Monday, October 19, 2026

 

 

Inside Teva's Weltruza Launch and Novo's GLP-1 Strategy

(10/16, Ayla Ellison, Fraiser Kansteiner, Zoey Becker, Fierce Pharma) ...First, Fierce Pharma's Fraiser Kansteiner speaks with Christine Fox, Teva's executive vice president of U.S. commercial and head of its innovative medicines franchise, and Eric Hughes, M.D., Ph.D., executive vice president of global R&D and chief medical officer. They discuss the FDA's recent approval of Weltruza, a once-monthly injectable treatment for schizophrenia, lessons learned from the company's earlier rollout of Uzedy and how its growing portfolio of innovative medicines fits into its broader strategy... Full

 

Physician Views Preview: Will Weltruza's Cleaner Label Have Psychiatrists Giving it a Shot?

(10/19, Jessica D'Amico, FirstWord PHARMA) ...The new drug's label does, however, provide a general warning for PDSS, and states that the risk with Weltruza is unknown. Still, Oppenheimer analysts called it a "best case," adding that its flat monthly wholesale acquisition price of $3950 — a 47% premium to their estimates — showed Teva's bullishness on the product. Still, the company is managing expectations, setting the stage for a slow rampup as it prioritises access, according to Jefferies analysts. They pointed to a modest launch until sales begin to pick up in the second half... Full

 

 

Trump's Drug Pricing Pressure Gives China a Chance to Cash In

(10/16, Caroline Hug and Stefanie Bolzen, Politico) ...China is accelerating in discovering new drugs, faster and more cheaply than the U.S. and Europe. Traditionally a producer of basic chemicals for cheap generic medicines, China's innovative biotech sector is now blossoming. This makes the country an increasingly attractive alternative source of more affordable new drugs for western markets..."It's a real risk, but not pushing [for higher prices in Europe]… is not the answer," a Trump administration official told POLITICO... Full

 

Medicare Agency Plans Generic Drug Copay Cuts, Directory Fixes

(10/16, Ganny Belloni, Bloomberg Law) ...The agency also plans to establish new accuracy and accountability requirements for Medicare Advantage provider directories. The rule would require plans to adopt new provider directory verification and maintenance standards, an annual accuracy analysis, public reporting of accuracy scores, and cost-sharing protections for enrollees who rely on inaccurate provider directory information... Sub. Req'd

 

CMS Proposes MA 'Ghost Network,' PBM Transparency Requirements

(10/16, Dave Muoio, Fierce Healthcare) ...The proposed rule issued Friday outlines a framework for Medicare Advantage plans to verify and update their provider directories at least once every 90 days, according to a release and fact sheet from the agency... Full

 

CMS Proposes $0 Generic Drug Copay, Reduced PBM Compensation In Rule To Implement CAA

(10/16, Gabrielle Wanneh, Inside Health Policy) ...CMS proposed a rule Friday (Oct. 16) to eliminate cost-sharing for generic drugs used by certain low-income Medicare Part D enrollees and to demand more transparency from pharmacy benefit managers working with standalone Part D plans, as well as adjusting the compensation PBMs and their affiliates receive for managing PDP drug benefits... Sub. Req'd

 

Trump's New Rule on Prescriptions Will Send the Cost of My Drugs Through the Roof — And Maybe Yours Too

(10/18, James Bovard, New York Post) ...Tim Smith, general manager of the Canadian International Pharmacy Association, said that people "are coming to us because they can't afford the drugs where they live." Big Pharma lobbyists who warn of the risks of imports ignore the risk of pricing Americans out of the market for drugs that can save them from dire medical fates... Full

 

Trump's Pharma Holdings Surged as Drugmakers Benefited From Medicare Price Negotiation Carveouts, Democrats Allege

(10/16, Fraiser Kansteiner, Fierce Pharma) ...In a statement issued alongside the JEC report, the committee's ranking member, Sen. Maggie Hassan, D-N.H., argued that the president and Republicans in Congress "intentionally force seniors to pay more for cancer treatment so that Big Pharma can rake in more money that Trump can personally profit from."... Full

 

FAQ: How Payers Can Ease Drug Cost Burdens for Patients, Physicians

(10/16, Sabrina McCrear, AJMC) ...Siva Mohan, MD, explains how drug costs drive silent nonadherence, PA burden, and biosimilar hesitancy, and what payers can do about it... Full

 

Industry Worries About Misbranding Exposure In US FDA's Distributed Manufacturing Path

(10/16, Aakash Babu, Pink Sheet) ...AAM and BIO argued the proposal does not clearly distinguish "distributed manufacturing" from traditional arrangements where a company manufactures the same product at more than one facility. BIO recommended that the FDA consider an elective pathway when networks do not qualify as DMEs. AAM said maintaining multiple qualified manufacturing sites for the same product is "a cornerstone of supply chain resilience and a key safeguard against drug shortages."... Global Sub. Full

