Thursday, October 23, 2025

Trump Touts Drug Price Wins Even as Plans for Savings Unclear

(10/23, Nyah Phengsitthy, Bloomberg Law) ...The agreements consist of selling existing medicines to Medicaid patients at steeply discounted prices, launching new drugs in the US at the lowest prices offered to peer countries, and participating in TrumpRx, a direct purchasing platform planned for next year to allow patients to purchase some medicines at a reduced cash price...Pharmaceutical companies acceded to Trump's plan, and his threats of higher tariffs and revoked drug approvals, but the secured deals lacked official guidance that could ensure lowered drug prices. The White House sent two pricing models to the Office of Management Budget for review, but industry watchers question if and when those will advance given drugmakers have already secured deals... Sub. Req’d

Trump Eyes Fresh Tariff Probe Focused on Foreign Drug Prices

(10/22, Madison Muller, Rachel Cohrs Zhang and Jordan Fabian, Bloomberg) ...President Donald Trump is planning to launch a new investigation into drug prices aimed at ensuring foreign countries pay as much as Americans do for their medicines, according to people familiar with the matter...Drug companies, for their part, appear to support Section 301 tariffs. AbbVie Inc. Chief Executive Officer Robert Michael said that the tariffs are something that can be used to address "unfair practices" related to international drug pricing... Sub. Req’d

Trump's Approach to Lowering Drug Costs Is Raising Questions

(10/22, Lia DeGroot, Roll Call) ...The key issue, health experts say, is that the public has had little visibility into these deals. "The hard part, of course, is we don't know exactly what's in there," said Spencer Perlman, managing partner and director of health research at the consultancy Veda Partners. The administration has held news conferences and put out fact sheets with bullet points, but experts have yet to review the fine print. And it's unclear how deep these actions will go, given that there are more than 2,500 pharmaceutical companies operating in the United States... Full

Pharma's Game of "Five-Dimensional Chess"

(10/23, Caitlin Owens, Axios) ...While the Trump administration says it has more drug pricing deals lined up with pharmaceutical manufacturers, the emerging template is still a tough sell for many companies... Full

Senate Aging Committee Proposes Fed Buyer's Market To Improve Generic Supply Chain

(10/22, Gabrielle Wanneh, Inside Health Policy) ...The lawmakers say establishing a buyer's market initially run by the Defense Department should be top priority for Congress and the Trump administration, noting the federal government's role as the largest purchaser of prescription drugs in the United States provides it power to incentivize reshoring pharmaceutical manufacturing. The model established by the Defense Department could eventually be expanded to include other federal purchasers... Sub. Req’d

To Reshore Generic Drugs, Use Sugar's Sweet Model

(10/22, Jon Toomey, CPA) ...Instead of the traditional platitudes of "level the playing field", the President promised to use "tariffs and import restraints" so our nation could be self-reliant for essential medicines. As it happens, there's one industry where we've already done that: sugar. It's a perfect model for generic drugs... Full

Dose of Reality: Merck Surpasses Milestone in Product-Hopping Strategy to Block Competition, Keep Prices High on Blockbuster Cancer Drug Keytruda

(10/22, The Campaign for Sustainable Rx Pricing) ...Executives from Merck have touted the new version of Keytruda as "a meaningful advance" and Merck's CEO even claimed that the new subcutaneous version of the drug is an "invention." However, as the Initiative for Medicines, Access & Knowledge (I-MAK) recently explained, Keytruda Qlex is created by "combining Keytruda's known immune PD-1 checkpoint inhibitor (pembrolizumab) with a form of the enzyme hyaluronidase… [h]yaluronidase, and variations of it, is a well-understood ingredient that companies have long used to enable subcutaneous delivery of biologic drugs."...So, the truth is, there is little actual innovation associated with Merck's new version of Keytruda — the change in delivery method and its timing is about extending monopoly pricing power, keeping prices high for patients, and maximizing Merck's profits... Full

Big Pharma Wrong to Attack 340B Program

(10/22, John Arcano, RealClearHealth) ...Fewer 340B providers means fewer discounted prescriptions. The previous discounted drugs would now be available at the retail price—the preference of drug companies. This guarantees that, however incremental, the average sales price of a given drug and drug prices overall would increase, contrary to pablum offered by the for-profit companies with an economic interest in higher prices...340B hospitals and their offshoot clinics provide quality cancer care to those with employer-based insurance and for many underinsured and uninsured patients as well. The savings from discount purchases on oncology therapies make that care possible. Without 340B, hospitals would lack the wherewithal to care for medically underserved cancer patients... Full

