Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FTC appointments possibly signal decreased scrutiny on biopharma M&A
- President-elect Donald Trump’s nomination of Andrew Ferguson and Mark Meador to the Federal Trade Commission signals a potential shift toward a more business-friendly antitrust approach, focusing on easing scrutiny of biopharma mergers and acquisitions.
- This contrasts with the aggressive stance under current FTC chair Lina Khan, who prioritized scrutiny of deals in the biopharma sector, according to Fierce Pharma.
Despite major drug approvals, uptake in gene therapy for sickle cell disease remains slow
- One year after approval of two major drugs, uptake of the groundbreaking gene therapies for sickle cell disease has been slow. This is primarily due to logistical challenges like complex treatment processes, patient hesitancy, lengthy preparation and limited accredited providers hindering widespread use, per BioPharma Dive.
- Despite the therapies’ strong efficacy, only a fraction of eligible patients are likely to seek treatment initially, with many opting for alternative treatments or clinical trials. Developers anticipate gradual adoption as barriers are addressed and familiarity with the therapies grows.
Bill that would extend price protection period for small molecule drugs faces hurdles in Congress
- Per BioSpace, the Ensuring Pathways to Innovative Cures Act, a bill supported by bipartisan efforts and industry backing, seeks to extend the price negotiation protection period for small molecule drugs, per the Inflation Reduction Act, to 13 years, matching biologics. Supporters of the bill argue the shorter protection period could harm small molecule research and development investment, shifting focus toward biologics.
- Budgetary constraints and concerns over federal savings could hinder the EPIC Act’s passage in the short term.
Expert panel endorses self-collection tests for HPV
- Fierce Pharma reports, the U.S. Preventive Services Task Force has proposed updated cervical cancer screening guidelines, including self-collected HPV tests for the first time, emphasizing the role of HPV testing for women aged 30-65 due to its link to 95% of cervical cancers.
- Recent Food and Drug Administration approvals for self-collection HPV test kits, while requiring administration in health care settings, aim to improve accessibility through use in mobile clinics or retail pharmacies. Screening programs have significantly reduced cervical cancer mortality by 70%, though incidence rates are rising among Black and Hispanic women, underscoring the need for expanded and accessible testing methods.
Large pharmaceutical M&A deals declined in 2024
- Nearly all acquisitions in the pharmaceutical industry remained under $5 billion during 2024, with the exception of one $14 billion deal. While M&A in previous years has been dominated by oncology, 2024 saw more variety, including endocrine, auto immune and immunology companies, according to BioSpace.
- Small biotech companies are increasingly pursuing market entry independently thus reducing late-stage acquisition opportunities. This has led large pharmaceutical companies to focus on sub-$5 billion deals.
For more insights in life sciences, check out RSM’s industry outlook.