Clovis Oncology, whose market value has plummeted by more than 80% over the past year, has secured a date with FDA advisers to make the case that its lung cancer treatment merits approval despite some disappointing data.
RNAi biotech Alnylam Pharmaceuticals is planning to spend $200 million on a manufacturing plant in a bet that its pipeline therapies will find their way to market in the coming years.
In a sign of the continuing headwinds for biotech, Shield Therapeutics has had to cut both its price and its original aims to see through its U.K. IPO.
Louisville, KY, drug developer Apellis Pharmaceuticals raised $47.1 million in venture cash to push its pipeline of treatments for rare diseases, regrouping after aborting an effort to go public earlier this month.
In this week's Chutes and Ladders, Geno Germano has left Pfizer, Jeffrey Huber was named CEO of Illumina spinoff Grail, and James Robinson was promoted to president of Astellas' Americas operation. Plus more hirings and retirings throughout the industry.
Novartis, which won the U.S.'s first-ever biosimilar approval last year, is expanding its reach in Europe, buying the continental rights to a Pfizer-developed take on the blockbuster Remicade.
In this week's EuroBiotech Report, the results from a Phase I trial of Heptares' muscarinic M1 receptor agonist have added to its belief that its pursuit of an Alzheimer's disease target that stumped Eli Lilly can pay off. And more.
AbbVie says it has racked up a second set of positive Phase III data for its endometriosis drug elagolix, setting up a regulatory filing for sometime next year.
Shire, awaiting the close of its $32 billion merger with Baxalta, is planning to move away from its penchant for acquisitions and focus on developing and launching products, CEO Flemming Ornskov said.
After an FDA-mandated three-month delay, Intercept Pharmaceuticals is set for a meeting with agency advisers to discuss obeticholic acid, an in-development liver drug tabbed by analysts as a potential blockbuster.
Jakafi has failed to help patients in a late-stage study for pancreatic cancer, and Incyte feels that it now has all the data it needs to prove that a JAK1 inhibitor is the wrong way to go in solid tumors.
AstraZeneca has kicked off another clinical trial of monalizumab, bringing to an end a rollout of studies it committed to when it struck its $1.3 billion (€1.1 billion) alliance with Innate Pharma. The fifth and final clinical trial in the first wave of studies is investigating the combination of monalizumab and AstraZeneca's big immuno-oncology hope durvalumab.
Mary Szela, the new CEO at Cambridge, MA-based Aegerion, has reached for the budget ax to help compensate for the rising tide of competition that has challenged its cholesterol drug Juxtapid. The company announced today that it is chopping about 25% of its staff--roughly 80 workers--as it whittles its roster of employees down to 230.
4D pharma has struck a deal to buy Tucana Health. The takeover, which is costing £3.1 million ($4.5 million) upfront with more tied to milestones, is intended to boost 4D pharma's ability to identify patients who may benefit from live biotherapeutics, starting with a treatment for irritable bowel syndrome.
These days there are two kinds of biotech IPOs that make it to the market: The select few solid successes in line with the range and some bargain selections that provide a haircut on the price, where the company ups the number of shares but sells at a significant discount to the range. Another group are just quietly leaving their IPOs on the shelves or pulling out altogether to wait out the storm.
FierceBiotech Radio on pharma's day on the Hill, biotech's paucity of M&A, and the gathering storm of biosimilars
FiercePharma's Eric Palmer and FierceBiotech's Damian Garde discuss a bizarre congressional hearing, how biotech's slump affects the buyout climate, and a major development in the world of biosimilars.
Ferring Pharmaceuticals is set to put its prostate cancer drug Firmagon up against AbbVie's Lupron in a Phase IIIb trial. The study is designed to assess the cardiovascular safety profile of the gonadotropin-releasing hormone receptor agonist and antagonist, potentially giving Ferring an edge over a product that generated $826 million (€744 million) for AbbVie last year.
ImmuPharma has raised £8.3 million ($12.0 million) to propel its lupus drug through a Phase III study. The cash will support ImmuPharma through to the data readout from its 200-person transatlantic trial, at which point management will weigh up commercialization options.
I hope you'll take a minute--just a minute--to provide a letter grade on just how well biopharma is doing on gender diversity. And take a second to let us know what you're thinking. I'll be following up.
Heptares is gearing up to advance a candidate from its muscarinic M1 receptor agonist program into Phase II in patients with Alzheimer's disease, schizophrenia or Lewy body dementia. While specifics of which drug to aim at which indication are still being decided, Heptares has seen enough in its first clinical data to continue pursuing a target that has shown more promise than most in Alzheimer's.