Although it wasn’t a shutout, Spectrum Pharmaceuticals Inc. didn’t get the support it needed from a U.S. FDA advisory committee Sept. 22 for its non-small-cell lung cancer candidate, poziotinib, which it has proposed marketing as Pozenveo. Read More
DBV Technologies SA blindsided investors by disclosing that the U.S. FDA had placed a partial clinical hold on its phase III Vitesse trial of its Viaskin Peanut patch immunotherapy for peanut allergy, calling for several changes to the study protocol. Its demands came just two weeks after the company claimed to have finalized the protocol in consultation with the agency. Read More
Spero Therapeutics Inc. has come out swinging after a U.S. FDA rejection for its oral antibiotic, tebipenem Hbr, picking up a potential $600 million licensing deal with pharma giant GSK plc after agreeing on a plan with the regulator to revive the drug. Read More
Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards. Read More
Innocare Pharma Ltd. raised ¥2.92 billion (US$412 million) in a second listing on the Shanghai STAR Market. Its shares opened at ¥10.86 apiece, sliding 15.4% to close at ¥9.33 on the first trading day, Sept. 21. The company will use the proceeds to support cancer and autoimmune drug R&D, improve its drug development platform, build its sales network, and upgrade its information technology, said Chief Commercial Officer Jin Xiaodong. Read More
Polaris Pharmaceuticals Inc.’s pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of significant improvement in progression-free survival in patients enrolled in the pivotal phase II/III Atomic study in malignant pleural mesothelioma. Read More
Investigators at Washington State University (WSU) have identified a set of eight proteins that were expressed in the serum of Ursus arctos horribilis, better known as the grizzly bear, specifically during their hibernation period. In addition to reporting new basic insights into hibernation, the study, which was published in the Sept. 21, 2022, issue of iScience, could also give clues to insulin resistance and its relationship to body fat. Read More
An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allogene, Aqualung, Chia Tai-Tianqing, Ensysce, Inventiva, Marinus, Pfizer, Plus, Servier, Sino, South Rampart, Tonix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Argenx, Astrazeneca, Biocodex, Cellenkos, Cidara, Fennec, Frontera, Immunitas, Verve. Read More
