News

Pfizer nabs a fast FDA review for breast cancer pipeline star palbociclib

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.

Smith & Nephew hit by setback as PhIII regenerative med study flops

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.

2014's most successful biotech IPOs

In 2013, biotech toasted its warmest Wall Street reception since the frothy days of the early millennium, helping more than 45 drug developers pull off IPOs that brought in more than $3 billion to...

Gilead wins FDA approval for its hep C combo pill, a blockbuster in the making

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 taps Oxford BioMedica in $90M immuno-oncology deal

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 heads to the FDA with its once-failed DMD treatment

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 rolls into Phase III with an orphan drug as it waits on Biogen

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.

Novartis to shed three division heads in midst of Glaxo, Lilly deal prep

Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Michael Gibney (email | Twitter)...

Regado's CEO steps down as the biotech limps forward

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 eyes a speedy approval for its leukemia contender

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.

AstraZeneca finally bails on troubled Targacept after years of failure

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.

Barbarian @ the gate: Carl Icahn joins Tumblr

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.

AstraZeneca gets some upbeat asthma data to back would-be IL-5 blockbuster

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.

Shire's long-delayed ADHD drug hits another FDA speed bump

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.

Biotechs tap a swelling tide of investment cash to fund growing R&D ops

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.

Auxilium takes money, runs from inversion with $2.6B Endo deal

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.

VC giant NEA recruits biotech vet Carol Gallagher to join its ranks of dealmakers

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 tanks as its hep B treatment disappoints in Phase II

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 declares a head-to-head PhIII win for Humira biosimilar

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.