Friday, October 24, 2025

US Could Have Saved $1.5 Billion on Costs With Drug Pricing Linked to Benchmark, Says Research Firm

(10/23, Sriparna Roy, Reuters) ...The data from the Institute for Clinical and Economic Review, based on an analysis of 23 drugs previously reviewed by the research firm, comes as President Donald Trump has called for U.S. drug prices to match those paid in other high-income nations..."Launch prices are going up, patient access is going down, and in many cases, we are overpaying for treatments," said ICER President and CEO Sarah Emond. The report is in line with Reuters' analysis of prices of newly launched pharmaceuticals, which was based on a different methodology... Full

Roche CEO Says US 301 Probe Could Reshape Drug Pricing Talks

(10/23, Fabienne Kinzelmann, Bloomberg Law) ...Roche Holding AG Chief Executive Officer Thomas Schinecker signaled that a new investigation into drug costs conducted by the Trump administration might pressure countries to review their own drug prices. "The US will launch 301 investigations against US trading partners that people should allocate a certain percentage of GDP into innovation of health care and medicines," he said on a conference call Thursday. "In all conversations with governments around the world, we do have conversations on what this all means, also for these governments. Because I think it's important to raise awareness."... Sub. Req’d

Democrats, Ethics Experts Question TrumpRx Drug Deals Over Family, Ethics Norms

(10/23, Maaisha Osman, Inside Health Policy) ...Congressional Democrats and public interest groups are questioning President Donald Trump's TrumpRx direct-to-patient drug deals, citing potential benefits to one of his sons and demanding more details. Ethics experts also warn the deals' requirement to onshore production to avoid import tariffs could benefit Commerce Secretary Howard Lutnick, reflecting a broader pattern of the president sidestepping long-standing ethics norms and setting a permissive tone for federal officials... Sub. Req’d

Editorial: Trump's Prescription for Lower Drug Prices Had Potential

(10/24, The Dallas Morning News) ...According to reporting from The Wall Street Journal, BlinkRx has invited executives from pharmaceutical companies to meet at a summit in Washington in December with members of the Trump administration. It's impossible to separate the TrumpRx rollout from his family's business orbit. When Trump is involved, money is almost always part of the calculation. What could have been a serious conversation, and an important one, about rethinking how Americans get their medications now has a stench of self-dealing attached... Sub. Req’d

TrumpRx And A Most Favored Nation Policy Won't Lower Prices For Patients

(10/24, Tahir Amin, STAT+) ...Instead of a "most-favored nation" anchored on international markets and getting other countries to pay more, we would become a most-favored nation for patients to receive generics and biosimilars as soon as they were available anywhere in the world. The real issue isn't foreign price controls or the "global freeloading" on American innovation as the pharmaceutical industry would have you think. It's a rigged system that lets drug companies exploit patents, block competition, and keep prices artificially high...TrumpRx and a most-favored nation policy won't lower prices for patients. Until we tackle patent abuse, corporate greed, and systemic profiteering, Americans will keep paying the price... Sub. Req’d

New Legislation In Works From Senate Working Group To Rein In 340B Misuses

(10/23, Gabrielle Wanneh, Inside Health Policy) ...The Senate 340B Working Group may soon introduce a bipartisan bill to rein in operational issues and covered entity practices that appear to be pulling the 340B drug discount program away from its mission to provide affordable medications to low-income, rural and otherwise underserved communities, Senate health committee chair Bill Cassidy (R-LA) said Thursday (Oct. 23) during the committee's second hearing on the program this year... Sub. Req’d

China's Pharma Leverage Is ‘Nuclear Option' in US Trade Talks

(10/24, Colum Murphy and Amber Tong, Bloomberg) ...A report last week from US Pharmacopeia, an industry standards body, found that nearly 700 US medicines are made using at least one key ingredient solely sourced from China...While Trump's tariffs may persuade big pharma to build facilities to ensure supply chains for best sellers, that's not going to happen with generics, where China dominates. Beijing's control poses the biggest threat to America's dirt cheap, commonly used generics that account for about 90% of the drugs prescribed in the US. API manufacturing is also highly polluting, and given the sector's razor-thin margins it makes little sense to reshore this kind of production to places with stringent environmental regulations... Sub. Req’d

