DUBLIN – Shares in Genmab A/S gained 5% during trading on Nasdaq June 10 on news of an oncology alliance with Abbvie Inc., in which it is banking $750 million up front and up to $3.15 billion in development, regulatory and commercial milestones for up to seven next-generation antibody-based therapeutics. Read More
Threads of hope and caution stitched together a wide-ranging appraisal of COVID-19 vaccines at June 9's BIO Digital plenary, "A Way Forward." The good news, delivered by one of the world's most sober participants in the pandemic response, mercifully came first. Read More
According to Todd Haim, chief of the Office of Small Business Research at the National Institute on Aging (NIA), Alzheimer’s disease (AD) is a major issue. In his opening remarks on a BIO Digital panel, titled “Brave Innovations: public and private solutions to advance Alzheimer’s therapeutics and diagnostics in a risk-averse climate,” he provided data showing why new treatments for AD and AD-related dementias (ADRD) are desperately needed. Read More
Checkmate Pharmaceuticals Inc., of Cambridge, Mass., completed an $85 million series C to continue developing CMP-001, a differentiated Toll-like receptor 9 (TLR9) agonist, for treating anti-PD-1-refractory melanoma and to study additional indications that include front-line melanoma and head and neck squamous cell carcinoma. Read More
PERTH, Australia – Melbourne, Australia-based Opthea Ltd. announced positive top-line results of its phase IIa trial evaluating safety and efficacy of OPT-302 administered with Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) in treatment-refractory patients with persistent diabetic macula edema (DME). Read More
BEIJING – Rare disease specialist Canbridge Pharmaceuticals Inc., of Beijing, said it is collaborating with the Horae Gene Therapy Center at the University of Massachusetts (UMass) Medical School to conduct gene therapy research with a focus on neuromuscular conditions. The move is expected to add new assets to the company’s portfolio. Read More
Before the lessons of COVID-19 fade into yesterday’s news, Congress should start preparing for the next pandemic, Sen. Lamar Alexander (R-Tenn.) is advising. As the chair of the Senate Health, Education, Labor and Pensions Committee, the senator issued a white paper Tuesday identifying areas that must be addressed. Read More
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients. Read More
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Biondvax, Catalyst, Dermata, Devonian, Impel, Merck, Opthea, Orpheris, Pfizer, Pulmatrix, Tychan. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bacainn, Curis, F2G, Fulcrum, Pharnext, Redhill, Rezolute, Vertex. Read More