To say a lot is riding on the Nov. 3 presidential and congressional election in the U.S. would be an understatement, as the outcome could impact drug pricing, patent reform, research spending and pandemic response and preparedness. Read More
Karyopharm Therapeutics Inc. posted positive top-line results from the phase III SEAL trial of Xpovio (selinexor), including meeting the study’s primary endpoint, and likely extending its reach into the company’s bottom line. Read More
CAR T therapy developer JW Therapeutics Co. Ltd. launched a HK$2.325 billion (US$300 million) IPO in Hong Kong by issuing 97.7 million shares at HK$23.8 apiece on Nov 3. The listing is set to help the company’s march toward the goal of winning the first CAR T product approval in China. Read More
Bristol Myers Squibb Co. reported that its first-in-class oral selective kinase 2 inhibitor, deucravacitinib (formerly BMS-986165), beat out Otezla (apremilast) in a head-to-head phase III trial in psoriasis. Read More
When entrepreneurs and emerging businesses raise seed capital for a new business or generate funding for business growth, they often turn to the exempt offering framework under the Securities Act. However, when doing so, they are faced with a confusing and complex system that must be navigated. To simplify the process, the SEC has announced that it is amending its rules that govern offering exemptions, which small and medium-sized business rely on to raise capital. Read More
Aurinia Pharmaceuticals Inc. is suspending further development of voclosporin ophthalmic solution (VOS) for dry eye syndrome after a dose-ranging trial of the candidate failed to meet its primary endpoint of improving a measure of the condition after four weeks of treatment. Read More
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has linked up with Hong Kong-listed China Grand Pharmaceutical and Healthcare Holdings Ltd. (CGP) in a licensing and commercial deal worth AU$400 million (US$285 million) plus sales royalties. Read More
HONG KONG – Aprinoia Therapeutics Inc. is poised to start phase III clinical trials for its positron emission tomography (PET) imaging tracer 18F-APN-1607 in China, after receiving the green light from the National Medical Products Administration. Read More
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome instruments for device evaluation. Read More
Biopharmas raising money in public or private financings, including: Aquestive, Cancer Genetics, Forte, Fountain Healthcare, Inhibikase, Jiya, Massive Bio, Quantum Genomics, Scholar Rock, Ultragenyx. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Adial, Aptevo, Aurinia, Biogen, BMS, Celltrion, Concert, Edesa, GW, Horizon, Karyopharm, Lilly, Prometic. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioasis, Calliditas, CEPI, Checkpoint, Clover, Genkyotex, Hoth, Humanigen, Immunoprecise, Inventiva, KPM, Minoryx, Sichuan Clover, Telcon RF, TLC, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Chemocentryx, Emmaus, Engene, Enlivex, Galapagos, Gensight, Gilead, Nanomab, Vifor Fresenius. Read More