European Pharmaceutical Freeloading: An Offer America Must Refuse

(10/23, Peter Pitts, RealClearHealth) ...President Trump should empower USTR to insist that foreign nations immediately end the use of claw-backs and other unfair coercive mechanisms deliberately aimed at suppressing drug prices below their fair market value and artificially reducing company revenues that jeopardize their ability to invest in important research and development programs. It's time for European claw-backs to sleep with the fishes... Full

The Hidden Giants Driving Higher Pharmaceutical Prices

(10/23, Jason Altmire, RealClearHealth) ...Pharmaceutical wholesalers, namely McKesson, Cardinal Health, and Cencora (formerly AmerisourceBergen), are drastically reshaping the healthcare landscape. These three companies now control 98 percent of the drug market and are not simply distributing medications. They are buying the practices that prescribe them. The study's authors, healthcare policy experts from Washington and Brown universities, note, "In recent years, wholesalers have engaged in multibillion-dollar acquisitions of medical practices, which they control by means of corporate entities known as management-services organizations (MSOs)."... Full

GDUFA IV Talks Begin, Embracing Traditional Process

(10/23, Derrick Gingery, Pink Sheet) ...The first meeting between the two parties, which was largely introductory, occurred on Oct. 22. Talks are expected to be held weekly or biweekly, barring holidays, until a reauthorization agreement is completed. Giuseppe Randazzo, senior VP of sciences and regulatory affairs at the Association for Accessible Medicines, a trade association that is negotiating on behalf of the generic drug industry, told the Pink Sheet that the schedule appears to be similar to the GDUFA III process. He said he hoped the talks would be completed before the spring of 2026... Global Sub. Full

FDA Publishes NDA Filing Checklist to Avoid Application Derailments

(10/23, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or subject to a refuse-to-file (RTF) decision, in an updated manual of policies and procedures (MAPP) on Thursday. FDA said the move is intended to boost transparency into the agency's filing procedures and cut down on the number of incomplete submissions it receives, which "consume resources and delay promising treatments."... Full

FDA's Drug Rejection Spree Is Harming Patients

(10/23, Ross Marchand, RealClearHealth) ...The FDA should build on that approach by striving to approve more medications, especially ones already approved by peer nations. Handing out expedited review vouchers is better than nothing, but nothing beats real reform... Full

AAM Moves to Block Connecticut's New Drug Price Law

(10/24, The Pharma Letter) ...The Association for Accessible Medicines (AAM) has filed for a federal injunction to prevent Connecticut from enforcing a new price-control law that it says threatens patient access to low-cost drugs and violates the US Constitution. The request was submitted October 23 in the US District Court for the District of Connecticut... Sub. Req’d

GSK Reports Positive Pivotal Phase III Data for Next-Generation Low Carbon Version of Ventolin Metered Dose Inhaler

(10/23, Pharmabiz.com) ...GSK plc announced positive phase III data from its clinical programme to develop a next-generation version of its metered dose inhaler (MDI), Ventolin (salbutamol). Data confirm that the formulation of salbutamol MDI containing an innovative low carbon propellant HFA-152a shows therapeutic equivalence and is comparable in safety to salbutamol MDI containing the current propellant, HFA-134a. The findings will support regulatory submissions for the next-generation version, with launch expected from 2026, an important advance to bringing a more sustainable option to patients with respiratory disease... Full

Samsung Bioepis Releases Fourth Quarter 2025 US Biosimilar Market Report Providing Annual Biosimilar Trends and Future Market Trajectory

(10/23, Samsung Bioepis) ...The report overviews the market status of all the biosimilars that are available in the US including approval and launch status, pricing (both Average Sales Price; ASP and Wholesale Acquisition Cost; WAC) after the Centers for Medicare & Medicaid Services (CMS) publishes updated quarterly ASP values for each product, and market uptakes per molecule. This issue features an interview with Dr. William Fleming, a former senior Medicare executive, on how payers are preparing for the upcoming implementation of the Maximum Fair Price (MFP) policy. As part of the Inflation Reduction Act (IRA), the CMS has been negotiating prices for some drugs with the highest Medicare expenditures. The newly negotiated prices of the first 10 selected drugs will become effective as of January 1, 2026... Full

