Apellis Pharmaceuticals Inc. could receive up to $1.25 billion from Swedish Orphan Biovitrum (Sobi) AB in their collaboration to develop systemic pegcetacoplan, a C3 therapy for treating several rare diseases in hematology, nephrology and neurology. Read More
Just weeks after exclusively out-licensing China rights for its anti-PD-L1 monoclonal antibody (MAb), sugemalimab, to Pfizer Inc., Cstone Pharmaceuticals Co. Ltd. has monetized it again in a valuable new deal with Eqrx Inc. Deal terms include $150 million up front and as much as $1.15 billion in milestones for Cstone in exchange for full commercial rights to sugemalimab and the anti-PD-1 MAb CS-1003 outside greater China. Cstone could also receive tiered royalties if the products reach market. Read More
LONDON – Three large scale population surveys conducted between late June and the end of September have shown the prevalence of SARS-CoV-2 antibodies in England declined by 26.5% over three months. The findings rest on the results of more than 350,000 self-administered lateral flow blood tests that were carried out at home by volunteers who were randomly selected from general practitioner registers. Read More
Shares of Cambridge, Mass.-based Scholar Rock Holding Corp. closed Oct. 27 at $30.02, up $16.30, or 119%, on positive six-month interim analysis results from the Topaz phase II trial with inhibitor of myostatin activator SRK-015 in type 2 and type 3 spinal muscular atrophy, and CEO Tony Kingsley pointed to “a rich cascade of data ahead of us.” Read More
Chinese drugmaker Simcere Pharmaceutical Group Ltd. raised HK$3.57 billion ($460.6 million) in Hong Kong by issuing 261 million shares at HK$13.7 apiece on Oct 27. Its debut hit a setback, with its share price (HKEX:2096) dropping over 20% in mid-morning and extending losses to nearly 24% to close at HK$10.46.
Two complete response letters for group members dispatched this month by the FDA was enough to contribute to a flat performance in October for the BioWorld Neurological Diseases index. Overall, the price-weighted index has remained underwater for most of the year with its value down about 5% during this period. Read More
Kala Pharmaceuticals Inc.’s anticipated win with Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease (DED) didn’t help shares (NASDAQ:KALA), which closed Oct. 27 at $6.28, down $1.44, or 18.7%, on word of the FDA approval. Read More
DUBLIN – The dateline says it all. Everyone and anyone with an interest in European biotechnology were due to assemble in Munich this week, the German biotech hub which was originally chosen to host Bio-Europe Fall 2020. Given the rising numbers of confirmed COVID-19 cases across the globe in recent months, that was never going to happen. Read More
PERTH, Australia – Neuroscience technology company Cogstate Ltd. and Japanese pharmaceutical company Eisai Co. Ltd. signed a deal under which Eisai will have global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the Cogstate Brief Battery (CBB) for use in health care and other markets. Read More
The ACTIV-3 phase III study testing Eli Lilly and Co.’s COVID-19 antibody candidate, LY-CoV555, which was paused two weeks ago following a participant’s unexplained illness, has now been halted, the company reported Oct. 26. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: FDA clarifies terms for generics; FDA to hold public meeting on DSCSA; Russia updates COVID-19 guidelines; First Circuit: Prescriber’s perk indeed a kickback; Companies warned for documentation, FAR violations. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atai Life, Cytodyn, Edigene, Exelixis, Kala, Moderna, Nektar, Pfizer, Prevail, RDIF, Vanda. Read More
