Topic:

Pipeline

Latest Headlines

Latest Headlines

Sanofi dumps KaloBios' antibiotic in another stinging setback

KaloBios was an early entrant in 2013's boom of biotech IPOs, touting its development technology as a springboard for high-quality antibodies. A year later, that promise hasn't come to fruition, and partner Sanofi is walking away from an antibacterial program for which the company had high hopes.

Sarepta's flash firing tightens the focus on a heavily scrutinized company

Sarepta Therapeutics' terse dismissal of its top scientist on Thursday has led to a swirl of rumors and anonymous-sourced reports of boardroom clashes, incompatible personalities and a possible coup attempt, bringing to light worrisome details on a company already under the microscope.

UCB inches toward the FDA with its latest epilepsy contender

A new epilepsy treatment from Belgian drugmaker UCB helped reduce the rate of seizures in a Phase III trial, the company said, setting the stage for an FDA application and a shot at widening its footprint in the field.

Shire inks a $225M rare disease deal on the eve of life with AbbVie

Shire has signed a $225 million agreement to brighten its future in rare diseases, bolstering a major selling point for AbbVie as the two prepare for a $54.7 billion merger.

J&J partner Aduro grabs an FDA 'breakthrough' nod for its immuno-oncology combo

Aduro BioTech joined the short list companies outside Big Pharma to pick up the FDA's coveted breakthrough therapy designation, impressing the agency with strong mid-stage results for its combo cancer therapy.

Amgen's kidney dialysis drug clears its first Phase III hurdle

Amgen's in-development treatment for patients on kidney dialysis met its primary and secondary goals in a late-stage trial, step one in the drug's three-part Phase III program.

InterMune bags a 'breakthrough' nod of its own in a race with Boehringer

InterMune secured the FDA's breakthrough therapy designation for an in-development treatment for a rare lung disease, evening the regulatory score with rival Boehringer Ingelheim as the two angle for position on the U.S. market.

Alkermes takes its Tecfidera beater into clinical trials for MS

Alkermes has its sights set on Biogen Idec's blockbuster multiple sclerosis treatment, advancing a me-better candidate of its own into Phase I study.

Boehringer's lung drug wins FDA 'breakthrough' tag

Boehringer Ingelheim's treatment for a rare and deadly lung disease picked up the FDA's coveted breakthrough therapy designation, a mark that guarantees a speedy regulatory review and could help the company beat its nearest rival to market.

GlaxoSmithKline and Theravance eye Phase III for another COPD contender

The blockbuster duo of GlaxoSmithKline and Theravance are pushing a new respiratory combo therapy into late-stage study, pooling the active ingredients from its last two approved COPD treatments to create a once-daily inhaler.