FDA Leadership Shakeup: Peter Marks' Forced Resignation Sends Shockwaves Through Biopharma Industry
• Peter Marks, head of FDA's Center for Biologics Evaluation and Research since 2016, was forced to resign after refusing to support HHS Secretary Robert F. Kennedy Jr.'s vaccine safety claims.
• The departure triggered significant stock declines for gene therapy and vaccine-focused companies including Taysha, Solid Biosciences, Sarepta and Novavax, with shares falling 5-10%.
• Industry leaders express concern that FDA's scientific independence is under threat, with BMO Capital Markets analysts calling the resignation "a significant negative for the biopharma and biotech sectors."
• Marks' exit follows other key FDA departures, including CDER head Patrizia Cavazzoni, raising questions about regulatory stability and the future of accelerated approvals for innovative therapies.
Ovid Therapeutics Advances Novel Neurological Drug Pipeline with Key Clinical Milestones Expected in 2025-2026
• Ovid Therapeutics is advancing its pipeline of neurological treatments, with topline results from OV329's Phase 1 study for drug-resistant epilepsies expected in Q3 2025 and first-in-human studies for KCC2 activator OV350 initiated in Q1 2025.
• The company has strengthened its leadership team with biotech pioneer Dr. Stelios Papadopoulos joining the Board of Directors and two industry veterans taking key management positions as Ovid prepares for critical clinical development phases.
• With $53.1 million in cash and equivalents as of December 31, 2024, Ovid expects to support operations and development programs into the second half of 2026, during which multiple pipeline and regulatory milestones are anticipated.
FDA Faces Turmoil: Leadership Changes and Operational Disruptions Raise Industry Concerns
• The FDA is experiencing significant disruption with approximately 1,000 employees laid off, though 300 may be rehired, while 30 facilities were initially slated for closure before some decisions were reversed.
• President Trump's FDA Commissioner nominee Marty Makary faced Senate questioning amid canceled vaccine advisory meetings, while other health agency nominees including Jay Bhattacharya (NIH) and David Weldon (CDC) generate controversy.
• Despite leadership turnover including the departure of CDER Director Patrizia Cavazzoni, industry analysts report minimal approval delays, with some suggesting new leadership may be more supportive of accelerated pathways for rare disease treatments.
FDA Layoffs Threaten Drug Safety and Innovation: Experts Warn of Widespread Impact
• Recent Trump administration layoffs at HHS agencies could affect up to 5,000 staff members, with significant cuts reported at FDA's device regulation office, potentially compromising public health oversight.
• The dismissals specifically target probationary staff and recently promoted employees, raising concerns about the FDA's ability to handle emerging technologies and maintain regulatory expertise.
• Former FDA Commissioner Robert Califf warns of far-reaching consequences, particularly in drug safety monitoring and approval processes, as the cuts may impair the agency's core regulatory functions.
Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments
• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions.
• Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways.
• These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets.
• The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
Global Clinical Trials for Dravet Syndrome Reviewed in 2024
• A new report offers an overview of the clinical trial landscape for Dravet Syndrome, also known as Severe Myoclonic Epilepsy of Infancy, providing key data and analysis.
• The review includes data on trial numbers, average enrollment, and top countries involved, segmented by region, phase, status, endpoints, and sponsor type.
• Key companies like Jazz Pharmaceuticals, UCB, Takeda, and others are profiled, with details on their ongoing trials and prominent drugs in development for Dravet Syndrome.
• The report identifies trends in clinical trial enrollment over the past five years and highlights recent news related to Dravet Syndrome research and development.
BioNTech's Bispecific Antibody BNT-327 Shows Promise in Triple-Negative Breast Cancer
• BioNTech's BNT-327, a bispecific antibody targeting PD-L1 and VEGF, has demonstrated positive early results in patients with triple-negative breast cancer.
• The bispecific antibody builds on the success of checkpoint inhibitors like Keytruda, potentially representing the next generation of immunotherapy drugs.
• Early trial data, presented at the San Antonio Breast Cancer Symposium, suggest BNT-327 could become a critical component in treating triple-negative breast cancer.
• The development of BNT-327 aligns with a broader interest in PD1/PD-L1 and anti-VEGF bispecifics, following promising results from Summit Therapeutics in lung cancer.
Epilepsy Pipeline Shows Promise with Novel Therapies in Clinical Trials
• Over 90 epilepsy treatment therapies are under development by more than 75 companies globally, targeting various mechanisms of action and routes of administration.
• Longboard Pharmaceuticals reported positive Phase Ib/IIa results for LP352 (bexicaserin) in developmental and epileptic encephalopathies (DEEs), showing a significant reduction in seizure frequency.
• Amzell has initiated a study comparing AMZ002 with Vigabatrin for treating infantile spasms, a rare and severe form of epilepsy, to assess efficacy and safety.
• Emerging therapies like RLS103, CT-010, Darigabat, and XEN496 are in different clinical trial phases, indicating potential advancements in epilepsy management.
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