Tuesday, September 30, 2025

Trump ‘Most Favored Nation' Drug Price Negotiations Extend Past Deadline

(9/29, Gabrielle M. Etzel, Washington Examiner) ...Several pharmaceutical companies told the Washington Examiner on Monday that they are still negotiating with the Trump administration over pricing...Several other companies put on notice by the Trump administration told the Washington Examiner that they are actively negotiating with senior administration officials on policies to lower drug prices for U.S. consumers. A Merck spokesperson, for example, said the company "supports raising foreign prices and lowering U.S. prices" and that foreign prices set by socialized medicine systems "unfairly disadvantage American patients and threaten continued investment in breakthrough life-saving and life-improving research."... Full

Trump and Big Pharma at Loggerheads Over Drug Prices

(9/30, Caitlin Owens, Axios) ...PhRMA, the drugmakers' top trade group, yesterday announced several actions it's taking or has already taken to answer Trump's "call to put America first," as CEO Stephen Ubl put it in a press release...Some companies, including AstraZeneca and Bristol Myers Squibb, have already announced that they'll let patients buy certain drugs directly, cutting out the middlemen that the drug industry blames for high patient costs...PhRMA's latest offer seems unlikely to satisfy the administration enough to forestall executive action. PhRMA "is definitely making an effort to align their efforts to Trump's executive order on drug pricing," said David Mansdoerfer, a Health and Human Services official in Trump's first administration... Full

Trump's Deadline On Drug Prices Arrives: What Next?

(9/30, Joseph Choi, The Hill) ...Novo Nordisk also said it was in discussions with the administration about the order, adding, "We remain focused on improving patient access and affordability, and we will continue to work to find solutions that help people access the medication they need." Steve Ubl, the president and chief executive of the pharmaceutical trade group PhRMA, announced the launch of a new portal called AmericasMedicines.com on Monday that will connect patients with manufacturers' direct-to-consumer programs...Among the companies listed on the website are Amgen, AstraZeneca. Bristol Myers Squibb, Genentech, Gilead, GSK, Johnson & Johnson, Eli Lilly, Merck and Novartis... Full

Historic Biopharmaceutical Investments: A Prescription for America's Future

(9/29, Stephen J. Ubl, PhRMA) ...The biopharmaceutical industry is stepping up with new innovative cures, infrastructure investments, new jobs, as well as patient resources. However, to reduce price differentials with other wealthy countries, we should require PBMs to share savings directly with patients and reform misaligned incentives, fix the 340B hospital markup program, and force foreign governments to pay their fair share for cutting-edge innovation... Full

How Trump's October Drug Price Plan Can Bring Families Relief

(9/29, Tom Price, The Washington Times) ...HHS should work with Congress to amend Hatch-Waxman to prevent this patent manipulation from continuing. This can be done by setting stricter standards for what counts as genuine innovation and capping the number of patents tied to a single product and the number of lawsuits one drugmaker can file against one generic competitor...The goal must be fairness: a system where competition is real, patients have choices, and no one can rig the rules to entrench monopoly power... Full

'Most Favored Nation' Drug Pricing Is a Bad Deal for Patients

(9/29, Gerard Scimeca, RealClearHealth) ...Simply put, we can't fix America's prescription drug market by copying foreign countries' backwards price-setting schemes...By focusing their reform efforts on the real culprits behind drug price inflation, namely pharmacy benefit managers and foreign free-riders, they can deliver lower prices without putting American innovation or leadership at risk...But, MFN price controls would do serious harm to America's world-leading innovation system and the patients who depend on it. If the administration instead cracks down on the cost inflation caused by PBMs and presses foreign governments to pull their weight in innovation, it could deliver real savings for patients today without jeopardizing the cures of tomorrow... Full

Sanders Report Shows Prices for 688 Prescription Drugs Rose Under Trump

(9/29, Jessica Corbett, Common Dreams) ...In response to the president's May executive order and July letters giving drugmakers 60 days to act, Sanders (I-Vt.), ranking member of the Senate Health, Education, Labor, and Pensions Committee, "directed his staff to examine prescription drug prices," explains the report, The Art of the Bad Deal: Trump's Failure to Lower Prescription Drug Prices. The committee staffers documented price increases for 688 medications—310 brand-name drugs and 378 generic ones—during Trump's second term, with a median increase of 5.5% and 25 treatments more than doubling in cost. "Of the 17 companies that received a letter from President Trump on July 31, 2025, 15 raised the price of at least one product since Trump took office," the report notes. "Since Trump sent letters asking drug companies to lower prices, the prices of 87 drugs have increased."... Full

