The FDA approved Purdue Pharma's latest pain drug, a hydrocodone formulation designed to prevent abuse, potentially spelling trouble for Zogenix and its controversial Zohydro.
San Diego's BioNano Genomics has raised a $53 million C round to bankroll its efforts to decode the so-called inaccessible genome, adding Novartis to its investor syndicate as it works to amplify its profile.
The Fred Hutchinson Cancer Research Center has tapped well-known drug investigator Gary Gilliland to become its new president.
Shares of Clovis Oncology slid 10% on Wednesday as investors and analysts juggled a new data set on its closely watched lung cancer drug rociletinib (CO-1686). Even though the updated Phase II results were promising, the numbers slipped a bit from its last snapshot delivered last summer at ASCO. And slipping now looks a lot like falling behind in its race with AstraZeneca's rival AZD9291, frequently touted as one of the pharma giant's top R&D comeback programs.
The U.K. is striving to brand itself as a hotbed for biotech R&D, promising new funds for startups, pledging to speed up its approval process and courting some major players to deepen their roots in the country.
Investors shouldn't expect any major change in the R&D game plan set up by the recently departed CEO Chris Viehbacher. Sanofi says it will stay committed to Viehbacher's "open innovation" strategy, relying heavily on partners like Regeneron to produce next-gen drugs needed to keep up its revenue.
U.K. biotech investment heavyweight Neil Woodford has invested $25 million in the U.S. biotech Northwest Biotherapeutics, gambling that its controversial Phase III study on a new therapeutic vaccine for brain cancer comes up a winner.
Federal regulators are proposing a rule that would require makers of drugs and medical devices to publicize the results of thousands of clinical trials, regardless of whether they succeed, part of a global move toward transparency in R&D.
Sanofi is putting together a short list of candidates to see who will take Chris Viehbacher's place as the next CEO, and not surprisingly there's a distinct French accent to the names being bounced around just now.
Shire is following the biopharma trend of ditching far-flung outposts in favor of a centralized hub, shifting workers from its former U.S. headquarters in Pennsylvania to its Boston-area home base in a move the company believes will better align its sprawling business.
The Cystic Fibrosis Foundation announced today that it had cashed in its royalty stream from Vertex Pharmaceuticals' breakthrough CF drugs it backed for a $3.3 billion windfall. But where the foundation trumpeted the blockbuster deal with Royalty Pharma as a prelude to more investments into next-gen drugs, the New York Times' Andrew Pollack had no trouble finding a critic eager to lambaste the foundation for the ultimate sin: putting profits ahead of patients.
Houston biotech Bellicum Pharmaceuticals is angling to raise $115 million in an IPO, funds that would help it accelerate its work in the high-profile field of cancer immunotherapy.
The market price of a priority review voucher at the FDA just doubled. Canada's Knight Therapeutics has auctioned off its voucher--which can be turned in to the FDA in exchange for a regulatory shortcut on a drug decision--for $125 million to Gilead, one of the most aggressive developers in the industry.
Bind Therapeutics believes its lead nanoparticle treatment can make a difference for a subgroup of lung cancer patients, pointing to some positive results from an otherwise mixed mid-stage trial as it prepares for further study.
Following up on positive Phase I data for its lead therapy, Agios has come through with its first snapshot of promising early results on its second cancer drug, gaining some fresh proof-of-concept data on acute myeloid leukemia to help guide an expanding clinical program.
Clovis Oncology has signed a deal to test whether its lead drug can make a difference in lung cancer when paired with GlaxoSmithKline's melanoma treatment Mekinist.
The Tufts Center for the Study of Drug Development created the industry standard on R&D budgets when it pegged average R&D costs at close to $1 billion for each new drug. Today, Tufts researchers updated their figures and boosted the total to $2.9 billion.
Sanofi and Regeneron's alirocumab resoundingly beat out Merck's Zetia in helping statin-intolerant patients lower their bad cholesterol in a study, data that bolster the case for a new class of highly anticipated cardio drugs.
Rounding out year two of CEO Pascal Soriot's turnaround mission at AstraZeneca, the U.K. drugmaker believes it has the pipeline assets to fuel double-digit submissions and approvals by 2017, reaffirming its promise to pump up sales by 75% as former suitor Pfizer creeps back into the frame.
Dubbed Intellia Therapeutics, the new company has come up with a $15 million bankroll in a Series A provided by the venture group and the Big Pharma outfit, which is intrigued by the potential this gene editing technology could play in two of the hottest fields in oncology.