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In addition to keeping our Eyes On Quarterly Results, we’ve also been tracking healthcare headlines. Some of the highlights include AI medical advancements, strategic industry movements, regulatory updates, and challenges within the pharma and biotech sectors in both the therapeutic and operational domains. Check out what we've been watching, and let us know what caught your eye.
FDA Gives the Go-Ahead for Testing Neuro Implant Al Tool
The FDA has given the green light to clinical trials for an innovative Al tool, marking a significant step forward in integrating artificial intelligence in healthcare. The Neuralink Implant represents a significant advancement in healthcare technology. It's a human brain chip implant that hopefully will be used to help treat various conditions. Currently, human patients are being tested for their ability to control devices [e.g., a computer mouse] with their thoughts.
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Legend/J&J CAR-T Therapy Gains CHMP Backing
European drug regulators have recommended J&J and Legend Biotech’s Carvykti for use as early as after the first relapse in multiple myeloma, potentially giving it an advantage over competitors.
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Moderna’s FY23 Update - RSV Vaccine Potential and Future Plans
Moderna is counting on its experimental RSV vaccine, currently under FDA review, to bolster future sales after a challenging transition year. Some investors are also positive about the CMV opportunity (one of the major causes of congenital birth defects). Ph3 data is expected later this year.
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FDA to Review Expanded Use of Sarepta’s Duchenne Gene Therapy
The FDA will decide by June 21 on broadening eligibility for Elevidys outside of the current 4–5-year-old patient indication. The current label is challenging in that this population represents only about 3% of DMD patients and are currently under-diagnosed. In addition, the level of education, testing, and pre-treatment needed may cause potential patients to age out before they can secure access to the therapy. Additional trials are on-going to expand the treatment to additional patient types, including both ambulatory and non-ambulatory, up to age 17-20.
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Gilead’s CymaBay Acquisition
Gilead’s proposed deal for CymaBay is its largest since acquiring Immunomedics, strengthening its position in this key area of expertise. The deal is expected to close in 1Q24, and was approved by both Gilead and CymaBay Boards.
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Bayer and BridgeBio Deal
Bayer will pay $310M for European rights to Pfizer’s Vyndaqel rival, acoramidis. The deal was “a highly competitive process,” according to BBIO consultant Jake Bauer. Some investors feel that the Bayer deal makes fundamental and operational sense due to Bayer’s €5.5B Euro CV franchise and strong commercial capabilities. The deal also helps Bayer shore up this franchise, which is facing several near-term patent expiries.
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Astellas and Kelonia Partnership
Astellas continues to invest in cell therapy capabilities, announcing their deal with Kelonia Therapeutics on 16 Feb 2024. Kelonia is expected to receive $40 million upfront and potentially $35 million more if Astellas opts into another program. Kelonia could receive up to $800 M in royalty payments if the products are successful.
According to BioPharmaDive, “the two companies will combine their respective technologies to develop medicines that introduce a gene to immune cells, modifying them inside the body rather than in a laboratory. Kelonia is supplying a way to precisely deliver genetic material into the body, while Astellas, through a subsidiary called Xyphos Biosciences, is bringing its cell therapy technology to bear."
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New EU Critical Medicines Alliance
Launched by the European Commission’s Health Emergency Preparedness and Response Authority (HERA), this alliance aims to combat shortages of critical medicines.
FDA Guidance on Remote Regulatory Assessments
The FDA issued draft guidance on conducting remote regulatory assessments, a move influenced by the benefits observed during the COVID pandemic.
Bavarian Nordic Exits Oncology
The Danish company has terminated its cancer vaccine work after Phase 1 testing to focus on infectious diseases research.
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