Horus Pharma Inks Agreement to Commercialize Formycon's Aflibercept Biosimilar FYB203 Under the Brand Name Baiama Across Key European Markets Including its Home Market France

(10/24, Pharmabiz.com) ...FYB203/Baiama will be the first biosimilar commercialized by Horus Pharma, underscoring the company's ambition to expand into new therapeutic areas and strengthen its presence in the retina segment. Horus Pharma already markets a treatment for diabetic macular edema, and with FYB203/Baiama, the company is now able to offer a broader range of therapeutic solutions for retinal pathologies... Full

Lupin Launches Generic Drug to Treat Urea Cycle Disorders in US

(10/24, Press Trust Of India) ...Drug firm Lupin has launched a generic medication in the US. This new drug treats urea cycle disorders. It is an authorized generic version of Ravicti oral liquid. The medication helps patients manage the disorder. This is for those who cannot be managed by diet alone. Lupin's shares saw a slight dip on the BSE... Full

FDA Cites Nephron Again for Ongoing Issues the Generics Manufacturer Has Failed to Resolve

(10/23, Kevin Dunleavy, Fierce Pharma) ...In a recent Form 483 report, the agency cited several problems that were evident in an August inspection of the facility. Most of the observations were repeat issues identified in Nephron's previous interactions with the agency. Most notably, the report identified a lack of procedures to prevent contamination of manufactured products. The procedures are "not established and written," the FDA said... Full

Sanofi Notes ‘Negative Buzz' Around Vaccines as Profit Beats Forecasts

(10/24, Bhanvi Satija, Reuters) ...Sanofi reported stronger than expected third-quarter profit on Friday, boosted by demand for blockbuster asthma drug Dupixent, even as the French drugmaker flagged lower vaccination rates partly due to a "negative buzz" around vaccines... Full

Sanofi Drops Toddler RSV Vaccine After Phase 3 Heads for Failure

(10/24, James Waldron, Fierce Biotech) ...The French Big Pharma was evaluating the intranasal live attenuated vaccine, dubbed SP0125, in a late-stage study of about 6,300 children aged between 6 months and 22 months. The study launched last year, according to the federal trials database, and was scheduled to complete at the end of 2027. But Sanofi—which markets the AstraZeneca-partnered RSV blockbuster Beyfortus—revealed this morning that it has recently terminated the SP0125 program after the study's independent data monitoring committee (IDMC) decided it was unlikely to demonstrate suitable efficacy... Full

Eli Lilly Reports Promising Data for Alopecia and Eczema Drugs, Eyes Label Expansion

(10/24, Sneha S K, Reuters) ...The company was testing baricitinib, sold under the brand name Olumiant, in 257 adolescent patients with severe alopecia areata or patchy hair loss. In the trial, a 4 milligram dose of baricitinib helped improve hair regrowth in more than 50% of adolescents after one year of treatment...In another trial, Lilly was testing Ebglyss, chemically known as lebrikizumab, in 103 patients with moderate-to-severe atopic dermatitis, a chronic skin condition commonly known as eczema. The company said lebrikizumab dosed every eight or four weeks provided long-lasting response... Full

With Nemluvio Sales Booming, Galderma Pledges to Spend $650M on US-Based Manufacturing

(10/23, Kevin Dunleavy, Fierce Pharma) ...Dermatology specialist Galderma has hopped on the U.S. manufacturing bandwagon, revealing a commitment to spend more than $650 million through 2030 as it taps domestic contractors to produce newly approved Nemluvio and other skincare treatments in its portfolio...As for U.S. tariffs, Galderma's chief financial officer, Thomas Dittrich, said the company's exposure is "already in effect and seems manageable." He added that tariffs largely affect the company's filler and biostimulator portfolio, which accounts for 7% of Galderma's net sales... Full

Time Has Never Been Better for Pharma Breakthroughs Than Today: Bayer Executive Stefan Oelrich

