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Top Ten most popular articles on Pharmafile.com this week

Published on 26/07/19 at 01:09pm

At the end of a week that could certainly be called "eventful" here in the UK - one that saw Conservative MP Boris Johnson take the country's top job after securing votes from less than 1% of the population - a number of big stories have emerged from the industry.

Among them is the great news that nine new generic versions of Pfizer's Lyrica will now be made available across the US, and the promising announcement that UK watchdog NICE is to review its sometimes-maligned decision-making process. However, the most popular story this week is the news that the FDA has rejected Biohaven's latest drug for amyotrophic lateral sclerosis.

10. Elizabeth Warren calls on Albert Bourla to reveal detail of appointment of former FDA commissioner Scott Gottlieb to Pfizer's board

Massachusetts Senator and Democratic Presidential Candidate, Elizabeth Warren, asked for “additional information regarding the announcement last month that Dr Scott Gottlieb, just weeks after leaving his job as Commissioner of the U.S. Food and Drug Administration (FDA), would be joining the Board of Directors of Pfizer.”

9. FDA approves nine generic versions of Pfizer's Lyrica

The US regulator awarded marketing approval to generic products from Teva, Dr Reddy’s Laboratories, Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals and Sciegen Pharmaceuticals.

8. Gilead buys Novartis' herpes, flu and cold virus preclinical programmes

Gilead has acquired the rights to three of Novartis’ preclinical antiviral programmes, including investigational compounds with the potential to treat influenza, herpes and human rhinovirus, the virus that causes the common cold.

7. BMS' blockbuster Opdivo flies high and falls short in non-small cell lung cancer

Bristol-Myers Squibb has pulled back the veil on new data from two  analyses of its blockbuster immunotherapy Opdivo (nivolumab) in the  first-line treatment of non-small cell lung cancer (NSCLC), and not all  of it was positive.

6. Takeda's subcutaneous formulation of Entyvio smashes primary endpoint in Crohn's disease

Takeda has unveiled new Phase 3 data for a subcutaneous formulation of its gut-selective biologic Entyvio, showing that the therapy met its primary endpoint as a maintenance treatment for moderately to severely active Crohn's disease (CD).

5. Humira biosimilar from Samsung Bioepis and MSD wins marketing authorisation in the US

The approval for the drug, known as Hadlima, covers the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, just like its reference product.

4. NICE to review its decision making processes

Britain’s cost-effectiveness body NICE has said it will review the methods it uses to develop guidance on drugs, medical devices, and diagnostics.

3. MSD trials long lasting PrEP implant for preventing HIV

MSD has tested a long duration pre-exposure prophylaxis (PrEP) implant in 12 healthy adults over a period of 12 weeks.

2. Diagnosing the drug supply: Exposing the bad practice of manufacturers in the developing world

The world needs cheap generic drugs and Indian manufacturers offer a steady supply. However the quality of generics has been sacrificed in the pursuit of bottom level prices. Louis Goss talks to investigative journalist Katherine Eban as she discusses the realities of the generic drug industry today.

1. FDA knocks back Biohaven's ALS drug over manufacturing concerns

Biohaven Pharmaceutical has seen its new therapy formulation for the treatment of amyotrophic lateral sclerosis (ALS) rejected by the FDA, it has emerged.

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