Thursday, October 2, 2025

Teva Closes In On Deal To Sell TAPI

(10/2, Dave Wallace, Generics Bulletin) ...Teva says it is in "advanced discussions" around a long-planned sale of its TAPI active pharmaceutical ingredients business. However, the firm cautioned that while "exclusive discussions" are ongoing, "issues remain, and there is no certainty that a deal will be reached." Teva promised to provide a "final update" to the market alongside its third-quarter results, which are due to be published on November 5... Global Sub. Full

Teva Closes in On Sale of API Business TAPI

(10/2, Dominic Tyer, European Pharmaceutical Review) ...Now that advanced talks about that sale have begun, Teva said it would provide a final update alongside its upcoming Q3 results. However, it cautioned that "issues remain, and there is no certainty that a deal will be reached". TAPI's fortunes have fluctuated since its planned divestment was announced, with the API business recording an 11 percent year-on-year drop in sales to $135 million in the second quarter of this year. The company said that performance was "mainly due to lower demand and timing of shipments" and previous quarters had generally seen single-digit growth. In this year's Q1 TAPI's sales rose two percent to $130 million, 2024's Q4 sales were flat at $145 million, and they were up six percent to $229 million in 2024's Q3... Full

Teva Signs Hybrid VPPA for Renewable Electricity

(10/1, E+E Leader) ...Teva Pharmaceuticals has signed a 15-year virtual power purchase agreement (VPPA) with Austrian renewables firm Enery to support a new 122-MW solar project with integrated battery storage in Bulgaria. The deal is expected to generate about 60,000 MWh annually, supplying renewable electricity to Teva's Bulgarian operations and marking the company's first hybrid VPPA in the Central and Eastern Europe region... Full

Trump Delaying Triple-Digit Pharma Tariffs to Negotiate Drug Price Deals

(10/1, Daniel Desrochers, Politico) ...President Donald Trump last week threatened triple-digit tariffs on pharmaceutical imports starting Wednesday. The White House now says it may not need to impose them. According to a White House official, the Trump administration has paused its plan to enact the duties as it attempts to negotiate agreements with pharmaceutical giants to avoid higher tariffs on their name-brand products — like the deal it announced with Pfizer Tuesday... Full

Trump Administration Backs Off 100% Pharma Tariffs Threatened to Start Today

(10/1, Daniel Payne, STAT+) ...The postponement signals that months of tough talk from the White House on pharma tariffs may ultimately be aimed at leveraging more voluntary commitments from drugmakers, such as investing in the U.S. and striking deals to lower their prices. The official pointed to Commerce Secretary Howard Lutnick's comments on Tuesday, when he said he would let drug companies' negotiations with the administration "play out" before imposing any national-security-related tariffs, which have been expected for months... Sub. Req’d

Drugmakers Pressured with Trump Tariffs After Price-Cut Talks Faltered

(10/1, Patrick Wingrove, Michael Erman, Maggie Fick, Reuters) ...One pharmaceutical industry lobbyist, who asked for anonymity, said Trump appeared to have lost patience with the political process, citing the U.S. government shutdown and his urgency to push through his agenda. A U.S. government shutdown began Wednesday after Congress and the White House failed to reach a funding deal. A White House official said that Trump was "wholeheartedly committed to lowering drug prices for Americans and will not hesitate to utilize tariffs to do so." The official said the Commerce Department would start preparing tariffs on October 1 for companies that do not move manufacturing or cut prices... Full

Swiss Pharma Companies Eye Follow Up to Pfizer-US Pricing Deal, Business Lobby Says

(10/1, Olivia Le Poidevin and Cecile Mantovani, Reuters) ...Stephan Mumenthaler, director general of Scienceindustries, which represents around 250 Swiss chemical and pharmaceutical companies, told Reuters he expected announcements of "mini-deals" to come one by one in the coming days and weeks from Swiss and global pharmaceutical companies. "They are thinking in similar schemes... How can you omit the margins that middlemen are taking away so that you basically have a similar price than before, but the end consumer still gets a lower price," he said in a video call from Basel... Full

