Shire and AbbVie have formally called it quits on a planned $55 billion merger, leaving each company to get by on the merits of its own pipeline and talk up the benefits of life without the other.
Earlier this year, Cytokinetics tanked as its lead prospect, a treatment for amyotrophic lateral sclerosis (ALS), missed its primary endpoint and a slew of secondary goals in a mid-stage trial. But the drug did come through on one measure of lung function, and, upon analysis of the results, the biotech believes that could be its ticket to FDA approval.
A panel of FDA advisers voted unanimously in favor of approving Novartis' new anti-inflammatory treatment, an expected positive outcome for the company as it races to be first in line among what promises to be a crowded field.
While its merger with AbbVie is looking dead, Shire is likely in line for a $1.6 billion breakup fee, cash that could fund a major M&A push. And with renowned dealmakers in its executive ranks, Shire may not be lonely for long.
While the testosterone therapy field is under fire from government regulators, Menlo Park, CA-based TesoRx is licensing its oral-testosterone replacement therapy to a subsidiary of South African generics maker Aspen Pharmacare.
After 11 years at the helm of Cubist Pharmaceuticals, CEO Michael Bonney is stepping down and handing the reins to COO and President Robert Perez.
Welcome to the hall of shame, where blockbuster drug projections go to die. This list includes some drugs that clearly should never have wound up in Phase III to begin with, a few that were steered back to the clinic in a doomed attempt to mine something positive, and a couple of notable exceptions that may have helped advance the field by exploring the outer limits of new drug technology.
Biotech startup machine PureTech has raised a $55 million round to fund the next stage of its evolution, recruiting some big thinkers to help it advance its stable of ventures and develop new technologies.
Biotech powerhouse Genentech is going all in with Ames, IA-based NewLink Genetics, partnering on an early-stage cancer program which has been billed as an important example of a new class of checkpoint inhibitor. And Genentech says that it plans to build a portfolio of programs pairing this therapeutic with Roche's closely watched PD-L1 drug.
As fervor surrounding a new class of cancer drugs builds, drug giants Merck and Roche are set to roll out new data for their opposing immunotherapy drugs for breast cancer by the end of the year.
Astellas and CoMentis are calling it quits on their partnership in Alzheimer's disease, as the Japanese drugmaker walks away from a deal valued at up to $760 million.
Sanofi and Regeneron have cut to the front of the line in the race to develop a new class of cardio drugs, but now rival Amgen has made a chess move of its own, filing a patent-infringement lawsuit designed to block its rivals from reaching what's expected to be a blockbuster market.
After years of clinical and regulatory setbacks, Repros Therapeutics was finally on the path to submitting its testosterone treatment to the FDA, scheduling a prefiling meeting for November with hopes of handing the drug in by year's end. But the agency has had some second thoughts, changing the agenda for the meeting and indefinitely delaying Repros' plans.
Adaptimmune's pioneering approach to cancer immunotherapy has charted some impressive results in a small study. And while the biotech is quick to point out that it's early days yet, the data underscore the potential of a therapy that has convinced GlaxoSmithKline to bet up to $350 million on its future.
Last quarter biotech attracted a whopping $1.8 billion in new venture cash, the biggest quarter since 2005.
In this week's EuroBiotech Report, AbbVie showed that efforts to clamp down on inversions are having an effect, while Ireland committed to closing the door on the "Double Irish" tax scheme. And more.
The benefits of Novartis' new anti-inflammatory treatment outweigh its risks, according to FDA reviewers, an opinion that improves the odds of approval for a drug the company hopes can bring in blockbuster sales.
Today Menlo Park, CA-based Canaan is rolling out a new fund, its 10th, with $675 million to invest in new companies--about a third of which will be devoted to biotech and healthcare.