(10/24, Vikas Dandekar and Teena Thacker, The Economic Times) ...Bayer, the renowned pharmaceutical powerhouse from Germany, is implementing a tiered pricing strategy on a global scale to make medications more accessible. The CEO emphasizes the necessity of earning returns to justify research investments. As innovation ecosystems shift, particularly towards regions like China, Bayer is proactively adapting... Sub. Req’d

Australia Feels Impact Of US Pharma Trade Measures

(10/23, Neena Brizmohun, Pink Sheet) ...The trade body, Medicines Australia, says it is already witnessing the effects of President Trump's policies, with a drop in the launch of new drugs in Australia. It is calling for urgent action to reform the country's health technology assessment system to make the Pharmaceutical Benefits Scheme faster, fairer and fit for the future. It believes that medicines in Australia need to be "more appropriately valued" so that the country can become more attractive for new launches... Global Sub. Full

Unpopular Choices Ahead For Pharma As France Wrestles With Spending Bill

(10/23, Francesca Bruce, Pink Sheet) ...A bill that lays out social security spending for 2026 in France would introduce price cuts, change the way the government collects revenue from pharmaceutical rebates and would update systems for ensuring earlier patient access to certain drugs. Whether the measures make it into the final version of the bill is uncertain as France faces continued political uncertainty. A difficult economic outlook means that tough choices affecting the biopharmaceutical industry and innovation will have to be made, say France Biotech's Alexandre Regniault... Global Sub. Full

Biosimilars: How Did Italy Save 3.1 Billion Euros?

(10/24, Elena Riboldi, Medscape) ...An analysis published in Value in Health Regional Issues found that biosimilars reduced drug spending by approximately 5% for the Italian National Health System, driven by rising use and lower prices of both originator biologics and their biosimilar equivalents. The researchers identified all the biologics (reference products) and related biosimilars approved in Europe and marketed in Italy until December 2022. Savings were estimated by multiplying the biosimilar sales volume by the annual cost difference between the reference products and the biosimilars... Full

Faster Access In England Under NICE-MHRA Scheme Hinges On ‘Optimal' Drug Status

(10/23, Eliza Slawther, Pink Sheet) ...Pharmaceutical companies in England are expected to benefit from quicker reimbursement decisions under a new aligned pathway between the health technology assessment (HTA) agency, NICE, and the drug regulator, the MHRA. The new approach will see NICE conduct public committee meetings to assess a drug's cost-effectiveness before a marketing authorization has been granted. The new approach will require companies to have HTA dossiers ready early, and companies will need to demonstrate a "commitment" to the pathway, a senior figure at NICE has said... Global Sub. Full

Abolis Bio Joins Forces with EUROAPI to Strengthen Corticosteroid Production

(10/24, The Pharma Letter) ...The partnership aims to reduce Europe's heavy dependence on Asian suppliers, who currently account for around 80% of the global corticosteroid market. Production will take place at EUROAPI's facilities in St Aubin-lès-Elbeuf, Normandy, and Vertolaye, Auvergne, the latter being the only European site making such treatments. Abolis will receive funding from Bpifrance and EUROAPI over four years... Sub. Req’d

Advocacy Groups Form a Buyer's Club to Obtain Generic Versions of Pricey Vertex Cystic Fibrosis Drug

(10/23, Ed Silverman, STAT+) ...The generic version of Trikafta will be priced at $6,375 for a child and $12,750 for an adult per year, compared with a list price that exceeds $300,000 annually in the U.S. And the drug will be made by Beximco Pharmaceuticals, a generic company based in Bangladesh, according to patient advocacy groups involved in creating the club. "This is a historic moment," said Gayle Pledger, who heads the Right to Breathe campaign and is based in the U.K., in a statement. "We've watched children suffer and die while a treatment sat on the shelf, priced out of reach. Today, that changes. We've proven that patient power can change what billion-dollar corporations refuse to."... Sub. Req’d

UK Industry Body Finds AstraZeneca in Breach of Code Over Symbicort Marketing

(10/24, Yamini Kalia, Reuters) ...AstraZeneca breached the UK pharmaceutical industry's code of practice after a website claim incorrectly stated that all newly diagnosed asthma patients aged 12 and above should receive its Symbicort drug as an "as-needed" reliever therapy, the industry self-regulatory body ruled on Friday... Full

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