GSK CEO Emma Walmsley Says Drugmaker Is ‘Betting Big' On the US

(10/1, Ashleigh Furlong and Ruth David, Bloomberg) ...GSK Plc is "betting big on the US" and engaged in constructive talks on drug pricing with US President Donald Trump's administration, according to Emma Walmsley, the outgoing chief executive officer of the British drugmaker. The US market is hugely important for all drugmakers and news on Tuesday that rival Pfizer Inc. has struck a medicines pricing deal with the Trump administration is a "step forward and it's progress," she said, speaking at Bloomberg's Women, Money & Power conference. "The markets see that as well, as it's about constructive dialog between the industry and government," Walmsley added. "The US is by far the biggest priority market for our industry because the US is the best country in the world to discover and develop innovation."... Sub. Req’d

Trump Claimed a Win On Drug Prices, But Big Pharma Also Scored

(10/2, Peter Whoriskey and Daniel Gilbert, The Washington Post) ..."This represents a win for" Pfizer, Akash Tewari, a Jefferies analyst, wrote in a note to clients Wednesday. He estimated that offering some new drugs at internationally comparable prices could cost Pfizer up to $723 million a year. That would amount to just over 1 percent of Pfizer's $63.6 billion revenue last year. Pfizer "may have done the rest of the industry a favor by giving a framework for a bespoke solution that we feel would be very tenable" for other big pharmaceutical companies and "would have a de minimis impact on their business going forward," Tewari wrote... Sub. Req’d

Third Cycle Guidance For Rx-Price Negotiations Comes Alongside Govt. Shutdown

(10/1, Gabrielle Wanneh, Inside Health Policy) ...Beginning with price applicability year 2028, CMS will choose certain drugs previously selected for price applicability years 2026 and 2027 to have the initial maximum fair price (MFP) renegotiated should a drug meet statutory criteria related to a new treatment indication, a material change to a factor CMS considered when first negotiating the drug's new price, or a change to its market monopoly status. All selected drugs eligible for renegotiation because of a change in monopoly status, whether they are a drug with an extended market monopoly or a change in status regarding a long market monopoly, will be selected for renegotiation... Sub. Req’d

CMS Spells Out New Orphan Drug Protections in IRA Negotiation Guidance

(10/1, Nicole DeFeudis, Endpoints News) ...The pharma industry's lobbying group criticized the final guidance on Wednesday. "CMS continues to double down on a flawed framework that threatens future cures and disregards stakeholder input," PhRMA deputy VP of media relations Chanse Jones told Endpoints News. "PhRMA remains committed to working with the administration to mitigate the harmful consequences of the IRA and ensure patients continue to benefit from medical innovation."... Sub. Req’d

Medicare Delays Combo Drug Negotiation Policy One Year

(10/1, Cathy Kelly, Pink Sheet) ...Final guidance for price implementation year 2028 postpones changes to a policy exempting fixed combinations from Medicare price negotiation along with an older drug with the same active moiety. CMS needs more time to revise the policy, but suggested the change will be proposed next year. The decision may be encouraging to Merck, which recently added a subcutaneous version of Keytruda that could be exempt under the original policy... Global Sub. Full

FDA Lists its Upcoming Research Priorities for Generic Drugs

(10/1, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration has listed more than half a dozen research areas related to generic drug development and authorization that it plans to prioritize in FY 2026. The agency's priorities include research to address nitrosamine drug impurities, evaluate bioequivalence, and use artificial intelligence to improve their decision-making. The list, published on September 30, was developed as part of the agency's commitment under the Generic Drug User Fee Amendments (GDUFA III) agreement... Full

Shutdown Begins – FR Notice Announces New and Revised PSGs – Surprise, Surprise

(10/1, Bob Pollock, Lachman Consultants) ...In today's pre-publication Federal Register notice (here), the FDA announced publication of 17 new product specific guidances (PSGs) and 58 revised PSGs. This is the first release of PSGs since the May 20, 2025 dump of 36 new and 15 revised PSGs. Not only is this good news for developers of generic drugs, release of the actual guidance documents has occurred, despite the shutdown... Full

