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