Randomized trials of the broad-spectrum antiviral favipiravir, marketed as an anti-influenza treatment by Fujifilm Holdings Corp., have shown "obvious efficacy" against COVID-19, according to Zhang Xinmin, head of the China National Center for Biotechnology Development.
Investigators at Stanford University Medical Center have treated the first patient in a pivotal phase III study of Abeona Therapeutics Inc.'s EB-101, an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The trial, delayed by an FDA clinical hold placed in September 2019, has now resumed, with the majority of its 15 expected participants pre-screened.
A U.S. Court of Appeals affirmation of a lower court ruling requiring the FDA to grant Eagle Pharmaceuticals Inc.'s bendamustine infusion product, Bendeka, seven years of orphan drug exclusivity appears to resolve a key piece of uncertainty that had troubled Eagle and others in similar circumstances.
Another volatile day of trading in health care stocks unfolded March 13, after a trebling of broader market carnage the day before and the declaration of a national emergency by U.S. President Donald Trump Friday afternoon. Substantial declines hit shares of Moderna Inc., Vaxart Inc. and Inovio Pharmaceuticals Inc., all of which had recently rallied on optimism over coronavirus-fighting efforts. Biopharma shares saw some recovery, with both the S&P 500 Health Care Sector and Nasdaq biotechnology indices each rising a bit more than 2% each before Friday's close.
Bridgebio Pharma Inc. subsidiary QED Therapeutics Inc., seeded in 2018 with $65 million and a license to Novartis AG's infigratinib, said the first patients have been dosed with the drug in two separate cancer trials.
South Korea's Bridge Biotherapeutics Inc. has enlisted San Francisco-based AI drug discovery shop Atomwise Inc. to help it identify up to 13 small-molecule inhibitors of Pellino proteins and other targets in an effort to develop new therapies for inflammatory diseases. Atomwise stands to receive an up-front payment of undisclosed value, as well as milestone and royalty payments under terms of the deal. Presuming success, it estimates the partnership's payoff could reach up to $1.08 billion.
In a setback for Astrazeneca plc's plans to tackle previously untreated cases of advanced bladder cancer, neither its immune checkpoint inhibitor, Imfinzi (durvalumab), nor a pairing of it with the investigational drug tremelimumab beat standard-of-care (SOC) chemotherapy in improving overall survival (OS) during a phase III trial evaluating the treatments as first-line (1L) care for patients with advanced disease.
An experimental gene editing therapy for an inherited form of blindness has become the first in vivo CRISPR medicine to be administered to patients, according to Editas Medicine Inc. and its partner, Allergan plc, which licensed the candidate in 2018.
With battles over the future of American health care being waged in the courts and at the ballot box, JAMA, the Journal of the American Medical Association, has devoted its latest issue to better understanding what Deputy Editor Gregory Curfman called the "challenging problem" of "relentless increases" in prescription drug prices.
Under steady pressure to accelerate development of vaccines against SARS-CoV-2 and treatments for COVID-19 as the global death toll reached 3,085 people on the afternoon of March 2, biopharma companies continued to detail progress, including in updates at a White House meeting between pharmaceutical executives and administration officials, including President Donald Trump.
