After posting some early clinical success with its first gene therapy project, University of Oxford spinout NightstaRx is looking to widen its pipeline of projects, recruiting venture giant New Enterprise Associates to pitch in on a $35 million funding round.
Eight months after Teva scooped up the promising SD-809 (deutetrabenazine) to correct a severe movement disorder afflicting some 500,000 patients in the U.S., the company has scored bragging rights to the FDA's breakthrough drug designation.
Olivier Brandicourt got his first shot at Sanofi's lead role in an annual investor day, and the reviews are not good. Brandicourt had a tough message to sell. The company's diabetes franchise is getting hammered, with the all-important Lantus business weakening, which means that R&D as well as SG&A are going to eat up a higher percentage of revenue for at least a couple of years.
Amgen is jumping back into the M&A game. And it's looking for another Onyx-sized deal that can deliver a late-stage drug ready to be hustled across the finish line.
Partners GlaxoSmithKline and Avalon Ventures have seeded a 7th startup in their company-building collaboration, lining up $10 million for a new effort to treat ALS.
GenSight Biologics has postponed its plans to go public after repeatedly downsizing its ambition, marking the latest setback for Wall Street-bound biotechs dealing with a sectorwide downturn.
Allergan CEO Brent Saunders, who once called Big Pharma's perceived need for drug discovery "a fallacy," has come around on early-stage research, a change in tone that happens to coincide with Pfizer's stated interest in buying his company.
Sanofi, stockpiling diabetes assets with eyes on Novo Nordisk and Eli Lilly, inked a deal worth up to $1.7 billion to bring in a late-stage treatment for the disease, partnering up with Lexicon Pharmaceuticals.
AstraZeneca agreed to buy ZS Pharma and its pending-approval kidney drug, one-upping rival bidder Actelion to get its hands on what it believes is a blockbuster in the making.
In this week's EuroBiotech Report, market analyst Biocom calculated that European biotechs raised €1 billion ($1.1 billion) through IPOs worldwide over the first 9 months of the year, 18% more than over the same period of 2014. And more.
KaloBios, battered by a string of clinical failures, is planning to soldier on with its thinning pipeline, cutting 61% of its workforce to conserve cash.
Gilead Sciences won FDA approval for another combination tablet designed to keep HIV from replicating itself, a drug the company touts as a safer alternative to products already on the market.
AstraZeneca, working to catch up with Merck and Bristol-Myers Squibb in the growing field of immuno-oncology, said its treatment is unlikely to win speedy approval in lung cancer due to the presence of more advanced agents.
Bluebird bio has seen its share price soar over the past year on the promise that its in-development gene therapy could be a functional cure for a rare blood disease. But new clinical data reveal that not all patients respond the same way, possibly dimming the potential of the company's lead treatment.
GlaxoSmithKline is preparing to move the granulocyte macrophage colony-stimulating factor antibody it licensed from MorphoSys into a Phase II trial in osteoarthritis of the hand. The move opens up a new possible indication for the drug, which GSK saw primarily as a treatment for rheumatoid arthritis when it picked it up in a €445 million ($483 million) deal.
Adocia has taken a step toward a planned Phase III trial of its combination of Eli Lilly's Humalog and Sanofi's Lantus. The latest hurdle to be cleared was a Phase Ib trial, in which Adocia's BioChaperone Combo triggered significantly bigger post-meal drops in blood glucose than Humalog alone.
Sanofi signed a deal worth up to $4.2 billion to get its hands on a trio of diabetes treatments from South Korean drugmaker Hanmi Pharmaceutical, filling out its pipeline as it contends with rivals Novo Nordisk and Eli Lilly.
GlaxoSmithKline and the Bill & Melinda Gates Foundation have contributed to a $56 million Series A investment in Atreca. The immuno-oncology biotech, which has yet to advance a program into preclinical testing, will plow the cash into a pipeline of drugs designed to boost the effectiveness of checkpoint inhibitors and immune activators.
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the latest turns in the Valeant Pharmaceuticals saga, the seeming inevitability of a Pfizer-Allergan merger, and Shire's up-and-down efforts to buy stuff it wants.