News

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.

Can Amgen sue its way to the top of the PCSK9 pile?

In the race to commercialize a new class of potential cardiovascular blockbusters, Amgen and its team of lawyers have filed a patent suit to fend off the advance of rivals Sanofi and Regeneron. But, looking at the patents in question and the history of such challenges, one analyst figures Amgen is unlikely to succeed in keeping its competitors off the market.

Alexion co-founder will retire in January

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)...

Boehringer taps WellPoint's outcomes data to develop new a-fib drugs

Boehringer Ingelheim is working with managed care giant WellPoint in an effort to use real-world data to inform the development of new treatments of atrial fibrillation, keeping up with a sweeping trend in cardiovascular R&D.

IPOs: FibroGen comes up big while NeuroDerm limps out of the gate

Biotech's protracted IPO boom is littered with high-dollar successes and deeply discounted close calls, making Friday's pricings microcosmic as FibroGen staged an upsized debut and NeuroDerm took a considerable haircut.

Puma shrugs off an 'expected' Phase II failure for its breast cancer drug

Puma Biotechnology's closely watched neratinib failed to beat out the blockbuster Herceptin in a mid-stage breast cancer trial, a miss the company said was no surprise as it touted success on a secondary goal.

U.K. dilutes R&D tax break, EU backs €200M in startup loans, Boehringer jilts KDEV's Athera

In this week's EuroBiotech Report, the United Kingdom yielded to pressure to change its patent box policy. The policy was part of what attracted Pfizer to AstraZeneca, but other countries--notably Germany--were less enamoured with the initiative. And more.

J&J bets up to $935M that Geron's drug can shake a checkered past

Days after finally getting the FDA's go-ahead to resume the stop-and-start development of its lead candidate, Geron has signed a deal to cut Johnson & Johnson in on the process, putting the biotech in line for as much as $935 million if all goes according to plan.

Are drug developers over-relying on genomics?

Over the past few decades, the harsh realities of complex biology have brought back to Earth some pie-in-the-sky projections about the value of genomics in biotech R&D. But the industry still devotes the vast majority of research spending to target-based drug development, an imbalance that could be a factor in Big Pharma's slumping efficiency rates.

Sanofi execs prep their pitch on a post-Viehbacher R&D strategy

One of the primary roles for any Big Pharma CEO is to act as a chief defender of the pipeline. Just months ago, Chris Viehbacher boldly asserted that Sanofi had one of the top 5 pipelines in the industry, if you added in some top programs among its close development partners.

Revance tanks on fresh delays for its next-gen Botox

Revance Therapeutics' top prospect, a topical successor to Botox, has fallen off schedule, putting off the company's Phase III plans until next year and sending its shares southward.