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]?” Read More
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. Read More
HONG KONG – Chinese eye disease specialist Arctic Vision (Shanghai) Biotechnology Co. Ltd. raised $32 million in a series A financing round to advance its lead program, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension), for treating macular edema associated with uveitis and to bolster its R&D. Read More
BEIJING – U.S.-Taiwan biotech Acepodia Inc., of Burlingame, Calif., and Taipei, has licensed out two of its cell therapy candidates, ACE-1702 and ACE-1655, to Chinese CAR T therapy developer JW Therapeutics (Shanghai) Co. Ltd. to develop and commercialize them in China, Hong Kong and Macau. Acepodia will receive up-front and milestone payments from JW Therapeutics, plus royalties on sales. Read More
PERTH, Australia – The University of Queensland’s Centre for Superbug Solutions has discovered a new class of antibiotics that has garnered an award from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).
HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials. Read More
Novocure Ltd. and Merck & Co. Inc. will work together to test the use of electric fields at specific frequencies in combination with anti-PD-1 immunotherapy Keytruda (pembrolizumab) to treat non-small-cell lung cancer (NSCLC). The pair plan to start a phase II pilot study during the second half of Novocure’s Tumor Treating Fields in combination with Keytruda as a first-line treatment for intrathoracic advanced or metastatic, PD-L1 positive NSCLC. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Bioaegis, Boehringer, GSK, Knopp, Lintonpharm, Neoimmunetech, Oramed.
