News

Merck wins breakthrough FDA approval for blockbuster cancer contender pembrolizumab

Merck has won the frenzied race to secure the first FDA approval for a new breed of cancer treatment, clearing the way for a U.S. launch and a scramble for dominance in a field expected to peak at nearly $35 billion a year.

Calico's Levinson leaves Roche board to focus on AbbVie R&D deal

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)...

Merck's new antibiotic hops on the FDA fast track

Merck has secured the FDA's fast-track designation for its latest antibiotic candidate, a mid-stage treatment for complicated infections.

Edison's orphan drug misses the mark in Phase II

Edison Pharmaceuticals' in-development rare disease treatment missed its primary endpoint in a mid-stage trial, denting the company's plans for an expansive take on CNS R&D.

Lilly claims another head-to-head victory over Lantus in PhIII diabetes showdown

Eli Lilly took another big step toward filing its long-acting insulin peglispro for an approval, racking up some more positive HbA1c Phase III data in a head-to-head showdown with Sanofi's bestselling Lantus.

Despite a late-stage flop, Kamada preps its orphan drug for EMA review

Israeli biotech Kamada confirmed that its lead candidate failed to meet both its primary and secondary endpoints in a late-stage trial--but that won't interrupt the company's plans to file for European approval.

J&J teams with Bavarian Nordic on an emergency Ebola vaccine program

The deadly outbreak of Ebola in West Africa is pushing related vaccine and drug development efforts from first gear into overdrive. Today it's J&J's turn to step up, teaming with the Danish biotech Bavarian Nordic to pair up vaccine components into a new jab with the help of the National Institute of Allergy and Infectious Diseases. And the pharma giant says it can start testing the new combination vaccine in a rushed clinical trial slated to start in early 2015.

UPDATED: AbbVie partners with Google's Calico on $1.5B R&D operation focused on aging

Hot on the heels of its $805 million development deal with Infinity, AbbVie Pharmaceuticals has followed up today with a plan to partner with Google's closely watched biotech upstart Calico on a new research operation that will cost up to $1.5 billion to get started.

Gene therapy biotech Voyager snags a former Lilly exec to take the reins

Third Rock Ventures' Voyager Therapeutics has named Steven Paul as its full-time CEO, tasking the longtime Eli Lilly R&D exec with shepherding its gene therapy candidates into clinical trials.

Roche CEO Schwan took a hands-on approach negotiating $8.3B InterMune buyout

The flurry of meetings and phone calls between Schwan and Welch are spelled out in an SEC document InterMune filed late last week.

Feds pledge up to $42M to hit the gas on Mapp's Ebola drug

Tiny biotech Mapp Biopharmaceutical made global headlines this summer when its early-stage Ebola treatment helped rescue a few patients from the deadly virus, and now the U.S. government is ponying up funds to help the company get its drug into clinical trials.

Teva's well-traveled asthma drug comes through in Phase III

Teva is inching toward an FDA application for reslizumab, touting positive late-stage results for an asthma antibody passed around for years in multiple buyouts.

Fresh funds in hand, VentiRx joins AstraZeneca, Ludwig and CRI for combo immuno-oncology study

Yesterday, Seattle-based VentiRx Pharmaceuticals put out the word that it had raised a new round of cash to back an ongoing mid-stage study of motolimod (VTX-2337), its TLR8 cancer vaccine, adding that the biotech had won fast-track status for the program. And today the company is following up with the news that it's partnering with the Ludwig Cancer Research and the Cancer Research Institute on a new immuno-oncology combo development effort with AstraZeneca's hot checkpoint inhibitor MEDI-4736.

AbbVie ties the knot with Infinity in $805M blood cancer collaboration

AbbVie has agreed to hand over $275 million upfront to Infinity Pharmaceuticals in exchange for rights to develop and commercialize duvelisib, its oral PI3k-delta/gamma inhibitor for blood cancers. And the blockbuster-size deal for Infinity's lead program comes with $530 million in potential milestones.

GSK's new Boston collaboration chief goes 'anti-pharma' as he prowls for partners

GSK vet Jason Gardner is the newly named VP for R&D in the greater Boston area, in charge of a small but growing team of specialists at a brand-new satellite facility that will help coordinate not only the 25-or-so ongoing scientific collaborations with groups like the Harvard Stem Cell Institute but also biotech partnerships with the likes of Epizyme.

Mapp's Ebola treatment comes through in a preclinical study

Tiny Mapp Biopharmaceutical's much-scrutinized Ebola treatment proved 100% effective in animal studies, the company said, stoking hopes that the investigational therapy can help curb an outbreak of the virus.

Servier and Amgen's cardio drug faces uncertain future after trial flop

Ivabradine, a heart rate-reducing drug from Servier and Amgen, failed to beat placebo in a huge study of patients with coronary artery disease, potentially clouding its future on two continents.

Bristol-Myers dumps $1B-plus Alder deal, punts rheumatoid arthritis drug

Shares of Alder BioPharmaceuticals took a hit Tuesday morning after the biotech reported that Bristol-Myers Squibb had dumped its $1 billion-plus collaboration deal on the IL-6 drug clazakizumab, which had cleared a Phase IIb study for rheumatoid arthritis.

Acadia surges after nabbing 'breakthrough' title for late-stage Parkinson's drug

The FDA has just added a fresh boost to Acadia Pharmaceuticals, naming its late-stage Parkinson's drug pimavanserin a "breakthrough" therapy deserving rapid regulatory response as it nears the finish line with a closely watched marketing application.

UPDATED: Setback forces Novo Nordisk to abandon anti-inflammatory R&D work, affecting 400 staffers

Among all the pharma companies, Novo Nordisk always stood out for its relentless R&D focus on diabetes and obesity. Today, the Danish company amped up that concentration another notch, jettisoning a group of clinical programs and winding down its work in anti-inflammatory treatments. And the pharma player added that the move would hit some 400 staffers, with close to half likely to lose their jobs at Novo.