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Clinical trials

Medicare Drug Price Negotiation Program, RYBREVANT FASPRO, and Sanofi: the issue of November 2, 2026

The week of November 2 to 8, 2026: 71 briefs, 17 stories, led by Medicare Drug Price Negotiation Program, RYBREVANT FASPRO, and Sanofi.

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In this story: Contents

The week of November 2 to 8, 2026 on The Priority Review: 71 briefs and 17 stories, led by Medicare Drug Price Negotiation Program, RYBREVANT FASPRO, and Sanofi. Every line links its page.

Stories this week

Terms this week

  • Biosimilar – a biologic that is highly similar to another biologic that is already FDA-approved. The FDA describes biosimilars as additional treatment choices. (FDA: Biosimilar and Interchangeable Biologics: More Treatment Choices)
  • Heart failure – heart failure means the heart cannot pump enough oxygen-rich blood to meet the body's needs. It does not mean the heart has stopped or is about to stop beating. (MedlinePlus: Heart Failure)
  • Overall survival – the time from randomization to death from any cause. Participants who were still alive at the clinical cut-off date are counted as of the last date known to be alive. (Registry record: EPCORE DLBCL-1 study record, NCT04628494)
  • SGK1 – the abbreviation for serum glucocorticoid inducible kinase 1, the target of Thryv's inhibitors. The company describes its lead candidate THRV-1268 as one of these inhibitors, tested in the Wave II and ASPIRE-HF trials. (Thryv Therapeutics: financing release, Nov. 3, 2026)
  • Psoriasis Area and Severity Index – a measure of the average redness, thickness and scaliness of psoriatic skin lesions, each graded from 0 to 4 and weighted by the area involved. The score runs from 0 to 72. (study record NCT06323356)
  • Apnea-hypopnea index – the number of apneas or hypopneas recorded by polysomnography per hour of sleep. The record defines an apnea as a cessation of airflow lasting at least 10 seconds. (study record NCT05811247)
  • Amyotrophic lateral sclerosis – a disease of the nervous system that attacks nerve cells called motor neurons in the brain and spinal cord. (MedlinePlus: Amyotrophic Lateral Sclerosis)
  • Stem cell transplant – a procedure that restores blood stem cells in people who have had theirs destroyed, for example by the high doses of chemotherapy or radiation therapy used to treat certain cancers. (National Cancer Institute: Stem Cell Transplants in Cancer Treatment)
  • US FDA-defined snapshot algorithm – the method the study used to classify each participant by the last available on-treatment HIV-1 RNA result in the Week 48 window, which ran between Days 295 and 378. (NCT06333808 study record)
  • Accelerated approval – an FDA program that allows earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate marker; companies are still required to conduct studies to confirm the anticipated clinical benefit. (FDA: Accelerated Approval Program)
  • HiSCR50 – a response measure for hidradenitis suppurativa: at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. (Incyte Corporation study record NCT05620836: A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS))
  • Meningococcal disease – the name for any illness caused by Neisseria meningitidis bacteria. These illnesses are often severe and can sometimes be deadly, and include infections of the lining of the brain and spinal cord (meningitis) and in the bloodstream (sepsis). (MedlinePlus: Meningococcal Disease)
  • Accelerated approval – earlier approval of a drug for a serious condition based on a marker thought to predict clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. (FDA: Accelerated Approval Program)
  • sponsor-investigator – A person who both starts a device study and conducts it, alone or with others. That person carries the duties of an investigator and the duties of a sponsor. (FDA: IDE Definitions and Acronyms)

Approvals briefs

  • FDA approves atezolizumab with chemotherapy for Stage III dMMR colon cancer. On October 8, 2026, the FDA approved atezolizumab (Tecentriq) in combination with a fluoropyrimidine and oxaliplatin for adult and pediatric patients two years of age and older with Stage III mismatch repair deficient colon cancer. The approval also covers Tecentriq Hybreza for patients 12 years of age and older who weigh 40 kg or greater. Source: FDA approval page, November 6, 2026.
  • FDA approves pembrolizumab or Keytruda Qlex for TMB-H solid tumors. On October 16, 2026, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors defined as ≥13 mutations/megabase. The approval converts the prior accelerated approval and amends the TMB-H definition to ≥13 mut/Mb, as efficacy was not confirmed in patients with TMB of 10 to <13 mut/Mb. Source: FDA approval page, November 6, 2026.
  • FDA approves RYBREVANT FASPRO for advanced head and neck cancer. The FDA granted accelerated approval to RYBREVANT FASPRO, a co-formulated amivantamab and hyaluronidase-lpuj, for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval excludes patients with HPV-associated oropharyngeal squamous cell carcinoma. Source: Source record, November 6, 2026.
  • Johnson & Johnson announces FDA approval of RYBREVANT FASPRO for advanced head and neck cancer. The FDA granted accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as a single agent for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval is based on a 42 percent overall response rate (95 percent CI, 32-52 percent) from the Phase 1b/2 OrigAMI-4 trial. Source: Source record, November 5, 2026.
  • FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for HNSCC. On November 5, 2026 the FDA granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for adults with recurrent or metastatic HNSCC who progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval is based on an overall response rate of 42% (95% CI: 32%, 52%) in 102 patients, and the product is not indicated for HPV-associated oropharyngeal squamous cell carcinoma. Source: FDA approval page, November 5, 2026.

