Wednesday, October 1, 2025

Trump Will Host Another Meeting On Drug Pricing Next Week

(9/30, Tyler Clifford, Bloomberg Law) ...President Trump says he will have "another meeting next week" to discuss drug pricing, after announcing a deal with Pfizer. "We're going to have another meeting next week on this. We have another great company coming in, similar kind of numbers," he says at the White House... Sub. Req’d

Pfizer Does Deal with Trump On Prescription Drug Prices

(10/1, Nandita Bose and Patrick Wingrove, Reuters) ...Pfizer and President Donald Trump on Tuesday said they had cut a deal in which the U.S.-based drugmaker agreed to lower prescription drug prices in the Medicaid program to what it charges in other developed countries in exchange for tariff relief. Trump also said Pfizer would offer that most-favored-nation pricing on all new drugs launched in the U.S. and flagged that other drugmakers will follow suit... Full

Pfizer Drug Price Cuts Yield Three-Year Trump Tariff Respite

(10/1, Damian Garde, Rachel Cohrs Zhang and Hadriana Lowenkron, Bloomberg) ...Similar deals could be forthcoming. Eli Lilly & Co. said it's in active discussions with the administration to further expand patient access, as the announcement Tuesday underscores the urgency of making medicines more affordable...The latest deal appears to resolve two major threats facing Pfizer. It averts more damaging pricing policies on medicines, while shielding the company from tariffs tied to the administration's Section 232 investigation into whether drug costs represent a national security threat... Full

Updated: Pfizer Offers Price Concessions, $70B US Outlay in Trump's 'Most Favored Nation' Push

(9/30, Fraiser Kansteiner, Eric Sagonowsky, Fierce Pharma) ...In a fact sheet issued midday Tuesday, the White House elaborated on a few of the discounts it secured with Pfizer, including an 80% price reduction for people purchasing the atopic dermatitis ointment Eucrisa directly, a 40% DTC discount for the immunology drug Xeljanz, and a 50% discount for Zavzpret, a migraine nasal spray approved by the FDA in 2023. Further terms of the deal were not disclosed, but the discount examples in the White House fact sheet reflect smaller drugs in the grand scheme of Pfizer's sales... Full

Pfizer-Trump Deal Blindsides Other Drug Companies

(10/1, Caitlin Owens, Peter Sullivan, Axios) ...Raymond James analyst Chris Meekins wrote the deal could also lead to higher U.S. launch prices if European countries, who'd potentially be charged higher prices under Trump's plan, delay product launches there. That could prompt drugmakers to offset those delays by raising U.S. prices. Most-favored-nation pricing within Medicaid is "immaterial" for Pfizer as the program represents less than 5% of U.S. sales, a Leerink Partners analyst note on the deal concludes... Full

White House Announces New Prescription Drug Website, TrumpRx

(9/30, Heather Landi, Fierce Healthcare) ...Matt Phipps, an analyst at William Blair, said he largely views the White House announcements as a way to relieve the pressure placed on large pharmaceutical companies, following a recent trend by Eli Lilly and Bristol Myers to offer therapies for cash paying patients at meaningful discounts to the list prices that likely do not differ much from the current net price. "Whether companies will need to specifically provide this option through TrumpRx.gov or their own programs like LillyDirect or BMS Patient Connect remains to be seen, and how these newly disclosed prices might impact VA or Medicaid pricing, among other questions, are outstanding," Phipps wrote in an analyst note... Full

How Trump's Drug-Buying Site ‘TrumpRx' Will Work

(10/1, Joseph Walker and Peter Loftus, The Wall Street Journal) ...The government website will direct patients on where to buy medications directly from manufacturers "often" at the MFN price, and "and always at lower prices than currently available," said Chris Klomp, director of Medicare. The site is expected to launch in early 2026. TrumpRx isn't like GoodRx, a popular website that helps patients get coupons to use at their local pharmacies. TrumpRx will direct patients to buy drugs directly from companies at sharp discounts... Sub. Req’d

