// Biotech and Pharma Therapeutics
Data Integration: The Essential Element in Telemedicine Sustainability
May 14, 2025 / telemedicine data integration / healthcare interoperability standards / rural broadband access / hospital-telehealth collaboration / EHR system training
Sustainable telemedicine depends on robust data integration, enabling secure information sharing, improved care coordination, and informed strategy development. Addressing interoperability, broadband access, and workforce training is critical for maximizing telemedicine’s reach, efficiency, and long-term healthcare impact.
WHO trims top management ranks amid financial crunch
May 14, 2025 / WHO leadership changes / Mike Ryan WHO / WHO financial crisis / global health governance / World Health Assembly 2025
Facing financial strain after U.S. withdrawal, WHO has reduced top leadership, including the departure of Mike Ryan, long-time head of the Health Emergencies Program, ahead of the World Health Assembly and upcoming strategic planning efforts.
Germany’s Merck drops China surcharge on orders after US-China tariff deal
May 14, 2025 / Merck China surcharge / U.S.-China tariff deal / life sciences supply chain / Merck reagents pricing / pharmaceutical trade policy
Merck KGaA has dropped its temporary life sciences surcharge on China orders after a U.S.-China tariff agreement eased trade tensions, aiming to stabilize supply chain costs impacting reagents and materials critical to pharmaceutical and research operations.
Roche and Genentech Announce New North Carolina Manufacturing Facility
May 12, 2025 / Genentech North Carolina facility / Roche obesity drug manufacturing / metabolic medicines production / biotech expansion Holly Springs / U.S. pharmaceutical job growth
Roche and Genentech will invest over $700 million in a new North Carolina facility to manufacture next-generation metabolic and obesity medicines, expanding U.S. biomanufacturing capabilities and creating over 400 permanent jobs to support the companies’ growing therapeutic pipeline.
Plenty of promise in Pfizer’s ASCO offering
May 14, 2025 / Pfizer ASCO 2025 / metastatic breast cancer treatment / Braftovi colorectal cancer / oncology clinical trial data / precision cancer therapy
Pfizer will present over 60 oncology abstracts at ASCO 2025, highlighting survival data for Braftovi in BRAF-mutant colorectal cancer and vepdegestrant in metastatic breast cancer, signaling continued advancement in precision oncology therapies.
// 4th Industrial Revolution
Duke’s chief nurse shows how VR and AI are changing nursing at the health system
May 14, 2025 / nurse-led innovation Duke / AI staffing healthcare / VR nurse safety training / nurse burnout solutions / compassionate healthcare leadership
Duke Health’s Chief Nurse Executive Theresa McDonnell is leading VR-based safety training and AI-powered staffing tools to combat burnout, improve retention, and elevate nurse-led innovation, aligning compassionate leadership with advanced technology to transform workforce strategy and patient care.
Synchron will enable thought control of Apple devices with brain implant
May 14, 2025 / brain-computer interface Apple / Synchron BCI implant / thought-controlled iPhone access / neurotechnology for ALS / hands-free device control
Synchron’s minimally invasive brain implant enables thought-controlled use of Apple devices for individuals with motor impairments. Native BCI integration supports hands-free digital access, offering a breakthrough in assistive neurotechnology and human-device interaction via Apple’s new BCI HID profile.
Nurses are fleeing the workforce – can scheduling tech help?
May 14, 2025 / nurse burnout solutions / flexible nurse scheduling / nursing workforce retention / healthcare staffing technology / AMN Healthcare 2025 report
Burnout and staffing challenges are driving nurses from the workforce, but AMN Healthcare’s 2025 report suggests flexible scheduling and workforce-focused tech solutions like self-scheduling apps can improve retention, reduce compassion fatigue, and reignite passion for nursing careers.
The AI Drug Discovery Boom Is Coming. We Are Not Ready.
May 14, 2025 / AI in drug discovery / clinical trial acceleration / generative AI healthcare / AI patient recruitment / future of drug development
AI may revolutionize drug discovery, but without parallel innovation in clinical development, breakthroughs won’t reach patients. Coordinated AI agents across sponsors, sites, and patients are essential to accelerate trials, streamline enrollment, and transform the entire drug development ecosystem.
Epic XGM Spotlights What’s Next for AI, Usability, Cosmos and Much More
May 14, 2025 /Epic XGM 2025 / AI in electronic health records / Cosmos research database / clinical workflow automation / healthcare data interoperability
Epic’s XGM 2025 showcased deep generative AI integration into clinical workflows, enhanced usability tools, expanded Cosmos research capabilities, and a push toward holistic care. The emphasis was on transforming EMR functionality, accelerating research, and improving clinician and patient experiences.
