A cloud hangs over the approval of Roche's Tecentriq in the second line treatment of bladder cancer following the failure of a confirmatory Phase III trial. Meanwhile, rival product Bavencio from Merck KGaA and Pfizer has been granted accelerated approval by the FDA.
A Phase III trial ‒ IMVigor211 ‒ in second-line urothelial (bladder) cancer of Roche's anti-PD-L1 immuno-oncology drug Tecentriq (atezolizumab) has failed to show a survival benefit. This study was required to confirm full approval with the US FDA following Tecentriq's accelerated approval last year based on the IMvigor210 study.
"This comes as a surprise to us, considering Merck & Co. Inc
Both high-profile failures and small investments that are yielding success so far characterize the dealmaking in MASH over the past 15 years or so.
BioMarin’s chief business officer James Sabry told Scrip that Inozyme’s enzyme replacement therapy INZ-701 aligns with the company’s existing portfolio and its areas of dealmaking focus.
A federal court jury found Amgen liable for violating antitrust laws in allegedly preventing Praluent from competing against Repatha.
Company surprises investors with Jørgensen's exit but insists its strategy will not change.
Company surprises investors with Jørgensen's exit but insists its strategy will not change.
The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.
Recent moves in the industry include changes at the top at Akamis Bio, Innospera Pharma & Ispen, plus Astellas Korea appoints an ex-Novartis Korea executive.