After Months of Investigation On Drug Tariffs, Trump Seals New Levies With a Social Media Post

(9/30, Anna Brown, Endpoints News) ...Since the beginning of the year, over $325 billion in manufacturing commitments have been pledged by drugmakers as part of Trump's push to onshore manufacturing. According to Trump's Thursday post, companies now have until Wednesday to start on these manufacturing promises if they want to avoid the tariffs... Sub. Req’d

Trump, Pfizer, and The Art of a Drug Pricing Deal

(9/30, Matthew Herper, STAT+) ...For Bourla, the upside is obvious. As Carter Gould, an analyst at the investment firm Cantor Fitzgerald, wrote in a note to clients: "For all the hype and commentary around delivering a transformative win for lower drug prices, it's worth noting that Pfizer's PR didn't change a single financial metric or piece of guidance." In other words, whatever costs were saved, Wall Street's perception is that these kinds of deals will not affect companies' bottom line. This may be particularly true for Pfizer, Leerink Partners analyst David Risinger said in a note to clients, because Pfizer only gets 5% of its revenue from Medicaid... Sub. Req’d

PhRMA Statement On Today's White House Announcement

(9/30, PhRMA) ..."Today's announcement does not do enough to address the real drivers of higher prices in the U.S. PBMs get big discounts on medicines while charging patients full price. Hospitals abuse the 340B program to mark up drug prices by 700% or more. Addressing these abusive practices would dramatically lower drug prices for U.S. patients. Similarly, the Trump administration is right to focus on foreign countries free riding off American innovation, but the administration needs to do more to address unfair practices abroad. Other countries routinely undervalue medicines and limit their citizens' access to the newest treatments. Most Favored Nation policies that would import these same prices into the U.S. would result in less access to treatments and cures and reduced investment in manufacturing and R&D. It happened in Europe. We don't want it to happen here."... Full

PCMA Statement On Trump Administration's Continued Efforts to Lower Drug Costs for American Patients

(9/30, PCMA) ..."America's pharmacy benefit managers (PBMs) applaud the Trump Administration for its continued focus on lowering prescription drug costs..."We look forward to working with the Administration to realize the goal of lower drug prices and better affordability for all patients."... Full

NCPA: MFN is Part of a Bigger Solution that Includes PBM Reform

(9/30, NCPA) ..."The president is absolutely right that American patients and taxpayers should not be subsidizing lower drug prices around the world," said NCPA CEO B. Douglas Hoey. "He is also right that we need to reduce our reliance on foreign countries that now supply the active ingredients for some of our most critical drugs. However, we don't want the president or Congress to lose their focus on reforming the health insurance/PBM conglomerates that have created this crisis in the first place."... Full

NACDS Issues Statement On White House Drug Pricing Proposal

(9/30, NACDS) ..."As we have stated and demonstrated, NACDS is committed to working with the Administration and with the Congress to lower healthcare costs and to prevent healthcare from falling out of reach of rural and vulnerable Americans. Comprehensive PBM reform remains a necessity, and it is unthinkable that the broadly-supported reforms that are ready to go in Congress have not yet been enacted. Congress and the Administration must prioritize that now – alongside strategic approaches to enhance Americans' access to pharmacist-provided services that the American people now expect."... Full

Will The White House Drug-Pricing Deal Lower Costs for Americans? Experts Are Skeptical

(9/30, Elaine Chen, STAT+) ...Experts wondered how Pfizer would benchmark prices of new medications to other countries, since drugmakers typically launch products in the U.S. first. Also, drugmakers could just raise prices in other countries, which is part of what Trump wants to see, but that would have no effect on lowering prices in the U.S., experts said. "The Trump administration is using this as a political win. Pfizer's going to use this as a political win," said Ben Rome, an assistant professor at Harvard Medical School who researches drug pricing. "But it's not clear that patients are going to win from this."... Sub. Req’d

