The FDA rejected IntelGenx and RedHill Biopharma's dissolvable migraine treatment VersaFilm due to problems with a third-party manufacturer, the companies said. The two still believe they can sway regulators and get the drug on the U.S. market.
New Enterprise Associates has stepped up to help with a $14 million A round designed to get Austin, TX-based startup Lumos Pharmaceuticals in the clinic with a new therapy for an autism spectrum disorder characterized by severe cognitive impairment.
Eisai has begun to lay the groundwork for a slate of marketing applications in the U.S., Europe and Japan for a new thyroid cancer therapy after wrapping up a successful Phase III study of the drug, which is also noteworthy for relying on an innovative collaborative approach to the development process
The National Institutes of Health has persuaded 10 rival drugmakers to briefly set aside their competitive spirits and collaborate on drug discovery projects in four major diseases, pooling their data and expertise to kick-start early-stage efforts.
Seattle biotech Acucela is on track to test whether the stateside IPO boom has legs overseas, pricing a public offering in Japan for $162.3 million.
Furiex Pharmaceuticals says it collected positive data from a pair of late-stage studies on its lead drug for irritable bowel syndrome. The developer expects the data to spur interest in a buyout based on what it sees as "blockbuster" potential for its therapy.
Japan's Dainippon Sumitomo Pharma has expanded its alliance with upstart Edison Pharmaceuticals, committing $50 million to jointly develop treatments for orphan diseases with nearly $4 billion more tied to down-the-road milestones.
Portola Pharmaceuticals' promising antidote for blood thinners has attracted a who's-who of Big Pharma partners, and now the biotech is advancing its reverser of Factor Xa inhibitors to Phase III with the help of Bayer and Johnson & Johnson.
Fast on the heels of two big biotech IPOs at the end of last week, Renaissance Capital is tracking 9 more life sciences companies looking to go public this week in a fresh burst of new offerings that could threaten to glut the market. Altogether, the developers have set their sights on raising roughly $500 million in a matter of days.
GlaxoSmithKline picked up a slate of new drug approvals in 2013, a key accomplishment for a pharma giant that set out several years ago to shake up a moribund, multibillion-dollar research operation.
A few days ago, as Pfizer executives reviewed the pharma giant's numbers for 2013 and plans for 2014, analysts detected a growing willingness to see if they could hunt up an accelerated approval for palbociclib if the Phase II study for breast cancer rang up promising results.
Right now, any biotech that might have the key to new and better checkpoint immunotherapies is the belle of the deal-making ball. And Belgium's Ablynx--which has been lining up pharma giants for a string of 9-figure deals to develop next-gen antibodies--just parlayed its tech know-how into a heavily backloaded $2.3 billion discovery deal with Merck, arguably the leader in the field.
Merck has joined the growing list of entities pulling the plug on chimpanzee research, folding to activist pressure and dismissing its primate subjects once and for all.
With the help of Syncona, the Wellcome Trust's venture arm, Oxford University spinout NightstaRx has $20 million and a plan to develop gene therapies for degenarative eye conditions.
AbbVie has wrapped up its late-stage studies of a promising interferon-free hepatitis C cocktail, setting the stage for near-term FDA application and a showdown with rival Gilead Sciences.
Amgen is batting 1.000 in its ambitious clinical program for the promising PCSK9 cholesterol drug evolocumab (AMG-145), unveiling a 5th successful Phase III study as it prepares for an FDA application that could give it first-mover status in a blockbuster field.
The big question at the beginning of this year was whether investors would continue to eagerly buy up shares offered in new biotech IPOs, continuing the burst of new offerings that injected billions of dollars into the industry last year. As of today, the answer--for at least a few select biotechs--is a boisterous "yes."
You can scratch Eli Lilly's copycat version of Lantus off its short list of near-term approval prospects. Sanofi says it has filed a lawsuit against Lilly claiming that the pharma rival infringed four of its patents, which is likely to delay any launch until the middle of 2016.
Aveo Oncology and Astellas Pharma are shutting down a Phase II study of tivozanib in breast cancer after failing to enroll enough patients, the partners announced.