Japanese firm in discussions with regulator as high-need novel therapy for spinocerebellar degeneration misses endpoint but shows promise in pooled analysis.

Scrip traces some of the prominent changes in the corner office at front-line, family-owned Indian firms Cipla and Dr Reddy’s in the decade gone by.

Full, planned acquisition of Tokyo-based operation will give US biotech giant a firmer foothold in key market and new platform for Otezla growth.

HanAll and Daewoong remain upbeat on dry eye candidate HL036 and are gearing up for a second Phase III US study despite the first missing its primary endpoint in just-released top-line results.

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

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.

A series of decisions on anticancer drugs from the UK’s NICE will act as a reminder to drug developers excited by potential breakthroughs that health technology assessment has become an exacting filter for new medicines to pass through.

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

Initial knock-back from NICE means Akcea will need to improve commercial offer.

Innate Pharma pursues refractory hairy cell leukemia opportunity with first-in-class CD22-directed immunotoxin, moxetumomab pasudotox-tdfk.

HanAll and Daewoong remain upbeat on dry eye candidate HL036 and are gearing up for a second Phase III US study despite the first missing its primary endpoint in just-released top-line results.

Manufacturers will face the “biggest PBM ever” in price negotiations for pharmacy benefit drugs as a result of the collaboration between the two pharmacy benefit managers.

With rebate reform efforts stalled, insulin manufacturer broadens efforts to lower prices through authorized generics, but PBMs may still like the big rebates they can get on the original brands.

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.

Co-developers gain nod for novel antibody-drug conjugate that provides new option for patients with advanced form of bladder cancer.