Clinical trials briefs

34 more briefs in Clinical trials.

Regulation briefs

  • FDA classifies external mechanical stimulator for congestion as class II. A final order has been issued to place the device for relieving congestion into category II, adding special controls. The action is intended to provide reasonable assurance of safety and effectiveness and to enhance patients' access to innovative devices by reducing regulatory burdens. Source: Federal Register rule, November 6, 2026.
  • CMS codifies Medicare Drug Price Negotiation Program for 2029. On Nov. 5 2026, the Centers for Medicare & Medicaid Services issued a final rule (CMS-4215-F) that codifies the Negotiation Program for the initial price applicability year 2029 and beyond, effective Dec. 5 2026. The rule also establishes new policies for selecting up to 20 drugs for negotiation each year and clarifies procedures for manufacturers and the publication of negotiated maximum fair prices. Source: Source record, November 5, 2026.
  • FDA classifies mild cognitive impairment prognostic software as class II. The FDA issued a final order classifying the prognostic assessment software of mild cognitive impairment into class II with special controls, as stated in the Federal Register. The order notes that this classification should provide reasonable assurance of safety and effectiveness and may enhance patient access by reducing regulatory burdens. Source: Federal Register rule, November 5, 2026.
  • FDA classifies wearable vibration device for orthopedic use as class II. The FDA finalized an order classifying the wearable vibration device for orthopedic use into class II with special controls, stating the classification will provide a reasonable assurance of the safety and effectiveness of the device. The agency said the action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. Source: Federal Register rule, November 5, 2026.
  • CMS finalizes broad Medicare integrity changes in home health final rule. CMS finalized a CY 2027 Home Health Prospective Payment System final rule that is expected to save taxpayers approximately $82 million annually by strengthening its ability to recover Medicare payments from noncompliant providers and suppliers. The rule also shortens the OASIS data submission deadline from 135 days to 45 days, potentially reducing the public reporting lag by up to three months. Source: Source record, November 4, 2026.
  • CMS finalizes CY 2027 Medicare Physician Fee Schedule rule. The Centers for Medicare & Medicaid Services published a final rule on November 4, 2026 that finalizes policy changes for Medicare payments under the Physician Fee Schedule effective Jan. 1, 2027. The rule includes a +0.75% conversion factor for qualifying APM participants and a +0.25% factor for non-qualifying participants, with overall payment reductions of 1.83% and 2.31% respectively compared to CY 2026. Source: Source record, November 4, 2026.

5 more briefs in Regulation.

Policy briefs

  • Halozyme says royalty revenue should remain minimal through 2035 under new CMS rule. Halozyme projects zero to minimal impact to its royalty revenues through at least 2035 based on its analysis of CMS's final rule for the Medicare Drug Price Negotiation Program issued November 5, 2026. The company also says the rule does not affect its ability to enter new ENHANZE partnership agreements. Source: Source record, November 6, 2026.
  • Lilly and Hims & Hers expand access to FDA-approved Lilly medicines. The agreement lets eligible patients receive prescriptions for Zepbound (tirzepatide) and Foundayo (orforglipron) through the Hims & Hers platform at self-pay prices of $299 and $149 per month, respectively. Patients can complete a consultation, receive a prescription, and have the medication shipped directly to their home. Source: Source record, November 6, 2026.
  • CMS final rule strengthens supports lasting drug savings. The CMS final rule establishes a permanent framework for negotiating prices of high-cost drugs, with policies taking effect in 2029. By Feb. 1, 2027, CMS will select up to 20 additional negotiation-eligible drugs for the fourth cycle of negotiations. Source: Source record, November 5, 2026.
  • Mary Tyler Moore Vision Initiative Welcomes Regeneron and Adaptive Sensory Technology. Regeneron Pharmaceuticals, Inc. and Adaptive Sensory Technology have joined the MTM Vision Consortium as founding and device members. Their participation will help scale the MTM Vision Biorepository and Resource Center and the MTM Vision Endpoints and Biomarker Data Resource Center, supporting expanded human ocular sample collection and characterization, enhanced biological and clinical data analysis, validation of useful biomarkers and endpoints supporting new regulatory pathways, and sample and data sharing. Source: Source record, November 5, 2026.
  • Lilac Biosciences names Adriana Coll De Peña, Ph.D., CEO. Lilac Biosciences Inc. announced that Adriana Coll De Peña, Ph.D., joined the company on September 15, 2026, as chief executive officer. The company said the new CEO will grow the ModQuantTM platform beyond its first RNA modification kit into a broader set of RNA tools for research and therapeutic discovery. Source: Source record, November 5, 2026.
  • Scinai reports 167% revenue growth in first nine months of 2026. Scinai Immunotherapeutics Ltd. reported revenue of $2.8 million for the nine months ended September 30 2026, up 167% from $1.05 million in the same period last year. The company cited expansion of its CDMO business, including the Yavne operations acquired on February 16 2026, as the primary driver of the increase. Source: Source record, November 5, 2026.

9 more briefs in Policy.

How this issue is made

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