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.

Biopharma stocks up 1.5% as markets continue to struggle

Despite a sharp increase in mid-August, BioWorld’s Biopharmaceutical Index (BBI) 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.

Pheon raises $68M series A to advance ADC programs

Pheon Therapeutics Ltd. is positioned to bring next-generation antibody-drug conjugate (ADC) payloads with potent in vivo efficacy and enhanced tolerability into the clinic, after closing a $68 million series A. The improved payloads rest on chemistry developed by David Thurston, professor emeritus at King’s College London and scientific adviser to Pheon, who was the inventor of the payload technology used in ADC Therapeutics SA’s Zynlonta (loncastuximab tesirine), a CD19-targeted ADC for treating relapsed or refractory large B-cell lymphoma, which was approved by FDA in April 2021.

Zai Lab acquires rights to Seagen’s ADC Tivdak for cervical cancer

Zai Lab Ltd. has agreed to pay $30 million up front to in-license from Seagen Inc. exclusive rights to the antibody-drug conjugate 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.

CRISPR activation mouse model can turn on previously silenced genes

Researchers at the Walter and Eliza Hall Institute of Medical Research 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.

US Medicare beneficiaries to get small relief in monthly premiums

The U.S. Centers for Medicare & Medicaid Services (CMS) is finally making the long-expected and requested adjustment to Medicare Part B premiums, which were raised an unprecedented 15% for 2022 in the wake of Biogen Inc.’s initial $56,000 annual price tag for its Alzheimer’s drug, Aduhelm (aducanumab). For 2023, CMS is lowering the Part B premium to $164.90 – a $5.20, or 3%, reduction from the current premium of $170.10. However, the 2023 premium is still 11% higher than the $148.50 seniors were paying in monthly premiums in 2021. When CMS jacked up the premium for 2022, it attributed $11.50, more than half of the increase, to a contingency reserve it created as a precautionary measure in case it decided to broadly cover Aduhelm for Medicare recipients. But that didn’t happen.

EBG’s Thompson rips FDA guidance for clinical decision support as ‘a disaster’ for developers

The saga of 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.

EFPIA says R&D incentive for antibiotics would work

To jumpstart the development of much-needed antibiotics, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report today demonstrating the economic benefit of granting additional exclusivity for another drug as a way of incentivizing antibiotic R&D. The analysis supports the implementation of a Transferable Exclusivity Extension proposal, “showing it to be the most credible and workable solution for driving antibiotic research in Europe,” according to the industry group. Under such a program, the developer of an eligible, novel antibiotic would be granted a transferrable voucher to extend the exclusivity of another drug for several months.

The BioWorld Insider Podcast – Psychedelic evolution: Mindset Pharma looks to change mental health treatment

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. Lanthier discussed challenges facing companies developing psychedelic treatments and how to overcome the one-size-fits-all, trial-and-error approach to mental health treatment that often seems stuck in the past.

Also in the news

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