Friday, July 3, 2026
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Policy•Endpoints News•Jul 3, 2026
When clinical AI gets real
background ▾
- •Cadence secured $100 million Series funding for clinical AI applications aimed at automating medical care delivery
Cadence
→ Read original articlePolicy•Endpoints News•Jul 2, 2026
Scribe Therapeutics files for IPO in test of appetite for early-stage biotechs
background ▾
- •Early-stage gene editing biotech Scribe Therapeutics is pursuing public markets, signaling confidence in investor demand for nascent biotech despite recent IPO market volatility
Scribe Therapeutics
→ Read original articlePolicy•Endpoints News•Jul 2, 2026
Court halts Colorado price cap on Amgen's blockbuster Enbrel
background ▾
- •Federal court blocked Colorado's 70% price cap on Enbrel, granting Amgen's preliminary injunction and signaling likely success on the merits
- •This ruling may set precedent limiting states' ability to unilaterally impose drug price controls, creating uncertainty for similar pending state legislation
- •Watch for potential appeals, other state legislative responses, and whether Colorado's law survives on constitutional grounds
AmgenEnbrel
→ Read original articlePolicy•Endpoints News•Jul 2, 2026
Vertex's sickle cell therapy approved for kids; United Therapeutics buys startup
background ▾
- •Casgevy pediatric approval expands the patient population eligible for this landmark CRISPR therapy, likely enhancing its market penetration and revenue potential
- •This regulatory decision reinforces CRISPR gene therapy's clinical viability and safety profile in younger populations, with implications for future gene-editing therapies in development
- •Watch for real-world evidence on treatment durability, long-term safety outcomes, and uptake rates in pediatric populations, as well as payer coverage decisions for this high-cost therapy
Vertex PharmaceuticalsUnited TherapeuticsCasgevyexagamglogene autotemcel
→ Read original articlePolicy•Endpoints News•Jul 2, 2026
Galderma gets CRL for anti-wrinkle drug; Kimball buys CDMO for $103M
background ▾
- •Galderma's anti-wrinkle drug CRL represents a significant setback for a dermatology-focused company in a competitive cosmetic/therapeutic market, with unclear timelines for resubmission
- •Kimball's $103M CDMO acquisition signals strategic vertical integration in manufacturing capabilities, though limited detail is provided on rationale or impact
GaldermaKimballLonza
→ Read original articleMarket Access
Market Access•Fierce Biotech•Jul 2, 2026
Fosun pays $32M to join Lilly and Novartis in fiercely competitive psoriasis market
background ▾
- •Roconkibart demonstrated strong efficacy in Phase 3 (91% achieving ≥90% improvement at 16 weeks; 65% achieving 100% improvement at 52 weeks), comparable to recently approved competitors like Akeso's gumokimab
- •The IL-17A psoriasis market in China is saturated with at least 6 approved drugs plus multiple pending candidates, significantly limiting differentiation and pricing power for new entrants
- •Monitor roconkibart's Chinese regulatory decision and post-approval market penetration—commercial success will depend on payer reimbursement, patient access programs, and head-to-head positioning against established and incoming competitors
Fosun PharmaFosun Wanbang PharmaceuticalJunshi BiosciencesroconkibartJS005Cosentyx
→ Read original articleMarket Access•Endpoints News•Jul 2, 2026
Sandoz launches direct-to-consumer platform with growth disorder drug
background ▾
- •Sandoz is entering the direct-to-consumer market, a strategic shift for a traditional generics manufacturer moving into brand-like commercial models
- •The platform launches with a growth disorder medication, suggesting focus on specialty/pediatric segments with higher margin potential than commodity generics
Sandoz
→ Read original articleMarket Access•Endpoints News•Jul 2, 2026
After landmark deal, AstraZeneca goes to CSPC again in up to $1.7B pact
background ▾
- •AstraZeneca is doubling down on its relationship with CSPC through a second major deal worth up to $1.7B, signaling strong confidence in the partnership model
- •The rapid succession of two landmark deals with the same Chinese partner within six months suggests accelerated commercialization plans for AstraZeneca's portfolio in China
- •Watch for details on which drug programs are covered under this new agreement and how this expands beyond the initial landmark deal
AstraZenecaCSPC (China Pharmaceutical Group)
→ Read original articleMarket Access•Endpoints News•Jul 2, 2026
IPF biotech Celea gets $180M to follow paths of PureTech's Karuna, Seaport
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- •Celea Therapeutics raises $180M to advance IPF-focused pipeline, leveraging PureTech Health's established spinout-to-commercialization model
- •Company aspires to follow proven exit/commercialization paths of Karuna Therapeutics and Seaport Therapeutics, both PureTech-affiliated successes
Celea TherapeuticsPureTech HealthKaruna Therapeutics
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•Jul 2, 2026
Roche orchestrates phase 3 KRAS lung cancer win over Amgen, BMS
background ▾
- •Divarasib met its primary endpoint (PFS) and key secondary endpoint (OS) in phase 3, establishing statistically significant superiority over both Lumakras and Krazati in previously treated KRAS G12C NSCLC
- •Roche's late-entrant KRAS G12C inhibitor can challenge Amgen and BMS despite their 2-3 year market lead, given incumbent underperformance (Lumakras ~$363M 2024 sales; Krazati ~$205M 2024 sales)
- •Watch for full trial data presentation at medical meetings and EMA/FDA submissions planned for 2027; results from ongoing first-line and adjuvant trials will determine peak sales potential ($1.2-$2.5B CHF forecast)
RocheAmgenBristol Myers SquibbdivarasibLumakrasKrazati
→ Read original articleClinical Trials•Endpoints News•Jul 2, 2026
Revolution Medicines shares promising data around KRAS drug combination
background ▾
- •Revolution Medicines is advancing to Phase 3 testing of a KRAS drug combination based on early-stage data, representing meaningful pipeline progression in an increasingly crowded KRAS market
- •The dual-agent approach suggests potential for overcoming resistance mechanisms that limit single-agent KRAS inhibitor efficacy
- •Watch for Phase 3 readout timing and competitive outcomes from Amgen, Mirati, and other KRAS players pursuing combination strategies
Revolution MedicinesKRAS inhibitor (specific agents not named in article)
→ Read original articleClinical Trials•Endpoints News•Jul 2, 2026
Otsuka reports long-term kidney data key to Voyxact's bid for full approval
background ▾
- •Otsuka presented long-term data for Voyxact targeting conversion from accelerated to full FDA approval in kidney disease
- •Data package directly addresses post-marketing study requirements tied to the accelerated approval pathway
- •Long-term efficacy and safety durability will be central to regulatory decision on full approval
OtsukaVoyxact
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