ALETH / LIFESCI-BRIEF / 2026-08-28 / FDA APPROVES REVMED PANCREATIC CANCER PILLThe Aleth Briefs link to the sources behind the stories and show how the week unfolded.
The week in five lines:
FDA approves RevMed pancreatic cancer drug, the first that targets RAS.
Akeso’s ivonescimab beats Imfinzi on biliary cancer survival.
FDA approves Jazz’s Ziihera for first-line stomach cancer.
Roche and Hanmi agree $2.3bn obesity deal.
PhRMA loses Medicare price negotiation appeal.
Browse by day:
Weekend: China trials · Vaccines · Guardant
Monday: Roche-Hanmi · GSK · Roche · Regenxbio · Capricor · J&J
Tuesday: Akeso · Ziihera · McKesson · Abbott · Antibodies
Wednesday: RevMed · Biohaven · Medicare · Shingrix
Thursday: Tezspire · Lisraya · Gilead
Friday: HUTCHMED Atled
Weekend catch-up
Two Republican lawmakers asked the FDA to reject clinical data from Chinese sites that it had not recently inspected.
House China committee chairman John Moolenaar and Congressman Ben Cline asked the FDA to accept data from Chinese trial sites only if it had conducted an in-person inspection within the previous 12 months. They also asked for a published assessment of how far US approvals rely on Chinese investigator-initiated trials, following reports of three patient deaths in such trials.
Chinese clinical data risks · Select Committee on the CCP
HHS opened a consultation, running to 20 September, on how US childhood vaccine recommendations are categorised.
The request for information, signed by HHS Secretary Robert F. Kennedy Jr., asks whether the existing recommendation categories should be changed or supplemented. It follows a Trump executive order of 10 August on childhood vaccine recommendations.
Categories in federal vaccine recommendations · Federal Register
A Delaware federal court ordered Guardant Health to pay TwinStrand and the University of Washington more than $245m over sequencing patents.
The final judgment preserved a 2023 jury verdict that Guardant wilfully infringed two patents underlying TwinStrand’s Duplex Sequencing technology. It awarded more than $245.2m in damages, accrued royalties and interest and set a 6% royalty on covered sales until the patents expire in March 2033. Guardant said on Monday that it would appeal, with execution of the judgment and collection of royalties stayed pending appeal.
$245m patent judgment against Guardant · TwinStrand
Guardant to appeal patent judgment · Guardant
Monday 24 August
Genentech agreed to pay up to $2.3bn for a Hanmi obesity candidate designed to preserve lean mass.
Genentech will pay $190m upfront for worldwide rights outside South Korea to HM17321, a urocortin-2 analogue designed to reduce weight while preserving lean mass. Hanmi will complete the phase 1 trial before Genentech takes over development from phase 2.
Genentech licenses obesity drug · Hanmi
GSK received the first approval for its hepatitis B drug Hibsago, in Japan.
Japan’s health ministry cleared Hibsago (bepirovirsen), an antisense drug licensed from Ionis, as a functional cure for chronic hepatitis B in adults who have taken nucleos(t)ide analogue antivirals for at least six months and start treatment with HBsAg ≤3,000 IU/mL and HBV DNA <90 IU/mL. In the B-Well phase 3 trials 19% of patients with HBsAg ≤3,000 IU/mL reached functional cure. Decisions elsewhere, including the US, are due in the coming months.
Japan approves hepatitis B drug Hibsago · GSK
The FDA cleared Roche’s Alzheimer’s blood test Elecsys pTau217, developed with Lilly.
It is the first FDA-cleared single-biomarker blood test that can both rule in and rule out amyloid pathology, in primary as well as specialty care, for people aged 55 and over with cognitive decline. It is designed to run across Roche’s installed base of more than 4,500 cobas analysers in US labs.
FDA clears Alzheimer’s blood test · Roche
The FDA put Regenxbio’s Hunter syndrome gene therapy on clinical hold.
