French drugmaker Servier has outlicensed some early-stage cancer treatments to Horizon Discovery, holding on to the rights to buy them back if they come through in preclinical development.
The European Medicines Agency has put Cell Therapy's Heartcel on its conditional approval pathway, raising the possibility the allogeneic stem cell therapy could come to market in 2017. And with the drug now nearing the market, Cell Therapy has begun to sound out investors about an IPO.
Euroscreen has topped up its bank balance to support the globalization of its clinical trial program. The €16 million ($18 million) round will allow the g-protein coupled receptor (GPCR) specialist to file an IND and advance ongoing Phase II trials of its lead candidate in women's health diseases.
Shares in DBV Technologies traded up as much as 13% in Paris following the publication of long-term data from a trial of its peanut allergy treatment. The open-label extension to a Phase IIb trial found the extra year of taking with Viaskin Peanut was associated with a rise in the proportion of kids who responded to the treatment.
Merck KGaA and Pfizer, playing catch-up among drug companies using the immune system to fight cancer, picked up the FDA's fast-track designation for their in-development therapy, designed to expedite its eventual review.
Big Pharma has been willing to pay hundreds of millions of dollars for a shortcut to FDA approval, buying up priority review vouchers created to incentivize new drugs for neglected diseases. But the agency seems less than enthusiastic about honoring its end of the bargain, with one top official expressing concerns about how the voucher program might harm the FDA's core mission.
Dermatology drug developer Aclaris Therapeutics priced its IPO well below its expected range, raising $55 million as a prolonged bear turn has dampened Wall Street's appetite for biotech debuts.
Atlas Venture startup Quartet Medicine added $6.25 million to its Series A fundraise, closing the round at $23.25 million as it moves toward clinical trials with a newfangled way of treating chronic pain.
Two weeks after reporting that its cancer vaccine spurred a positive response among a group of cervical cancer patients in a small clinical trial, Advaxis waited until after the market closed today to reveal that the FDA has placed the same cancer vaccine--axalimogene filolisbac (ADXS-HPV)--on a clinical hold, slamming the brakes on four studies.
U.K. biotech Adaptimmune Therapeutics is expanding its ranks as it moves forward with a pipeline of cancer immunotherapies, leasing a big R&D facility near its native Oxford.
Cambridge, MA-based Rodin Therapeutics has recruited biotech vet Adam Rosenberg as its new CEO.
Is the long-running bull market for biotech dead? Or will it rebound later this year? Take the poll.
Axovant Sciences, rolling the dice on a once-failed Alzheimer's disease treatment, kicked off its big Phase III trial, a make-or-break effort that could spawn a blockbuster drug or liquidate the company's value.
Genentech has added another piece of the trial puzzle for its MEK inhibitor cobimetinib. The big Roche subsidiary's partner Exelixis announced early Tuesday that the drug combined with Zelboraf hit the mark in a Phase III study, offering a statistically significant overall survival benefit among advanced melanoma patients carrying a BRAF V600 mutation.
Alkermes picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia.
Seattle-based Theraclone is launching a new biotech focused on the burgeoning field of cancer immunotherapies--OncoResponse--that will operate in Houston in partnership with the entrepreneurial researchers at MD Anderson, setting out with a $9.5 million Series A.
Otonomy, developing treatments for ear disorders, got FDA clearance to start a clinical trial of its therapy for tinnitus.
Turing Pharmaceuticals has revealed its first post-Daraprim R&D project: an early-stage therapy for rare and severe brain disorders. Called TUR-004, Turing's candidate is designed to serve as an add-on treatment for easing seizures tied to epileptic encephalopathies, a group of syndromes that crop up in early childhood and are often fatal.
Fidelity Biosciences, a big venture backer of dozens of global biotech companies, is tying up with Devonshire Capital--which once was called Fidelity Capital--and changing its name to F-Prime Capital.
U.S. trade officials have finally delivered a Pacific Rim accord designed to forge closer business ties with eastern Asia and knit together Pacific commerce. But to complete the Trans-Pacific trade deal, the U.S. reportedly had to step far back from a hotly sought-after provision that would have guaranteed market exclusivity for new biologics by 12 years throughout the vast region.