Trump Outlines Plan for Third Round of Medicare Drug Price Talks

(9/30, Nyah Phengsitthy, Bloomberg Law) ...The 381-page final guidance by the Centers for Medicare & Medicaid Services outlines how the US government plans to set the prices of up to additional 15 drugs in the program. The negotiations for the third cycle are slated to begin in 2026 and prices will go into effect in 2028... Sub. Req’d

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

(9/30, Bridget Silverman, Pink Sheet) ...The US FDA is facing a busy month of October, with more than 20 user fee goal dates on the calendar, but novel agents are conspicuously absent. Pivotal oncology data releases stoked excitement about new indications for Regeneron's Libtayo, Jazz Pharmaceuticals' Zepzelca plus Roche's Tecentriq, and Syndax's Revuforj. Sydnexis' atropine eyedrop formulation for myopia aims to take over a market dominated by compounding... Global Sub. Full

‘Likely' Government Shutdown Threatens to Stress An Already Depleted FDA

(9/30, Zachary Brennan, Endpoints News) ...The biopharma industry could take a major hit if a shutdown goes on for an extended period of time. The FDA, which already saw its staff levels cut by more than 3,000 in April, will not be able to accept any new drug, biologic, generic drug or biosimilar applications that require a user fee payment during a shutdown. The agency also will be limited in its ability to conduct for-cause and certain surveillance inspections of drug and device facilities... Sub. Req’d

What to Expect When You Are Expecting a Shutdown--FDA Edition

(9/30, Steven Grossman, FDA Matters) ...The FDA plan states: "In the event of a lapse of appropriation, 13,872 (86%) of FDA staff will be retained, including 10,740 (66%) who are exempt (their activities or position are already funded or otherwise exempted) and 3,132 (19%) who are excepted (their activities are deemed necessary by implication, or for the safety of human life or protection of property)." In other words, a significant number of FDA employees are exempt or excepted for reasons other than user fees. For reference, user fees--both medical product and $700 million of tobacco fees--are about 47% of the agency's FY 25 budget. Over the last few years, medical product and tobacco user fees have paid for about half of the agency's staff, while the other half has come from appropriations... Full

Onshoring: Drugmakers Seek Enhancements to FDA's PreCheck Program

(9/30, Joanne S. Eglovitch, Regulatory Focus) ...Many stakeholders at the meeting suggested expanding the PreCheck program to include existing facilities, as well as new ones. Peter Qiu, external advocacy lead for China from Roche Genentech suggested FDA consider expanding the program to existing facilities to quickly shift manufacturing to the US. Lisa Wright of Novo Nordisk noted that her company has already invested billions of dollars in US manufacturing. "How will this work for facilities that are already constructed?" she asked. Other participants concurred, with one suggesting that the program be expanded to cover manufacturing changes, such as different types of packaging or alternate container materials, or new manufacturing technologies that are rolled out at existing US facilities... Full

Arkansas's PBM Ban Is Unconstitutional Protectionism

(9/30, Frank Francone, RealClearHealth) ...By attempting to bar national PBMs from owning or operating pharmacies, Arkansas tried to do in statute what the Constitution forbids: erect economic barriers against out-of-state commerce and usurp federal authority over military health benefits. Those twin defects—protectionism at the state level and intrusion into the federal domain—made Act 624 vulnerable the moment it was signed, something that should give pause to legislators elsewhere contemplating similar measures... Full

County Leaders Urge Prescription Drug Board to Set ‘Upper Payment Limits'

(9/30, Danielle J. Brown, Maryland Matters) ...County leaders urged the Prescription Drug Affordability Board on Monday to move quickly to set an upper payment limit on two popular drugs prescribed for the treatment of Type 2 diabetes... Full

State Interference Will Lead to Higher Prescription Prices

(10/1, George S. Ford, Governing) ...At its core, the war on PBMs is an attack on lower prescription prices as a favor to drug manufacturers and pharmacies. It is also a textbook case of how regulation nominally intended to protect consumers can end up harming them... Full

Amneal Files Xolair Biosimilar In US ‘Earlier Than Expected'

