Don Tracy, Associate Editor 

White House Unveils Pharma Most-Favored-Nation Executive Order

reported that President Trump issued an executive order titled Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, aiming to lower US drug prices by requiring pharmaceutical companies to match or beat prices offered in other developed countries, with potential penalties including tariffs and FDA action.

FDA, CDC call for pause of chikungunya shot rollout in older adults

The FDA and CDC have recommended pausing the use of Valneva’s chikungunya vaccine, Ixchiq, in adults over 60 years of age because of ongoing investigations into serious adverse events, The move follows similar actions by European health authorities.

AI is already delivering pharma value — and not just in drug discovery

AI is already delivering value in pharma beyond drug discovery, with significant advances in clinical trials, diagnostics, and data management, though challenges remain in fully integrating AI into drug development, according to Jessica Owens of Initiate Ventures.

Public Perception of Clinical Research Amidst Policy Changes

, Krinx Kong, chief commercial officer, Cognivia, discussed how potential policy shifts in vaccine trials could affect public perception and trust, emphasizing the importance of behavioral insights to enhance communication, recruitment, and retention amidst stricter regulations.

Lexeo laid off 15% of staff in April to focus on lead cardiac gene therapies

Lexeo Therapeutics laid off 15% of its staff in April to reallocate $20 million from its pipeline to focus on its lead cardiac gene therapy programs, LX2006 and LX2020, while sidelining its Alzheimer disease gene therapy candidates.

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Pharma Pulse 5/13/25: White House Unveils Pharma Most-Favored-Nation Executive Order; FDA, CDC Call for Pause of Chikungunya Shot Rollout in Older Adults

FDA chief Martin Makary sets June deadline for genAI rollout

FDA Commissioner Martin Makary has set a June 30, 2025 deadline for full agency-wide rollout of generative AI to streamline scientific reviews and reduce bureaucratic workload, amid concerns about whether the technology can offset recent staffing cuts under HHS Secretary Robert F. Kennedy Jr.

Moderna’s flu-COVID vaccine beats standard shots: Study

Moderna’s combination flu-COVID vaccine, mRNA-1083, generated stronger immune responses than standard vaccines in adults over 50 during a large phase 3 trial, according to results published in 

Bridging the Gap: A Large Pharma Blueprint

 article, David Kamenir outlines a five-step blueprint for large pharmaceutical companies to develop and execute resilient, growth-driven strategies by clarifying intent, empowering teams, and maintaining adaptability while avoiding overly cautious decision-making that can hinder innovation.

The Potential for Stricter Regulations in Vaccine Trials

 interview, Krinx Kong, CCO, Cognivia, warned that potential stricter regulations in vaccine trials could complicate recruitment and retention, emphasizing the need for behavioral insights, flexibility, and communication to address patient hesitations and reduce dropouts.

US, UK reach deal on tariffs, market access

The US and UK have reached a trade agreement under the Trump administration that maintains a 10% US tariff on British imports while lowering UK tariffs on US goods, sets quotas on automobiles and metals, and expands US market access for agricultural and industrial exports.

Pharma Pulse 5/12/25: FDA Chief Martin Makary Sets June Deadline for GenAI Rollout, Moderna’s Flu-COVID Vaccine Beats Standard Shots

Teva plots thousands of job cuts as restructuring drive enters 'acceleration' phase

Teva is set to cut around 2,400 jobs, about 8% of its workforce, as part of its "Acceleration Phase" in the ongoing restructuring plan aimed at saving $700 million by 2027, streamlining operations, and strengthening its position in generics and innovative medicines.

Takeda has announced plans to invest $30 billion into its US operations over the next five years, highlighting the US as a leading market for biopharmaceutical innovation amid potential tariff threats.

Time Horizon: An Early Career Perspective

In a reflection on career planning, Troy Trygstad emphasizes the importance of considering long-term time horizons, particularly in pharmacy, where changing business models, emerging technologies like AI, and evolving clinical services will shape the future of the profession.

Hikma Pharma to pay $50 million to settle narcolepsy drug antitrust case

Hikma Pharmaceuticals has agreed to pay $50 million to settle a class action lawsuit accusing the company of delaying a generic version of Jazz Pharmaceuticals' narcolepsy drug, Xyrem, thereby causing higher prices for health plans, with a separate $145 million settlement from Jazz also in place.

US judge sides with FDA's removal of Lilly's weight loss drug from shortage list

A US federal judge has upheld the FDA's decision to remove Eli Lilly's weight loss drugs Zepbound and Mounjaro from the shortage list, halting compounding pharmacies from producing generic versions of the drugs.

Pharma Pulse 5/9/2025: Teva Plots Thousands of Job Cuts as Restructuring Drive Enters 'Acceleration' Phase, Takeda to Invest $30B Into US Operations

J&J survey finds pace of oncology innovation is overwhelming physicians

A recent J&J survey reveals that oncologists are overwhelmed by the rapid pace of oncology innovation, highlighting the need for additional support and continuing medical education to help them keep up with new treatments and guidelines.

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues

Vinay Prasad, named head of the FDA’s Center for Biologics Evaluation and Research, is expected to bring a more stringent, evidence-based approach to drug approvals, especially for cancer, gene therapies, and biologics, based on his critical views on the use of surrogate endpoints, cost-effectiveness, and the effectiveness of non-curative treatments.

FDA ends advance notice for foreign drugmaker inspections: 5 notes

The FDA is ending advance notice for inspections of foreign drug manufacturing sites to ensure more rigorous oversight and level the playing field with domestic producers, following a history of higher deficiency rates in foreign facilities.

Creating a Gray Zone in Payer Messaging: Outflanking Comparability

 discusses how second-to-market pharmaceutical companies can create a "gray zone" in payer messaging by highlighting unique clinical strengths, such as improved tolerability, dosing, or trial design, to secure better access despite potential challenges with cost or efficacy comparisons to incumbents.

FDA set to meet this month on COVID vaccines

The FDA is set to meet on May 22 to discuss updating COVID-19 vaccine formulas for the fall and winter season, with a new director leading the agency and heightened scrutiny around booster recommendations and approval processes.

Pharma Pulse 5/8/2025: J&J Survey Finds Pace of Oncology Innovation is Overwhelming Physicians, Biotech is Guessing How Vinay Prasad Might Change the FDA