Thursday, May 7, 2026
← Back to archivePolicy
Policy•Endpoints News•May 6, 2026
Amgen, AbbVie say IRA negotiations impacted Q1 sales
background ▾
- •IRA price negotiations are delivering measurable negative sales impact in Q1, confirming industry concerns about margin compression and revenue reduction
- •Multiple large-cap pharmas acknowledging IRA headwinds simultaneously suggests a sector-wide effect rather than company-specific issue, likely to influence full-year guidance
- •Watch for additional Q1 earnings calls to quantify IRA impact across pipelines and whether companies adjust 2024 financial guidance or adjust portfolio strategy
AmgenAbbVie
→ Read original articlePolicy•Fierce Pharma•May 7, 2026
Alnylam rebuked by FDA over efficacy claims on Amvuttra website
background ▾
- •FDA found Alnylam presented open-label data in a way that created a misleading impression of Amvuttra's efficacy on the drug's consumer-facing website.
- •An untitled letter is a lower-level enforcement action than a warning letter, but signals regulatory concern about promotional practices that may need remediation.
Alnylam PharmaceuticalsAmvuttra
→ Read original articlePolicy•Fierce Pharma•May 7, 2026
Sanofi asks to pull Tzield bid from FDA's controversial CNPV program: report
background ▾
- •Sanofi is withdrawing Tzield from the FDA's CNPV program, indicating that the reputational and political risks of the controversial fast-track pathway may outweigh expedited review benefits
- •The CNPV program's credibility is in question if major pharma companies view participation as damaging rather than advantageous
- •Monitor whether other sponsors withdraw applications or whether the FDA modifies CNPV criteria and transparency measures in response to industry and stakeholder pressure
SanofiTzield
→ Read original articlePolicy•Fierce Pharma•May 7, 2026
FDA rolls out 1-day assessment pilot in bid to refocus inspection resources
background ▾
- •FDA is piloting abbreviated one-day inspections to improve resource deployment and increase inspection coverage
Policy•Fierce Pharma•May 7, 2026
FDA blocks publication of COVID, shingles vaccine safety studies: NYT
background ▾
- •FDA reportedly prevented dissemination of its own safety data on widely deployed vaccines, creating a potential transparency and scientific publication governance issue with regulatory implications
- •The blocked studies reportedly confirmed safety and efficacy, suggesting the issue centers on publication process rather than adverse findings
- •This development may prompt scrutiny of FDA's internal study publication policies and communication protocols with the scientific and medical community
GSKShingrixCOVID-19 vaccines
→ Read original articleMarket Access
Market Access•Fierce Biotech•May 6, 2026
Ipsen scuttles liver disease candidates from $952M Albireo acquisition
background ▾
- •Ipsen has shelved two of three pipeline assets from the Albireo acquisition, suggesting the $952M deal was heavily dependent on Bylvay's success rather than a diversified candidate portfolio.
- •The termination of ritivixibat's PSC trial due to recruitment failure contrasts with competitive progress—Mirum's rival IBAT inhibitor posted a phase 2 win in the same indication this week, indicating potential mechanism viability but execution challenges at Ipsen.
- •Monitor Bylvay's pediatric biliary atresia program and whether Ipsen can achieve meaningful sales expansion beyond the current €180M annual run rate to justify the acquisition's valuation.
IpsenAlbireoMirum PharmaceuticalsBylvayritivixibatA3907
→ Read original articleMarket Access•Fierce Biotech•May 6, 2026
Bayer buys Perfuse in $2.4B deal for midphase eye disease prospect
background ▾
- •Bayer is investing heavily ($2.4B total value) to secure a midphase eye disease candidate as its blockbuster Eylea faces declining sales and patent cliff risk
- •PER-001's phase 2 data demonstrated safety and early efficacy signals across multiple retinal indications, but pivotal trials have not yet initiated despite prior late-2025 timeline guidance
- •Watch for phase 3 trial initiation announcements and Bayer's development timeline clarification; clinical and regulatory success on PER-001 will be essential to justify the milestone structure
BayerPerfuse TherapeuticsRegeneronPER-001Eylea
→ Read original articleMarket Access•Fierce Biotech•May 6, 2026
GSK pens $1B deal with China’s SiranBio for oligonucleotide that could reduce abdominal fat
background ▾
- •GSK is building a complementary oligonucleotide pipeline for cardiometabolic disease, targeting ALK7 to reduce visceral adiposity—a distinct mechanism from GLP-1 drugs that could enable combination therapy approaches.
