News

FDA revokes breakthrough status for BMS hep C drug

US regulators are reportedly gearing up to revoke breakthrough status for Bristol-Myers Squibb’s hepatitis C drug daclatasvir, just days after it emerged that Merck & Co’s hep C combo will suffer the same fate.

FDA sets April date for Amgen T-Vec review

Advisors to the US Food and Drug Administration will meet at the end of April to review Amgen’s closely-watched oncolytic immunotherapy T-Vec for melanoma.

GSK acquires Switzerland’s GlycoVaxyn

GSK has acquired GlycoVaxyn, the Swiss vaccine-maker it has held a minority stake in since 2012, paying $190 million in cash to take full ownership.

Sanofi, Voyager in $845m gene therapy deal

Sanofi group Genzyme has signed a major deal with gene therapy start-up Voyager Therapeutics, which will see the groups embark on a journey to discover new treatments for serious central nervous system conditions such as Parkinson’s disease.

Charity challenges Gilead Sovaldi patents in Europe

The NGO Doctors of the World (Médecins du Monde) is contesting Gilead Sciences’ intellectual property on Sovaldi as part of a campaign to cut prices on the blockbuster hepatitis C drug.

FDA sets date for Celltrion biosimilar of Remicade

Advisors to the US Food and Drug Administration will meet next month to review Celltrion’s biosimilar of Johnson & Johnson and Merck & Co’s anti-inflammatory blockbuster Remicade.

Takeda’s ixazomib soon to be filed for multiple myeloma

Takeda’s flagship experimental cancer drug ixazomib is a giant leap closer to being filed with regulatory authorities around the globe for multiple myeloma, after turning in a solid performance in late-stage trials.

Vaccine patch firm Vaxxas raises $20m

University of Queensland spin out Vaxxas has managed to secure equity funding of A$25 million ($20 million) in a new round of financing to help advance a suite of clinical programs and develop a pipeline of new vaccine patches.

8,000 new GPs needed by 2020, RCGP warns

Some parts of England will need a 50% increase in community GPs by 2020 to meet the demands of the growing population, the Royal College of General Practitioners has warned.

Achillon shares leap on hep C data

Shares of Achillion Pharmaceuticals shot up as much as 20% Monday morning as it emerged that patients with hepatitis C taking its investigational therapy were cleared of the virus after just six weeks.