Spine scans found small nodules or cystic masses in five boys treated with RGX-121 three to six years ago, which investigators judged non-serious and likely benign. Regenxbio no longer expects to refile soon and is concentrating on Duchenne, where it plans to file this quarter.
RGX-121 regulatory update · REGENXBIO
The FDA gave Capricor’s Duchenne cell therapy three more months of review.
The decision on deramiocel moves to 22 November. After a July advisory committee meeting, Capricor filed 24-month open-label extension data from the phase 3 HOPE-3 trial to support a refined proposed indication focused on upper limb function. The FDA classed the submission as a major amendment.
Deramiocel review extended · Capricor
J&J’s Imaavy became the first approved treatment for warm autoimmune haemolytic anaemia.
The FDA cleared Imaavy (nipocalimab), already approved in myasthenia gravis, for patients aged 12 and over currently or previously treated with corticosteroids. In the phase 2/3 ENERGY study about three times as many patients on the approved dose achieved a durable haemoglobin response as on placebo.
FDA approves Imaavy for wAIHA · J&J
Tuesday 25 August
Akeso reported an overall survival benefit for ivonescimab over Imfinzi in biliary tract cancer.
In the China-only phase 3 HARMONi-GI1 trial, the PD-1/VEGF bispecific plus chemotherapy showed a statistically significant overall survival benefit over Imfinzi (durvalumab) plus chemotherapy at an interim analysis in first-line advanced biliary tract cancer. It also met its progression-free survival and response-rate goals.
It is ivonescimab’s first phase 3 readout outside lung cancer. Partner Summit, which holds rights in territories including the US and Europe, noted that Akeso alone generated and analysed the data. Full results are due at a medical congress.
Ivonescimab survival benefit in biliary cancer · Summit
The FDA approved Jazz’s Ziihera in first-line HER2+ stomach cancer.
The FDA cleared Ziihera (zanidatamab), Jazz Pharmaceuticals’ HER2-targeted bispecific antibody, for first-line treatment of HER2-positive gastric, gastrooesophageal junction and oesophageal adenocarcinoma in two regimens: with chemotherapy and BeOne’s Tevimbra (tislelizumab) for IHC 3+ or IHC 2+/ISH+ disease, and with chemotherapy alone for IHC 3+ disease only. In the HERIZON-GEA-01 trial the three-drug regimen extended median overall survival to 26.4 months from 19.2 months on Herceptin and chemotherapy. Two Roche companion diagnostics were approved alongside it.
FDA approves first-line Ziihera · FDA
FDA approves first-line Ziihera · Jazz Pharmaceuticals
McKesson agreed to buy Precision Medicine Group for $2.25bn.
Clinical research and commercialisation services provider Precision Medicine Group will report within McKesson’s Oncology & Multispecialty segment once the deal closes, subject to regulatory clearance.
Acquisition of Precision Medicine Group · McKesson
Abbott received FDA authorisation for the first sensor that tracks both glucose and ketones.
Libre Duo 10 Day warns people with diabetes of rising ketones that can lead to diabetic ketoacidosis, alongside continuous glucose readings. It is cleared for ages 2 and over, and Abbott plans a US launch later this year.
FDA authorises dual glucose-ketone sensor · Abbott
An audit documented nearly 19,000 apparently manipulated or otherwise problematic validation images across 15 antibody suppliers.
In an audit published on 25 August, Reese Richardson documented 18,943 images across 17,495 antibody products. The examples include repeated background noise, painted-over Western blots and images reused across products or brands. Richardson cautioned that the work was not a complete audit of any supplier’s catalogue and that original high-resolution images would be needed to establish falsification.
15 antibody companies use faked antibody validation data · Reese Richardson
Wednesday 26 August
The FDA approved Revolution Medicines’ pancreatic cancer drug Rasonque.
Rasonque (daraxonrasib), a RAS inhibitor, is cleared for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy or cannot take multi-drug chemotherapy. The once-daily pill is on sale now at a wholesale acquisition cost of $39,800 for 30 days.
