Thursday, September 17, 2026
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Policy•STAT News•Sep 17, 2026
Opinion: What happened to oppositional defiant disorder?
background ▾
- •ODD diagnosis has become conspicuously absent from clinical practice despite being historically one of the most common behavioral diagnoses in child psychiatry
Policy•STAT News•Sep 17, 2026
New lawsuit argues NIH violated First Amendment rights of grant applicants
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- •NIH is using computational text analysis tools to systematically screen grants for ideologically disfavored language, forcing researchers to self-censor critical terminology in their field
- •If successful, this class action lawsuit could invalidate NIH's screening process government-wide and restore funding for hundreds of terminated or modified research grants across the biomedical landscape
- •Monitor outcome of this First Amendment case and parallel Administrative Procedures Act challenges; potential ruling could fundamentally reshape federal research funding priorities and researcher autonomy
Policy•Endpoints News•Sep 16, 2026
Drugmakers cooperate with House probe of China trial sites
background ▾
- •Congressional probe into clinical trials at Chinese military hospitals signals escalating regulatory and political scrutiny of pharma's reliance on Chinese trial sites
- •Five major pharma companies voluntarily cooperating suggests potential reputational or compliance concerns with existing trial practices in China
- •Outcome could trigger new FDA guidance on foreign trial site oversight, stricter data validation requirements, or legislation limiting trial conduct in sensitive geopolitical jurisdictions
Unspecified (5 large pharmaceutical companies)
→ Read original articlePolicy•Endpoints News•Sep 16, 2026
FDA faces questions on 'America First' provisions in latest user fee agreement
background ▾
- •Academic leaders are publicly questioning the efficacy and actual impact of 'America First' incentives embedded in the FDA's latest user fee agreement
- •The debate highlights tension between protectionist policy rhetoric and real-world benefits for the U.S. pharmaceutical industry
- •Watch for FDA response to these concerns and potential modifications to implementation of the user fee agreement provisions
Policy•Endpoints News•Sep 16, 2026
Novo signs Anthropic deal to test Claude Science in R&D
background ▾
- •Novo Nordisk is testing Claude AI for R&D applications, reflecting broader pharma adoption of generative AI tools
- •This partnership extends Anthropic's footprint in life sciences following similar engagements with other pharmaceutical companies
Novo NordiskAnthropic
→ Read original articleMarket Access
Market Access•Fierce Biotech•Sep 16, 2026
CEO O’Day tells Fierce how Gilead’s cancer, inflammation expansion has reached ‘critical mass’
background ▾
- •Gilead's portfolio-building strategy across oncology and inflammation is now mature enough to support internal development from early research to commercialization, with recent approvals (Livdelzi, Trodelvy) and pipeline candidates (anito-cel) validating the approach.
- •The company has invested heavily in research infrastructure and talent (17,000 employees globally, 4,700 at Foster City headquarters) and is committing $32 billion to U.S. expansion, signaling confidence in the strategic pivot but also suggesting limited appetite for transformational acquisitions.
- •Watch for FDA approval of anito-cel (CAR-T) in December 2024 as validation of the Arcellx/Kite partnership; monitor how successfully Gilead integrates three 2024 acquisitions and whether newly approved or pipeline assets deliver competitive oncology/inflammation revenue.
