Esperion shifts to show not tell
After spending years insisting that its cholesterol-lowering medicine has a place between statins and PCSK9 inhibitors, Esperion must now prove it.
First fragile X test is approved, and Zynerba could benefit
The fragile X pipeline is strewn with failures, and crunch time is approaching for Zynerba’s cannabinoid.
Olympus banks on acquisitions to sustain its high
A strategic change towards Olympus's medical business, and particularly therapeutic procedures, has reignited growth. Next up: acquisitions.
US FDA approval tracker: a first for Aimmune
January saw Aimmune receive an FDA approval for Palforzia, a first for peanut allergy, alongside decisions for Blueprint Medicines and Horizon Therapeutics.
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.
