It took a few years and three tries, but Heron Therapeutics Inc. finally got its pain drug, HTX-011, now branded Zynrelef, over the FDA finish line. Even so, the approval comes with a less broad label than Heron would have liked. Zynrelef (bupivacaine and meloxicam), which had a May 12 PDUFA date, is approved for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. Read More
Flare Therapeutics Inc. emerged from stealth mode with $82 million in series A financing and an ambitious agenda to systematically drug transcription factors associated with cancer and other neurological, genetic and immunological conditions. Read More
Collectively, lysosomal storage disorders (LSDs) are caused by malfunctions in metabolic enzymes in the lysosome system. Depending on which enzyme is missing, toxic metabolites accumulate. While the LSDs are highly heterogenous – even within one disease, presentation can vary widely – neurodegeneration is a common feature in these disorders. Read More
Roughly a year and a half after the start of the COVID-19 pandemic, many unknowns remain about the future of the virus. How it will mutate, how long protection from either illness or vaccination will last, when it will cease to be a pandemic and instead be endemic, even whether the worst is still ahead. And there is also an increasing acknowledgment that there remain unknowns about SARS-CoV-2’s past. Read More
More than 150 U.S. patents could be at stake if the World Trade Organization (WTO) were to adopt an intellectual property waiver as originally proposed by India and South Africa. Read More
The potential for using real-world data (RWD) to support the development of cancer drugs for children has yet to be realized as researchers, sponsors and regulators continue to struggle with the collection of meaningful data. Read More
Venture capitalists in China are adopting different models to quickly create value from biopharma companies and are able to exit much faster than their U.S counterparts, new data suggest. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Gene & Cell Therapy annual meeting, including: 4D, Affinia, Arcellx, Generation, Homology, Rocket, Sio Gene, Uniqure. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Cnpharm, Curevac, Cytodyn, Evelo, Galera, Hyundai, Immuron, Inventiva, Macleods, Merus, Osmol, Progenetics, Rinri. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annovis, Antengene, Ascendis, Heron, Palisade, RDIF, Strongbridge. Read More
