Less than four months after accepting Alnylam Pharmaceuticals Inc.'s NDA for Givlaari (givosiran), the FDA has approved the new RNAi therapy for the treatment of adults with the rare genetic disorder acute hepatic porphyria (AHP). The condition is defined by a buildup of toxic porphyrin molecules formed during the production of heme. That buildup can cause incidents of severe pain and paralysis, respiratory failure, seizures and mental status changes, according to the agency. Read More
Stephen Hahn, of the MD Anderson Cancer Center, generally managed to avoid any controversy in today’s Senate confirmation hearing for the FDA commissioner’s job, stating for instance that he is “open to all science and data that could potentially support” drug reimportation as a solution to the drug pricing problem. Read More
Even though November’s full moon had come and gone more than a week previous, Werewolf Therapeutics Inc. came out of the shadows Wednesday with a $56 million series A fundraiser to state its plans to develop immune-stimulatory therapeutics to trigger immune responses to cancer. Read More
Aravive Biologics Inc. dispelled doubts that may have persisted after the disclosure of early data from the ongoing phase Ib portion of the phase Ib/II trial with AVB-500 in platinum-resistant ovarian cancer, and Wall Street rewarded the company’s shares (NASDAQ:ARAV) with an 48.1% hike, or $3.13, to close Wednesday at $9.64. Read More
HONG KONG – SK Holdings Co. Ltd. invested KRW10 billion (US$8.6 million) in Standigm Inc., an artificial intelligence (AI)-powered biotech company based in Seoul, Korea. It is the second big investment Standigm has attracted this year after a KRW13 billion series B round in March. Read More
HONG KONG - South Korean biopharmaceutical company Ph Pharma Co. Ltd., based in Seoul, and U.S. biotech Immunome Inc., of Exton, Pa., are working together on antibody-drug conjugates (ADCs) in a partnership agreement under which Immunome will discover antibodies using its platform while Ph Pharma will develop the ADC candidates and verify safety and efficacy. Read More
HONG KONG – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) NDA for surufatinib as a treatment for patients with advanced non-pancreatic neuroendocrine tumors (NET) has been accepted for review by China’s National Medical Products Administration (NMPA). Read More
BEIJING – Questionable data found in research papers supervised by renowned Chinese immunologist Cao Xuetao have caused a stir in the life sciences community, shaking the reputation of an internationally prominent figure in the field of immunology. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
