The pharmaceutical industry in 2025 is set to undergo significant changes with new regulatory policies under a second Trump administration and Federal Trade Commission actions targeting pharmacy benefit managers to improve transparency. Biosimilars are poised to further disrupt the drug market by providing more affordable alternatives, while Mark Cuban's Cost Plus Drug will advance transparency and reduce prices through strategic partnerships.

Pharmacists at the American College of Clinical Pharmacy 2024 annual meeting emphasized that organ transplant recipients can travel safely with proper planning, despite the heightened infection risks from immunosuppressants. They stressed the importance of medication adherence, the increased risk of foodborne illnesses and taking preventive measures against diseases like malaria and fungal infections to ensure a safe trip.

The FDA has mandated that RSV vaccines from GSK and Pfizer include a warning about Guillain-Barre syndrome after data indicated a potential link. The FDA emphasized that the benefits of the vaccines still outweigh the risks, noting that the vaccines are a major tool against RSV, especially for adults older than 75.

Aetna recently brought suit against 20 major pharmaceutical companies including Pfizer, Novartis and Teva Pharmaceuticals USA, alleging a conspiracy to fix pricing for 111 generic drugs. The lawsuit was filed in Connecticut.

The FDA has issued draft guidance setting efficacy standards for investigational obesity therapies, requiring a minimum 5% weight loss versus control after one year. The guidance also emphasizes safety evaluations, particularly for cardiovascular and neuropsychiatric effects.

The FDA's 2024 mandate for boxed warnings on chimeric antigen receptor-T cell therapies due to potential T-cell malignancies has been questioned by clinicians and researchers. Studies indicate that the risk of secondary malignancies is low, comparable to other treatments, and a review in JAMA Oncology also suggests that the benefits of CAR-T outweigh the small risk of secondary cancers.

Commercial health insurance plans deny more claims than public payers, affecting both health care providers and patients. About 21% of people with employer-sponsored insurance reported denied claims, compared with 10% covered by Medicare, according to a 2023 analysis by KFF, and a 2024 survey from Premier found that around 15% of initial claims submitted to private payers, including Medicare Advantage and managed Medicaid plans, are denied, but about 54% of those denials are eventually overturned on appeal. AvMed and UnitedHealthcare have the highest denial rates among major commercial insurers, according to ValuePenguin, and Kaiser Permanente has the lowest.

Employers are increasingly requiring nutrition counseling to manage the rising cost of glucagon-like peptide-1 drugs, benefiting startups such as Virta Health and Omada Health. However, pharmacy benefit managers and drug manufacturers have lowered rebates when "employers are requiring a lifestyle management intervention as part of the drug criteria, so it has been challenging for employers to put in place the right programs to support their workers and family members," says Randa Deaton of Purchaser Business Group on Health.

A study in the Journal of Clinical Investigation found that more than 15 million people in the US were diagnosed with autoimmune diseases from 2011 to 2022, with women nearly twice as likely to be affected as men. The research, using electronic health records from six health care systems, highlights rheumatoid arthritis as the most prevalent condition.

The US leads 30 countries with the highest overdose death rate, followed by Puerto Rico and Scotland, according to a report from the Commonwealth Fund. Despite a slight decrease in 2023, over 100,000 people died from overdoses that year, with fentanyl, a potent synthetic opioid, playing a major role in these deaths. Other countries have implemented more harm-reduction measures, such as increased access to Naloxone and drug consumption rooms, contributing to lower overdose rates, compared with the US.