Gilead SciencesKite PharmaImmunomedicsYescartaTrodelvyLivdelzi
→ Read original articleMarket Access•Endpoints News•Sep 17, 2026
Roche turns to Dualitas to find new bispecific approaches for immunology
background ▾
- •Roche is partnering with Dualitas to screen 300,000 bispecific antibody combinations for inflammatory indications, reflecting continued industry focus on multispecific modalities
- •The deal indicates Roche's confidence in platform-based discovery approaches for immunology, potentially accelerating time-to-candidate versus internal discovery
RocheDualitas
→ Read original articleMarket Access•Endpoints News•Sep 16, 2026
Gilead reaches HIV PrEP agreements; Hong Kong investigates Cloudbreak IPO
background ▾
- •Gilead expands Latin American market access for HIV PrEP, addressing a region with substantial unmet HIV prevention needs
- •What to watch: Details on pricing structure, which partner organizations are involved, and whether this signals broader emerging market strategy for HIV prevention
Gilead SciencesHIV PrEP
→ Read original articleMarket Access•Fierce Biotech•Sep 16, 2026
Novartis pays Sironax $125M to acquire platform for crossing the blood-brain barrier
background ▾
- •Novartis exercised a $125M option on Sironax's BBB-crossing platform, reflecting validation of the technology after a 14-month trial period and demonstrating strategic commitment to solving a major CNS drug delivery bottleneck
- •Novartis views BBB delivery as requiring multiple technologies rather than a single solution, indicating this is part of a broader portfolio strategy to enable application across its 14-asset neuroscience pipeline
- •Watch for clinical advancement of Sironax's small-molecule programs and announcement of which Novartis large-molecule assets will incorporate the platform; monitor whether this technology enables previously stalled Novartis neuroscience programs to advance
NovartisSironax
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•Sep 16, 2026
Novartis ends ALS program after phase 2 flop, adding to R&D woes
background ▾
- •VHB937 failed to demonstrate efficacy in ALS despite mechanistic rationale that TREM2 activation would protect motor neurons via microglial activation—a significant setback for the TREM2 target class in neurodegeneration
- •This is Novartis' third major R&D failure in weeks (CAR-T safety pause, Lp(a) lowering failure, muscle-wasting therapy failure), intensifying M&D pressure and raising strategic questions about pipeline robustness and deal-making urgency
- •Watch whether the ongoing phase 2 in Alzheimer's will validate TREM2 as a viable target in that indication; also monitor whether Novartis' $125M Sironax acquisition can unlock brain delivery barriers that have challenged its neuroscience portfolio
NovartisAlectorAbbVieVHB937lifonebartRhapsido
→ Read original articleClinical Trials•Endpoints News•Sep 16, 2026
Researchers implant human neurons in mice brains to study disease
background ▾
- •Human neuron-engrafted mice enable more physiologically relevant preclinical modeling of neurological disorders than conventional transgenic approaches
Clinical Trials•STAT News•Sep 16, 2026
WHO expresses cautious optimism about bid to control Ebola outbreak in DRC
background ▾
- •WHO-sponsored Phase 3 trial of Ebola vaccines launching imminently, with Merck's Ervebo as lead candidate despite uncertain cross-protection against circulating Bundibugyo strain
- •Innovative dual-vaccine observational design (Ervebo + Sudan strain vaccine) will generate field efficacy data in real epidemic settings, potentially informing future outbreak response strategies
- •Vaccine trials proceed despite complex operational challenges: decades of regional violence, population displacement, and competing health threats (malaria, hunger) that initially undermined outbreak control efforts
MerckDoctors Without BordersErvebo
→ Read original articleClinical Trials•Fierce Biotech•Sep 16, 2026
Sling reels in $123M series C to fund oral Tepezza rival through phase 3 trial
background ▾
- •Linsitinib has demonstrated clinically meaningful efficacy in Phase 2b/3 (52% response rate) and is now transitioning into Phase 3 with full funding, positioning it as a potential near-term competitor to Tepezza and Lumvoa in the TED market.
- •The oral formulation and distinct mechanism of action (IGF-1R phosphorylation inhibition vs. direct receptor binding) could expand the addressable patient population by capturing patients resistant to or preferring alternatives to IV monoclonal antibody therapy.
- •Monitor Phase 3 trial readout timing and comparative safety profile, particularly regarding tolerability versus IV competitors; also track potential partnerships given commercial opportunity in an expanding TED market.
Sling TherapeuticsForbionTPG Life Sciences InnovationslinsitinibTepezzaLumvoa
→ Read original articleClinical Trials•Endpoints News•Sep 16, 2026
Novartis' TREM2 drug fails Phase 2 ALS trial
background ▾
- •Novartis TREM2 ALS drug failed Phase 2, prompting program termination and signaling potential weakness of TREM2 as a therapeutic target for ALS
- •This represents a notable setback for neuroinflammatory approaches to ALS and may influence investor confidence in similar mechanisms in development by competitors
- •Monitor whether other companies with TREM2 programs in ALS or related neurodegenerative diseases adjust development timelines or strategies based on this readout
NovartisTREM2 (mechanism)
→ Read original article