Google made major waves two months ago when it landed former Genentech CEO Art Levinson to run its still-murky Calico offshoot. Now the biotech elder statesman is reuniting with his former chief medical officer, convincing Hal Barron to leave his post at Roche and oversee R&D at the nascent company.
Last year, Anthera Pharmaceuticals pulled the plug on its lead drug after the cardiovascular disease treatment ran into some insurmountable efficacy problems in Phase III but failed to mention that the now-discarded varespladib actually increased patients' risks of heart attack and stroke. The study's lead investigator said Anthera dragged its feet in releasing the data.
The FDA has accepted an NDA for Nektar Therapeutics' naloxegol, triggering a $70 million milestone payment from partner AstraZeneca.
AstraZeneca and its stilted R&D division aren't scheduled to move to Cambridge, U.K., until 2016, but the drugmaker can't wait to settle in at what it calls "one of the world's preeminent biosciences hotspots," planning to send an advance team of scientists to plant some collaborative seeds.
Gilead Sciences is sprinting toward FDA approval with the promising idelalisib, a targeted cancer therapy that met all its Phase III endpoints, giving the company another boost in the competitive landscape for chronic lymphocytic leukemia treatments.
In the latest trove of promising Phase III data for Amgen's T-Vec, the cancer-fighting virus increased overall survival by four months compared to standard growth factor therapy, driving optimism that the drug can win approval and make some noise in the melanoma market.
Merck highlighted evidence of a rising response rate to its closely watched immunotherapy MK-3475, spotlighting an 81% overall survival rate for advanced melanoma patients after 12 months of therapy with 41% of all patients demonstrating tumor shrinkage--rising to an impressive 51% for one group at the high end of the dose range.
The Strüngmann brothers' expensive taste for biotech companies has helped generate another big venture round for Ganymed Pharmaceuticals, a German biotech with claims to some cutting-edge cancer drug technology.
As of last year, biotech products accounted for 71% of the revenue generated by the top 10 pharmaceutical-biotech products, according to a new report from the Tufts Center for the Study of Drug Development.
Pfizer's venture arm has chipped in to a $32 million venture round for Mission Therapeutics, a Cambridge, U.K.-based biotech developing deubiquitylating enzyme inhibitors. Existing investors Sofinnova Partners, Imperial Innovations, S.R. One (GlaxoSmithKline) and Roche Venture Fund also contributed to the round.
With Gilead's pioneering hepatitis C drug sofosbuvir moving closer to a likely approval and a megablockbuster market, AbbVie is looming from behind with some promising results from the first of 6 Phase III studies of its breakthrough triple-threat therapy.
Shifting more of its focus to clinical drug development, Cambridge, MA-based Aileron Therapeutics has rounded up $30 million in Series E cash to fund a Phase I/IIa study of its p53-targeted cancer drug candidate.
Four months after Sanofi wrote off its late-stage cancer drug iniparib as a total loss, the pharma giant has been forced by safety concerns to shutter its program for the JAK2 inhibitor fedratinib in another major blow to its efforts to develop a portfolio of oncology treatments.
BioMarin's drug for a rare enzyme deficiency resulted in a "modest" improvement for patients, according to an FDA staff review, possibly lowering expectations for the company's Tuesday meeting with an agency advisory panel.
On the heels of new guidelines casting doubts on a much-hyped new class of cholesterol drugs, the FDA said it would not demand long and costly outcomes trials before approving PCSK9 treatments from the likes of Amgen, Sanofi and Regeneron, clearing the way for treatments expected to rake in up to $3 billion a year.
Long-troubled biotech Cell Therapeutics has landed a big-name partner for its Phase III myelofibrosis drug, convincing Baxter to shell out $60 million upfront for a cut of pacritinib.
Promising results from early-stage work on Zafgen's weight drug beloranib clear a path to a Phase IIb trial that can fine-tune the dose while taking more time to gauge the long-term impact of its treatment on weight and set the right tone for ongoing talks with investors about a new financing round for the biotech.
Cambridge, MA's Catabasis Pharmaceuticals has landed a $32.4 million Series B to advance its triglyceride-fighting drug, setting sights on a swelling market with a compound the company believes can outperform its competitors.
Riding high on a surprisingly positive FDA staff review, Vanda Pharmaceuticals and its drug for a rare sleep disorder skated to an expected endorsement from a panel of agency advisers, sending the company's shares up another 20% after hours.