// Business & Markets
GSK Makes a Big Liver Disease Move With $1.2B Deal for Phase 3-Ready MASH Drug
May 14, 2025 / GSK liver disease pipeline / efimosfermin MASH drug / FGF21 analog treatment / fatty liver disease therapy / GSK Boston Pharma acquisition
GSK acquired efimosfermin alfa for $1.2B to strengthen its liver disease pipeline. The FGF21 analog, showing promising Phase 2 MASH results, offers monthly dosing and complements GSK’s siRNA asset, supporting future monotherapy or combination approaches for liver fibrosis treatment.
Pager Health and Protera Health Partner to Deliver Streamlines Virtual MSK Care
May 14, 2025 / virtual MSK care / Pager Health partnership / Protera Health musculoskeletal / value-based orthopedic care / digital health navigation platform
Pager Health and Protera Health are partnering to deliver streamlined, value-based virtual musculoskeletal (MSK) care. The integration enhances care navigation, improves conservative treatment access, and reduces unnecessary procedures, aiming to lower costs and improve outcomes for MSK conditions.
Novo to work with Septerna in hunt for oral obesity drugs
May 14, 2025 / Novo Nordisk obesity drugs / oral GLP-1 therapy / GPCR-targeted weight loss / Septerna drug discovery / obesity treatment innovation
Novo Nordisk is partnering with Septerna to develop oral obesity drugs targeting GPCRs like GLP-1, GIP, and glucagon receptors. The collaboration supports Novo’s shift toward convenient oral therapies as competition intensifies in the rapidly growing obesity treatment market.
AbbVie pays ADARx $335M cash for next-gen siRNA options
May 14, 2025 / AbbVie siRNA partnership / ADARx RNA therapeutics / genetic medicine collaboration / siRNA drug development / next-gen RNA therapies
AbbVie is investing $335M upfront in ADARx to advance next-gen siRNA therapies across neuroscience, immunology, and oncology. The partnership aims to accelerate RNA-based medicines targeting disease-causing genes with long-lasting effects and minimal genomic alteration risks.
Women’s health faces growing headwinds, despite jump in venture investment
May 13, 2025 / women’s health venture funding / maternal health innovation / preeclampsia treatment development / women’s health policy impact / gender disparities in research
Despite record-breaking venture investment in women’s health, research and treatment gaps persist amid rising political and funding headwinds. Conditions like preeclampsia, menopause, and maternal health are gaining attention, but policy uncertainty threatens progress in both academic and commercial innovation.
// Legal & Regulatory
FDA moves to ban fluoride supplements for kids, removing a key tool for dentists
May 13, 2025 / FDA fluoride supplement ban / pediatric dental health policy / fluoride and gut microbiome / children’s cavity prevention / fluoride prescription controversy
The FDA plans to ban pediatric fluoride supplements over microbiome concerns, despite inconclusive evidence and opposition from major health organizations. Experts warn this move removes a critical tool for preventing cavities in children without access to fluoridated water.
US FDA accepts Regenxbio’s application for MPS II gene therapy
May 14, 2025 / RGX-121 gene therapy / MPS II treatment FDA / Hunter syndrome gene therapy / Regenxbio BLA approval / CNS-targeted gene therapy
The FDA has accepted Regenxbio’s BLA for RGX-121, a one-time gene therapy targeting MPS II (Hunter syndrome), granting Priority Review. RGX-121 delivers the IDS gene to the CNS, aiming to replace weekly enzyme therapy and improve neurodevelopmental outcomes.
Federal appeals court sends CRISPR-Cas9 patent case back to patent office for reconsideration
May 12, 2025 / CRISPR patent dispute / Broad vs CVC CRISPR / gene editing legal battle / CRISPR-Cas9 in eukaryotes / FDA-approved CRISPR therapy
A federal appeals court has ordered the U.S. Patent Office to reconsider its CRISPR-Cas9 decision, questioning Broad Institute’s claim to gene editing in eukaryotic cells. The ruling could impact patent rights in the rapidly advancing field of gene therapy.
Omada Health Files for IPO
May 12, 2025 / Omada Health IPO / virtual chronic care / digital diabetes management / telehealth for hypertension / chronic condition care platform
Omada Health has filed for IPO, highlighting strong revenue growth and narrowing losses. The company delivers virtual chronic care for conditions like diabetes and hypertension, leveraging a “between-visit” model to support over 679,000 members through employer-based partnerships.
Upheaval at FDA pushes some biotech firms to move early trials out of US
May 14, 2025 / FDA clinical trial delays / biotech trials move overseas / regulatory uncertainty FDA / early-stage drug development Europe / U.S. biotech exodus
Due to FDA restructuring, layoffs, and regulatory uncertainty under the Trump administration, U.S. biotech firms are increasingly shifting early-stage clinical trials to Europe and Australia, raising concerns about delays, increased costs, and a weakening of U.S. leadership in drug innovation.
