Clovis Oncology says that the FDA demanded fresh efficacy data for the lung cancer drug rociletinib (CO-1686) in order to complete its review. And while the biotech plans to hand that over today, it adds that the fresh data include a worse response rate than expected and could force a delay in the accelerated March 30, 2016, deadline that the FDA had set for a marketing decision.
Failure-prone KaloBios--which launched with a repeated reassurance to investors that developing antibodies had become a lot easier--says that after a brief look at alternative scenarios the best next step now is to wind down operations.
Australian biotech Mesoblast priced its U.S. IPO below expectations, raising $60 million to support its pipeline of cell therapies.
Regeneron Pharmaceuticals, riding high with a top-selling eye drug and some promising pipeline assets, is planning to invest $150 million in its native New York, supporting 300 new jobs at its fast-growing R&D campus.
AstraZeneca gained a crucial accelerated FDA approval for its targeted lung cancer drug AZD9291 today, offering tangible evidence of the R&D turnaround CEO Pascal Soriot had promised investors several years ago. And now the drug, to be marketed as Tagrisso, will be put to the market test to see if it can live up to Soriot's $3 billion peak sales estimate while staring down a strong rival in late-stage development at Clovis Oncology.
Merck, the last Big Pharma standing in CETP inhibition, is pressing forward with a huge cardiovascular trial after getting the green light from its independent advisers, stepping over the scattered failures of similar projects in hopes of hitting upon a blockbuster.
NantKwest, an oncology biotech in Patrick Soon-Shiong's constellation of companies, made headlines over the summer when it pulled off a $200 million IPO that valued it at more than $2.5 billion. But the company's share value has slipped by nearly a third in the ensuing months, and instead of pouring money into developing its self-described breakthrough medicines, management has taken the uncommon tack of laying out $50 million to buy back stock.
Auven Therapeutics has staked a late-stage claim on a share of the dry eye market, posting some mixed Phase IIb/III data that included hitting a statistically significant improvement on a key measure of the increasingly common ailment.
In this week's EuroBiotech Report, some people within the industry are concerned that a skills shortage in certain areas could threaten Britain's ability to remain at the forefront of research and development. And more.
FierceBiotech Radio on Sanofi's middling future, Amgen's $10B shopping list, and a novel pharma lawsuit
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss Sanofi's uninspiring forecast, Amgen's return to high-dollar dealmaking and a lawsuit that accuses a drug company of deliberately being bad at making drugs.
Thanks to some recent breakthroughs, a bevy of companies are pushing forward with messenger RNA, or mRNA, projects designed to turn human cells into in vivo drug factories.
China's Food and Drug Administration is cracking down on drugmakers, rejecting 11 applications for generic treatments in a move widely seen as an effort to bolster confidence in the country's biopharma industry by demanding that players meet higher standards.
Portola Pharmaceuticals' anti-anticoagulant came through in a pair of Phase III trials, rapidly reversing the effects of blood thinners Xarelto and Eliquis and setting the stage for a final FDA submission.
When it comes to publishing a full set of trial data on new drugs, the biopharma industry overall has a poor record on transparency, according to a new report from a bioethics watchdog group. And some companies--like Sanofi and Gilead--fall well below the "legal and ethical" standards on this score.
Biogen CEO George Scangos and his team are focused on two home run swings in an R&D game that will take years to play out. And that has analysts betting Biogen will start doing some late-stage biotech deals or face continued speculation that the big biotech will become a target itself.
Four years ago, when Derma Sciences reported out positive Phase II data for its diabetic foot wound healing remedy DSC127 (aclerastide), CEO Edward Quilty called the results "transformational" and excitedly predicted big things ahead for the Phase III study. This morning, though, the company was forced to concede that the Phase III was a flop and hinted at some restructuring ahead.
Throughout the tough times faced by the British biopharma industry, the country could always point to its scientific excellence as a source of pride. Now, with more money swilling around, the sector should be enjoying better days, yet as financial woes have receded another resource shortage has come into view: The United Kingdom appears to be running low on scientists.
Kitov Pharma is looking to a Nasdaq IPO to fund the final steps in development of its osteoarthritis drug. The product, which is already deep into Phase III, is a combination of Pfizer's Celebrex and an antihypertensive drug, a mix Kitov thinks will enable it to avoid the black-box warnings that blight other treatments for osteoarthritis.
Pierre Fabre has struck a deal to use implantable biosensor chips in its clinical trials. The first step is to assess the feasibility of using the chips in a schizophrenia pilot project, after which Pierre Fabre may expand use of the technology to any study in which it wants to track drug concentrations and other metrics.