// Biotech and Pharma Therapeutics
50 canceled vaccination clinics, and other local impact from HHS cuts
April 1, 2025 / measles ourbreak / Texas / HHS Budget Cuts / CDC Grant Termination / Vaccination Clinic Cancellations
Federal HHS cuts and CDC grant terminations forced Dallas to cancel 50 measles vaccination clinics amid an active outbreak, eliminating key public health staff and jeopardizing local outbreak response and disease prevention efforts.
Bausch + Lomb recalls Envista intraocular lenses over safety risks
March 31, 2025 / Bausch Lomb Lens Recall / Envista Intraocular Lens / IOL Safety Concerns
Bausch + Lomb has recalled multiple Envista intraocular lens products due to rising cases of toxic anterior segment syndrome (TASS), an inflammatory eye reaction, posing safety risks for cataract surgery patients.
Pharma majors put lobbyists to work to stagger tariff rollout: Reuters
April 1, 2025 / Pharma Tariffs 2025 / Trump Drug Import Tariffs / Lobby Trade Policy / US Drug Manufacturing Reshoring
Pharma giants are lobbying to delay Trump’s proposed 25% tariffs on foreign-made drugs, fearing increased production costs, disrupted supply chains, and patient access issues. The industry warns that sudden tariffs could escalate drug prices and limit R&D investment.
Streamlining development and assessment of biosimilar medicines
April 1, 2025 / EMA Biosimilar Approval / Reduced Clinical Trials Biosimilar
The EMA proposes reducing clinical data requirements for biosimilar approvals by emphasizing analytical and pharmacokinetic comparability, aiming to streamline development, uphold safety, and improve patient access across the EU.
End of the line for Inspirna as biotech sector faces strain
April 1, 2024 / Inspirna biotech closure / ompenaclid RGX-202 / gastrointestinal cancer therapy / RAS mutation drug
Inspirna, a biotech developing ompenaclid for advanced GI cancers, is shutting down after 10 years. The closure reflects broader financial pressures in the biotech sector. The future of its Merck-partnered asset remains unclear.
// 4th Industrial Revolution
Serve You Rx Integrates With Waltz Health’s AI Specialty Pharmacy Platform
April 1, 2025 / “Specialty Pharmacy AI / Waltz Health Integration / Specialty Drug Cost Savings / AI-powered pharmacy platform
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Serve You Rx will integrate Waltz Health’s AI-driven platform to optimize specialty medication management. The partnership enhances access, affordability, and efficiency by matching patients with cost-effective, clinically appropriate pharmacies, addressing rising specialty drug costs.
ATA Action Acquires Digital Therapeutics Alliance, Forms New Digital Health Coalition
March 31, 2025 / Digital Therapeutics Alliance / telehealth policy advocacy / Remote Patient Monitoring / AI in Digital Health
ATA Action has acquired the Digital Therapeutics Alliance and launched the Advancing Digital Health Coalition to strengthen advocacy for digital therapeutics, remote monitoring, AI, and telehealth, aiming to embed digital health technologies in U.S. healthcare policy and delivery.
Chatbots Transforming Healthcare: From Diagnosis to Patient Support
March 31, 2025 / healthcare chatbots / AI in medical diagnosis / digital health innovation
AI-powered chatbots are increasingly used across healthcare for screening, symptom detection, treatment planning, and patient support. Clinical studies highlight their potential to enhance engagement, efficiency, and early intervention, particularly in oncology, psychiatry, and chronic disease management.
Off the charts’ patient satisfaction at LifeBridge Health’s virtual urgent care center
April 1, 2025 / Insprina Biotech Closure / gastrointestinal cancer treatment / RAS mutation therapy
Oncology biotech Inspirna is shutting down after 10 years. Its lead drug, ompenaclid, targeted the CKB/SLC6A8 pathway in advanced GI cancers, including RAS-mutated tumors. The program’s future remains unclear following the company’s closure.
Unleash Your Data Archives to Empower Your AI Efforts
April 1, 2025 / healthcare data archiving / AI in healthcare medical data interoperability
MediQuant enables healthcare organizations to unlock legacy data for AI by cleaning, integrating, and securing historical records. This supports effective AI deployment, risk mitigation, and improved clinical and operational decision-making using complete, accurate longitudinal datasets.
