Silenseed has formally scrapped its plan to list on Nasdaq. The developer of RNAi-based cancer drugs pitched up on Wall Street more than one year ago with a view to raising $36.4 million (€33.9 million), but has now admitted defeat.
NeuroDerm has received written confirmation from the FDA that it can file for approval of its Parkinson's disease treatment on the strength of data from one clinical trial, freeing it of the need to run a second, 360-person study. But with the FDA also demanding additional GMP documents from NeuroDerm's device supplier, investors were unsure whether the update was good or bad news.
Forum Pharmaceuticals has gotten out from under an FDA clinical hold on a Phase III schizophrenia study for its lead drug, but the company's efforts to develop the treatment for Alzheimer's disease remain halted.
Google Life Sciences joined the American Heart Association in creating a new $50 million research initiative to find better heart drugs.
Brent Saunders has vaulted from Bausch & Lomb to Forest Labs and then on to the helm of a rapidly evolving Allergan. And with Allergan now in amiable discussions for a megamerger with Pfizer, the management team quarterback clearly has his sights set on the big prize: CEO of a greatly expanded pharma giant.
German drugmaker Boehringer Ingelheim is planning to dial down its R&D spend over the next 5 years, turning to a growing stable of external collaborators to feed its pipeline of new therapeutics.
As Wall Street vacillates on the whole biotech sector, each week becomes an unwitting referendum on just how long the IPO window for drug developers might stay open. Voyager Therapeutics and Wave Life Sciences, raising a combined $172 million this week, demonstrated that biotech's years-long boom on the public markets is not quite through.
Some of the old San Diego gang that brought you Lumena--bought out by Shire last year--have moved into top positions at Amplyx Pharmaceuticals as the biotech heads in a new direction, pointing a recently in-licensed antifungal product toward the clinic with $40.5 million from a high-profile group of venture players.
Just weeks after announcing a fresh batch of promising Phase III data, the FDA has handed Genentech and its biotech partner Exelixis an approval to market cobimetinib in combination with Zelboraf among a genetically defined group of melanoma patients.
Sophiris Bio's treatment for enlarged prostate met its main goal in a Phase III trial after looking like a sure miss in a prior peek at results, rewarding the company's faith and setting the stage for a second late-stage study.
Amgen's knockoff of AbbVie's top-selling Humira measured up to its reference product in a Phase III trial, clearing the way for the Big Biotech as it waits for the blockbuster injection to lose patent protection next year.
Roche has inked a collaboration deal with Madison, WI-based Cellular Dynamics for a supply of induced pluripotent stem cell-derived iCell products that can be used to ID new drug candidates.
Boulder, CO-based miRagen Therapeutics has scooped up a $41 million C round designed to get its lead microRNA drugs into the clinic in the hunt for some convincing proof-of-concept data.
AstraZeneca says it has a prime late-stage drug contender in the clinic that has the potential to compete for the lupus market. But it is lining up against GlaxoSmithKline, which has been touting promising Phase III data this week for a new subcutaneous formulation of Benlysta, a drug that has frequently disappointed analysts who have been tracking its sales over the years.
Back in 2011, when Sanofi acquired Genzyme for about $20 billion, it promised the company's shareholders up to $3.8 billion more tied to the then-in-development multiple sclerosis treatment Lemtrada. Things went awry in 2013 when the FDA rejected the therapy, but a new shareholder lawsuit claims that's just what Sanofi wanted.
Astellas Pharma has stepped up with a $379 million bid for Ocata Therapeutics, a pioneering--and often controversial--stem cell company that has managed to survive a years-long roller coaster ride through the hype, hope and disappointments of the past decade.
One of Agios Pharmaceuticals' blood cancer treatments demonstrated promise in a Phase I study against solid tumors, but the results fell short of some investors' expectations, sending the company's share value down about 10%.
Former Aveo Oncology CEO Tuan Ha-Ngoc has left his post as chairman of the company's board, walking away from the struggling drugmaker as it tries to reverse a long line of missteps.
A little more than two years ago Amgen and its partner Cytokinetics were hit by a backlash as their IV version of the heart drug omecamtiv mecarbil failed a key Phase IIb trial for heart disease. A follow-up study of an oral version of the drug, though, proved positive, the partners announced over the weekend, opening up a potential path forward into late-stage studies.
Collegium Pharmaceutical won FDA approval for its abuse-deterrent take on oxycodone, but an ongoing patent dispute with Purdue Pharma stands in the way of the drug's launch.