// Research & Development
Roche reports final overall survival outcomes from breast cancer treatment trial
May 14, 2025 / Perjeta breast cancer trial / HER2-positive early breast cancer / Roche APHINITY study results / trastuzumab pertuzumab combination / 10-year survival breast cancer
Roche’s final Phase III APHINITY trial results show a Perjeta-based regimen reduces 10-year mortality risk by 17% in HER2-positive early breast cancer, with consistent safety and sustained disease-free survival, reinforcing its role as standard of care globally.
Using Real-World Data to Identify Barriers to Treatment Adoption
May 14, 2025 / real-world data in healthcare / treatment adoption barriers / patient journey analysis / diagnostic workflow optimization / precision medicine uptake
Structured patient journey analysis using real-world data reveals key barriers to treatment adoption, such as diagnostic delays and workflow gaps. This approach helps pharmaceutical and clinical teams identify actionable insights to improve access, uptake, and precision medicine delivery.
Tvardi maps out path to Phase II data after Cara merger
May 14, 2025 / Tvardi Cara merger / fibrosis drug development / biotech company consolidation / Tvardi Phase II trials / Nasdaq biotech listing
Following its merger with Cara Therapeutics, Tvardi Therapeutics has secured a Nasdaq listing and increased cash reserves, positioning itself to advance its fibrosis drug pipeline toward Phase II data, amid broader biotech consolidation trends.
Aficamten scores in Phase III trial, after FDA decision delay
May 14, 2025 / aficamten Phase III trial / hypertrophic cardiomyopathy treatment / Cytokinetics heart drug / FDA aficamten decision / MAPLE-HCM trial results
Cytokinetics’ aficamten outperformed metoprolol in improving peak exercise capacity in patients with obstructive hypertrophic cardiomyopathy in a Phase III trial, despite an FDA approval decision delay until December. The therapy also demonstrated favorable safety and tolerability.
Herantis Pharma doses final cohort in phase 1b trial of HER-096 for Parkinson’s disease
May 14, 2025 / HER-096 Parkinson’s trial / Herantis Pharma Phase 1b / disease-modifying Parkinson’s therapy / blood-brain barrier drug / CDNF peptidomimetic treatment
Herantis Pharma has dosed the final cohort in its Phase 1b trial of HER-096, a first-in-class peptidomimetic targeting Parkinson’s disease progression. The subcutaneous therapy crosses the blood-brain barrier, offering potential disease-modifying effects beyond current symptomatic treatments.
// Politics
Roche to reconsider US investment projects if Trump follows through on pricing order
May 14, 2025 / Roche U.S. investment threat / drug pricing executive order / Most Favored Nation policy / pharma R&D impact / Trump healthcare policy
Roche warns it may scale back its $50 billion U.S. investment plan if President Trump’s “Most Favored Nation” drug pricing order takes effect, citing concerns it would undermine pharmaceutical R&D, economic growth, and the U.S.’s innovation leadership.
5 questions on Trump’s plan to lower US drug prices
May 13, 2025 / Trump drug pricing plan / most favored nation policy / Medicare drug cost reform / U.S. pharma pricing strategy / healthcare policy uncertainty
President Trump’s renewed push to align U.S. drug prices with lower international rates through a “most-favored nation” policy reflects his “America First” agenda, though implementation remains uncertain following prior legal setbacks during his first term.
Prescription Drug Costs Should the U.S. Government Regulate Prescription Drug Prices?
May 12, 2025 / prescription drug pricing / Medicare drug reform / pharmaceutical cost regulation / U.S. healthcare policy
With U.S. drug prices over double those in other nations, debate intensifies over federal regulation, balancing affordability, innovation, and patient access. Policy proposals range from price caps to market-based reforms amid growing public demand for lower prescription drug costs.
Embecta restructures again, outlines tariff costs
May 13, 2025 / Embecta corporate restructuring / insulin patch pump discontinuation / medical device tariff impact / SG&A cost reduction / MedTech organizational changes
Embecta has initiated a second restructuring since November to enhance operational efficiency and reduce SG&A expenses, following the discontinuation of its insulin patch-pump program. The company also anticipates $3–9 million in tariff-related margin impacts through 2026.
Trump Admin Cuts $11 Billion In Health Funds — Local Governments Fight Back
May 9, 2025 / public health grant cuts / Trump administration funding lawsuit / American Rescue Plan health funds / CDC pandemic preparedness funding / HHS mass termination decision
Local governments are suing the Trump administration over the abrupt termination of $11.4 billion in public health grants, arguing the cuts undermine pandemic preparedness, violate federal law, and disrupt essential services funded through the American Rescue Plan Act.