Top Biopharma News for 05/29/2024


Here are the latest stories being discussed in biopharma news headlines today:

Company Developing Video Games for ADHD Announces Sale

Akili Interactive, known for creating video game-based therapies for ADHD, is set to merge with Virtual Therapeutics, a private digital health company. This decision follows Akili’s recent restructuring, which included a significant staff reduction. Akili’s EndeavorRx, distinguished as the first video game to receive FDA authorization for prescription mental health treatment, struggled with insurance coverage. This merger represents a strategic effort to address challenges faced by pioneers in digital therapeutics.

BioNTech Increases mRNA Vaccine Footprint in Africa with $145M Investment

BioNTech is reinforcing its commitment to expanding mRNA vaccine production in Africa with a substantial investment. Partnering with the Coalition for Epidemic Preparedness Innovations (CEPI), BioNTech will use up to $145 million to establish R&D and manufacturing capabilities in Kigali, Rwanda. This initiative aims to produce 60% of required vaccine doses locally by 2040, reducing Africa’s reliance on imported vaccines.

Lilly’s Retevmo Lands New Accelerated Approval for Pediatric Cancers

The FDA granted accelerated approval for Eli Lilly’s cancer therapy, Retevmo, to be used in pediatric patients with specific thyroid cancers and solid tumors with RET gene alterations. Approved for patients as young as two, the approval is based on positive outcomes from a Phase 1/2 study showing significant response rates among young patients.

Amgen Secures FDA Approval for First Soliris Interchangeable Biosimilar

Amgen’s Bkemv has been approved by the FDA as the first interchangeable biosimilar for Soliris, a treatment for rare blood disorders. Set to launch by March 2025, Bkemv can replace Soliris in treating paroxysmal nocturnal hemoglobinuria and hemolytic uremic syndrome. The launch is the result of a settlement from a previous patent dispute with Alexion, now part of AstraZeneca.

FDA Approves Tris Pharma’s Non-Stimulant Pediatric ADHD Liquid Medication

Tris Pharma’s Onyda XR has received FDA approval as the first liquid non-stimulant medication to treat ADHD in children aged six and older. This reformulated version of clonidine hydrochloride offers an alternative to stimulant medications and is designed for once-daily administration, including at bedtime. Onyda XR is expected to be available in the latter half of 2024.