// Business & Markets
Widespread job cuts begin at health agencies
April 1, 2025 / HHS mass layoffs / CDC job cuts / FDA workforce reduction / public health restructuring
The Trump administration has initiated mass layoffs at HHS, cutting 10,000 jobs across key health agencies like the CDC, FDA, and NIH, affecting public health initiatives, drug regulation, and outbreak response amid a major restructuring push by Robert F. Kennedy Jr.
TeamHealth, Array Behavioral Care Partner to Advance Emergency Behavioral Health Treatment
April 1, 2025 / emergency psychiatric care / virtual mental health services / TeamHealth Array partnership
TeamHealth and Array Behavioral Care have partnered to integrate virtual psychiatric evaluations into emergency departments, addressing rising behavioral health crises and improving access to mental health care in facilities lacking on-site psychiatric resources.
Digital twin company Unlearn partners with Trace Neuroscience
April 1, 2025 / ALS clinical trials / digital twin technology / Unlearn Trace Neuroscience partnership
Unlearn and Trace Neuroscience have partnered to use AI-generated digital twins in ALS trials. The technology simulates disease progression, enabling smaller, faster studies and smarter trial design targeting the UNC13A protein in neurodegenerative therapy development.
Flagship-backed Sail Biomedicines lays off staff following review of organizational structure
April 1, 2025 / Biotech Layoffs / Flagship Pioneering / Laronde / Senda Biosciences
Sail Biomedicines, focused on circular RNA (eRNA) therapeutics for diseases like autoimmunity and metabolism, laid off 12 employees amid restructuring. The company continues advancing its preclinical pipeline, including in vivo CAR reprogramming and GLP-1 programs.
SonderMind Expands Personalized Mental Healthcare Services Nationwide
April 1, 2025 / personalized mental healthcare / mental health app / AI-driven therapy / nationwide mental health access
SonderMind expands personalized mental healthcare nationwide, integrating in-person/video therapy, psychiatric care, and AI-driven self-care through its free app. This comprehensive model ensures tailored, continuous support for individuals across all stages of their mental health journey.
// Legal & Regulatory
Gold-standard maternal mortality database in limbo as CDC staff placed on leave
April 1, 2025 / maternal mortality data / PRAMS CDC layoffs / pregnancy health surveillance
The CDC placed the entire PRAMS team on administrative leave amid HHS layoffs, jeopardizing the nation’s gold-standard maternal health database and threatening critical research into the U.S.’s high maternal and infant mortality rates.
Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and Schizophrenia
March 31, 2025 / Bysanti FDA submission / milsaperidone bipolar treatment / schizophrenia antipsychotic drug / Vanda Pharmaceuticals NDA
Vanda Pharmaceuticals has submitted an NDA to the FDA for Bysanti™ (milsaperidone), an atypical antipsychotic targeting acute bipolar I disorder and schizophrenia. If approved, it could launch in 2026, with extended exclusivity potentially into the 2040s.
FTC concerned about privacy protections in 23andMe bankruptcy
March 31, 2025 / 23andMe bankruptcy privacy / genetic data protection / FTC health data concerns
The FTC is raising concerns over potential privacy violations if 23andMe’s genetic data is sold during bankruptcy proceedings, highlighting risks to personal health information security following a major data breach affecting 7 million customers in 2023.
HHS firings undermine federal government’s ability to care for vulnerable Americans
April 1, 2025 / HHS layoffs impact / disability healthcare disruption / vulnerable populations health services
Advocates warn that mass HHS layoffs driven by the U.S. Department of Government Efficiency jeopardize services for people with disabilities, risking care disruption, increased anxiety, and system-wide instability for already vulnerable populations.
Texas judge strikes down FDA rule on lab-developed tests regulation
April 3, 2025 / FDA lab-developed tests ruling / LDT medical device regulation / Texas court FDA decision
A Texas judge struck down the FDA’s rule to regulate lab-developed tests (LDTs) as medical devices, siding with clinical labs that argued such oversight would hinder innovation, inflate costs, and restrict access to critical diagnostic services.
// Research & Development
Combination Immunotherapy Shrank a Variety of Metastatic Gastrointestinal Cancers
April 1, 2025 / Tumor-infiltrating lymphocyte therapy / Metastatic gastrointestinal cancer treatment / NIH cancer clinical trial
NIH researchers found that combining pembrolizumab with selected tumor-infiltrating lymphocyte (TIL) therapy significantly shrank metastatic gastrointestinal tumors in 24% of patients, offering new promise for personalized immunotherapy in common solid cancers resistant to standard treatments.
Axsome’s Sunosi comes up short in trial but shows promise in treating MDD with daytime sleepiness
April 1, 2025 / Axsome / Sunosi / Central Nervous System / Narcolepsy
Axsome’s Sunosi (solriamfetol) failed to meet its primary endpoint in a Phase 3 MDD trial, but showed promise in patients with excessive daytime sleepiness (EDS), prompting plans for a targeted Phase 3 trial in that subgroup.
Merck KGaA pays $85M to nab global rights for Abbisko’s rare tumor drug after phase 3 win
April 1, 2025 / Merck KGaA / Abbisko Therapeutics / Licensing Deals / Tumor
Merck KGaA has acquired global rights to Abbisko’s CSF-1R inhibitor pimicotinib for $85M after strong Phase 3 results in tenosynovial giant cell tumors (TGCTs), with a 54% response rate versus 3.2% for placebo at 25 weeks.
AIRNA nets $155M series B to launch clinical test of RNA editing tech
April 1, 2025 / Fundrasing / Living Disease / Lung Disease / Venrock
AIRNA raised $155M in a Series B round to advance AIR-001, an RNA editing therapy for alpha-1 antitrypsin deficiency (AATD), into Phase 1/2 trials and expand its early-stage pipeline targeting cardiometabolic and genetic diseases.
AstraZeneca’s AZD0780 shows ‘potential to be a game changer’
April 1, 2025 / AZD0780 LDL cholesterol / AstraZeneca / PURSUIT Phase IIb trial / Oral cholesterol-lowering therapy
AstraZeneca’s oral PCSK9 inhibitor AZD0780 significantly reduced LDL-C levels in the Phase IIb PURSUIT trial when added to statin therapy, showing promise as a potential game-changing treatment for patients with uncontrolled cholesterol despite standard lipid-lowering therapies.
// Politics
After RFK Jr.’s ‘radical transparency’ pledge, HHS shutters much of its communications, FOIA operations
April 1, 2025 / HHS communication layoffs / RFK Jr. health transparency / CDC media team cuts / FOIA health information access
Despite RFK Jr.’s pledge of “radical transparency,” HHS cut key communications and FOIA teams, including CDC media, web, and social staff—potentially hindering public access to essential health information during emergencies and ongoing public health efforts.
Pivot: Discussing the Impact of a Proposed HIPAA Security Update
April 1, 2025 / HIPAA encryption mandate / healthcare cybersecurity update / HHS data protection rule / patient health information security
HHS has proposed making data encryption mandatory under HIPAA, aiming to strengthen patient data security. Cybersecurity expert Bryan Marlatt discusses how this shift addresses growing digital threats and the implications for healthcare organizations’ compliance and IT infrastructure.
At CDC, Trump administration’s job cuts wipe out wide array of specialists
April 1, 2025 / CDC job cuts 2025 / Trump HHS layoffs / public health workforce reduction / disease prevention disruption
The Trump administration’s job cuts eliminated 2,400 CDC positions, impacting key public health areas including tobacco control, injury prevention, reproductive health, and substance abuse—threatening the agency’s longstanding disease prevention capabilities and coordination across essential health programs.
Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner
April 1, 2025 / Martin Makary FDA Commissioner / FDA leadership 2025 / Dr. Makary health policy
The Trump administration is retracting $11.4 billion in COVID-19 funding from state and local health departments, citing the pandemic’s end. The CDC will begin recovering funds within 30 days, raising concerns about future public health preparedness.
Exclusive-Pharma industry lobbies Trump for phased tariffs, sources say
April 1, 2025 / Trump pharmaceutical tariffs / Pharma industry lobbying / Drug import tariffs 2025 / U.S. pharma trade policy
Pharmaceutical companies are urging President Trump to implement import tariffs in phases, aiming to mitigate financial impact and allow time for manufacturing shifts, as the administration prepares to include drug products in a sweeping new trade policy.
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