Biosimilar executives Leah Christl and Chad Pettit see reasons for optimism in the US market as new launches and sales begin to add up. Amgen’s portfolio is annualizing at $1bn as of the fourth quarter.

A new study looks at list drug price increases and manufacturer discounts over 11 years and finds that despite significant rebates, net price increases still grew 3.5 times more than inflation.

The Trump administration does not believe its partnership with industry on therapeutics for COVID-19 should include conditions on pricing, US Health Secretary Alex Azar tells Congress.

With several Chinese manufacturing facilities shut at least till 10 February, Indian pharma companies are keeping a close watch on the evolving coronavirus situation. API inventory can last for a while, but if intermediates supplies don’t resume soon the fallout could be grim.

Tecfidera accounts for nearly one-third of Biogen's revenues, so the patent decision relieves one overhang for the company. However, other ANDA challenges are ongoing.

Draft guidance questions lack of evidence comparing new nasal treatment with older therapies.

Novartis’s AveXis unit has received a CHMP nod for the spinal muscular atrophy gene therapy at its latest meeting, sending it on the final steps to market in the EU.

Designers of the UK’s experimental antibiotic payment system aim to identify two drugs later this year which will then undergo a novel technology assessment in 2021.

UK pharma groups planning M&A deals ‘must get their skates on’ and begin filing now if they want to benefit from the EU’s review process before the Brexit transition period ends on 31 December.

CDER’s postponing of meetings planned through the end of April likely means a later advisory committee date to review OCA in NASH. The US PDUFA date previously was pushed back to late June.

With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored.

Acacia's bids to get the thumbs-up in the US for its post-operative nausea and vomiting therapy have finally borne fruit. CEO Mile Bolinder tells Scrip that his experienced team is now firmly focused on gaining as many hospital formulary approvals as possible for Barhemsys.