Pfizer has picked up a priority review designation for its closely watched cancer drug palbociclib, potentially slicing four months off the review timeline for a therapy that is being hustled along at an accelerated rate.
Last spring a prominent analyst suggested that a successful late-stage study for Smith & Nephew's spray-on cell therapy for wound healing could be a catalyst to break up the company a la Abbott and Baxter. But today, the discussion of the much buzzed-about trigger event turned bitter after the company reported that the Phase III trial flopped.
Gilead Sciences picked up a much-anticipated FDA approval for Harvoni, a combination therapy for hepatitis C that promises to cure the majority of patients without the need for painful injections that have plagued patients for years.
Novartis has expanded its relationship with the U.K.'s Oxford BioMedica, signing a deal worth up to $90 million that will support the drugmaker's efforts in CAR-T immunotherapies.
Prosensa has begun the FDA submission process for its treatment for Duchenne muscular dystrophy, planning to fully file by year's end with hopes of finally winning approval for a drug that has survived a few brushes with failure.
Isis Pharmaceuticals has kicked off a Phase III trial on ISIS-SMNrx, a treatment for the rare spinal muscular atrophy, moving forward with the orphan drug as partner Biogen Idec considers whether to take the plunge on the program.
David Mazzo is out at Regado Biosciences, resigning from the CEO post as the company he led into Phase III works to move on from a disastrous clinical roadblock.
Amgen is angling for an early FDA nod for the leukemia treatment blinatumomab, racing to market with what the company hopes will be the first of many cancer therapies derived from its proprietary T cell platform.
After 9 years of fruitless work on treatments for Alzheimer's disease and depression, AstraZeneca is dissolving its partnership with Targacept, leaving the battered biotech to pick up the pieces of its dwindling pipeline.
Famed corporate raider Carl Icahn is taking his agitating to Tumblr, from now on posting his musings in the realm of cat GIFs, teenage fan fiction and some questionable respect for intellectual property.
After acknowledging a midstage setback for its key respiratory drug benralizumab in COPD last month, AstraZeneca's big MedImmune division has come back with positive, though somewhat mixed, Phase IIb data underscoring the effectiveness of knocking down eosinophils--white blood cells--in preventing asthma attacks.
Welcome to the latest edition of our weekly EuroBiotech Report.
Shire's plans to squeeze more sales out of its blockbuster Adderall franchise are facing another delay, as the FDA wants more data on a new long-acting ADHD treatment that has languished in agency purgatory for years.
Biotech R&D is on a roll. For the third year in a row, the life sciences group at BDO has tracked a spike in R&D spending at a wide swath of public biotechs in the U.S. For drug developers with $50 million to $300 million in revenue, research budgets swelled 28%--to an average of $137 million--last year.
Endo found the magic number in its negotiations with Auxilium Pharmaceuticals, boosting its offer to $2.6 billion and finally convincing its target to abandon plans for a tax-saving deal.
After more than 25 years in drug development that culminated in a corner office at Calistoga Pharmaceuticals, Carol Gallagher decamped for the venture world last year, and now she has accepted a position at New Enterprise Associates to help nurture the next generation of disruptive biotechs.
Arrowhead Research watched its shares nose-dive after a peek at Phase II data on its in-development treatment for hepatitis B revealed that the RNAi therapy isn't measuring up to its preclinical promise.
Amgen has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie's megablockbuster anti-inflammatory. The Big Biotech reports today that its knockoff of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis.