumor types.

While the regulatory landscape for these targeted medicines is clear, the path to market for the molecular tests that do the targeting is not. That uncertainty continues to stifle investment in the innovative tests that make personalized medicine possible. The result is a clinical environment in which the patients who could benefit from personalized medicines are often never identified because the necessary tests aren’t available to them.

Finally, increasing pressure on pharmaceutical and diagnostic companies to decrease prices without considering their value to individual patients and the health system could also deter investment in innovative solutions that address unmet medical needs, particularly for smaller patient populations.

Confronted with unprecedented opportunities in personalized medicine, policymakers would do well to ensure that our research, regulatory, and reimbursement systems facilitate the development of and access to these promising new therapies. Only then can we ensure that Keytruda’s groundbreaking approval represents the beginning of a new era that promises better health and a more cost-effective health system.

Edward Abrahams, Ph.D., is president of the Personalized Medicine Coalition.

 

 

 

SOURCE

From: <cwells@personalizedmedicinecoalition.org>

Date: Wednesday, June 21, 2017 at 1:38 PM

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

Subject: PMC in STAT: “Landmark FDA Approval Bolsters Personalized Medicine”


e-Scientific Publishing: The Competitive Advantage of a Powerhouse for Curation of Scientific Findings and Methodology Development for e-Scientific Publishing – LPBI Group, A Case in Point

Author and Editor-in-Chief: Aviva Lev-Ari, PhD RN

 

In this article I cover the Business Synopsis and the following Four Parts of the Business:

Part 1: The Vision

Part 2: Scientific Journal – Site Statistics on 6/20/2017

Part 3: BioMed e-Series

Part 4: Real Time Coverage of 50 Biotech Top Conferences

 

 

Synopsis

  • Interdisciplinary Journal covers interfaces of six domains

(Life sciences, Pharmaceuticals, Medicine, Healthcare Policy, Biotech Intelligence and Medical Devices)

  • Curations of Scientific Findings of peer reviewed articles in top three journals in each of the Six domain
  • Curations written on a multi-Authoring platform by MDs, MD/PhDs, PharmD and PhDs, all 15 years after graduation of the advanced degree program, and each has a publication list before joined my team – they write clinical and medical interpretations of the scientific frontier as evidenced in the Scientific Finding section of published articles in Cell, Nature, Science, NEJM, other top journals in these six domains.
  • Volume, ~5,150 Scientific articles, +500 categories of Research defining the Journal Ontology, 9,500 tags, 7,300, scientific comment on the articles submitted and exchange recorded between the Scientific community and our Team members
  • top two articles >25,000 eReaders
  • Clicks on two Top Authors: >551,000
  • from NIH +3,700 hits
  • 2250 Journal subscribers by e-mail
  • +6,200 Biotech Executive following up on LinkedIn
  • BioMed e-Series: 16 volumes, 9 on Amazon.com

https://www.amazon.com/s/ref=dp_byline_sr_ebooks_9?ie=UTF8&text=Aviva+Lev-Ari&search-alias=digital-text&field-author=Aviva+Lev-Ari&sort=relevancerank

  • In House Developed Methodology for Real Time Press Coverage of Biotech Top International conferences – selective  topics covered at conferences lead to NEW Curations in the Journal

 

Part 1: The Vision

https://pharmaceuticalintelligence.com/vision/

Part 2: Scientific Journal – Site Statistics on 6/20/2017

https://pharmaceuticalintelligence.com/

1.3 Million eReaders on WordPress.com in 6/2017

Best ever daily views

2,508 views

Our DOMAINS in Scientific Media

I.  Pharmaceutical: Biologics, Small Molecules, Diagnostics

II.  Life Sciences: Genomics and Cancer Biology

III.  Patient-centered Medicine: Focus on #1: Cardiovascular, #2: Cancer, #3: Physiology: Metabolomics, Immunology

IV. Biomedicine, BioTech, and MedTech (Medical Devices)

V.  HealthCare: Patient-centered Medicine and Personalized/Precision Medicine

 

All time

1,236,276 eReaders & 1,239,246 on 6/25/2017

2,243 Subscribers by e-mail

7,270 Scientific comments

5,126 Scientific Articles

561 Categories of Research – Journal Ontology

9,591 Tags

Followers (includes Publicize)

790 Twitter

699 Facebook

67 Tumblr

Top Posts >3,000 Views for all days ending 2017-06-20 (Summarized)

Clicks for all days ending 2017-06-20 (Summarized)

Referrers All Time >1,000 from one Source

Referrer Views
Search Engines   641,404
linkedin.com   24,641
Facebook 7,042
lnkd.in 6,285
scholar.google.com 3,747
Twitter 3,134
android-app 1,100
investorshub.advfn.com 1,062

Content

Top Authors for all days ending 2017-06-20 (Summarized)

