By Eric Sagonowsky
Even as many biosimilar companies await their agreed-upon launch dates for their versions of the world’s bestselling drug—AbbVie's Humira—Alvotech is still busy battling the drug giant in court. This week, the company scored a big win.
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By Kevin Dunleavy
After nearly nine months without a permanent FDA leader and after watching the agency withstand a torrent of criticism, President Joe Biden finally ready—almost—to announce a nominee for the beleaguered agency.
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By Andrea Park
The billion-dollar investment is estimated to quadruple the total number of at-home, rapid tests available to Americans by December. Beginning that month, that number will reach 200 million tests per month, which will be available for purchase and distribution by government entities, employers and consumers alike.
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By Dave Muoio
The return of Humana-Centene purchase rumors and more merger and acquisition news from the month of September.
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By Nick Paul Taylor
Arch Venture Partners has taken the lid off its big bet on neuroscience. Having quietly put the startup together over the past 18 months, Thursday Arch unveiled Neumora Therapeutics—a biotech that starts life with $500 million, a collaboration with Amgen and a pipeline of eight prospects.
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By Anastassia Gliadkovskaya
One startup is looking to disrupt the $370 billion prescription drug marketplace by offering a new "no compromises" approach to the traditional PBM model. Prescryptive acts as a PBM, negotiating prices directly with pharmacies. That allows the company to maintain fair rates, executives said. But pharmacists say many of these startups perpetuate the existing PBM model and don't address the need for more price transparency.
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By Kevin Dunleavy
Amid some reluctance by parents to vaccinate their younger children, Pfizer and BioNTech have asked the FDA to authorize their COVID-19 shot for kids aged 5 to 11, the companies revealed on Thursday.
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By Heather Landi
In the eight years since its launch in the U.K., Babylon has become a digital healthcare company to watch as it has expanded its reach from Rwanda all the way to Missouri. "I think somebody in healthcare will build one of the world’s largest and most valuable companies and there may be more than one. Every decision we make at Babylon is about that long-term game," Babylon founder and CEO Ali Parsa told Fierce Healthcare.
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By Conor Hale
Cue plans to add real-time tracking of viral variants and sequencing data, bolstered by artificial intelligence programs to help identify newly emerging threats.
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By Andrea Park
The recall comes just a few weeks after two of Abbott’s COVID tests became subject to a false-positive warning of their own, and less than a year after the Ellume test became the first over-the-counter self-test to receive emergency authorization from the FDA.
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By Kyle LaHucik
Brickell Biotech reached statistical significance on all measures for both of its pivotal late-stage studies of a sweat gel. That gives the Colorado biotech the confidence to ask the FDA for approval in mid-2022.
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By Kyle LaHucik
Joanne Chang departed Novartis after heading up worldwide medical affairs for ophthalmology for the past four years to be chief medical officer of Oculis. With a fresh set of eyes leading the medical affairs of the eye treatment biotech, Oculis will expand its presence in Hong Kong.
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By Angus Liu
Yale University spinout Cybrexa Therapeutics has developed a peptide-drug conjugate that, instead of aiming for a specific antigen, targets the acidic environment of cancer cells to deliver a toxic payload. The drug improved the efficacy of checkpoint inhibitors in mouse models of cancer.
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