Still riding high on some strong early-year data for its liver disease treatment, Intercept Pharmaceuticals' shares shot up once more as its lead drug came through in Phase IIb, dismissing some earlier safety worries and setting the table for late-stage study.
After making international headlines with the West's first approval for a gene therapy, pioneering biotech uniQure is working to flesh out its pipeline of one-time treatments, buying into an early-stage shot at heart failure that could put its technology on the biggest stage yet.
Connecticut biotech Biodel is touting midstage results for its long-acting insulin, as the in-development BIOD-531 better controlled glucose than two Eli Lilly therapies.
Denmark's Forward Pharma has a plan to contend with Biogen Idec and its multibillion-selling multiple sclerosis drug Tecfidera, eyeing $200 million in a U.S. IPO to bankroll its offensive.
Johnson & Johnson's canagliflozin was the first to win FDA approval among a new class of diabetes therapies, and now it's the star of the first such combination therapy to pass agency muster, helping the drug stand out in an increasingly cluttered market.
Calico, Google's first major foray into biotech, has been quietly filling its ranks and fleshing out its mission in the months since its existence first came to light, bringing together industry luminaries to tackle the broad issue of aging.
MannKind has finally nailed down the major league pharma player it always wanted to roll out its inhaled insulin product Afrezza. But after going it alone to nail down an FDA approval on a new therapy that continues to generate heavy skepticism about its marketing potential, the numbers involved so far are still strictly minor league.
It took GlaxoSmithKline 30 years to get its new malaria vaccine ready for regulatory review. But global health officials--driven by a worldwide clamor--are excitedly pointing to GSK now as one of its prime candidates for getting a vaccine to fight Ebola in a matter of months.
A week ago, Israel's VBL Therapeutics had just priced a $65 million IPO and was gearing up for late-stage work on its lead cancer candidate. Now, after an "unexpected situation," the company said its public debut has come undone.
Sanofi has reached out to Seattle biotech Immune Design, looking to borrow the company's drug discovery platform to develop new treatments for food allergies.
Japanese drugmaker Astellas Pharma has teamed up with Cancer Research U.K. to join forces on early-stage oncology R&D, working to identify new treatments for pancreatic cancer.
Salt Lake City biotech Tolero Pharmaceuticals has raised $14.2 million in Series B cash to bankroll the development of alvocidib, a marrow cancer treatment on the verge of late-stage trials.
GlaxoSmithKline has again scaled back its expectations for an anti-inflammatory treatment licensed from Galapagos, calling off any plans for late-stage study after a few Phase II miscues dulled the drug's potential.
Shares of Tekmira got a boost Thursday night after the company spread the word that the FDA had switched its full clinical hold on an experimental Ebola drug to a partial hold, clearing the path to its possible use to fight a sudden outbreak in Africa that has been sparking chilling headlines the world over.
In this week's EuroBiotech Report, Roche took another step back into RNA, striking a $450 million (€335 million) deal to acquire Santaris Pharma and committing to making the Danish biotech's lab its RNA therapeutics research unit. And more.
Seattle's CTI BioPharma picked up the FDA's fast-track designation for pacritinib, a late-stage treatment for blood cancer.
Tobira Therapeutics and Microlin Bio are pressing pause on their Wall Street hopes, postponing IPOs that would have totaled $88 million at their midpoint and falling victim to a back-and-forth market for biotech debuts.
Daiichi Sankyo, Japan's second-largest pharma outfit, has agreed to pay up to $650 million to get its hands on some hydrocodone combo medications, striking a deal with Charleston Laboratories with hopes of cashing in on the demand for pain pills.
It's not often that the president of the United States is asked to weigh in on whether an experimental drug should be OK'd for human use ahead of human trials. But when it comes to an outbreak of a lethal virus--even one that's been percolating in equatorial Africa for decades--everything is potential fodder for reporters operating in a 24-hour news cycle.