Our Team Authors Author Views
Aviva Lev-Ari, PhD RN 322,313
Larry H Bernstein, MD, FCAP 226,768
Tilda Barliya, PhD 48,229
Stephen J Williams, PhD 40,966
Dror Nir, PhD 24,975
Sudipta Saha, PhD 22,713
Ritu Saxena, PhD 15,448
Demet Sag, Ph.D., CRA, GCP 13,315
Aviral Vatsa, PhD 8,132
Ziv Raviv, PhD 7,649
zs22 3,874
Gail S Thornton, MA, PhD(c) 3,535
Anamika Sarkar, PhD 3,280
Danut Dragoi, PhD 2,746
Prabodh Kandala, PhD 2,118
Alan F. Kaul, PharmD., MS, MBA, FCCP 2,065
Aashir Awan, PhD 1,865
Justin D Pearlman, MD, PhD, FACC 1,467
Meg Baker, PhD 1,447
Irina Robu, PhD 969
S. Chakrabarti, Ph.D. 641
Ed Kislauskis, PhD 585
Howard Donohue, PhD 537
David Orchard-Webb, PhD 465
Evelina Cohn, PhD 371
Stuart Cantor, PhD 368
Marzan Khan, BSc – Research Associate 355
apreconasia, DVM 342
Jukka Karjalainen, MD, PhD 229
anayou1, PhD 224
Sreedhar Tirunagari, PhD 158
gerag2015, ESQ 112
Larry Mulligan , PhD 91
Kelly Perlman, BSc (c) Research Associate 66
Rosalind Codrington, PhD 32

Graphics for 4/2012 to 3/10/2015

Part 3: BioMed e-Series

  • The Methodology of Co-Curation


Image Source: Original Graphic Conceptualization of the Co-Curation Concept by Stephen J Williams, 3/10/2015

Titles in the BioMed e-Series: 16 e-Books in Medicine and Life Sciences

https://www.amazon.com/s/ref=dp_byline_sr_ebooks_9?ie=UTF8&text=Aviva+Lev-Ari&search-alias=digital-text&field-author=Aviva+Lev-Ari&sort=relevancerank

9 results for Kindle Store : “Aviva Lev-Ari”

  • Product Details

    Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics

    Nov 28, 2015 | Kindle eBook

    by Justin D. Pearlman MD ME PhD MA FACC and Stephen J. Williams PhD
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC
  • Product Details

    Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy and Nanotechnology in Therapy Delivery (Series C Book 2)

    May 13, 2017 | Kindle eBook

    by Larry H. Bernstein and Demet Sag
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC
  • Product Details

    Perspectives on Nitric Oxide in Disease Mechanisms (Biomed e-Books Book 1)

    Jun 20, 2013 | Kindle eBook

    by Margaret Baker PhD and Aviva Lev-Ari PhD RN
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC
  • Product Details

    Cancer Biology and Genomics for Disease Diagnosis (Series C: e-Books on Cancer & Oncology Book 1)

    Aug 10, 2015 | Kindle eBook

    by Larry H Bernstein MD FCAP and Prabodh Kumar Kandala PhD
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC
  • Product Details

    Genomics Orientations for Personalized Medicine (Frontiers in Genomics Research Book 1)

    Nov 22, 2015 | Kindle eBook

    by Sudipta Saha PhD and Ritu Saxena PhD
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC
  • Product Details

    Metabolic Genomics & Pharmaceutics (BioMedicine – Metabolomics, Immunology, Infectious Diseases Book 1)

    Jul 21, 2015 | Kindle eBook

    by Larry H. Bernstein MD FCAP and Prabodah Kandala PhD
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC
  • Product Details

    Milestones in Physiology: Discoveries in Medicine, Genomics and Therapeutics (Series E: Patient-Centered Medicine Book 3)

    Dec 26, 2015 | Kindle eBook

    by Larry H. Bernstein MD FACP and Aviva Lev-Ari PhD RN
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC
  • Product Details

    Regenerative and Translational Medicine: The Therapeutic Promise for Cardiovascular Diseases

    Dec 26, 2015 | Kindle eBook

    by Justin D. Pearlman MD ME PhD MA FACC and Ritu Saxena PhD
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC
  • Product Details

    Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation: The Art of Scientific & Medical Curation

    Nov 29, 2015 | Kindle eBook

    by Larry H. Bernstein MD FCAP and Aviva Lev-Ari PhD RN
    Subscribers read for free.
    Auto-delivered wirelessly
    Sold by: Amazon Digital Services LLC

Forthcoming e-Books in 2017 & 2018

https://pharmaceuticalintelligence.com/biomed-e-books/

 

 

Analytics for the BioMed e-Series based on:

  1. Number of Articles per Volume
  2. E-Readers per Article
  3. Volume e-Impression since DATE of Publication [Summation of 2, above for all articles inside each Volume, before it was inside an e-Book and after the DATE of publication [Product details per Volume in attachment – Five e-Series – several Volumes per e-Series]

PENDING

 

Part 4: Real Time Coverage of 50 Biotech Top Conferences

https://pharmaceuticalintelligence.com/press-coverage/

 

Other related articles to e-Scientific Publishing include the following: