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Archive for the ‘Pharmaceutical Industry Competitive Intelligence’ Category


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

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/3/2017

Fears over a medical gold rush in cancer drug race

With almost 800 trials under way observers warn scientific rigour is being compromised
“There is some pushback,” said Jill O’Donnell-Tormey, chief executive of the Cancer Research Institute. “Are there too many trials? Are we just throwing spaghetti at the wall, by taking compound ‘X’ or ‘Y’ and adding it together just to see what happens?”  Most scientists say checkpoints do not need to be replaced with something else, but rather augmented with new drugs that can further cajole the immune system into fighting cancer. This has led to an unprecedented amount of clinical research sponsored by drugmakers, which are combining checkpoints with other medicines to try to find a magic bullet to treat cancer.  The sheer number of studies has sparked fears that some companies are engaging in a medical gold rush, hoping to chance upon the right cocktail without doing the appropriate scientific groundwork.

https://www.ft.com/content/00092dde-578c-11e7-9fed-c19e2700005f?mhq5j=e3

 

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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Drug Price-increase Caps by Big Pharma

Reporter: Aviva Lev-Ari, PhD, RN

 

Sanofi’s new pricing promises:

  • The company committed not to increase the list price of existing drugs in the US by more than the rate of healthcare inflation, as measured by the Centers for Medicare and Medicaid Services’ National Health Expenditure. In 2015, the NHE rate is expected to be 5.4%, and it’s expected to increase by 5.6% each year on average through 2025.
  • Sanofi also plans to launch new drugs with included rationale regarding how it set the price.
  • The company also decided to release its average list and net price increases going forward. It’s something other companies have been doing as well.

Sanofi’s list price increased 4% in 2016, but after factoring in discounts and rebates paid to pharma middlemen, the net price decreased by 2.1%.

Allergan committed to only single-digit drug-price increases (a line it closely hugged for some drugs), since September 2016.

Novo Nordisk, another diabetes drugmaker, also committed to capping increases to single digits.

SOURCE

http://www.businessinsider.com/sanofi-commits-to-not-raise-drug-prices-above-health-inflation-2017-5

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Tax Cuts Potential Impact on Overseas (ex-US accounts) by Top 9 Biopharma holdings of $133B in M&A 

Reporter: Aviva Lev-Ari, PhD, RN

 

Amgen has been sheltering a cache of about $35 billion in ex-US accounts, according to some numbers that EvercoreISI’s Umer Raffat put together as he began assessing the impact tax reform could have on the top players in overseas holdings.

 

SOURCE

The top 9 overseas accounts in biopharma hold $133B in M&A firepower by john carroll April 27, 2017 06:42 AM EDT, Updated: 08:15 AM

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World’s Top Ten Cancer Drugs by 2020  (million USD)

Reporter: Aviva Lev-Ari, PhD, RN

 

 

Image Source: Statista (www.statista.com)

Opdivo Setback May Yield Lessons for Pharma – Advancing Immunotherapies With PD-L1 Testing

Sep 12, 2016 | Turna Ray

The anti-PD-1/PD-L1 drug market is estimated to be worth around $30 billion by 2020. The negative Phase III results for Opdivo in first-line NSCLC shocked market analysts, and pharmaceutical companies developing drugs in this space “are taking stock of the situation” and surely assessing whether they have the right test methods in place in their drug studies, said Peter Keeling, CEO of consulting firm Diaceutics.

Most drugmakers developing anti-PD-1/PD-L1 drugs are evaluating whether their therapies work especially well in patients whose tumor cells express PD-L1, a protein that cancer cells use to hide from an immune system attack. But studies have demonstrated that PD-L1 expression status doesn’t neatly bucket responders and non-responders in the same way that testing for EGFR mutations or ALK rearrangements can, making it difficult for pharmaceutical companies to integrate PD-L1 testing for patient stratification in clinical trials.

In the absence of a universal diagnostic, Cancer Genetics is one lab that does offer all the FDA-approved companion and complementary PD-L1 tests, but also spends a lot of time educating doctors and pathologists on the differences between these tests and which to order for a particular immunotherapy. “There’s a big need for our pharma cousins to really push more knowledge about the associated diagnostics and tests and how to use them,” Sharma said. “That’s the only way they’re going to get uptake in the community setting.”

Despite the muddled messages around PD-L1 testing, healthcare providers and researchers nonetheless seem interested in PD-L1 testing as part of the tumor profiling workup for patients. Diaceutics’ surveys show a sharp uptick in the number of labs offering PD-L1 testing over the past year-and-a-half and 52 labs in the US offer at least one PD-L1 test. The company also reviewed biomarkers being studied in 95 Phase II/III NSCLC, and found that approximately half are incorporating patients’ PD-L1 status either alone or in combination with other markers, such as EGFR and ALK mutations.

At Cancer Genetics over the past year, there has also been a notable ramp up in orders for PD-L1 testing for lung cancer patients, but also for melanoma and head and neck cancer patients. “One our biggest volume increased tests this year has been PD-L1 testing,” Sharma said. “We think there is a lot of opportunity for significant additional growth.”

https://www.genomeweb.com/molecular-diagnostics/opdivo-setback-may-yield-lessons-pharma-advancing-immunotherapies-pd-l1

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Precision Medicine Market size worth $87.7BIL by 2023

 Article Publication Request by

Jui Kate | SEO Analyst

Global Market Insights

E-mail: jui.k@gminsights.com | Web: www.gminsights.com 

Published Date: July 25, 2016   Author: Global Market Insights, Inc.

Precision Medicine Market size is expected to reach USD 87.79 billion by 2023; as per a new research report by Global Market Insights, Inc.
Increasing demand for personalized medicine specifically in cancer treatments and advancements in new healthcare technologies will drive precision global medicine market size. Favorable government regulations and standards will help sustain revenue growth.
The individualized diagnosis approach has dramatically improved owing to large-scale biologic database development, efficient methods for patient characterization, and computational tools to analyze large data sets. Emphasizing the need for public health database, The White House dedicated USD 55 million for creation of its largest database ‘Precision Medicine Initiative’ (PMI).

 

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Recent research advances have helped expand benefits to various aspects of healthcare by enabling better understanding of disease mechanisms, assessment of disease risks and prediction of optimal therapy. A large number of investments in diagnostic research will further accelerate the shift from treatment to preventive medicine in healthcare.
Gene sequencing market size was over USD 8 billion in 2015. Post announcement of the PMI, FDA has recently issued draft guidelines on next generation sequencing-based tests to develop a new kind of healthcare that takes into account individual differences in people’s genes, environments and lifestyles.
Browse key industry insights spread across 94 pages with 85 market data tables & 62 figures & charts from the report, “Precision Medicine Market Size By Technology (Big Data Analytics, Gene Sequencing, Drug Discovery, Bioinformatics, Companion Diagnostics), By Application (Oncology, CNS, Immunology, Respiratory), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Scandinavia, Italy, Japan, China, India, Singapore, Mexico, Brazil, South Africa, UAE, Qatar, Saudi Arabia), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2023” in detail along with the table of contents:

https://www.gminsights.com/industry-analysis/precision-medicine-market
Key insights from the report include:

  • Drug discovery technology contributed over USD 9 billion to the global precision medicine market size in 2015, and is estimated to expand at 8.3% CAGR from 2016 to 2023. NGS and other such technologies will open new opportunities for industry participants. Regulation of NGS based test development will help create regulatory processes for genetic test development and application.
  • The global companion diagnostics market is predicted to reach USD 17 billion by 2023. It plays a significant role in development of targeted drugs, thus speeding up the move towards more precise and individualized pharmacotherapy.
  • Oncology application was over 30% of the precision medicine market share in 2015. There have been significant developments taken place across the globe in the area of breast cancer and other related cancers. Predictive biomarkers in lung cancer therapy targets receptors such as c-ros oncogene 1 receptor tyrosine kinase (ROS1), Epidermal Growth Factor Receptor (EGFR), Immune Checkpoints, and Anaplastic Lymphoma Kinase (ALK).
  • U.S. precision medicine market share accounted for over 65% of the North American revenue in 2015, and is anticipated to continue witnessing growth due to increased government initiatives. For instance, The President’s budget in 2016 has allocated USD 130 million to the NIH for development of a national research cohort of a million voluntary U.S. participants, and the data is linked to EHR for easy access to academic scientists and physicians.
  • China contributed 25% to the Asia Pacific precision medicine market size in 2015, mainly due to considerable government initiatives supporting growth in the region. Pfizer, Novartis, Covance, Medtronics, Qiagen, Quest Diagnostics, Roche Holding, Teva Pharmaceuticals, and Biocrates Life Sciences are some notable industry participants.

Global Market Insights has segmented the precision medicine industry on the basis of technology, application, and region:

  • Precision Medicine Market Technology Analysis (Revenue, USD Million; 2013 – 2023)
    • Big data analytics
    • Gene Sequencing
    • Drug discovery
    • Bio Informatics
    • Companion Diagnostics
  • Precision Medicine Market Application Analysis (Revenue, USD Million; 2013 – 2023)
    • Oncology
    • CNS
    • Immunology
    • Respiratory
  • Precision Medicine Market Regional Analysis (Revenue, USD Million; 2013 – 2023)
    • North America
      • U.S.
      • Canada
    • Europe
      • UK
      • Germany
      • France
      • Italy
      • Scandinavia
    • Asia Pacific
      • China
      • Japan
      • India
      • Singapore
    • Latin America
      • Mexico
      • Brazil
    • MEA
      • South Africa
      • Saudi Arabia
      • Qatar
      • UAE

SOURCE

From: Jui Kate <jui.k@gminsights.com>

Date: Friday, February 17, 2017 at 6:35 AM

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

Subject: Article Publication Request

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Pharmacovigilance Market size to exceed $8BIL by 2024

Article Publication Request by

Jui Kate | SEO Analyst

Global Market Insights

E-mail: jui.k@gminsights.com | Web: www.gminsights.com 

Published Date: December 13, 2016   Author: Global Market Insights, Inc.

Pharmacovigilance Market size is expected to exceed USD 8 billion by 2024; according to a new research report by Global Market Insights, Inc.
Growing number of adverse drug reactions (ADRs) coupled with increasing prevalence of chronic diseases will drive global pharmacovigilance market size. Furthermore, growing geriatric population base is associated with increased drug consumption for treatment of chronic diseases such as diabetes, oncology cardiovascular and respiratory disorders.
Rising demand for drugs has driven the need for new drug development through clinical trials. Pharmaceutical companies are collaborating with CROs to streamline R&D, medical writing, manufacturing operations, clinical data management and other pharmacovigilance activities to achieve greater efficiency at reduced cost. Outsourcing should enable better regulatory compliance, higher productivity and improved strategic outcomes spurring pharmacovigilance market growth.
Increasing number of National pharmacovigilance centers across the globe along with rising patient awareness regarding adverse drug events will stimulate global pharmacovigilance market growth. However, lack of skilled professionals and risk associated with data security and web-based drug sales will hamper business expansion.

 

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The phase IV clinical trial market size was valued more than USD 2 billion in 2015 and is expected to grow at over 10% by 2024. Phase IV studies ensure that restrictions could be imposed on a drug being sold depending on its safety performance.
Contract outsourcing market size was valued over USD 1 billion in 2015, poised to grow at 12.2% from 2016 to 2024 and surpass USD 4 billion by 2024. Contract outsourcing reduces overall economic losses linked with drug approval delays and trial failures. It is widely opted by companies to avoid huge investments and delegate such activities to specialized firms in this area.
U.S. pharmacovigilance market size was valued at more than USD 1 billion in 2015, with expectations to grow at 10.7% over the forecast period, owing to favorable governmental regulations, huge clinical trial volume and presence of large scale research companies. Additionally, growing patient concerns related to the drug safety and rising adverse drug events related mortality rates will positively impact pharmacovigilance market share.
Spain pharmacovigilance market size was valued over USD 230 million in 2015 and should witness 10.2% CAGR from 2016 to 2024, to surpass USD 550 million by 2024. Rising demand for new drug development, growing geriatric population and increasing outsourcing by pharmaceutical companies should fuel regional industry growth. India pharmacovigilance market growth was more than 14% from 2016 to 2024, and expected to reach USD 668 million by 2024. The strong and robust growth is attributed to increasing number of clinical trials conducted across Asian countries, owing to low cost trial advantage over developed countries.
Key industry players such as Quintiles offer literature monitoring, safety aggregate reporting, benefit risk management, analytics and signal detection services. Synowledge offer signal detection services, which help clinical experts determine medical significance with the use of hi-tech visualization techniques.
Many industry participants are focusing on outsourcing pharmacovigilance services as a feasible cost reduction avenue. Outsourcing helps achieve better pharmacovigilance through regulatory compliance, better quality, enhanced productivity and improved strategic outcomes.
Browse key industry insights spread across 111 pages with 66 market data tables & 6 figures& charts from the report, “Pharmacovigilance Market Size By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, Phase IV), By Service Provider (In-house, Contract outsourcing) Industry Analysis Report, Regional Outlook (U.S., Canada, UK, Germany, Spain, Italy, France, China, Japan, India, Australia, Argentina, Brazil, Mexico, South Africa, Saudi Arabia, UAE, Qatar), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2024” in detail along with the table of contents:

https://www.gminsights.com/industry-analysis/pharmacovigilance-market
Key insights from the report include:

  • Europe pharmacovigilance market size was over USD 790 million in 2015 growing at anticipated close to 10% CAGR. Germany, UK, Spain together contributed for over 70% of regional pharmacovigilance market share in 2015.
  • Brazil pharmacovigilance market share was more than 60% of regional revenue for 2015, with target slated to exceed USD 300 million by 2024. South Africa pharmacovigilance market size was more than USD 37 million and anticipated for over 5% growth.
  • Phase III clinical trial market size was more than USD 450 million in 2015, with expectations to grow over 10% CAGR, due to increasing requirement for drug safety monitoring and evaluation.
  • Contract outsourcing held more than 50% of pharmacovigilance market share with target market size of over USD 1.7 billion in 2015. Increasing outsourcing trend adopted by pharmaceutical companies will serve as a high impact driver for the business growth.
  • Global pharmacovigilance market will be driven by collaboration between pharmaceutical companies and contract research organizations (CROs). The key industry participants include Accenture, Quintiles, Cognizant Technology Solutions, Boehringer Ingelheim, Covance, PAREXEL International Corporation, Bristol-Myers Squibb, Janssen Research & Development, Synowlwedge, United BioSource Corporation and ICON.

Pharmacovigilance market research report includes in-depth industry coverage with estimates & forecast in terms of revenue in USD million from 2012 to 2024, for the following segments:

Pharmacovigilance Market By Clinical Trial

  • Preclinical
  • Phase I
  • Phase II
  • Phase III
  • Phase IV

Pharmacovigilance Market By End User

  • In-house
  • Contract outsourcing

 

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
  • Latin America
    • Argentina
    • Brazil
    • Mexico
  • Middle East and Africa
    • South Africa
    • Saudi Arabia
    • UAE
    • Qatar

SOURCE

From: Jui Kate <jui.k@gminsights.com>

Date: Friday, February 17, 2017 at 6:35 AM

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

Subject: Article Publication Request

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Teva – Dr. Sol J. Barer Named Chairman of the Board, Appoints Dr. Yitzhak Peterburg as Interim Chief Executive Officer, Succeeding Erez Vigodman

Reporter: Aviva Lev-Ari, PhD, RN

 

February 06, 2017 4:53 p.m.
Teva Appoints Dr. Yitzhak Peterburg as Interim Chief Executive Officer, Succeeding Erez Vigodman

Dr. Sol J. Barer Named Chairman of the Board

JERUSALEM–(BUSINESS WIRE)–Feb. 6, 2017– Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that Dr. Yitzhak Peterburg, who has served as Chairman of the Teva Board of Directors since January 2015, has been appointed Interim President and Chief Executive Officer, effective immediately. This follows the mutual agreement between the Board of Teva and Erez Vigodman that Mr. Vigodman is stepping down. Mr. Vigodman’s service on the Teva Board of Directors has also ended.

In accordance with the Israeli Companies Law, Dr. Yitzhak Peterburg has stepped down from his role as Chairman in order to serve as Interim Chief Executive Officer. Prior to rejoining Teva’s Board of Directors in 2012, Dr. Peterburg led the Company’s innovative R&D efforts as Teva’s Group Vice President, Global Branded Products, from October 2010 until October 2011, after serving on Teva’s Board of Directors from 2009 until July 2010. Previously, he served as President and CEO of Cellcom Israel Ltd. from 2003 to 2005, Director General of Clalit Health Services, the leading healthcare provider in Israel, from 1997 to 2002 and CEO of Soroka University Medical Center, Beer-Sheva, from 1995 to 1997.

The Board has elected Dr. Sol J. Barer, who has been a member of the Teva Board since January 2015, as Chairman. Dr. Barer brings deep knowledge of the global pharmaceutical industry. He was a founder of the biotechnology group at Celanese Corporation, later spun off as Celgene Corporation, where he served in top leadership roles from 1987 to 2011, including as Chairman and CEO from 2007 to 2010.

The Company’s Board of Directors is undertaking a search to identify a permanent Chief Executive Officer with the assistance of a search firm.

“I believe that now is the right time for me to step down,” said Mr. Vigodman. “It has been a privilege to lead Teva, and I am proud of all we have accomplished. I am confident that the Company’s future is bright.”

Dr. Yitzhak Peterburg said, “The Company is focusing on executing its strategic priorities to transform Teva, with immediate focus on realizing the cost synergies and strategic benefits of the Actavis Generics acquisition. I look forward to working with the entire Teva team to conduct a thorough review of the business to find additional opportunities to enhance value for shareholders. Teva has a deep bench of talented leaders and today’s announcement has no impact on our ability to execute going forward. With the strength of our generics pipeline, unique R&D capabilities and unparalleled footprint, coupled with our existing assets and growing pipeline in specialty medicines, I believe in Teva and the Company’s long-term growth prospects.”

Dr. Barer said, “We are grateful to Yitzhak for taking on the role of interim CEO. Teva’s Board of Directors, with its decades of collective pharmaceutical industry experience, will continue to play an active role in driving the Company’s strategy, and I look forward to working with the management team to execute on the value creation opportunities ahead. We intend to conduct a comprehensive search to identify the best person to lead the Company for years to come. On behalf of the Board, I want to thank Erez for his many contributions to Teva over the years and wish him well in the future.”


SOURCE

http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2243437

http://www.biopharmadive.com/news/teva-ceo-out-erez-vigodman-exit-successor/435574/

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