News

Is the CF Foundation's $3.3B royalty windfall good or bad for patients?

The Cystic Fibrosis Foundation announced today that it had cashed in its royalty stream from Vertex Pharmaceuticals' breakthrough CF drugs it backed for a $3.3 billion windfall. But where the foundation trumpeted the blockbuster deal with Royalty Pharma as a prelude to more investments into next-gen drugs, the New York Times' Andrew Pollack had no trouble finding a critic eager to lambaste the foundation for the ultimate sin: putting profits ahead of patients.

Bellicum plots a $115M IPO to cut in on the CAR-T race

Houston biotech Bellicum Pharmaceuticals is angling to raise $115 million in an IPO, funds that would help it accelerate its work in the high-profile field of cancer immunotherapy.

UPDATED: Go-go execs at Gilead nab an FDA priority review voucher for $125M

The market price of a priority review voucher at the FDA just doubled. Canada's Knight Therapeutics has auctioned off its voucher--which can be turned in to the FDA in exchange for a regulatory shortcut on a drug decision--for $125 million to Gilead, one of the most aggressive developers in the industry.

Bind shares dented after heralding cancer drug data from a mixed PhII

Bind Therapeutics believes its lead nanoparticle treatment can make a difference for a subgroup of lung cancer patients, pointing to some positive results from an otherwise mixed mid-stage trial as it prepares for further study.

UPDATED: Agios shares jump on another round of 'exciting' early data for cancer drug

Following up on positive Phase I data for its lead therapy, Agios has come through with its first snapshot of promising early results on its second cancer drug, gaining some fresh proof-of-concept data on acute myeloid leukemia to help guide an expanding clinical program.

Clovis taps GlaxoSmithKline to team up on lung cancer

Clovis Oncology has signed a deal to test whether its lead drug can make a difference in lung cancer when paired with GlaxoSmithKline's melanoma treatment Mekinist.

Average cost of drug R&D? Try $2.9B on for size

The Tufts Center for the Study of Drug Development created the industry standard on R&D budgets when it pegged average R&D costs at close to $1 billion for each new drug. Today, Tufts researchers updated their figures and boosted the total to $2.9 billion.

Sanofi and Regeneron's alirocumab tops Zetia, fueling PCSK9's blockbuster bluster

Sanofi and Regeneron's alirocumab resoundingly beat out Merck's Zetia in helping statin-intolerant patients lower their bad cholesterol in a study, data that bolster the case for a new class of highly anticipated cardio drugs.

AstraZeneca toasts to independent living with big plans for its Pfizer-free future

Rounding out year two of CEO Pascal Soriot's turnaround mission at AstraZeneca, the U.K. drugmaker believes it has the pipeline assets to fuel double-digit submissions and approvals by 2017, reaffirming its promise to pump up sales by 75% as former suitor Pfizer creeps back into the frame.

Novartis joins Atlas in launching a CRISPR Cas biotech with a $15M bankroll

Dubbed Intellia Therapeutics, the new company has come up with a $15 million bankroll in a Series A provided by the venture group and the Big Pharma outfit, which is intrigued by the potential this gene editing technology could play in two of the hottest fields in oncology.

FDA orders CytRx to halt patient enrollment after death of a cancer patient

CytRx has run into an unexpected roadblock with its cancer drug conjugate aldoxorubicin, slamming the brakes on new patient recruitment in all their clinical trials after the FDA dropped a partial clinical hold on the program. According to the biotech the hold was forced by the death of a patient who was given the drug through a compassionate use program.

Novartis revs up a promising pharmacoeconomic case for heart failure drug LCZ696

Novartis execs have already expressed just how delighted they are in the Phase III efficacy data that's been emerging about the heart failure drug LCZ696. This afternoon, their enthusiasm in the would-be "multiblockbuster" was supported by the addition of some promising pharmacoeconomic data--particularly in cutting the need for acute care.

Novartis adds to its case for secukinumab for ankylosing spondylitis

Novartis continued to build its case for secukinumab (AIN457), an IL-17A inhibitor in development for a range of inflammatory conditions.

Juno takes its hot CAR-T cancer tech to Wall Street in $150M IPO

In what will likely be the most closely watched IPO in biotech, Juno Therapeutics has rolled out a $150 million offering that is likely to make a big splash on the market.

Pfizer powers into immuno-oncology with $2.85B R&D pact with Merck KGaA

Pfizer is determined to be a major player in the fast-emerging field of immuno-oncology, and the pharma giant is paying handsomely to buy its way into an anti-PD-L1 program now underway at Merck KGaA. In a deal announced Monday Pfizer outlined plans to pay a whopping $850 million upfront and up to $2 billion in milestones for the right to co-develop and co-market MSB0010718C and any other IO drugs they put in the pipeline.

UPDATED: Actavis bags top 10 Big Pharma status with $66B Allergan buyout

Actavis and Allergan have come to terms on a buyout that values the Botox maker at $66 billion, dwarfing a bid from Valeant and William Ackman that forced the biotech into play. And it gives Actavis CEO Brent Saunders exactly what he's been looking for: Bragging rights to top 10 status in the Big Pharma world--after brushing aside a weakening Eli Lilly.

AstraZeneca's PhIII gout data for lesinurad includes a hit, a strikeout and a missing player

AstraZeneca has detailed the data from two of three studies of its late-stage combination program for lesinurad, a new drug for gout obtained in their $1.26 billion buyout of Ardea, which showed that the treatment hit the desired biomarker for blood levels of uric acid as promised--but added today that it failed to actually reduce the rate of painful flare-ups of the disease for patients in the study.

Bristol-Myers adds to impressive Opdivo survival data with PhIII melanoma results

Bristol-Myers Squibb has pulled the covers off of impressive Phase III data on Opdivo (nivolumab), pointing to a 73% survival rate among advanced melanoma patients after one year of therapy compared to 42% for the long-used chemo drug dacarbazine.

FDA reverses an embarrassing rejection of Sanofi's Lemtrada, OKs MS drug

Late on Friday the FDA put out the word that it has reversed its earlier decision against Sanofi's multiple sclerosis drug Lemtrada, agreeing to allow the pharma giant the right to market the treatment--with some tight controls on just who will get this drug for the relapsing form of the disease.

EU's top regulator canned on a technicality

The European Medicines Agency didn't follow procedure when it appointed Executive Director Guido Rasi, a court has ruled, forcing the continent's top drug regulator to step down and sending the organization scrambling for answers.