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.

Draft guidance questions lack of evidence comparing new nasal treatment with older therapies.

ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.

Often dismissed as a meeting of the global elite, Davos is nevertheless a chance for biopharma leaders to take part in ‘big picture’ debates

Bayer’s drive to lead a new market opportunity in Europe for histology-independent cancer agents like Vitrakvi has been set back by interim decisions from the UK’s NICE and Germany’s IQWiG, but there is a now a clear pathway to follow.

Genfit will delay unblinding of data from its nearly complete Phase III study of elafibranor to get insight from the FDA on statistical methods in order to optimize its NDA.

Aimmune has secured approval for the first ever peanut allergy treatment, but safety, cost and administration issues could limit the drug's uptake.

The innovative collaboration should accelerate access to the first-in-class cholesterol lowering drug acquired with The Medicines Company buy.

The US election will intensify  the spotlight on drug costs, regulators will have their hands full with advanced therapy filings, and the need to address rising infectious disease threats will mount. Biosimilars, cannabis and Brexit are among other hot topics for 2020.

The leading PARP inhibitor gets a new tumor type added to its label after a narrow ODAC vote in favor less than a fortnight ago.