FDA keeps the faith in surrogate endpoints
The US regulator granted 14 accelerated approvals in 2019, fewer than in the previous two years, and the sector remains slow at conversions.
Go or no go? Esperion's double whammy and a look to priority reviews
Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early approvals.
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.
Another blockbuster year looms for approvals
Biogen’s Alzheimer’s candidate and Fibrogen’s new anaemia pill top the list of the biggest commercial hopes that could reach the market in 2020.
Morphosys gets a major tafasitamab endorsement
Incyte hands across $750m up front and buys $150m of Morphosys equity for rights to the anti-CD19 project.
Clinical developments over the Christmas period
The most important clinical readouts of the holiday period concerned Google Health, Axsome, Wave and Spectrum.
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.
Why a 2020 spotlight will fall on tafasitamab
The anti-CD19 MAb is Morphosys’s lead pipeline asset, and an imminent filing could see it approved next year.
Biogen stacks the deck but the path forward is no clearer in Alzheimer’s
The presentation of Biogen’s hugely complex aducanumab pivotal programme confirms that the US regulator is destined to make another polarising decision.
