Thursday, May 28, 2026
← Back to archivePolicy
Policy•Fierce Biotech•May 27, 2026
Insulet issues voluntary correction for Omnipod devices in leaky insulin fault
background ▾
- •Manufacturing defect affecting ~7 million Omnipod units across three product lines with potential for serious patient harm (24 adverse events including hospitalization) creates significant financial and reputational risk to Insulet
- •Up to $50 million estimated cost impact in 2026 signals material financial headwind; timing and full scope of manufacturing remediation remain critical unknowns
- •Monitor for additional adverse event reports, regulatory actions from FDA or international authorities, and impact on customer confidence in Omnipod platform given this is the second major correction in 2025
InsuletOmnipod 5Omnipod DASHOmnipod Eros
→ Read original articlePolicy•Fierce Biotech•May 27, 2026
FDA delays ruling on AstraZeneca’s breast cancer drug after negative adcomm vote
background ▾
- •FDA advisory committee voted 6-3 that camizestrant failed to demonstrate clinically meaningful benefit in the switching study design, prompting the FDA to request additional analyses before making an approval decision.
- •AstraZeneca will present circulating tumor DNA clearance data at ASCO linking to longer-term efficacy outcomes—likely the key evidence to address FDA concerns about study design and clinical meaningfulness.
- •The approval timeline remains uncertain pending FDA review of new data; however, AstraZeneca is simultaneously pursuing adjuvant and first-line indications that may offer stronger commercial pathways if the Serena-6 switching indication fails, and European approval (Etcamah) is already secured.
AstraZenecaRocheBayercamizestrantEtcamahLynkuet
→ Read original articlePolicy•Fierce Biotech•May 26, 2026
As calls for COINS Act expansion grow, will new rules sweep up China biotech licensing?
background ▾
- •Republican lawmakers including House Foreign Affairs Committee chair Brian Mast and House Select Committee on China chair John Moolenaar are formally requesting Treasury add biotechnology to COINS Act implementation, signaling serious political momentum for the expansion.
- •NewCo deal structures—where Chinese licensors take <20% equity stakes in newly formed U.S. biotech companies—are identified as particularly vulnerable under potential COINS Act expansion, potentially disrupting a growing deal model in early-stage drug development.
- •Treasury Department is currently updating COINS Act regulatory details; the outcome of these deliberations and whether lawmakers successfully broaden transaction-type definitions beyond equity/debt will determine the practical impact on biotech licensing and M&A.
Policy•Fierce Pharma•May 28, 2026
As J&J separates from its orthopedics business, it's laying off 56 employees in New Jersey
background ▾
- •J&J is executing workforce reductions tied to its orthopedics business separation, indicating active progress on the previously announced spin-off plan
Johnson & Johnson
→ Read original articlePolicy•Fierce Pharma•May 28, 2026
Outlook moves toward potential US nod for thrice-snubbed eye drug with FDA appeal win
background ▾
- •FDA formally reversed its previous stance on Lytenava after appeal, establishing that efficacy evidence is now deemed sufficient—a rare outcome after three consecutive rejections
- •The dispute resolution process represents an escalated regulatory pathway that companies use when disagreeing with FDA guidance, indicating Outlook pursued an intensive review strategy
- •Approval timeline and any remaining regulatory conditions or post-marketing commitments are not yet specified
Outlook TherapeuticsLytenava
→ Read original articleMarket Access
Market Access•Fierce Biotech•May 27, 2026
Apogee bags $1.3B Blackstone royalty funding deal to push eczema challenger into phase 3
background ▾
- •Apogee secured the largest pre-phase 3 royalty financing deal on record ($800M royalties + $500M debt option), enabling fully non-dilutive phase 3 advancement without shareholder dilution despite already holding $1.3B in cash
- •Phase 2b primary endpoint met with 65.9% achieving ≥75% eczema improvement at mid-dose, supporting phase 3 dose selection and competitive positioning versus entrenched IL-4Rα antagonists
- •Watch phase 3 enrollment completion and efficacy readout (likely 2026-2027) to validate claimed differentiation; expansion into eosinophilic esophagitis (H2 2026) and asthma (H1 2027) could broaden addressable market
Apogee TherapeuticsBlackstone Life SciencesEli LillyzumilokibartEbglyssDupixent
→ Read original articleMarket Access•Endpoints News•May 27, 2026
#ASCO26: Cancer immunotherapy's magic bullet era is fading. Here's what's next
background ▾
- •Keytruda and Opdivo, representing the checkpoint inhibitor class's commercial dominance, are entering their patent expiration periods, fundamentally reshaping the immuno-oncology market landscape
- •The industry must transition beyond checkpoint inhibitor monotherapy toward combination strategies and novel mechanisms to maintain growth and clinical efficacy
- •Watch for announcements of next-generation immunotherapy approaches, combination trial readouts, and how Merck and BMS position their pipeline to offset patent cliff erosion
MerckBristol Myers SquibbKeytrudaOpdivo
→ Read original articleMarket Access•Fierce Pharma•May 28, 2026
Kaléo speaks up on allergy awareness to amplify patient stories
background ▾
- •Kaléo is executing a patient engagement and brand awareness strategy for AUVI-Q in the competitive epinephrine auto-injector market
