Analysts were upbeat about positive results from Eisai Co Ltd. and Biogen Inc.’s phase III confirmatory Clarity Alzheimer’s disease (AD) trial of lecanemab that met both primary and secondary endpoints, and most agreed that the data should be enough to gain FDA approval for mild cognitive impairment due to AD. Read More
Despite a sharp increase in mid-August, BioWorld’s Biopharmaceutical Index ended that month up a mere 1.4% and rose only slightly in September to 1.5% as of the 26th. It has done significantly better than the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are down 23.2% and 19.5%, respectively. Read More
Pheon Therapeutics Ltd. is working to bring next-generation antibody-drug conjugate (ADC) payloads and enhanced tolerability into the clinic after closing a $68 million series A. Read More
Zai Lab Ltd. has agreed to pay $30 million up front to in-license from Seagen Inc. exclusive rights to the antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin) in mainland China, Hong Kong, Macau and Taiwan. Seagen is also eligible to receive development, regulatory, and commercial milestone payments of undisclosed value, as well as tiered royalties on net sales of the drug in Zai’s territory.
Researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne, Australia, have developed a new genome editing technique than can activate any gene, including those that have been silenced, allowing new drug targets and causes of drug resistance to be explored. Read More
The U.S. Centers for Medicare & Medicaid Services is finally making a long-expected, and requested, adjustment to Medicare Part B premiums, which were raised nearly 15% for 2022 in the wake of Biogen Inc.’s initial $56,000 annual price tag for its Alzheimer’s drug, Aduhelm (aducanumab). Read More
The saga of U.S. FDA regulation of clinical decision support (CDS) software has spanned six years since the passage of the 21st Century Cures Act, yielding two FDA draft guidances and a final guidance that emerged only Sept. 27, 2022. Regulatory attorney Brad Thompson blasted the final guidance for its addition of “time-critical decision making” to the definition of a regulated medical device, one of several features he argued are extra-statutory and which effectively handcuff both developers of CDS and the physicians who use their products to aid in selecting drug and device treatments. Read More
To jumpstart the development of much-needed antibiotics, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report Sept. 28 demonstrating the economic benefit of granting additional exclusivity for another drug as a way of incentivizing antibiotic R&D. 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
New hires and promotions in the biopharma industry, including: 4D Molecular, Code, Immune, Intrommune, Nuvectis, Pneumagen, Rapt, Satellos, Zentalis. Read More
Biopharmas raising money in public or private financings, including: Calttic, Cleara, Direct, Gamida, Mindmed, PT Etana, Qnovia, Sudo and Zyversa. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angel, Astrazeneca, Atai, Avidity, Ayala, Bellerophon, Corvus, Crispr, Legend, Merck & Co., Moonlake, NMD, Vertex. Read More
