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.
Merck has secured the FDA's fast-track designation for its latest antibiotic candidate, a mid-stage treatment for complicated infections.
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.
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.
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.
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.
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.
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.
The flurry of meetings and phone calls between Schwan and Welch are spelled out in an SEC document InterMune filed late last week.
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 is inching toward an FDA application for reslizumab, touting positive late-stage results for an asthma antibody passed around for years in multiple buyouts.
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 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 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.
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.
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.
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.
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.
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.