FDA Faces Ad Comm, User Fee Delays Amid Shutdown

(10/1, Jessica Karins, Inside Health Policy) ...While a greater percentage of FDA employees are protected from being furloughed during the government shutdown that began Wednesday (Oct. 1) than have been in previous years, many planned FDA events will likely have to be rescheduled or canceled as the lapse in funding continues, including upcoming advisory committee meetings. The agency also can't collect user fees during a shutdown... Sub. Req’d

Shutdown: FDA Will Not Accept Submissions Until Funding Resumes

(10/1, Joanne S. Eglovitch, Regulatory Focus) ...FDA said that during the funding lapse, it will not have the legal authority to accept user fees for Fiscal Year 2026 until an appropriations bill or Continuing Resolution is enacted. Consequently, the agency will be unable to accept any regulatory submissions that require a fee payment for FY 2026 if those submissions are made during the lapse period. Shortly after the shutdown, FDA posted a message at the top of its homepage blaming the shutdown on Democrats... Full

Biocon Sets Stage For Immediate US Denosumab Launch With Amgen Settlement

(10/1, Dave Wallace, Generics Bulletin) ...Biocon Biologics has agreed a settlement with Amgen that will allow the Indian firm to launch its Bosaya and Aukelso denosumab biosimilars immediately in the US, from October 1. Amgen is already facing considerable competition to its Prolia/Xgeva brands from other biosimilars, with three pairs of denosumab biosimilars having already launched earlier this year...And Teva also filed a denosumab candidate with the FDA last year, marking the Israeli firm's first internally-developed biosimilar to be submitted to the FDA, with other biosimilars so far partnered. However, unusually in the biosimilar denosumab field – that has typically seen dual filings for Prolia and Xgeva rivals submitted simultaneously – Teva specified that it had initially filed only for a Prolia rival, with a biosimilar Xgeva candidate still in trials... Global Sub. Full

Formycon Reaches Settlement With Regeneron Over U.S. Eylea Biosimilar Patent Disputes

(10/2, RTTNews) ...Formycon AG, in collaboration with its license partners Klinge Biopharma GmbH and Valorum Biologics, has reached a settlement and entered into a license agreement with Regeneron Pharmaceuticals Inc. The agreement resolves all outstanding patent disputes concerning Formycon's FDA-approved biosimilar to Eylea for the U.S. market, Formycon said in a statement. Under the terms of the agreement, Valorum may launch AHZANTIVE in the United States in the fourth quarter of 2026, or potentially earlier under certain circumstances... Full

Lupin Launches Generic Drug in US

(10/1, Press Trust Of India) ...Drug maker Lupin on Wednesday said it has launched an anticoagulant medication in the US. The company has launched Rivaroxaban for Oral Suspension (1 mg/mL), a generic version of Janssen Pharmaceuticals, Inc.'s Xarelto for Oral Suspension, in the US, the drug maker said in a statement... Full

AbbVie Charts Next Leg of US Investment Journey with $70M Expansion in Mass.

(10/1, Fraiser Kansteiner, Fierce Pharma) ...With $10 billion earmarked to grow its U.S. operations through 2035, AbbVie continues to lay out the particulars on its decade-long domestic investment strategy...AbbVie is specifically building out additional biologics manufacturing areas at the site, as well as a new three-story building that will contain a laboratory, warehouse and office space. The company said it expects the project to hasten the production transfer of certain oncology meds from Europe to the U.S... Full

GoodRx Stock Soars After CEO Hints at Potential TrumpRx Partnership

(10/1, Louis Juricic, Investing.com) ...GoodRx Holdings stock surged 18% Wednesday after CEO Wendy Barnes suggested the digital healthcare platform could potentially partner with the Trump administration on its new drug pricing initiative. In an interview on Fox Business, Barnes revealed that GoodRx has been having "conversations" with the Trump administration regarding efforts to deliver more affordable drug pricing. She noted that the government's TrumpRx proposal would complement GoodRx's existing business model, adding that the company could "perhaps partner" with the administration on the initiative... Full

