Friday, the EU's Committee for Medicinal Products for Human Use (CHMP) recommended 11 new drugs for a variety of diseases--the most nods it's given in a single meeting all year.
GlaxoSmithKline got a double dose of good news today about its respiratory drug Breo Ellipta, known as Relvar Ellipta in other markets. Regulators in Europe recommended the potential blockbuster be approved there for COPD and asthma, while regulators in Japan gave it the OK for asthma.
A European Union regulator has recommended approval of 11 new drugs for a range of diseases such as HIV, breast cancer and diabetes. And the nods could lead to final approvals from the European Commission in the coming months.
GlaxoSmithKline and Prosensa today conceded defeat in the Phase III study for drisapersen, one of two closely-watched therapies for Duchenne muscular dystrophy which had been vying for the lead in the field. Investigators reported that the therapy failed to significantly improve walking distance in patients.
Will a new generation of flu shots pay off big for vaccine makers? We'll soon find out. As Reuters reports, several top drug companies are rolling out vaccines that fight four strains of influenza, rather than the usual three. And they're expecting to sell those vaccines at a big premium.
Delivering a vaccine against an emerging pandemic flu strain requires developers to make a lot of quick decisions about dosing, use of adjuvants and other factors. With H7N9, however, China's success in limiting the virus' spread has given other countries more time to prepare.
Agenus has had a topsy-turvy month. Its share price fell off a cliff after the GlaxoSmithKline vaccine that uses its adjuvant failed a Phase III trial, only to rally this week on the back of news about its own clinical candidate.
Agenus has struck a deal to raise about $6.5 million from institutional backers in a direct offering of common stock and warrants. The financing was announced a day after the Lexington, MA-based biotech company revealed that patients with glioblastoma multiforme, a cancer which attacks the brain, who took its experimental vaccine lived more than twice as long without their cancer getting worse than those on the standard of care.
This morning ChemoCentryx reported that GlaxoSmithKline has returned all rights to the Crohn's drug vercirnon, a day after the pharma giant confirmed to FierceBiotech that it had shuttered the three remaining late-stage studies it had mounted for the program.
The parade of new pharma board chairs is growing longer. GlaxoSmithKline is reportedly eyeing Sir Philip Hampton, now chairman at Royal Bank of Scotland, to take up where Sir Christopher Gent leaves off next year, according to the London Evening Standard.