Monday, July 27, 2026
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Policy•Fierce Biotech•Jul 24, 2026
Chutes & Ladders—Biogen R&D vet gets in Formation
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- •Michael Ehlers, former head of R&D at Biogen, joins AI-focused Formation Bio as chief scientific officer—bringing significant Big Pharma and academic credentials to an emerging biotech platform
Formation BioBiogenVerdiva BioVRB-103VRB-101semaglutide
→ Read original articlePolicy•STAT News•Jul 27, 2026
Opinion: E-bikes, e-scooters are a burgeoning pediatric public health emergency
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- •E-scooter injuries in children aged under 18 increased 71% year-over-year (5,012 to 8,545 injuries) between 2020-2021 according to National Electronic Injury Surveillance System data
Policy•STAT News•Jul 27, 2026
Opinion: How midwives like me can help fight medical misinformation
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- •This is an opinion essay rather than news reporting, reflecting on clinical practice challenges rather than announcing regulatory changes, market decisions, or trial results
Policy•KFF•Jul 24, 2026
Medicaid Work Requirements: Federal Outreach Requirements and State Plans
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- •44 states must implement Medicaid work requirements by January 1, 2027, affecting millions of ACA expansion group enrollees and certain waiver program participants, representing a fundamental shift in Medicaid eligibility policy
- •CMS interim final rule creates mandatory outreach requirements with unexpected final changes that will necessitate revisions to state notices and materials, adding implementation complexity with tight deadlines
- •States face operational capacity constraints including limited workforce, call center accessibility gaps, and difficulty creating clear, accessible messaging for complex eligibility rules that apply to only some enrollees—watch state compliance filings and early implementation outcomes in late 2026
Policy•Fierce Biotech•Jul 24, 2026
Amgen sheds around 40 staffers amid continuing struggles
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- •Tavneos faces potential U.S. market removal due to liver toxicity and study integrity concerns; Amgen submitted data to FDA for hearing to retain approval
- •Recent pipeline attrition includes termination of Sjögren's disease and UC candidates, plus Kyowa Kirin rocatinlimab collaboration exit, signaling portfolio contraction strategy
- •Monitor MariTide phase 3 trial readouts in 2025 and Tavneos FDA hearing outcome as critical inflection points for Amgen's near-term trajectory
AmgenChemoCentryxHorizon TherapeuticsTavneosdaxdilimabrocatinlimab
→ Read original articleMarket Access
Market Access•Fierce Biotech•Jul 24, 2026
Merck stages expanded access to monthly HIV PrEP pill ahead of approval
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- •Merck is pre-emptively establishing generic manufacturing partnerships for alimatravir across LMICs before phase 3 data readout—an unprecedented early-stage access strategy in HIV prevention that directly addresses supply chain failures seen with Yeztugo.
- •The inclusion of African manufacturers in initial voluntary licensing represents a structural shift toward regional manufacturing capacity and equitable global access architecture.
- •Alimatravir's once-monthly oral dosing offers logistical advantages over Yeztugo's twice-yearly injections, but the inferior dosing frequency may compromise real-world adherence, the critical determinant of PrEP efficacy.