AAM: U.S. Could Miss $234B In Savings If Competition Barriers Remain

(9/29, Gabrielle Wanneh, Inside Health Policy) ...A new report from the generic drug lobby warns consumers and patients could lose $234 billion in total health care savings over the next 10 years unless policymakers eradicate barriers to generic drug and biosimilar access, such as outdated regulatory hurdles that slow the development and market entry, patent practices commonly used by brand drug companies to delay to competition and extend market monopolies, formulary practices that incentivize preferred treatment for expensive brand drugs, and unintended consequences of Inflation Reduction Act placed upon generic and biosimilar medicines... Sub. Req’d

Opinion: How To Bring Generic Drug Manufacturing Back to the US

(9/30, Vic Suarez, BioSpace) ...In an era of geopolitical instability and heightened awareness surrounding national health security, the importance of reshoring the production of active pharmaceutical ingredients cannot be overstated. According to the Olin Business School at Washington University in St. Louis, more than 80 of the top 100 generic medicines have no U.S.-based source for their active pharmaceutical ingredients (APIs), the components that provide the drugs' therapeutic benefit... Full

FDA Staff Could Be Exempt From Shutdown Reductions In Force

(9/29, Jessica Karins, Inside Health Policy) ...With just two days for Congress to reach a short-term funding agreement before appropriations run out Wednesday (Oct. 1), HHS has published a contingency plan which would retain 86% of FDA staff in the event of a government shutdown, and the FDA commissioner says workers may exempted from a plan to lay off additional staff during the funding lapse... Sub. Req’d

Federal Judge Declines to Pause Illinois Generic Drug Price Law

(9/29, Celine Castronuovo, Bloomberg Law) ...The Association for Accessible Medicines, which represents the generic drug and biosimilars industry, hasn't clearly demonstrated that it's likely to succeed with its claim that the Illinois law is unconstitutional by directly regulating prices charged in transactions that take place outside of Illinois, Judge Virginia M. Kendall of the US District Court for the Northern District of Illinois wrote in her ruling denying AAM's renewed motion for a preliminary injunction... Sub. Req’d

Arkansas Pharmacists Worry as AstraZeneca Cuts Local Pharmacies in Price Strategy

(9/29, Christopher Gay, ABC 7) ...The pharmaceutical company AstraZeneca is one of several companies that will now sell their drugs directly to patients. With that lack of pharmacy involvement, it worries Arkansas pharmacists like Anne Pace, the owner of Kavanaugh Pharmacy in Little Rock. "There's going to be no pharmacist-patient interaction, and that's an incredibly important part of our healthcare and delivery system."..."So why do we need to have AstraZeneca and other drug manufacturers selling direct to patients when they could sell them to their local pharmacies for the exact same price for what they're saying they want to do direct to consumers," asks Pace... Full

AZ, Daiichi's Enhertu Shows Early Breast Cancer Prowess with Another Trial Win, Topping Roche's Kadcyla

(9/29, Zoey Becker, Fierce Pharma) ...AstraZeneca and Daiichi Sankyo's star antibody-drug conjugate (ADC) Enhertu has chalked up another win in an early breast cancer setting, this time besting Roche's Kadcyla in a phase 3 study. Enhertu proved its prowess across patients with HER2-positive early breast cancer who are at high risk of recurrence and have residual invasive disease in the breast or axillary lymph nodes following neoadjuvant treatment in the 1,635-patient wide Destiny-Breast05 trial... Full

Axsome Sues Apotex to Block Copies of Symbravo Migraine Drug

(9/29, Christopher Yasiejko, Bloomberg Law) ...Apotex Inc.'s proposed copies of Symbravo infringe 75 patents for the migraine drug, Axsome Therapeutics Inc. said in what appears to be its first patent suit since Symbravo's approval earlier this year. Axsome alleged Apotex's generic tablets combining Symbravo's active ingredients of meloxicam and rizatriptan infringe patents covering the drug's composition and use in treating acute migraines, according to a complaint filed Sept. 26 in the US District Court for the District of New Jersey... Sub. Req’d

6 Drugs in Shortage

(9/29, Alexandra Murphy, Becker's Hospital Review) ...Irinotecan hydrochloride injection: Multiple manufacturers have discontinued various presentations of irinotecan hydrochloride injection, an oncology medication used in treatment of colorectal and other cancers. Fresenius Kabi is discontinuing its 40 milligram/2 milliliter and 100 milligram/5 milliliter injections. Jiangsu Hengrui Pharmaceuticals is discontinuing its 40 milligram/2 milliliter and 100 milligram/5 milliliter injections. Teva Pharmaceuticals indicated its 20 milligram/1 milliliter injections will not be available beyond mid- to late September or October... Full

Why Are Some Generic Adderall Medications Being Recalled? Find Out About Manufacturers

