Verastem Oncology Inc. gained accelerated approval from the U.S. FDA of the Avmapki/Fakzynja co-pack for adults with KRAS-mutated recurrent low-grade serous ovarian cancer who have been given systemic therapy. The drug, to be available in about a week, comes as avutometinib capsules and defactinib tablets. Avmapki inhibits MEK kinase activity and blocks its reactivation by upstream RAF, while Fakzynja inhibits FAK, a mediator of drug resistance. Shares of Verastem (NASDAQ:VSTM) were trading at $7.28, up 34 cents.

Navigating the Trump tariffs, part two: Amgen, Biogen, others

As biopharma companies continue to roll out their first-quarter (Q1) earnings, Trump administration tariffs remain at the top of investors’ minds. While executives offer their various strategies to appease concerns, the uncertainty prevails, making it difficult to clearly satisfy all of the questions. In addition to leadership that shared their views in recent weeks, as reported by BioWorld, top officials from another five biopharma firms responded in Q1 investor calls to inquiries over how global tariffs announced April 2 by U.S. President Donald Trump may affect business.

Swiss biotech: Private investments drive industry growth in 2024

Private biotechs in Switzerland raised CHF833 million (US$1.002 billion) in 2024, driving an overall increase in capital investment in the sector to $3 billion, up from $2.4 billion in 2023. Over the year, these private companies invested a record $1.68 billion in R&D. For those with products, revenues grew to a combined $2.4 billion, an increase of 10% over 2023, according to the 2025 Swiss Biotech Report. This was in the face of significant financial and market challenges, and the news was not all rosy as 2024 was a difficult year for several publicly listed companies.

US court reversed in safe harbor overreach

Finding that a lower court went too far with an injunction that ignores the Hatch-Waxman safe harbor protections for drug development, the U.S. Court of Appeals for the Federal Circuit handed Avadel CNS Pharmaceuticals LLC a win of sorts. The case revolved around Avadel’s Lumryz, a (b)(2) drug, or “paper NDA,” that relied on the FDA’s safety and effectiveness findings for Jazz Pharmaceuticals Inc.’s Xyrem, a sodium oxybate product oral solution approved to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy.

Cynata’s MSC cells show positive results across variety of delivery systems

The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd. Results from a preclinical study using Cynata’s MSCs in a model of myocardial infarction evaluated a new, minimally invasive method to deliver MSCs over an extended period using a retrievable encapsulation device. The device, which can be implanted under the skin, protects the cells while still permitting the release of molecules into the circulation.

Still a strong start for 2025, even as biopharma deals drop to $12.8B in April

In April, biopharma transactions amounted to $12.8 billion, a sharp decline from March’s $29.48 billion. However, with $79.66 billion in deal value during the first four months of 2025, the sector has already achieved its highest start to a year in BioWorld’s records since 2019.

Also in the news

2seventy, Aligos, ALX, Amgen, Arcutis, Ashvattha, Ausper, Bioarctic, BMS, Brii, Cassava, Cognition, Context, Eli Lilly, Evotec, Gilead, Gri, GSK, Hemogenyx, Immunewalk, JCR, Korro, Medipal, Mira, Neurocrine, Nkgen, Novavax, Pathos AI, Peptone, Phoremost, Phosphorex, Rallybio, Ratio, Revolution Medicines, Scenic, SCG Cell Therapy, Seamless, Sibylla, Syndax, Synnovation, Telix, Transcode, Valneva, Viatris, Viridian, Vor, Yamo