Regulus Therapeutics, at work on a microRNA approach to hepatitis C, watched its shares skyrocket on positive early data for its lead candidate, which significantly reduced viral loads with a single dose.
Following the FDA's advice, Omeros has hit the brakes on a mid-stage human trial of its Huntington's disease treatment in light of data from a separate animal study, news that tanked the biotech's share value.
Shire and AbbVie have formally called it quits on a planned $55 billion merger, leaving each company to get by on the merits of its own pipeline and talk up the benefits of life without the other.
Earlier this year, Cytokinetics tanked as its lead prospect, a treatment for amyotrophic lateral sclerosis (ALS), missed its primary endpoint and a slew of secondary goals in a mid-stage trial. But the drug did come through on one measure of lung function, and, upon analysis of the results, the biotech believes that could be its ticket to FDA approval.
Sanofi and Regeneron have cut to the front of the line in the race to develop a new class of cardio drugs, but now rival Amgen has made a chess move of its own, filing a patent-infringement lawsuit designed to block its rivals from reaching what's expected to be a blockbuster market.
After years of clinical and regulatory setbacks, Repros Therapeutics was finally on the path to submitting its testosterone treatment to the FDA, scheduling a prefiling meeting for November with hopes of handing the drug in by year's end. But the agency has had some second thoughts, changing the agenda for the meeting and indefinitely delaying Repros' plans.
A banner year for Berkeley, CA-based Aduro just got better. The biotech has inked its second licensing pact of the year with Johnson & Johnson, which kicked in a $30 million upfront and boosted its total milestone package to the $1 billion-plus category.
AstraZeneca is expecting word from European regulators next week on whether they'll recommend approval for its new ovarian cancer treatment, a drug the company hopes can bring in $2 billion a year at its peak.
GW Pharmaceuticals' in-development treatment for ulcerative colitis missed its primary endpoint in a midstage trial, a setback for the U.K. drugmaker and its pipeline of cannabinoid treatments.
Prosensa has begun the FDA submission process for its treatment for Duchenne muscular dystrophy, planning to fully file by year's end with hopes of finally winning approval for a drug that has survived a few brushes with failure.