Pharmaceutical firms conducting clinical trials of drugs in India will no longer be able to escape responsibility in case of injury or death of participants. According to new draft rules for clinical trials and new drugs, if the sponsor fails…
Indian pharma cos get record 300 USFDA generic drug nods in 2017
Domestic pharmacompanies received more than 300 approvals in 2017 to launch generic drugs in the US, which is an all-time high. The clearances came despite regulatory pressure from the US Food and Drug Administration (FDA), and unprecedented warning letters issued…
Indian pharma majors are rushing to ‘Make in America’
US President Donald Trump’s ‘Make in America’ pledge may have spooked many, but Indian pharmaceutical companies are optimistic. Several Indian drugmakers that have large operations in the US are now pushing to acquire assets there by either investing in greenfield…
Google invests in UK vaccine pioneer Vaccitech
Google has invested £20 million ($27.1m) in a biotech firm spun out of Oxford University working on novel treatments which include a universal flu vaccine and a therapeutic cancer vaccine. The tech giant’s GV division (formerly known as Google Ventures)…
Spark and Pfizer’s gene therapy wows in haemophilia B
Gene therapy company Spark Therapeutics has published data showing its one-time treatment can almost entirely eliminate bleeds in patients with haemophilia B. The news confirms Spark as a frontrunner in the groundbreaking field, where it is poised to gain the…
Clovis PARP drug gets fast US review in new ovarian cancer use
The FDA has promised a fast review for expanded use of Clovis Oncology’s ovarian cancer pill Rubraca, that could bring it up to speed with a rivals from AstraZeneca and Tesaro. Clovis wants approval for its Rubraca (rucaparib) twice-daily pill…
Novartis/Amgen’s migraine drug excites with phase 3 data
Novartis and Amgen’s migraine drug erenumab has got a further boost with new phase 3 data showing it halved migraine days in 50% of patients. The companies published top line results from STRIVE around a year ago, but they have…
New Teva CEO axes R&D chief Hayden in boardroom shakeup
Shares in troubled Teva Pharmeceuticals have ticked up after incoming CEO Kare Schultz pledged to tackle “internal inefficiencies”, shaking up the company and axeing three high-profile executives. This includes Michael Hayden, who has been the company’s head of research since…
Catalyst to re-submit rare disease drug after trial success
Catalyst Pharmaceuticals is to go back to the FDA with new data from Firdapse, its treatment for ultra-rare neuromuscular disease, Lambert- Eaton myasthenic syndrome (LEMS). The drug was rejected last February when the FDA refused to review Firdapse, saying its…
Vanessa Research starts Phase 2 clinical trials in early 2018 for Shylicine™
Vanessa Research, Inc. (VRI), an emerging healthcare and biotech company, attended its first meeting with the European Medicines Agency in October and will now start its Phase 2 clinical trials in the first quarter of 2018 for the rare disease…