MerckGilead SciencesAspen PharmacarealimatravirMK-8527lenacapavir
→ Read original articleMarket Access•Endpoints News•Jul 25, 2026
Anthropic’s life science plans; Novartis CEO on China deals; and more
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- •Multiple major pharma earnings announcements are imminent, suggesting potential updates on pipeline progress, revenue guidance, and strategic direction
ModernaAstraZenecaGSK
→ Read original articleMarket Access•Endpoints News•Jul 24, 2026
Novo asks court to block Lilly ads; Merck strikes HIV PrEP deal
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- •Novo Nordisk is pursuing litigation to restrict Eli Lilly's GLP-1 advertising, indicating fierce competitive battles are moving beyond clinical efficacy into legal and regulatory arenas
- •Merck's HIV PrEP partnership signals continued strategic M&A and licensing activity across infectious disease, while other major players execute parallel deals
- •The ad dispute outcome may establish precedent for permissible marketing claims in the GLP-1 market, with implications for how competitors position efficacy and safety
Novo NordiskEli LillyMerck
→ Read original articleMarket Access•Endpoints News•Jul 24, 2026
Michael Ehlers joins Formation Bio to lead R&D; Black Diamond co-founder dies at 67
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- •Michael Ehlers transitions from CEO of Ascidian Therapeutics to head of R&D at Formation Bio, marking a significant leadership change in exon editing space
- •Move reflects growing industry trend toward AI-driven drug discovery platforms attracting experienced R&D talent
Ascidian TherapeuticsFormation BioBlack Diamond
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•Jul 27, 2026
AstraZeneca execs ‘very confident’ in homegrown ADC pipeline despite scrapping 2 candidates
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- •AstraZeneca terminated two phase 1/2 ADC programs due to pharmacokinetic/pharmacodynamic issues and lack of efficacy, demonstrating disciplined portfolio management in the highly competitive ADC space
- •Sonesitatug vedotin (in-licensed from KYM) met dual primary endpoints in phase 3 gastric cancer trial, positioning it as a potential standard-of-care replacement for chemotherapy in CLDN18.2-positive patients
- •AstraZeneca has 6+ internally developed ADCs in clinical development including phase 3 candidates torvutatug samrotecan (FRα-targeted) and puxitatug samrotecan (B7-H4-targeted); monitor phase 3 readouts for these programs to validate internal platform strategy
AstraZenecaDaiichi SankyoKYMtilatamig samrotecanAZD4360Enhertu
→ Read original articleClinical Trials•Fierce Biotech•Jul 24, 2026
Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects
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- •Patient germline genetics act as a major intrinsic determinant of both CAR-T expansion and clinical toxicity, with PTPN22 variants particularly striking for cell proliferation across both trials
- •STXBP2 mutations associated with toxicity in high-disease-burden patients; ADAMTSL3 protective variants identified; findings could enable rational engineering of safer CAR-Ts
- •Study enrolled predominantly European-descent patients—lack of diversity in original trial populations limits applicability to other genetic backgrounds; field must address this gap as CAR-T use expands
Kite PharmaYescartaaxi-cel
→ Read original articleClinical Trials•Endpoints News•Jul 24, 2026
Ipsen’s Bylvay fails key trial in children with rare liver disease
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- •Bylvay failed primary endpoints in Phase 3 biliary atresia trial, eliminating a potentially valuable pediatric indication
- •Biliary atresia represents high unmet medical need with few approved therapeutics, making this failure strategically significant for Ipsen
- •Watch for Ipsen's next steps: potential trial design reassessment, focus shift to other cholestatic indications, or program termination in this disease
IpsenBylvay
→ Read original articleClinical Trials•Endpoints News•Jul 24, 2026
Biogen’s Alzheimer’s data spur excitement, confusion about tau-targeting drugs
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- •Biogen's tau-targeting Alzheimer's trial has produced results that support continued development of this drug class, but clinical interpretation and commercial implications are not yet clear
- •The data has generated both enthusiasm and confusion among industry observers, suggesting the results may be borderline or require careful contextualization
- •Monitor for regulatory feedback on tau-targeting agents and competitive announcements from other tau program developers (e.g., Eli Lilly, others in the space)
Biogentau-targeting agents (unspecified)
→ Read original articleClinical Trials•Endpoints News•Jul 24, 2026
Sanofi nixes Kymab-originated OX40L antibody in atopic dermatitis
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- •Sanofi has terminated an OX40L antibody program from its Kymab acquisition that was being developed as a potential Dupixent successor in atopic dermatitis.
- •The decision signals either clinical trial failure or competitive positioning concerns, representing a notable pipeline setback for a major dermatology franchise.
- •Watch for Sanofi's next strategic moves in atopic dermatitis—whether it will pursue alternative mechanisms or focus on maximizing Dupixent's lifecycle.
SanofiKymabOX40L antibodyDupilumabDupixent
→ Read original article