KaléoAUVI-Q
→ Read original articleMarket Access•Fierce Pharma•May 28, 2026
Viridian, awaiting FDA decision, taps WuXi Bio in eye drug supply deal
background ▾
- •Viridian secured CDMO capacity with WuXi Biologics to de-risk manufacturing scale-up for its pipeline eye drug candidate
- •The move signals Viridian's confidence in FDA approval likelihood and intent to compete in Amgen's blockbuster ophthalmology market
Viridian TherapeuticsWuXi BiologicsAmgen
→ Read original articleMarket Access•Fierce Pharma•May 28, 2026
GLP-1 manufacturer CordenPharma strikes deal for peptide CDMO, lining up new production sites in US and China
background ▾
- •CordenPharma is aggressively expanding peptide CDMO capacity across multiple geographies to meet surging GLP-1 demand
- •The company is now pursuing parallel expansion strategies—a $1 billion standalone GLP-1 initiative plus new partnership-based peptide sites—signaling confidence in sustained market growth
- •Watch for announcements on the identity of the manufacturing partner, site locations, expected capacity metrics, and timelines for US and China facility launches
CordenPharmaGLP-1 agonists
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•May 28, 2026
GSK’s hepatitis B drug cures one-fifth of patients in ‘major step’ for pervasive disease
background ▾
- •Bepirovirsen achieved functional cure in 19% of all treated patients and 26% in the HBsAg-low subset—the highest reported cure rates for any HBV therapeutic, representing a major paradigm shift from suppressive-only strategies
- •Safety profile includes increased grade 3+ adverse events versus placebo, predominantly transient ALT elevations; investigators interpret enzyme spikes as a marker of immune reactivation/efficacy, but this will require careful clinical monitoring and potentially treatment interruption protocols
- •Regulatory pathway forward: GSK must obtain FDA/EMA approval (likely with restricted patient population given safety profile); commercial potential is substantial given 240M+ chronic HBV patients globally, but uptake will depend on how well ALT flares can be managed in clinical practice and payer willingness to reimburse for functional cure indication
GSKIonis PharmaceuticalsBristol Myers SquibbbepirovirsenBaracludeViread
→ Read original articleClinical Trials•Fierce Pharma•May 28, 2026
ASCO preview: With expectations jacked up, Akeso's ivonescimab to face scrutiny in high-stakes plenary
background ▾
- •Ivonescimab's Harmoni-6 plenary presentation at ASCO 2026 suggests efficacy data strong enough to merit premium conference visibility in first-line NSCLC, a heavily contested indication.
- •Plenary status creates both opportunity and risk—while it elevates the profile of positive results, it also guarantees intense scrutiny that could expose limitations or concerns about the asset's competitive positioning.
- •Watch for details on comparator arms, patient subpopulations, durability of response, and safety profile relative to established checkpoint inhibitor combinations; these will determine whether ivonescimab can differentiate in a saturated market.
Akesoivonescimab
→ Read original articleClinical Trials•Endpoints News•May 28, 2026
GSK spells out positive Phase 3 data for hepatitis B drug it licensed from Ionis
background ▾
- •GSK's Phase 3 hepatitis B program derived from Ionis demonstrates positive efficacy and safety data, positioning the asset for regulatory submission
- •The licensed asset expands GSK's virology franchise and represents successful translation of Ionis's antisense technology into late-stage development
- •Monitor for regulatory filing timelines and potential label positioning relative to existing hepatitis B treatments (entecavir, tenofovir, etc.)
GSKIonis Pharmaceuticals
→ Read original articleClinical Trials•Fierce Biotech•May 27, 2026
Kordata Dynamics launches with neural-focused AI clinical trial model
background ▾
- •Kordata's neural data processing platform is explicitly designed to align with FDA's new real-time clinical trial review framework, representing a timely regulatory arbitrage opportunity
- •The company leverages BIOS Health's existing AI dosing technology, reducing development risk compared to building core capabilities from scratch
- •Success will depend on demonstrating that real-time neural data processing and AI-driven insights actually compress trial timelines and improve recruitment—claims that remain unvalidated in commercial practice
Kordata DynamicsBIOS HealthMAVRK Celestia Fund
→ Read original articleClinical Trials•Fierce Biotech•May 27, 2026
D&D sees fibrosis improvements, MASH resolution after rolling dice on GLP-1 drug
background ▾
- •At Week 48, 62.5% of zabopegdutide-treated patients achieved fibrosis improvement with no MASH worsening, and 62.5% achieved MASH resolution without fibrosis worsening—effect sizes comparable to or exceeding approved MASH therapies in early-stage data
- •The competitive MASH landscape now includes two FDA-approved agents (Rezdiffra, Wegovy) and multiple phase 2/3 pipeline programs (Lilly's tirzepatide and retatrutide, Boehringer Ingelheim's GLP-1/glucagon agonist), suggesting continued clinical validation of GLP-1/glucagon pathway activation
- •D&D must advance zabopegdutide to phase 3 to generate larger, more rigorous efficacy and safety data; small phase 2 studies often fail to predict phase 3 outcomes, and regulatory approval will require demonstration of durable benefit in a larger population
D&D PharmatechNovo NordiskMadrigal PharmaceuticalszabopegdutideWegovyRezdiffra
→ Read original article