Mylan secures first FDA approval for generic version of Biogen’s Tecfidera following patent dispute

August 20, 2020
Sales and Marketing Biogen, FDA, Mylan, generic, tecfidera

The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is …

FDA delays BioMarin’s gene therapy for haemophilia A

August 20, 2020
Research and Development, Sales and Marketing FDA

The FDA has delayed Roctavin, BioMarin’s gene therapy for haemophilia A, by a year to wait for more extensive results, …

Johnson & Johnson seals largest pharmaceutical merger of the year by purchasing Momenta for $6.5 billion

August 20, 2020
Business Services, Sales and Marketing Johnson and Johnson, Momenta

Johnson & Johnson is set to buy the Cambridge based Momenta Pharmaceuticals for $6.5 billion, making it the largest pharmaceutical …

Former MP and Labour leadership candidate joins Bristol Myers Squibb

August 20, 2020
Business Services Big Pharma, Pfizer

Owen Smith, the former Labour MP and leadership candidate, has joined Bristol Myers Squibb as its UK Government Relations Director. Smith …

MSD unveils plans for $1.3bn central London research centre

August 19, 2020
Manufacturing and Production, Research and Development London, MSD, pharma

MSD has lifted the lid on plans to build a $1.3 billion research centre in central London.The London Discovery Research …

Australia signs first COVID-19 vaccine deal for 25 million doses of AstraZeneca/Oxford University candidate

August 19, 2020
Research and Development AstraZeneca, Australia, COVID-19, pharma

Australia has signed its first deal to secure doses of a potential COVID-19 vaccine for its citizens, inking a partnership …

US states seek $26.4 billion from major pharmaceutical manufacturers and distributors to settle opioid litigation

August 19, 2020
Research and Development opioid crisis, opioid epidemic, opioids

Multiple Attorney Generals from across the US are seeking billions of dollars in damages to settle opioid cases against major …

UK Government officially announces National Institute for Health Protection to replace Public Health England

August 19, 2020
Research and Development opioid, opioid crisis, opioid epidemic

The UK Government has officially announced that Public Health England will be replaced by the National Institute for Health Protection. …

Pharmafile.com’s weekly COVID-19 news round-up

August 19, 2020
Research and Development coronavirus, top 10

Potentially unsafe coronavirus treatments are in the headlines this week, as President Donald Trump reportedly wants to approve Phoenix Biotechnology’s …

Poseida suspends CAR T therapy trial in prostate cancer due to patient death

August 18, 2020
Manufacturing and Production, Research and Development CAR T, CAR-T, Poseida, patient death, pharma

Poseida’s Phase 1 trial that used an investigational CAR T therapy for treating prostate cancer has been suspended due to …

Bristol Myers Squibb pays $475 million for exclusive rights to Dragonfly Therapeutics’ IL-12 immunotherapy programme

August 18, 2020
Manufacturing and Production, Sales and Marketing Bristol Myers Squib, Drgonfly Therapeutics, pharma, pharma deal

Bristol Myers Squibb has scooped up the sole rights to the interleukin-12 (IL-12) immunotherapy programme of Massachusetts-based biotech Dragonfly Therapeutics, …

Trump allegedly “enthusiastic” for oleandrin to be approved as a COVID-19 treatment

August 18, 2020
Manufacturing and Production, Research and Development coronavirus vaccine, covid19

President Donald Trump reportedly wants to approve Phoenix Biotechnology’s oleandrin as a coronavirus treatment, despite a lack of evidence for …

China approves its first biosimilar of Roche’s Herceptin in HER2+ cancers

August 18, 2020
Manufacturing and Production, Sales and Marketing China, Henlius, Herceptin, Roche, biosimilar

China’s National Medical Products Administration (NMPA) has given the green light to Shanghai’s Henlius for its biosimilar version of Roche’s …

NHS guidelines on prescription cannabis to be challenged in court

August 18, 2020
Manufacturing and Production, Research and Development CBD, cannabis, epilepsy

The cannabis guidelines followed by the NHS are set to be challenged in court by the parents of a three-year-old …

China’s drug regulator says vaccines must have 50 percent efficacy to be approved

August 17, 2020
Sales and Marketing COVID, China, coronavirus, vaccines

The Chinese Centre for Drug Evaluation (CCDE) has said that coronavirus vaccines must show 50 percent efficacy to be approved.  …

Public Health England set to be replaced by a new agency to specifically deal with pandemics

August 17, 2020
Sales and Marketing COVID, Public Health England, pandemic, phe

Public Health England is set to be replaced with a new agency to prepare the country to deal with future …

Amazon Pharmacy launches in India

August 17, 2020
Sales and Marketing India, amazon, pharma

Amazon has entered the pharmaceutical market by launching ‘Amazon Pharmacy’ in India. 

Sanofi to buy Principia Biopharma for $3.4 billion

August 17, 2020
Sales and Marketing MS, Sanofi

Sanofi is set to buy California based Principia Biopharma in a deal that is worth $3.4 billion. This deal means …

FDA approves Roche’s Enspryng for neuromyelitis optica

August 17, 2020
Sales and Marketing COVID, COVID-19, coronavirus

The FDA has granted approval for Roche’s Enspryng for treating the central nervous system disorder neuromyelitis optica. The drug (satralizumab) …

FDA panel votes 9-1 in favour of approval for Mesoblast’s Ryoncil in paediatric steroid-refractory acute graft versus host disease

August 14, 2020
Medical Communications, Sales and Marketing FDA, Mesoblast, Ryoncil, pharma

It’s good news for Mesoblast as an expert FDA panel gave a glowing recommendation for the approval in the US …

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