Gel That Quickly Halts Severe Bleeding Gets FDA Clearance
Traumagel, from Cresilon, can be used for life-threatening injuries and could be a vital new tool for EMTs. Separately, the FDA approved a non-small cell lung cancer treatment from AstraZeneca.
Reuters:
US FDA Clears Use Of Cresilon's Gel To Stop Severe Bleeding In Seconds
The U.S. Food and Drug Administration has cleared Cresilon's gel to quickly control bleeding, the privately held company said on Thursday, potentially giving emergency medical technicians and combat medics a tool to prevent death from blood loss. Unlike its previously approved product for small nicks and cuts, the new gel, Traumagel, can be used for life-threatening injuries, CEO and co-founder Joe Landolina told Reuters. (Singh, 8/15)
Reuters:
US FDA Approves AstraZeneca's Non-Small Cell Lung Cancer Treatment
The U.S. Food and Drug Administration approved AstraZeneca's blockbuster cancer drug, Imfinzi, for the treatment of patients with a type of non-small cell lung cancer on Thursday. The health regulator approved Imfinzi as an additional treatment after surgery in adult patients with non-small cell lung cancer. The drug is already approved in the U.S. for patients with a late-stage form of the disease, where the cancer cannot be removed through surgery. (8/15)
Reuters:
Bayer Wins Victory In US Legal Battle Against Roundup Cancer Claims
Bayer won a legal victory in its fight to limit liability from claims that its Roundup weed killer causes cancer, as a U.S. appeals court on Thursday said federal law shields the German company from a lawsuit by a Pennsylvania landscaper. The 3rd U.S. Circuit Court of Appeals in Philadelphia rejected plaintiff David Schaffner's claim that Bayer's Monsanto unit violated state law by failing to put a cancer warning on the label for Roundup. Schaffner was diagnosed in 2006 with a kind of cancer called non-Hodgkins lymphoma, a common claim for Roundup plaintiffs. (Stempel, 8/16)
Stat:
Lykos Therapeutics Cuts 75% Of Staff After FDA Rejects MDMA-Assisted Therapy
Lykos Therapeutics, whose MDMA-assisted psychotherapy for post-traumatic stress disorder was rejected late last week by U.S. regulators, announced Thursday that it would cut 75% of its staff, and that the company’s founder would step down from its board. (Keshavan, 8/15)
The Atlantic:
Why People Are Breaking Open Their Mounjaro Pens
By the time Lisa started breaking open her Mounjaro pens with pliers, she had run out of other ideas. She was 300 pounds. She had already tried bariatric surgery. (It had limited success.) She had tried getting her insurance company to cover Mounjaro. (It stopped after a month.) She had tried a cheaper copycat version from a compounding pharmacy. (It didn’t work as well, and she worried about what she was actually getting.) “I was absolutely desperate to stay on,” she says, but she could not afford the sticker price. (Zhang, 8/15)
Axios:
UN Talks Aim To Turn DNA Data Into Assets
Negotiators from around the world are meeting in Montreal this week to hammer out how to divide the billions of dollars and other benefits derived from using genetic sequences to make new drugs, cosmetics and agricultural products. (Snyder, 8/15)
