Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diatherix, Medtronic, Photopharmics, Psychemedics, Senseonics, Vuno.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Bioiq, Canon Medical Systems, Centene, Current Health, Dexcom, DFP Healthcare Acquisitions, ELT Sight, Intersystems, Labcorp, Masimo, Matrix Medical Network, Mayo Clinic, Medable, Medical Diagnostic Laboratories, Medplace, Mindray, Proteogenix, Pure Health, Quest Diagnostics, Seasun, Soc Telemed, Tmk Manufacturing, Trinity Health, Vander-Bend, Windtree.
Keeping you up to date on recent developments in orthopedics, including: Physio support in COVID-19 recovery; Co-delivery of IL-10 and NT-3 to enhance spinal cord injury repair; European countries face a costly 23% increase in fragility fractures by 2030.
Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
Six of six critically ill COVID-19 patients survived after being treated as compassionate care cases with Capricor Therapeutics Inc.’s lead candidate, an off-the-shelf cardiac cell therapy. The success prompted the FDA to review the data and approve the company’s expanded access protocol for treating as many as 20 more COVID-19 patients.
A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).
PERTH, Australia – Roughly 40% of Australia’s biotech companies are seeking capital as they feel the pinch from international travel bans that seriously hamper capital raising, according to a recent Ausbiotech survey.
HONG KONG – Israeli biopharma Redhill Biopharma Ltd. is looking to extend access to its new investigational drug, opaganib (Yeliva, ABC-294640), following the drug’s initial success from a compassionate-use study treating six patients in Israel hospitalized with moderate to severe COVID-19 symptoms.
LONDON – The U.K. has started a fast track national trial of experimental drugs in COVID-19 patients, with Bergenbio ASA’s phase II cancer immunotherapy, bemcentinib, the first of six products that are due to join the study.