Micurx Pharmaceuticals Inc. has won marketing approval from China's NMPA for its lead antibacterial, contezolid, for treating adults with complicated skin and soft tissue infection (cSSTI), marking the first NDA for the Shanghai drugmaker. Set to be marketed as Youxitai in China, Micurx discovered the new-generation oral oxazolidinone antibiotic, developing it over 12 years. It’s designed to treat multidrug-resistant gram-positive bacteria such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci. Read More
DUBLIN – Ronopterin (VAS-203) failed to meet the primary endpoint of a phase III trial in traumatic brain injury (TBI), but developer Vasopharm GmbH is nevertheless convinced that it has an active drug on its hands. It has also received backing from the study’s data monitoring committee, which has provided, Vasopharm said, a “positive benefit-risk assessment” on the basis of the efficacy signals detected and the drug’s known safety profile. Read More
Stablix Therapeutics Inc. has raised $63 million in series A funding to pioneer a novel class of small-molecule drugs, designed to selectively stabilize proteins that would otherwise undergo degradation in the ubiquitin-proteasome system (UPS). It represents what its founding investors consider the first company focused on inhibiting the UPS in a target-specific fashion. Read More
DUBLIN – Auris Medical Holding Ltd., an early pioneer of targeted therapy for hearing disorders, is planning to exit the field and pivot into RNA-based therapeutics by acquiring a U.S. firm, Trasir Therapeutics Inc., which has developed an oligonucleotide delivery platform for delivery of short interfering RNA and other therapeutic RNA payloads to sites outside the liver. Read More
Two weeks ago, it was a grilling by the House Oversight Committee over the pricing of blockbuster drugs Humira and Imbruvica and a request for the FTC to launch an investigation into Abbvie Inc.’s patent settlements that delayed Humira biosimilar competition in the U.S. until 2023. This week, Abbvie became the face of a new investigation by the Senate Finance Committee over how multinational companies are shifting profits overseas as a way to avoid U.S. taxes. Read More
Novartis AG’s CAR T therapy, Kymriah (tisagenlecleucel), is heading for a third indication after the Basel, Switzerland-based pharma announced supportive results from a pivotal phase II trial, lining it up to compete with Gilead Sciences Inc.’s rival, Yescarta. Read More
The American Society for Clinical Oncology’s (ASCO) virtual annual meeting began June 3 with the release of late-breaking abstracts, including LBA-1 on “Olympia: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant?olaparib?after (neo)adjuvant chemotherapy in patients with germline BRCA1 and BRCA2 mutations and high risk HER2-negative primary breast cancer.” Read More
The U.S. Federal Trade Commission (FTC) is turning the biopharma industry’s claim about rebates on its ear, saying some rebates paid to pharmacy benefit managers and third-party payers are an anticompetitive tool drug companies use to maintain their U.S. market power. Read More
Preparing for the full implementation of the 2013 Drug Supply Chain Security Act (DSCSA), the FDA finalized two guidances June 3 and released two draft guidances to help supply chain partners comply with the law’s requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023. Read More
New hires and promotions in the biopharma industry, including: Dyne, George Medicines, Immunoprecise, Myeloid, Nabriva, Repertoire Immune, Sierra Oncology. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch, Can-Fite, Celltrion, Clearside, Dermavant, Eli Lilly, Iaso, Innovent, Micurx, Protagonist, Roivant. Read More
