The FDA has slammed the brakes on the late-stage Alzheimer's development program for encenicline after investigators reported a "small" number of serious gastrointestinal adverse events among patients taking the drug, the lead therapy for Waltham, MA-based Forum Pharmaceuticals.
Nine months after Patrick Soon-Shiong struck a deal to acquire the global rights to a failed cancer drug at Amgen, the biotech billionaire has come back for a second oncology program. Soon-Shiong's NantPharma has in-licensed Amgen's AMG 337, a mid-stage MET inhibitor in the clinic for gastric cancer.
The biotech arm of Merck KGaA is building a 16,000-square-meter addition to accommodate 200 research staffers, noting that the facility should be ready in 2017.
Sanofi's second pivotal trial for a new diabetes drug combo came through with positive head-to-head results against Lantus, according to its biotech partner. And that clears the last hurdle standing in the way of marketing applications on both sides of the Atlantic as it tries to shore up an eroding blockbuster franchise against heated competition.
Collegium Pharmaceuticals' hard-to-abuse opioid treatment won unanimous backing from a panel of FDA advisers, clearing the path to a likely approval next month.
"From a U.S. perspective, I think the fundamentals of the sector are broadly still sound," says SVB London-based analyst Nooman Haque.
Dimension Therapeutics is preparing to execute the next carefully planned step in its evolution, filing for a $115 million IPO close to 5 months after its crossover round landed. The filing came just days after the FDA accepted Cambridge, MA-based Dimension's IND for its lead gene therapy program, targeting a genetic fix for hemophilia B.
Raptor Pharmaceuticals is pulling the plug on a treatment for a pervasive liver disease after its top prospect failed in a Phase IIb study, torpedoing the company's market value.
Last fall, Acacia Pharma's virtual crew cheered the late-stage success of a drug designed to prevent postoperative nausea and vomiting by bringing in strategic advisers to help hammer out a path forward. And evidently, they concluded that setting out to raise $230 million on the London Stock Exchange was the right way to go.
Melinta Therapeutics CEO Mary Szela has left the company in the middle of a late-stage program for its lead antibiotic, a move that comes just months after the biotech raised $67 million in equity financing.
Days after Gilead Sciences spurred a wave of buyout rumors with its effort to bring in $10 billion, Biogen laid out plans to raise $6 billion of its own, providing few details as it looks to bolster its cash position.
Eli Lilly, blueprinting an R&D hub outside Boston, is expanding the square footage of its new outpost, snatching up more of the increasingly costly lab space in biotech's most in-demand neighborhood.
NantCell, one of billionaire entrepreneur Patrick Soon-Shiong's biotech ventures, raised $100 million in equity cash, moving forward with some in-licensed immuno-oncology treatments.
Merck KGaA is bringing cladribine--the multiple sclerosis pill scuttled by regulatory rejections on both sides of the Atlantic four years ago--back from the dead.
A panel of FDA advisers voted against approving the latest pain treatment from Purdue Pharma, worried that quirks in the pill's dosing could put patients at risk.
FierceBiotech Radio on GSK's latest setback, Kyle Bass' 'truthful irrelevancy,' and Horizon's web presence
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the latest setback in a bad run of form for GlaxoSmithKline, Kyle Bass' trouble with drug patents, and a new twist in the buyout battle between Horizon Pharma and Depomed.
In this week's EuroBiotech Report, Finland's Faron Pharmaceuticals and the U.K.'s Shield Therapeutics are both gunning for London IPOs, with the latter's £110 million ($169 million) fundraising goal setting the exchange up for a big-ticket end to 2015. And more.
ZS Pharma, awaiting FDA approval for a kidney drug, saw its share value soar about 30% after Actelion confirmed that it's discussing a multibillion-dollar buyout with the company.
Up to now, San Diego-based AnaptysBio has raised close to $49 million in cash directly from collaborators looking to the antibody shop to use their technology to create some promising new programs--slightly more than its cumulative burn rate over the years. Now, it's filed papers with the SEC for an $86 million IPO, looking to join the queue of biotechs out to test the marketplace in the wake of some severe turbulence.