(9/29, Presley Bo Tyler, Shreveport Times) ...There is an ongoing shortage of ADHD medications that is affecting the U.S., including Louisiana, which began in 2022 and continues to impact patients seeking the medication, according to the American Society of Health-System Pharmacists. While not all ADHD medications are facing a shortage, most of the common brand names are currently unavailable, says MEDvidi. If patients are unable to fill an Adderall prescription, it's reccommended that patients consult their doctors, try other dosages and check with different pharmacies... Full

INVESTIGATING GENERICS: Real People Share Their Struggles With Generic ADHD Medications

(9/29, Emma Yasinski, MedShadow Foundation) ...For the past decade, Kacie says she has relied on a combination of Vyvanse and immediate-release Adderall. The "crashes" she experiences when the extended-release drug fades are especially severe, she says, leaving her exhausted and unable to function — because she also lives with narcolepsy...There have been notable issues. The Teva-manufactured generics she received in June 2025 wore off far too quickly, she says. "I don't know if it's something they add, but for whatever reason, I just metabolize it differently."...Bridget notes with frustration that even the Teva-made version, which had once been reliable, now feels different. Pills that used to break cleanly so that she could take half of an instant-release pill multiple times a day are now crumbling in her hands. More importantly, the medication no longer seems as effective as it had been before... Full

Lilly's Head Scientist Discusses Its GLP-1 Pill, Alzheimer's Strategy, and Finding Promising Ideas and Startups

(9/30, Jonathan Wosen, STAT+) ...STAT sat down with Lilly's chief scientific officer, Daniel Skovronsky, who was in town for the opening and made clear that the site's launch is as much about supporting the biotech ecosystem as it is about building relationships between startups and the pharma giant that could lead to future deals. Skovronsky also spoke more broadly about the company's R&D ambitions... Sub. Req’d

Q&A: Genmab CEO On The ‘Very Fair' $8B Merus Deal and Finding a ‘Rough Diamond We Can Polish'

(9/29, Kyle LaHucik, Endpoints News) ...Endpoints News caught up with Genmab CEO Jan van de Winkel to discuss the deal, which he described as a "very fair price" for Merus' shareholders. Genmab is paying $97 per share $MRUS, which is a 41% premium to Friday's closing price...The companies have known each other for two decades, but over the past two years, Genmab had been closely following Merus' lead drug candidate for head and neck cancer, an EGFRxLGR5 antibody called petosemtamab. Talks ramped up after Phase 2 data were presented at ASCO this summer... Sub. Req’d

Q&A: GSK's Emma Walmsley On Succession Planning, Her Time at the Company and What's Next

(9/29, Drew Armstrong, Endpoints News) ...One of the few female leaders of a major pharma, her exit once again leaves a shortage of women at the top of the industry. In a conversation with Endpoints News on Monday, Walmsley, 56, suggested she's not done yet and has plenty of "executive energy" remaining. She spoke with executive editor Drew Armstrong about her time at GSK, her successor and what comes next... Sub. Req’d

AbbVie Breaks Ground On Chicago API Manufacturing Plant

(9/29, Charlie Sternberg, Contract Pharma) ...[Azita Saleki-Gerhardt, Ph.D., executive vice president and chief operations officer, AbbVie] "Over the next decade, AbbVie plans to invest more than $10 billion in capital to add multiple new U.S. manufacturing plants and improve the lives of millions of patients in the U.S. and worldwide who depend on our medicines." AbbVie's new North Chicago API facility, once completed, will significantly expand its chemical synthesis capabilities. This expansion will enable AbbVie to relocate API production for select products from Europe and Asia to the US. This move will support domestic production of current and next-generation neuroscience, immunology, and oncology medicines... Full

Drug Manufacturers See Long-Term Opportunity in Climbing AI Use

(9/30, Nick Paul Taylor, BioSpace) ...Ultimately, AI advocates envisage the technology altering almost every aspect of drug production. Nicole Murphy, head of pharmaceutical operations and technology at Biogen, told BioSpace the goal is to achieve "end-to-end integrated process control" and "fully automated fill-finish operations." Similarly, end-to-end process optimization is one of Sanofi's long-term objectives for AI, a spokesperson for the French drugmaker told BioSpace. The plan, they added, is to "simulate and optimize entire production lines, leading to significant improvements in efficiency and quality." The shift from applying AI to distinct activities to using the technology to oversee and improve the whole production process is part of a broader ratcheting up of the industry's ambitions... Full

Q&A: Transparent, Pass-Through PBMs Gaining Traction Over Big 3

(9/29, Brian Nowosielski and Bill Wolfe, Drug Topics) ..."It's refreshing to see the traction. I don't expect the Big 3 to go away," Bill Wolfe, COO at WriteWise and former President of Aetna's Pharmacy Management team, told Drug Topics. "Their integrated offerings do have some value, but I think that having some transparency and really focusing on patient engagement, as well as focusing on the outcome and on managing costs at the same time that you're managing quality, is gaining traction."... Full