- •SA030 is early-stage (phase 1), with efficacy and tolerability data still pending; success depends on SiranBio completing phase 1 before handoff to GSK, introducing execution risk on both sides.
- •Watch for SA030 phase 1 readout and GSK's clinical strategy for combining ALK7 inhibitors with GLP-1 agonists; also monitor GSK's oligonucleotide pipeline maturation (bepirovirsen phase 3 for hepatitis B, Arrowhead collaboration for NASH).
GSKSiranBioArrowhead PharmaceuticalsSA030bepirovirsenEMP-012
→ Read original articleMarket Access•Fierce Pharma•May 7, 2026
Novo CEO cites pricing 'sweet spot' as Wegovy pill debuts with $355M quarter
background ▾
- •Novo's oral semaglutide achieved $355M in Q1 2026 revenue, demonstrating robust commercial traction for the first-to-market oral GLP-1 obesity therapy
- •Novo maintains competitive advantage over Eli Lilly's oral GLP-1/GIP therapy, which has not yet launched, providing a critical window for market share capture
- •Pricing strategy appears validated by payer/patient acceptance, suggesting oral formulations can support premium pricing despite oral delivery's commoditized perception in other therapeutic areas
Novo NordiskEli Lillysemaglutide (Wegovy pill)tirzepatide
→ Read original articleMarket Access•Fierce Pharma•May 7, 2026
Bayer diagnoses how to build trust in cell and gene therapies
background ▾
- •Cell and gene therapy developers must prioritize sustained stakeholder engagement to build trust—a critical market access lever for an emerging modality facing adoption barriers
Bayer
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•May 6, 2026
BioCryst scraps eye candidate to focus on rare diseases
background ▾
- •BioCryst terminated avoralstat development after a phase 1b DME trial enrolled only 9 patients, signaling a strategic pivot toward rare genetic disorders where the company has demonstrated clinical and commercial traction.
- •Orladeyo's strong commercial performance ($148.3M in Q1 2025) and successful market entry validate BioCryst's kallikrein inhibitor platform, but the company is consolidating resources rather than expanding the class into new indications.
- •Monitor BioCryst's BCX17725 development for Netherton syndrome and whether the company seeks additional rare disease targets to justify its refocused pipeline strategy.
BioCryst PharmaceuticalsKalVista PharmaceuticalsChiesi GroupavoralstatBCX17725Orladeyo
→ Read original articleClinical Trials•Fierce Biotech•May 6, 2026
After a decade of hype, Najat Khan is bringing Recursion back down to earth
background ▾
- •REC-1245 demonstrated clean early safety data with target engagement, positioning it as a validation of Recursion's AI platform; efficacy signals expected within 2-3 dose escalations this year
- •New CEO Khan is aggressively repositioning Recursion away from founder Gibson's discredited "100 medicines in 10 years" promise toward selective, data-driven programs with clear commercial potential
- •Watch for REC-1245 efficacy readout and FDA decision on REC-4881 registrational path; monitor whether Recursion's consolidated pipeline (post-Exscientia merger) yields additional clinical advances to validate platform claims
Recursion PharmaceuticalsExscientiaJohnson & JohnsonREC-1245REC-4881
→ Read original articleClinical Trials•STAT News•May 7, 2026
Opinion: Eugene Braunwald, ‘father of modern cardiology,’ told me he had two dreams. One came true
background ▾
- •Braunwald's research fundamentally transformed cardiology practice through the ejection fraction test and demonstration that ACE inhibitors prolong survival after myocardial infarction
ACE inhibitors
→ Read original articleClinical Trials•Endpoints News•May 6, 2026
BeOne culls five cancer programs and an autoimmune Phase 2
background ▾
- •BeOne Medicines has terminated six development programs (five oncology and one Phase 2 autoimmune asset) as part of portfolio optimization
- •The terminations occur despite the company's aggressive pipeline expansion, indicating selective focus on lead candidates rather than across-the-board advancement
BeOne Medicines
→ Read original articleClinical Trials•Endpoints News•May 6, 2026
Avalo scores Phase 2 success in comeback bid, raises $375M
background ▾
- •Avalo achieved Phase 2 efficacy in inflammatory skin disease, de-risking a core pipeline asset and supporting the company's strategic comeback
- •The $375M financing round provides substantial runway for Phase 3 initiation and commercial preparation, signaling investor confidence in the program
- •Detailed Phase 2 data (effect size, safety profile, primary endpoint margins) and Phase 3 timeline remain unclear from the brief announcement
Avalo Therapeutics
→ Read original article