The company conference call related to Akebia Therapeutics Inc.’s complete response letter (CRL) for vadadustat, an HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease, brought on the ongoing and perhaps inevitable comparisons with a similar product from Fibrogen Inc., rejected by the agency last August. Read More
Clovis Oncology Inc. is trying to claw its way into ovarian cancer relevance against vastly larger competitors Astrazeneca plc and Glaxosmithkline plc with positive top-line phase III data from its study of PARP inhibitor Rubraca (rucaparib). The study’s monotherapy arm of Rubraca as a first-line maintenance treatment of ovarian cancer hit the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared to placebo. The median PFS was 20.2 months for Rubraca compared to 9.2 months for placebo in the intent-to-treat group. Read More
A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but missed statistical significance on the measure, the study's primary endpoint. Read More
Jiangsu Recbio Technology Co. Ltd. raised HK$765 million ($97.7 million) in a Hong Kong stock exchange IPO on March 31. Shares of the vaccine maker (HKEX: 2179) opened at HK$25 per share and rose 1.8% to close at HK25.25 apiece. The Jiangsu, China-based company plans to use about half the proceeds, or HK$317.9 million, to support development and commercialization of its HPV vaccines, including its lead asset, a phase III recombinant HPV 9-valent vaccine REC-603, a spokesperson told BioWorld. The company also plans to set up an HPV manufacturing facility in Taizhou, China. Read More
Less than a year after winning approval in China for the first domestically developed antibody-drug conjugate (ADC), Remegen Co. Ltd. raised ¥2.6 billion (US$410 million) and picked up a listing on the Shanghai STAR market to support further work on its monoclonal antibodies and ADCs. Read More
After hitting a low in late February, BioWorld’s Neurological Diseases Index is rebounding, although it is still down by 8.9% this year, following the same path of the broader markets. Read More
Publicly traded companies in the life sciences face a number of sources of litigation, including lawsuits over alleged securities fraud, and a new report by Dechert LLP highlights a diminishing number of such lawsuits across the U.S. economy. However, the proportion of such lawsuits directed at drug and device makers has not diminished, making clear that companies in the life sciences must tread carefully when disclosing information such as the status of products in development for fear that a perceived misrepresentation could spark expensive and time-consuming litigation. Read More
With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acer, Adagio, Ascletis, Cellphire, Concentric, Genentech, Immutep, Prometheus, Revelation. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Hasten, Immuneid, Myeloid, Numab, Ono, Prime, Takeda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abionyx, Antengene, ASC, Biogen, Guerbet, Hipra, Nurix, Realta, Receptor, Taiho, Viiv. Read More
