News

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded that the benefits of Bayer’s acne drug Diane 35 and its generics outweigh the risks, “provided that several measures are taken to minimise the risk of thromboembolism”.

Lundbeck and Takeda have presented more positive late-stage data  on their recently-filed antidepressant Brintellix.

The European Union (EU) is being put at risk because millions of patients in the region cannot afford their medicines, a leading EU politician has warned.

The former chairman of NICE Sir Michael Rawlins has attracted criticism after taking up the position of a board member at US biotech firm Intra-Cellular Therapies.

After announcing plans to restructure its R&D operations in France last year, Sanofi says it will now maintain a research presence in Toulouse for five years, but probably no longer.

Singapore’s Agency for Science, Technology and Research (A*Star) and Switzerland’s Cytos Biotechnology say that the first healthy volunteer has been dosed in a Phase I trial with their H1N1 influenza vaccine candidate.

Bayer has boosted its consumer care business by acquiring fellow Germany-based company Steigerwald Arzneimittelwerk, which specialises in pharmacy-only herbal medicines.

India’s new Drug Price Control Order (DPCO) has now been introduced, and is expected to lead to reductions in the prices of 348 essential drugs by up to 80%.

In final draft guidance NICE is recommending Astellas’s Betmiga (mirabegron) for the treatment of overactive bladder syndrome in patients for whom antimuscarinic drugs – the established treatment for the condition – are not suitable.

Sanofi is getting ready to file its JAK2 inhibitor for myelofibrosis on strong late-stage data for the rare, but serious blood disease.

Shire has once again fallen foul of the ABPI Code of Conduct after using a press release for its Gaucher’s disease drug Vpriv to knock a rival product.

UCB has teamed up with IBM to “harness super-computer power” and help improve treatment for epilepsy patients.

Fresh from returning to public ownership with a US$947 million offering, Quintiles has made a significant addition to its roster of strategic alliances in the form of a five-year clinical development agreement with Merck Serono.

Roche has filed obinutuzumab on both sides of the Atlantic to treat chronic lymphocytic leukaemia.

Sanofi and longtime partner Regeneron Pharmaceuticals have started enrolling patients for two new late-stage trials of their investigational rheumatoid arthritis treatment sarilumab.