Despite two recent clinical trial failures, Orphazyme A/S’s arimoclomol is still on track for its June 17 PDUFA date in treating Niemann-Pick disease type C. The newest stumble is in the pivotal study of arimoclomol for treating amyotrophic lateral sclerosis (ALS) as it failed to hit its primary and secondary endpoints. Read More
DUBLIN – Michael Greve, one of Germany’s most successful internet entrepreneurs and investors, is personally committing €300 million (US$362 million) to building a portfolio of biotechnology firms focused on different aspects of aging. His investment vehicle, Kizoo Technology Capital GmbH, of Karlsruhe, has already provided seed funding to more than a dozen early stage firms. Greve is now ready to invest in follow-on rounds, particularly in four core companies he described as “category openers” in rejuvenation biotech. “We are really super focused, because there are so many things we could do,” he told BioWorld. Read More
Beigene Ltd.’s PARP inhibitor, pamiparib, won conditional approval from China’s National Medical Products Administration for treating patients with germline BRCA mutation-associated recurrent advanced ovarian, fallopian tube or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. Read More
HONG KONG – Olix Pharmaceuticals Inc. has entered an extensive research collaboration to test its RNAi therapeutic, OLX-104C, with Fimanac, PCI Biotech Holding ASA’s delivery technology for nucleic acid-based therapies, with the aim of reducing off-target effects while treating androgenic alopecia, or hair loss. Read More
With 2021 biopharma financings already at 40% of last year’s total, there is a good likelihood that a new record will be made for the industry, assuming wide open public windows and robust venture capital activity continue. Read More
The COVID-19 pandemic’s impact on inspections of drug and device manufacturing sites is a matter of record, but the agency says it is on track to resume inspections for high-risk considerations. However, the FDA also said it will likely make more extensive use of virtual inspection tools going forward, a development that may ease some of the operational interruptions engendered by conventional on-site inspections. Read More
While it remains to be seen whether the FDA will break with its advisory panel and approve Biogen Inc.’s high-profile Alzheimer’s candidate by the June 7 PDUFA date, the clinical data for beta-amyloid-targeting aducanumab didn’t exactly impress experts at the Institute for Clinical and Economic Review, who suggested an annual price tag of $2,560 to $8,290. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Corcept, Enanta, Medicenna, Orphazyme, Palisade, Tarsus, Vaxart. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Biontech, Chemocentryx, Eisai, Glaxosmithkline, Merck, Pfizer, Vir. Read More
