In its first fully virtual markup session, the House Energy and Commerce Committee Wednesday set aside politics to approve a bill that would make the U.S. Strategic National Stockpile (SNS) a better emergency resource – at least for the next few years.
While members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee all recognized the severity of hepatorenal syndrome type 1 (HRS-1) and the significant unmet need in the space, they were divided on whether the FDA should follow the decades-old lead of regulators in 60 other countries in approving Mallinckrodt plc’s terlipressin as an HRS-1 treatment.
An editorial yesterday in The New England Journal of Medicine (NEJM) marveled that “the world has now witnessed the compression of six years of work into six months,” and went on to ask the question that’s on everyone’s pandemic-wrenched mind: “Can the vaccine multiverse do it again, leading to a reality of a safe, efficacious COVID-19 vaccine for the most vulnerable in the next six [months]?”
LONDON – Twenty-three pharma companies are joining forces in the AMR Action Fund and have raised $1 billion in new money for the clinical development of antibiotic drugs.
HONG KONG – Tokyo-headquartered Fujifilm Holdings Corp. will increase production of Avigan on the back of a partnership with India’s Dr. Reddy’s Laboratories Inc. and Dubai-based Global Response Aid.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent. Shares of Equillium (NASDAQ:EQ) closed at $26.50, up $23.31, or 731%, after trading as high as $27.05. “We recognize we have to do a robust study,” said Bruce Steel, CEO of the La Jolla, Calif.-based firm. Talks with the FDA about design come next, but the clinical bid will “very likely include sites outside the U.S.,” where the need is high and where there is “somewhat less competition for patients,” he said.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent.
HONG KONG – Tokyo-headquartered Fujifilm Holdings Corp. will increase production of Avigan on the back of a partnership with India’s Dr. Reddy’s Laboratories Inc. and Dubai-based Global Response Aid, an affiliate of logistics company Agility.
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