 

FDA Finalizes Risk-Based Guidance For Biosimilar Manufacturing Changes

(10/16, James Jarvis, Inside Health Policy) ...According to the final guidance, published in the Federal Register Tuesday (Oct. 13), manufacturers can generally rely on analytical and other quality data alone when those studies provide enough assurance that the product remains comparable before and after a manufacturing change and that any differences do not pose an increased safety risk or affect the drug's efficacy. But additional nonclinical or clinical studies may be needed, FDA says, if testing shows the change introduced new impurities, affected stability or altered other product characteristics and available testing cannot adequately determine whether those differences could affect patients... Sub. Req'd

 

US FDA Sets up Board to Oversee Drug Exclusivity Determinations

(10/16, Sneha S K in Bengaluru, Reuters) ...The US FDA's drug evaluation department said on Friday it has formed a board to oversee and advise on exclusivity determinations made by the department, aiming to improve clarity and consistency of those decisions... Full

 

Rare Disease Group To FDA: Align PDUFA With Drug Development Framework

(10/16, Lauren Brensel, Inside Health Policy) ...The Haystack Project is calling on FDA to implement the fit-for-purpose structure established by the agency's Rare Disease Framework Initiative in the next cycle of the Prescription Drug User Fee Amendments program. The group asks FDA to remove references to trial design "feasibility" and "flexibility"... Sub. Req'd

 

The FDA Must End Unnecessary Drug Trials | Opinion

(10/16, Dr. Sarfaraz K. Niazi, Newsweek) ...A clinical trial is ethical only when it can meaningfully improve our understanding or change a regulatory decision. Modern analytical methods can compare a biologic's molecular structure, purity, and functional properties with extraordinary precision. PK studies can establish how a medicine moves through the body. If these findings, alongside appropriate safety and immunogenicity assessments, establish biosimilarity, another efficacy trial may add little useful information... Full

 

Pink Sheet Podcast: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework

(10/16, Derrick Gingery, Sue Sutter and Nielsen Hobbs, Pink Sheet) ...Pink Sheet editors discuss the reasons Office of Generic Drugs Director Iilun Murphy decided to step down for another position and the potential impact of the FDA's ideas for systematic rare disease application review... Global Sub. Full

 

Study: Patient, Consumer Reps at FDA Adcomms Increasingly Hold Ties to Pharma-Backed Advocacy Groups

(10/16, Jeff Craven, Regulatory Focus) ...More than a third of US [FDA] Center for Drug Evaluation and Research (CDER) drug advisory committee meetings held between 2013 and 2022 included a patient or consumer representative belonging to an advocacy organization that received industry funding, according to the results of a recent analysis published in Health Affairs Scholar... Full

 

 

AbbVie's Next-Gen Crohn's Disease Combo Beats Skyrizi in Phase 2 Trial

(10/19, Nick Paul Taylor, Fierce Biotech) ...AbbVie randomized 300 people with moderate-to-severe Crohn's to receive Skyrizi, trosunilimab or the two treatments in combination. At Week 12, 30.2% of patients treated with the drug combination, code-named ABBV-466, met the primary endpoint of endoscopic remission. The remission rates in the Skyrizi and trosunilimab monotherapy cohorts were 21.3% and 18.0%, respectively. The ABBV-466 rate is higher than in AbbVie's phase 3 trials of Skyrizi in Crohn's, which reported (PDF) endoscopic remission in 24% and 19% of patients, respectively. Differences between the studies complicate cross-trial comparisons... Full

 

Johnson & Johnson Announces New Data Showing TREMFYA(R) (guselkumab) Is the Only IL-23 to Deliver Durable Fistula Remission Through 48 Weeks in Crohn's Disease with Perianal Fistula

(10/19, Johnson & Johnson) ...Johnson & Johnson (NYSE: JNJ) today announced one-year results from the Phase 3 FUZION study showing TREMFYA(R) (guselkumab) maintained or improved fistula remission through 48 weeks in adults with Crohn's disease (CD).(1) The findings build on the previously reported Week 24 results and further support the use of TREMFYA in one of the most difficult-to-treat manifestations of CD (2) . The late-breaking findings are being presented at the 2026 United European Gastroenterology Week (UEG Week)... Full

 

Lilly to Showcase Advances Across its Oncology Pipeline at the 2026 European Society for Medical Oncology (ESMO) Congress