(9/30, Dave Wallace, Generics Bulletin) ...Citing an "earlier than expected" submission of its Kashiv-partnered Xolair biosimilar to the US FDA, Amneal says it is eyeing a potential "first-wave" launch into a US omalizumab market that is worth more than $4bn...In the US, the Xolair biosimilar race is currently led by Celltrion, whose Omlyclo (omalizumab-igec) was approved with an interchangeability designation by the FDA in March and has also recently been launched in Europe. Other omalizumab biosimilar sponsors with products currently in development include Teva with its TEV-45779 candidate. However, Roche stated earlier this year that no biosimilars to Xolair are expected to launch in the US in 2025, despite key omalizumab formulation patents expiring in November... Global Sub. Full

Regeneron Deal Clears Formycon's Eylea Biosimilar for Late 2026

(9/30, Christopher Yasiejko, Bloomberg Law) ...Formycon AG can launch its biosimilar version of Regeneron Pharmaceuticals Inc.'s blockbuster eye-disease drug Eylea in the fourth quarter of 2026 after the companies settled their US patent litigation...The multidistrict litigation still includes Samsung Bioepis Co., Celltrion Inc., and Amgen Inc. In January, the US Court of Appeals for the Federal Circuit upheld injunctions blocking Samsung Bioepis and Celltrion from launching their biosimilars, while allowing Amgen's Pavblu to proceed because the court found its formulationdistinct... Sub. Req’d

Biocon Inks Settlement, License Pact with Amgen to Market 2 Biosimilars in US

(10/1, Press Trust Of India) ...Biotechnology firm Biocon on Wednesday said its unit has inked a settlement and license agreement with Amgen Inc., paving the way for commercialisation of two biosimilars used in the treatment of osteoporosis and cancer-related bone conditions...Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial are biosimilars to Amgen's Prolia and Xgeva, respectively... Full

Itochu And Mochida Take Stakes In Japan's AND Pharma

(9/30, Dave Wallace, Generics Bulletin) ...Japan's Itochu and Mochida Pharmaceutical have each acquired a 20% stake in local generics firm AND Pharma for more than $100m apiece. AND Pharma's subsidiary companies include Nichi-Iko, Kyowa Pharmaceutical Industry and the T's Pharma/T's Seiyaku firms formerly known as Teva Takeda. The firms' goals include collaborating to reinforce supply chain resilience and developing diverse distribution channels... Global Sub. Full

Novartis, MSN End Trademark Appeal Over ‘Novadoz' Entresto Copy

(9/30, Annelise Levy, Bloomberg Law) ...The dismissal, which was approved the same day, ends MSN's appeal of a preliminary injunction blocking its "Novadoz"-branded copy of Novartis' Entresto. Novartis' appeal of its loss in a separate patent infringement suit against the generics maker remains before the US Court of Appeals for the Federal Circuit. Both appellate courts rejected Novartis's request to block the launch of MSN's copy during the appeals... Sub. Req’d

Pay-for-Delay Suit Involving Lipitor Runs Into Dubious Court

(9/30, Katie Arcieri, Bloomberg Law) ...A panel of Third Circuit judges seemed skeptical of plaintiffs' plea to revive a case accusing Sun Pharmaceutical Industries Ltd. of conspiring to delay the generic version of cholesterol-reducing drug Lipitor. During oral arguments Tuesday afternoon, Judge Patty Shwartz pressed plaintiffs' counsel on whether a reasonable jury could find that a generic version of Lipitor would have been approved earlier by the Food and Drug Administration if not for an alleged deal between Sun and Pfizer Inc., Lipitor's manufacturer, to prevent the less expensive drug from launching until November 2011. "What evidence do we have to make that inference?" she asked... Sub. Req’d

Polpharma Biologics Splits into Biosimilars and CDMO Businesses

(10/1, Dominic Tyer, European Pharmaceutical Review) ...Polpharma Biologics is demerging into two independent companies, including a biosimilars business that will keep the original brand name and be operated from Switzerland. The other entity will be a contract development and manufacturing organisation (CDMO) focused on biologics that be known as Rezon Bio and take on Polpharma's facilities in Gdansk and Duchnice near Warsaw... Full

