Rare diseases top another strong year for novel drug approvals
A clutch of swift FDA decisions boosted average US drug approval times in 2019, helping biopharma to deliver another bumper crop of new medicines.
Internal FDA documents reveal a familiar story for Sarepta
The unexpected approval of Vyondys 53 followed an FDA power struggle, and turned on a vague commitment from Sarepta, it has emerged.
A quiet six months for device approvals
The second half of 2019 saw half as many innovative medical devices approved as the first.
Blueprint beats Deciphera to the punch
In the battle between two Kit/PDGFRα kinase inhibitors first blood goes to Blueprint’s avapritinib.
Corporate and regulatory developments over the Christmas period
On the corporate front Astellas continued to buy, while Qiagen decided that it was not, after all, up for sale.
Go or no go? Enhertu’s destiny revealed and FDA decisions due for Epizyme, Novo
Enhertu gets an early thumbs up from the FDA – now decisions are due for Epizyme’s tazemetostat and Novo Nordisk's Rybelsus and Ozempic.
Avatera Medical becomes the newest robotic surgery group in Europe
The German start-up must navigate the hazards that have felled other surgical robot developers while simultaneously dealing with a more crowded market.
Global Blood’s sickle cell approval is no guarantee of success
Rather than nipping at Adakveo’s heels, Global Blood Therapeutics’ newly approved sickle cell drug Oxbryta might end up floundering in the Novartis product’s wake.
Speedy nod sets Alnylam up for its second launch
Alnylam unveils a novel pricing strategy for its second RNAi launch, which was greenlit by the US regulator with notable speed.
Kickstarting ideas
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