Three companies that began trading on Nasdaq on July 16 are contributing to this year’s record-setting pace of biotech IPOs. Erasca Inc., which is looking to raise $300 million, led the pack with shares (NASDAQ:ERAS) ending the day at $17.43, an 8.94% rise from the opening asking price of $16. Read More
A sometimes contentious policy roundtable on how to handle Alzheimer’s disease therapies followed the July 15 meeting of the California Technology Assessment Forum, an independent evidence appraisal committee of the Institute for Clinical and Economic Review (ICER). CTAF’s 15 panelists voted unanimously that the evidence was not adequate to prove Biogen Inc.’s recently approved Aduhelm (aducanumab) superior to supportive care alone. Read More
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China. Read More
PERTH, Australia – Suda Pharmaceuticals Ltd. saw its stock shoot up nearly 44% on the heels of an oversubscribed AU$3.65 million (US$2.71 million) capital raise after acquiring a new invariant natural killer T (iNKT) cell therapy platform for oncology. Read More
Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013. Read More
The COVID-19 pandemic brought in-person inspections of device manufacturing sites to a near halt, but that has left the agency with a significant backlog in these inspections. The FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin said recently that the FDA is intent on prodding Congress to provide the Office of Regulatory Affairs (ORA) with more monies, particularly given the meager increases in funding for oversight of the med-tech industry in the past few years. Read More
Having created a profitable preclinical services business, Biocytogen Pharmaceuticals Co. Ltd. is now working to develop its own pipeline of antibody therapeutics, recently inking a partnership with China Resources Biopharmaceutical Co. Ltd to develop drugs for oncology and immunology indications and raising “tens of millions of dollars” in a new financing round to support the development of its antibody drugs. Read More
While overall clinical trial activity appears to be slowing, June was the busiest month for the year, and, in fact, all of last year, with a total of 436 items of news related to phase I, phase II and phase III research. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaxis, Aeglea, Bio-Thera, Compugen, Galapagos, Incyte, Mirror, Synlogic, Transcenta, Vir. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Checkmate, Constellation, Exevir, Generate, Gentibio, Forge, Halucenex, J&J, Kuros, Lexaria, Mithra, Morphosys, Pharmenable, Puma, Red Light Holland, Rubius, Sana, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Canbridge, Direct, Emmaus, Navidea, NLS, Ocugen, RDIF, Theratechnologies. Read More
