Welcome to the latest edition of our weekly EuroBiotech Report.
The FDA has slapped down Bristol-Myers Squibb's closely watched hep C drug daclatasvir, handing out a complete response letter for the linchpin drug in its cocktail strategy.
Novartis has washed its hands of a researcher who admitted to falsifying results in a series of published papers, promising to dig into his work at the company to determine whether the pattern continued in its own labs.
Scientists with the UC Irvine School of Medicine and the Italian Institute of Technology have spotlighted what they call the "very first class" of acid ceramidase inhibitors that could eventually go on to help amp up the effectiveness of chemotherapies.
The growing biotech hub in the Boston area has attracted drug developers virtual and multinational to set up shop near the bay, but the boom in demand is threatening to outstrip inventory, according to the Boston Business Journal.
What makes Woodford such a potent figure is the example he sets in backing global drug development, where even small companies knit together scientific, administrative and support functions from an international cast of players.
While investors have been pouring hundreds of millions of dollars into a virtual Manhattan Project on new immuno-oncology drugs, a startup that sprang out of a lab at New York University's Langone Medical Center has taken the first steps in what it sees as a unique follow-up to the first wave of therapies.
Ampio Pharmaceuticals has postponed a plot to spin out one of its subsidiaries through an IPO, citing unfavorable market conditions.
Amgen and AstraZeneca have racked up their third straight Phase III win for brodalumab in plaque psoriasis, beating J&J's Stelara in a head-to-head study. The news comes just two weeks after the pharma partners posted their latest positive results, positioning them for a run at regulators on both sides of the Atlantic.
Five years after the FDA formally rejected J&J's Yondelis (trabectedin) for ovarian cancer, and three years after an aborted effort to get it back on track, the pharma giant has finally made its way back to the agency for another try at an approval--this time as a treatment for soft tissue sarcoma.
Promethera Biosciences has put together €25.3 million ($31.4 million) in equity and loans to hit the gas on its stem cell treatment for rare liver diseases.
Will they or won't they? That question seems to be on quite a few minds these days as the oddsmakers assess the chances of another Pfizer megamerger bid for AstraZeneca after the U.K.'s cooling off period ends on Wednesday.
The FDA wants more time to deliberate on Novartis' panobinostat, a multiple myeloma treatment that failed to impress a panel of independent experts, signaling a delay that could nearly negate the agency's previous promise of a speedy review.
London's Cell Medica has raised a £50 million ($78 million) B round to support its work on treatments that train the body's immune system to fight cancer and infectious disease, rolling through midstage trials with an oncology candidate.
High-profile U.K. investor Neil Woodford made headlines last week when he invested $25 million into Northwest Biotherapeutics, and that's a sign of much more to come, according to reports, as the ex-Invesco manager is planning to unveil a new fund devoted solely to emerging biotechs.
Johnson & Johnson is following in the footsteps of pioneers like Novartis, Celgene and GlaxoSmithKline, inking a discovery-stage development deal--but turning to the little-known Transposagen Biopharmaceuticals to make its entry.
PRA Health Sciences and INC Research have both seen their shares tick upward since pulling off IPOs earlier this month, a sign that, despite biotech's boom and bust, the window for CRO debuts remains open.
Bristol-Myers Squibb has signed a deal with Five Prime Therapeutics to determine whether a combination of its star immuno-oncology contender and the biotech's antibody can make a difference in a range of cancers.
Amgen is calling off all clinical studies on rilotumumab in advanced gastric cancer after a peek at Phase III data revealed that the drug was actually making matters worse for patients, further marring the value of the company's oncology pipeline.
Polaris Partners, an ambitious venture investor that's been behind a legion of cutting-edge biotech startups, has come up with $450 million for its latest fund. The cash tops the $400 million mark that the VC had outlined in an SEC filing last summer, signaling another success for the year's blossoming class of new biotech venture funds.