GoodRx Shares Soar as CEO Floats Potential TrumpRx Partnership

(10/1, Avalon Pernell and Bryan Pietsch, Bloomberg) ...CEO Wendy Barnes said that the government's TrumpRx proposal is something that would continue to enable what they are already doing and added that GoodRx could "perhaps partner" with them..."A partnership would be welcome news, and is in line with our recent conversation with CFO Chris McGinnis where he highlighted how GDRX is well-positioned to benefit from the shift to the DTC drug channel," writes Citi analyst Daniel Grosslight... Sub. Req’d

GoodRx Expands Tie-Up With Kroger to Offer Branded Drugs at Discounted Price

(10/1, Mariam Sunny, Reuters) ...The retail tie-up, RxSmartSaver, could help customers access GoodRx savings services for branded treatments at nearly 2,200 Kroger pharmacies across the U.S. as well as help drug manufacturers expand the reach of their direct-to-consumer programs, the telehealth firm said...The company said it has also launched the program with a smaller retailer Hy-Vee and plans to roll it out with additional retailers in the coming months... Full

Biogen Owes Genentech $88 Million in MS Drug Dispute, US Judge Says

(10/1, Blake Brittain, Reuters) ...A California federal judge has determined that biotech company Biogen owes Roche's Genentech more than $88 million in patent royalties for sales of Biogen's blockbuster multiple-sclerosis and Crohn's disease drug Tysabri. U.S. District Judge Yvonne Gonzalez Rogers said on Tuesday that Biogen owed Genentech royalties for Tysabri produced using Genentech's patents before the patents expired, even if the drugs were sold after their expiration... Full

U.K. is Urged to Probe Drugmakers for Conspiring to Scrap or Halt Investments Amid Pricing Disputes

(10/1, Ed Silverman, STAT+) ...The U.K.'s antitrust regulator has been asked by patient advocacy groups to investigate several large drugmakers and their U.K. lobbying organization for "suspected" and "coordinated" efforts to drive up the prices of medicines..."Their intention is to drive up the prices of their products in the U.K., and increase their profits. This pressure poses an extremely serious risk to the country, the NHS and patient health," the groups Balanced Economy Project, Just Treatment, and Global Justice Now wrote to the CMA. "We believe there is a significant public interest in finding out whether or not such cartel behavior has occurred."... Sub. Req’d

Novo, Lilly Weight-Loss Drugs Should Be First Option Obesity Treatments, European Doctors Say

(10/2, Nancy Lapid, Reuters) ...Novo Nordisk's and Eli Lilly's blockbuster weight-loss drugs should be the first medicines doctors reach for to treat obesity and its complications, a major European medical association advised on Thursday. Semaglutide, the active ingredient in Novo's Wegovy and Ozempic, and tirzepatide, sold as Zepbound and Mounjaro by Lilly, are so effective that they should be the first choice in almost all cases when substantial weight loss is necessary, according to a new guideline from the European Association for the Study of Obesity published in Nature Medicine... Full

Sandoz Canada Launches PrSandoz® Sacubitril-Valsartan, Expanding Access to Heart Failure Treatments

(10/1, Sandoz) ...Sandoz Canada, a leader in affordable medicines, today announced the launch of PrSandoz® Sacubitril-Valsartan, a high-quality affordable alternative to the reference medicine PrEntresto, approved for all its indications. This launch marks another important step in line with Sandoz Purpose of pioneering access for patients by expanding its portfolio of cardiovascular therapies for Canadian patients... Full

WHO Says the Antibacterial Pipeline Reveals a Dual Crisis: Scarcity and Lack of Innovation

(10/2, Ed Silverman, STAT+) ...The upshot is that the antibacterial pipeline faces a "dual crisis" encompassing both scarcity and innovation, according to the World Health Organization, which released the report. The global health agency noted that only five of the antibacterial agents were found to be effective against at least one of the bacteria deemed to be critical. "Antimicrobial resistance is escalating, but the pipeline of new treatments and diagnostics is insufficient to tackle the spread of drug-resistant bacterial infections," said Yukiko Nakatani, the WHO's assistant director-general for health systems division, in a statement... Sub. Req’d

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