The approval came 6.5 months before the PDUFA date under the Commissioner’s National Priority Voucher pilot and rests on the phase 3 RASolute 302 trial against chemotherapy. Median overall survival was 13.2 months on Rasonque against 6.7 months on standard chemotherapy. The FDA called it a first-in-class targeted therapy for metastatic pancreatic cancer.
FDA approves Rasonque · Revolution Medicines
First RAS-targeted pancreatic cancer therapy · FDA
Biohaven licensed its Kv7 epilepsy platform, led by opakalim, to SK Biopharmaceuticals for a $400m upfront fee.
SK pays $350m at closing and $50m a year later, plus up to $150m in milestones and royalties of up to the low twenties per cent on US sales. It also takes on up to $245m in milestones owed to Knopp Biosciences. Biohaven keeps running the phase 2/3 trials and will file for approval.
Biohaven-SK epilepsy licensing deal · Biohaven
A federal appeals court rejected PhRMA’s constitutional challenge to Medicare drug price negotiation.
The Fifth Circuit upheld a district court ruling against the suit PhRMA brought with the National Infusion Center Association and the Global Colon Cancer Association. Judge Leslie Southwick, agreeing with the Second Circuit, wrote that manufacturers “lack a protected interest in selling to Medicare beneficiaries at a preferred price” because taking part in Medicare is voluntary.
On Monday a federal judge in Washington had also ruled against Merck, rejecting its arguments that the programme breaches the First and Fifth Amendments.
National Infusion Center Association v. Kennedy · Fifth Circuit
Merck v. Kennedy · US District Court
An Oxford study linked Shingrix to a lower cardiovascular disease burden than Zostavax.
Comparing more than 70,000 US adults vaccinated either side of the 2017 switch from Zostavax to Shingrix, researchers found Shingrix recipients had a 9% lower cardiovascular disease burden over seven years, including 10% less coronary heart disease and 12% less heart failure. A lower stroke risk was seen in men. The researchers said clinical trials are needed before shingles vaccination could be recommended for preventing cardiovascular disease.
Shingrix and cardiovascular risk · Nature Medicine
Shingrix linked to lower heart disease risk · University of Oxford
Thursday 27 August
Tezspire met both co-primary and all key secondary endpoints in a phase 3 eosinophilic oesophagitis trial.
In CROSSING, AstraZeneca and Amgen’s Tezspire (tezepelumab) showed statistically significant and clinically meaningful improvements versus placebo at week 24 in histologic remission and in the frequency and severity of difficulty swallowing, with improvements across all key secondary endpoints. The effects were sustained to week 52 at both doses tested.
Tezspire phase 3 EoE results · AstraZeneca
The FDA approved Roivant’s Priovant drug Lisraya, the first targeted treatment for dermatomyositis.
Lisraya (brepocitinib), a first-in-class dual TYK2/JAK1 inhibitor, is approved for adults with dermatomyositis. In the phase 3 VALOR trial 55% of patients on Lisraya reached at least moderate improvement on the Total Improvement Score with minimal or no steroid use, against 30% on placebo.
FDA approves Lisraya · Roivant
The FDA approved Gilead’s Bixlenvo, a once-daily HIV pill pairing bictegravir with lenacapavir.
Bixlenvo is cleared as a complete regimen for virologically suppressed adults on stable antiretroviral therapy with no known or suspected resistance to either component, including people on complex regimens who cannot take existing single-tablet options. Treatment starts with two days of Bixlenvo plus oral Sunlenca, followed by Bixlenvo alone once daily.
FDA approves Bixlenvo · Gilead
Friday 28 August
China conditionally approved HUTCHMED’s Atled for FGFR2-altered intrahepatic cholangiocarcinoma.
Atled (fanregratinib), an oral FGFR1-3 inhibitor, is cleared for previously treated adults with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma with FGFR2 fusions or rearrangements. In the phase 2 registration cohort 42.5% of patients responded and median overall survival was 16.6 months.
Approval for Atled · HUTCHMED
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