Sanofi Pins Future Growth On Vaccines and Immunology

(10/1, The Pharma Letter) ...France's biggest drugmaker Sanofi has spent the last five years remaking itself. Once anchored in diabetes and cardiovascular drugs, the group now leans heavily on its vaccines unit and the breakout success of Dupixent (dupilumab) to power growth. With diabetes franchises commoditized and cardiovascular bets scaled back, Sanofi's long-term trajectory hinges on whether these two engines, vaccines and immunology, can sustain momentum and withstand looming pressures... Sub. Req’d

Bristol Myers, Takeda to Pool Data for AI-Based Drug Discovery

(10/1, Sneha S K, Reuters) ...Bristol Myers Squibb, Takeda Pharmaceuticals and Astex Pharmaceuticals are coming together to share proprietary data for training an artificial intelligence model to assist drug discovery and development. The companies are joining a consortium that includes AbbVie and Johnson & Johnson , and will contribute data from several thousand experimentally determined protein–small molecule structures to train an AI model called OpenFold3, life sciences company Apheris said on Wednesday... Full

Cardinal Expands US Drug Distribution Network with New Indianapolis Facility

(9/30, Christy Santhosh, Reuters) ...The drug distributor said the new facility was expected to create more than 100 new jobs and would use automation services such as a robotic storage and retrieval system to support deliveries of specialty drugs across the U.S. The company said the Indianapolis facility was likely to be fully operational by fall 2027 and would be its second center following its announcement to build a facility in Columbus, Ohio, last year... Full

How the UK's ‘Credibility Challenge' Hinders Attempts To Reverse Pharma's Flight

(10/1, Nick Paul Taylor, BioSpace) ...Pharma no longer sees the U.K. as such a viable option. The question now is whether the U.K. government can change the narrative and save an industry that it recently called "one of our greatest national assets."... Full

Sanofi's German, French Premises Hit by EU Probe Amid Vaccines Market Abuse Concerns

(10/1, Ben Adams, Fierce Pharma) ...The European Commission—the EU's executive arm—announced in a statement Monday that it conducted inspections at the premises of a company "active in the vaccines sector" in relation to "concerns that the inspected company may have violated EU antitrust rules that prohibit abuses of a dominant market position."...However, a Sanofi spokesperson confirmed to Fierce Wednesday morning that it is the company at the center of the investigation. The inspections took place at Sanofi sites in France and Germany on Monday, according to the Big Pharma, which added that the visits were related to "an investigation into conduct in the seasonal flu vaccine space."... Full

Dublin Launches Formal Talks with Pharma Industry On New Drug Pricing Framework

(9/30, Brian Maguire, Euractiv) ...The negotiations are intended to replace the current 2021–2025 Framework Agreement, signed in December 2021, which governs pricing and reimbursement mechanisms for branded medicines. A separate agreement with Medicines for Ireland (MFI), representing generic and biosimilar manufacturers, is expected to be renegotiated in the coming weeks... Full

Generic Drug Approvals in US Poised for a Rise, Indian Drugmakers Continue to Dominate

(10/1, Viswanath Pilla, Moneycontrol) ...Indian pharmaceutical manufacturers are a dominant force in the US generic market, accounting for a substantial portion of all ANDA approvals. Their share ranges from 35-45 percent of total ANDA approvals... Full

Seoul Holds Emergency Meeting with Pharma Exporters to Address US Tariffs

(10/1, Kwak Sung-sun, Korea Biomedical Review) ...The Ministry of Health and Welfare and the Ministry of Trade, Industry and Energy co-hosted an emergency meeting on Monday with five pharmaceutical export companies, the Korea Health Industry Development Institute, the Korea Trade-Investment Promotion Agency, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the KoreaBIO, the Korea Biomedicine Industry Association, and the Korea Pharmaceutical Traders Association. The five pharmaceutical companies attending the meeting were SK Biopharm, Samsung Biologics, Lotte Biologics, Daewoong Pharmaceutical, and Celltrion... Full

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