EMA Tells Sponsors to Incorporate Patient Experience Across Product Lifecycle

(9/29, Joanne S. Eglovitch, Regulatory Focus) ...The European Medicines Agency (EMA) has released a reflection paper regarding the use of patient experience data (PED) in drug development. In the document, the EMA states that PED should be incorporated into all phases of drug development, as it can significantly contribute to the overall evidence generated throughout the lifecycle of a medicine... Full

Biotech Act An Opportunity To Tackle Clinical Trial Hurdles In EU, Says Commission

(9/29, Eliza Slawther, Pink Sheet) ...The European Commission's proposed Biotech Act could help address ongoing regulatory challenges faced by study sponsors in the EU following the introduction of the Clinical Trials Regulation (CTR). The CTR was introduced to harmonize the review process for clinical trials in the EU, but sponsors have continued to face regulatory challenges and fragmentation when running studies in member states. Experts from the European Commission and the European Medicines Agency have acknowledged these challenges and outlined steps being taken to address them... Global Sub. Full

AbbVie Joins BMS in Taking a Hard Line On UK Drug Pricing

(9/30, Phil Taylor, Pharmaphorum) ...AbbVie suggested that it may not be able to launch its new ovarian cancer therapy Elahere (mirvetuximab soravtansine) for use by NHS patients if ongoing negotiations with reimbursement authority NICE do not result in a reasonable price for the drug..."Scientific progress in treating ovarian cancer and other serious diseases requires a collaborative approach among all developed nations," said Jeff Stewart, AbbVie's chief commercial officer. "Developed markets must recognise and support the value that innovative therapies bring to patients and societies to help ensure sustainable access and continued investment in medical innovation so that patients everywhere benefit from the next generation of therapies."... Full

French Pharma Demands ‘Political Leap' To Revive ‘Suffocating' Industry

(9/29, Francesca Bruce, Pink Sheet) ...The French government has been drafting the new social security financing bill, which will likely have implications for the French pharmaceutical industry with regard to drug pricing and spending. The French pharma industry association, Leem, has warned that without action, access to medicines in France will continue to decline and has outlined suggestions for improvement. Suggestions include a sustainable spending plan for medicines and better recognition of the value of medicines... Global Sub. Full

Talks Begin On New Medicines Supply Agreement

(9/29, Michael McHale, Irish Medical Times) ...Talks have begun between the Government and an organisation representing pharmaceutical companies over improving the accessibilty and affordability of new medicines. Minister for Health Jennifer Carroll MacNeill announced that the State and the Irish Pharmaceutical Healthcare Association (IPHA) have opened discussions on the new framework agreements on the supply and pricing of medicines... Full

Indian Pharma Cos to Benefit as Drugs Worth $236 Billion Expected to Go Off-Patent in Next Five Years

(9/30, Nandita Vijayasimha, Pharmabiz.com) ...The next few years will be critical as the industry navigates this transformation and adapts to the rising dominance of generics and biosimilars. With 750+ US FDA-approved plants, India is well primed to take advantage of this opportunity. Companies like Cipla and Sun Pharma are gearing up to unlock the next level of growth in this period by expanding their portfolios and de-risking their US supply chains by adopting multi-site manufacturing, said Dr. Purav Gandhi, CEO & founder, Healthark... Full

Datanomics: India Doubles its Share in Prescription Drugs to the United States (US)

(9/30, IBEF) ...In FY25, nearly 35% of India's pharmaceutical exports were destined for the United States (US), with industry estimates indicating that over 95% of these shipments comprised generic drugs, while the remainder were branded or patented products. The latter now face 100% tariffs in the US, which could affect larger Indian pharmaceutical firms; however, generic drug manufacturers are expected to remain largely unaffected. Indian generics have steadily increased their presence in the US market, with their share of total prescription drugs rising from approximately 21% in 2013 to 42% in 2022, while contributions from other countries nearly halved over the same period... Full

US Confirms 15% Tariff On Japanese Drugs, But Confusion Lingers

(9/30, Lisa Takagi, Pink Sheet) ...Japanese pharmaceutical products seem likely to avoid the broader possible 100% US tariff on imported pharmaceuticals and will be subject to a 15% rate instead, as previously agreed between the two countries, the White House has confirmed to multiple Japanese media outlets. While the 15% levy is the same as that imposed by the US on European drugs, the actual impact on Japanese pharma firms remains unclear and many are cautiously monitoring other US policies in the sector, including relating to drug pricing... Global Sub. Full

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