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.
Two experimental antivirals are about to undergo snap clinical trials in Africa as doctors scramble to find an effective remedy for the lethal outbreak of Ebola. Doctors Without Borders says that it plans to launch studies of brincidofovir from Chimerix as well as Fujifilm's favipiravir.
CRO conglomerate PRA Health Sciences pulled off a $306 million IPO, joining the growing list of Big Pharma contractors cashing in on Wall Street after years under private equity stewardship.
It's not often that a Big Pharma company puts out a press release announcing the launch of a preclinical drug program. Yet AstraZeneca, which has been trumpeting a major turnaround in its pipeline, has done just that--even going so far as to hype its new drug's potential impact on the market by bolstering a struggling product.
Shares of South San Francisco-based Oxigene slumped this morning, dropping 10% in the wake of its analysis of a Phase II study of its experimental therapy for tough-to-treat cases of ovarian cancer. The data for fosbretabulin overall were positive, putting the company on the road to a pivotal Phase III study. But an analysis from Adam Feuerstein at TheStreet may have taken the wind out of its sails.
Third Rock Ventures startup Blueprint Medicines has hauled in a $50 million C round, cash that'll see its way through clinical trials and keep its promising platform generating new candidates.
Whatever Cambridge, MA-based Millennium learned over the past two years it's been collaborating with Presage Biosciences, the experience must have been rewarding.
Fujifilm is confident its recently approved flu treatment can combat the spread of ebolavirus in West Africa, preparing for a surge in manufacturing as it waits on clinical trial results.
Just a few weeks after claiming success with a pair of late-stage studies of its prolonged dosing approach to diabetes, Boston-based Intarcia has followed up with a billion dollar-plus sized commercialization deal for ex-U.S. and Japan commercial rights with France's Servier.
Amgen and its Big Pharma partner AstraZeneca have roped in another round of promising Phase III plaque psoriasis data for their IL-17 blockbuster contender brodalumab, which beat Johnson & Johnson's big earner Stelara in a head-to-head study.