(10/18, Lilly) ...Eli Lilly and Company today announced that new data from across its oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 23–27 in Madrid, Spain. Highlights include new Phase 1 data in platinum-sensitive ovarian cancer (PSOC) for sofetabart mipitecan (Sofe-M), Lilly's investigational FRa-targeting antibody-drug conjugate (ADC), in combination with bevacizumab, along with updated findings for olomorasib, Retevmo (selpercatinib), and Verzenio (abemaciclib) in lung, thyroid, and breast cancers, respectively... Full

 

BioNTech to Showcase Oncology Late-Stage Pipeline Progress and Pumitamig Novel-Novel Combination Data at ESMO 2026

(10/19, Biontech) ...Key oral presentations will focus on clinical data for pumitamig (BNT327/BMS986545), a PD-L1×VEGF-A bispecific immunomodulator being jointly developed with Bristol Myers Squibb ("BMS"), plus docetaxel in second-line metastatic non-small cell lung cancer ("NSCLC") as well as pumitamig in combination with elfetabart drozuntecan (elfe-D or BNT324/DB-1311), a B7-H3-targeting antibody-drug conjugate ("ADC") being jointly developed with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), across several advanced solid tumors – complementing the data in lung cancer presented earlier this year... Full

 

 

Samsung Bioepis Reports Comparable Results for Keytruda Biosimilar Ahead of ESMO

(10/19, Kim Yoon-mi, Korea Biomedical Review) ...The Korean biosimilar developer will present the findings at the European Society for Medical Oncology (ESMO) Congress 2026, scheduled for Oct. 23-27 in Madrid, Spain. It will also present scientific evidence supporting the use of its denosumab biosimilar SB16 in oncology indications... Full

 

Lupin Gets CDSCO Nod for Nivolumab Biosimilar

(10/18, ETPharma.com) ...Lupin Limited has secured approval to manufacturer and market a biosimilar alternative of Bristol Myers Squibb's blockbuster immunotherapy, nivolumab in India. The approval, granated earlier this week, extends to the indications authorised for the innovator product and is backed by a local phase 3 study undertaken by Lupin to establish its efficacy, immunogenicity and pharmacokinetics with the innovator... Full

 

Biosimilars Are Poised to Accelerate Patient Access to High-Quality Biological Therapies: Amol Choulwar

(10/16, Yash Ved, Pharmabiz.com) ...As regulatory frameworks continue to converge toward evidence-based development pathways, biosimilars are poised to accelerate patient access to high-quality biological therapies, enhance healthcare sustainability, and maximize the societal impact of biopharmaceutical innovation. These advancements collectively enhance development efficiency, reduce costs, and expand patient access while maintaining robust quality and safety standards, according to Dr Amol Choulwar, associate director- regulatory affairs at Cipla... Full

 

AARP Exposes How Drugmakers Delay Cheaper Generics

(10/19, Tobi Opeyemi Amure, TheStreet) ...A brand-name company can stretch its exclusive window long after the original invention, and every extra year at a monopoly price shows up in your pharmacy bill and your Medicare premiums. That's the problem at the center of a new report from the AARP Public Policy Institute (PPI)... Full

 

 

Roche Does $400M Upfront, $15B Deal with China's Hansoh

(10/19, Kyle LaHucik, Endpoints News) ...The Monday move with the Shanghai biotech marks Roche's sixth China collaboration since August and at least its eighth of 2026, according to an Endpoints News tally. Roche and Hansoh are familiar with each other after last year's deal. To sweeten their latest pact, Hansoh also gets a $110 million payment on the first anniversary of the alliance. Hansoh disclosed the agreement in a Hong Kong Stock Exchange filing... Sub. Req'd

 

Lundbeck Names Former Novo Nordisk CEO Lars Fruergaard Jorgensen as Next Board Chair

(10/18, Reuters) ...Danish drugmaker H. Lundbeck said on Sunday that board chair Dorothea Wenzel will step down at its annual general meeting in 2027, with the board intending to elect former Novo Nordisk CEO Lars Fruergaard Jorgensen as her successor. Jorgensen will join the board as an observer from November 10... Full

 

 

IGBA Kicks Off Global Biosimilars Week 2026

(10/19, Dave Wallace, Generics Bulletin) ...After last year's campaign focused on biosimilars as a wise investment for global health, this year's event revolves around realizing the global value of biosimilars and aims to "expand understanding of the powerful and life-changing impact biosimilar medicines can have for patients, healthcare systems, economies and societies around the world."... Global Sub. Full

 

Pharma Wants UK's Risk-Based AI Rules To Work Across Global Development Programs

(10/16, Dean Rudge, Pink Sheet) ...The UK's pharma industry association wants the MHRA's forthcoming 2027 AI medicines plan to spell out what AI-generated evidence regulators will accept, while avoiding UK-specific rules that could add cost and complexity to global drug development... Global Sub. Full

 

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