News

CAR-T player Juno picks up 'breakthrough' status for lead cancer therapy

Biotech upstart Juno Therapeutics has added an FDA "breakthrough" drug title to its considerable list of accomplishments, gaining regulators' commitment to hurry along a lead cancer program to a potential approval.

Merck steps into Ebola vaccine race with NewLink rights deal

Merck has snapped up the exclusive rights to NewLink Genetics' Ebola vaccine, which is being rushed into a Phase III study as part of a global effort to head off an outbreak in West Africa.

BioMarin buys Prosensa for up to $840M, shoots for quick OK of Duchenne drug

BioMarin just bought itself a pricey ticket into a high-profile Phase III drug development race. The rare-disease specialist has stepped in to buy the Dutch biotech Prosensa for $680 million in cash while offering up to $160 million more in near-term milestones if it can land an early approval for its late-stage drug for Duchenne muscular dystrophy.

AstraZeneca earmarks $200M to support its burgeoning biologics pipeline

Thanks in part to its all-hands approach to immuno-oncology, AstraZeneca's pipeline is now nearly 50% biologics, leading the company to lay out $200 million to build the capacity it will need to follow through on those in-development projects.

Biotech Neothetics pulls off a $65M IPO and promptly takes a tumble

San Diego's Neothetics, developer of a fat-busting treatment, came through on its plans to raise $65 million in an IPO, but, in keeping with a growing trend in biotech, watched its shares slide shortly after its debut.

Beware sketchy biotechs with big plans for Ebola, SEC says

The SEC has suspended the trading of a few microcap companies touting unverified Ebola treatments and tests, warning investors of penny stock peddlers looking to cash in on the West African outbreak that has killed thousands.

Novartis' Enbrel beater bounds toward psoriasis approval ahead of the crowd

Novartis is well on its way to leading a new class of anti-inflammatory treatments, convincing European regulators to recommend approving its injected therapy for psoriasis and putting the company in line for transatlantic launches next year.

AbbVie gets an EU green light for its next-gen hep C treatment

AbbVie is one step closer to challenging Gilead Sciences' dominance in the hepatitis C market, securing a likely European approval for its rival combo treatment as it awaits a U.S. nod.

Fred Hutchinson brings on ex-Merck cancer R&D chief Gilliland as president

Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Michael Gibney (email | Twitter)...

U.K. starts ambitious drug dev review, Onxeo to raise €41.6M, Galapagos mulls Nasdaq listing

In this week's EuroBiotech Report, the U.K. government kicked off a review it hopes will deliver a faster, cheaper way of developing drugs. Onxeo unveiled plans to raise €41.6 million ($52.2 million). And more.

Purdue wins a pain pill approval with Zohydro in its crosshairs

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.

BioNano bags $53M to dig deeper into genomics with Novartis on board

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.

Ex-Merck cancer R&D chief Gilliland takes the helm at Fred Hutch

The Fred Hutchinson Cancer Research Center has tapped well-known drug investigator Gary Gilliland to become its new president.

Clovis shares dented after lung cancer contender mirrors AstraZeneca's rival

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 open for biotech business, and Merck is buying in

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.

Sanofi sticks to Viehbacher's R&D script as it rolls out a $38B pipeline vision

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. heavyweight Woodford gambles $25M on controversial brain cancer vaccine

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.

Success or failure, feds want trial results posted online

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's shortlist of CEO candidates so far has a distinct French accent

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 orders 500-plus staffers to move to Boston-area biotech 'Mecca'

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.