Top Biopharma News for 05/31/2024


Here are the latest stories being discussed in biopharma today:

‘Invisible Hand’ of Inherited Genetics Can Drive Cancer Risk, New Study Suggests

New research from Stanford University indicates that minor genetic variations present at birth can significantly influence the aggressiveness of breast cancer. By examining the genomes of nearly 6,000 breast cancer patients, scientists have developed a genetic risk score that predicts how likely cancer is to avoid the immune system’s defenses and advance. The study, published in Science, underscores the significant role these small inherited genetic factors play in shaping tumor growth, immune response, and treatment susceptibility.

FDA Questions Data on MDMA-Based Therapy in PTSD Ahead of Advisory Committee

The FDA has raised concerns about the data from Lykos Therapeutics’ clinical trials of an MDMA-based therapy for PTSD just days before an advisory committee meeting. Although patients in two Phase 3 trials who received MDMA along with psychotherapy showed significant improvements over placebo, regulators worry about potential bias due to the psychoactive nature of MDMA. Most patients were able to guess their treatment assignment, which could have influenced the outcomes. The advisory committee will soon vote on the efficacy and safety of this PTSD treatment.

Merck CEO Says Keytruda Is ‘Not a Repeatable Model’

Speaking at the American Society of Clinical Oncology conference, Merck CEO Rob Davis described the company’s blockbuster cancer drug, Keytruda, as a ‘once-in-a-lifetime’ success that is unlikely to be replicated. Developed at a cost of $46 billion and generating $25 billion annually, Keytruda has received approval for 39 indications across 17 different tumor types since its initial approval a decade ago. Davis emphasized that Merck is not specifically seeking a follow-up to this phenomenal drug, acknowledging its unique breakthrough status.

CHMP Recommends 14 New Approvals, Seven Label Expansions

The European Medicines Agency’s human medicines committee has recommended 14 new drugs for approval, including Pfizer’s gene therapy for hemophilia B, now to be marketed as Durveqtix in the EU. The therapy, already approved in the U.S. as Beqvez, significantly reduces annual bleeding rates and has been priced at $3.5 million. The CHMP also recommended seven label expansions for other medications.

Joe Jimenez and Mark Fishman Target $400M for Third Fund After Leaving Novartis

Former Novartis executives Joe Jimenez and Mark Fishman are seeking $400 million for a third fund for Aditum Bio, a firm that licenses translational-stage drugs and builds companies around them. This new fund target is significantly larger than their previous funds, reflecting a trend among life sciences firms towards larger capital pools. The fund’s launch comes amid robust fundraising efforts in the sector by firms like Flagship, ARCH, and Cormorant.

Novartis Sues Maryland Over State Law Banning Limits on Discounts to 340B Contract Pharmacies

Novartis has filed a lawsuit against the state of Maryland to challenge a new law prohibiting drugmakers from limiting discounts to pharmacies supplying medications to low-income and uninsured patients. The lawsuit argues that the state law conflicts with federal statutes governing the 340B drug pricing program and improperly establishes a state-level enforcement mechanism. The contentious law is scheduled to take effect on July 1.