Annual Family Premiums for Employer Coverage Rise 6% in 2025, Nearing $27,000, with Workers Paying $6,850 Toward Premiums Out of Their Paychecks

(10/22, KFF) ...Family premiums for employer-sponsored health insurance reached an average of $26,993 this year, KFF's annual benchmark health benefits survey of large and smaller employers finds. On average, workers contribute $6,850 annually to the cost of family coverage, with employers paying the rest..."There is a quiet alarm bell going off. With GLP-1s, increases in hospital prices, tariffs and other factors, we expect employer premiums to rise more sharply next year," KFF President and CEO Drew Altman said. "Employers have nothing new in their arsenal that can address most of the drivers of their cost increases, and that could well result in an increase in deductibles and other forms of employee cost sharing again, a strategy that neither employers nor employees like but companies resort to in a pinch to hold down premium increases."... Full

US FDA Plans Move Back To More Generalist Inspectorate

(10/22, Sarah Karlin-Smith and Derrick Gingery, Pink Sheet) ...The FDA will merge all its medical product and clinical research inspectorates as part of an effort known as "Simple Reform," HHS confirmed to the Pink Sheet. The change would reverse a 2017 effort known as "program alignment," designed to ensure agency inspectors were specialized to the commodity areas they covered. Experts questioned whether a return to generalist inspectors would be successful, given the very different knowledge bases needed to inspect the range of FDA commodities... Global Sub. Full

Stakeholders Ask for Flexibility, More Examples in FDA Guidance on Overall Survival in Cancer Trials

(10/22, Ferdous Al-Faruque, Regulatory Focus) ...Stakeholders asked the US Food and Drug Administration for more examples in comments on a recently issued guidance on the use of overall survival as an endpoint in oncology drug clinical trials. They also asked for more flexibility when choosing what endpoint to use and alignment with international guidelines. The guidance noted that overall survival should be prioritized as the primary endpoint when feasible but also acknowledged that there are situations when that may not be possible... Full

Is Your Medication Made in a Contaminated Factory? The FDA Won't Tell You.

(10/23, Debbie Cenziper and Megan Rose, ProPublica) ...For decades, the FDA has blacked out the names of generic drugs on inspection reports for foreign factories that were found to have safety and quality violations...In July, newly named FDA Commissioner Marty Makary promised "radical transparency" and the agency released more information about why it had denied applications for new drugs and biological products. Nearly seven months into his tenure, the agency has yet to release detailed information about where generic drugs are being made... Full

Here's What Happened When ProPublica Reporters Tried to Find Out Where a Popular Prescription Drug Was Made

(10/23, Debbie Cenziper and Megan Rose, ProPublica) ...ProPublica wanted to know something simple: Where a widely used generic drug was made and whether that factory had any quality problems. Instead, we found ourselves navigating a labyrinth of company names and complex databases that few regular consumers would even know exist. And even after all that detective work, we hit a dead end... Full

Drug With a 30-Year Monopoly Is Target of State-Level Push to Curb Prices

(10/23, Rebecca Robbins, The New York Times) ...Enbrel first arrived on the market nearly 30 years ago with a sticker price of about $11,000 a year. Today, that has reached $106,000, although many employers and government programs pay far less with discounts. Starting in January, Medicare will demand a lower, negotiated price of about $30,000 a year for the drug. And in 2027, Colorado will mandate that same Enbrel price under certain insurance plans, a first-of-its-kind move at the state level. Washington State is also scrutinizing Enbrel's price... Sub. Req’d

Cingulate Builds Infrastructure Ahead Of FDA Decision On Hybrid ADHD Candidate

(10/23, Dean Rudge, Generics Bulletin) ...Cingulate is preparing for the commercialization of its lead ADHD treatment, CTx-1301, as the FDA reviews the dexmethylphenidate hybrid with a PDUFA decision date of May 31, 2026. The company is enhancing manufacturing through a partnership with Bend Bio Sciences, which will be the sole US manufacturer of the product pending FDA approval. CTx-1301 utilizes a unique trimodal extended-release formula designed for quick onset and sustained symptom control for up to 16 hours... Global Sub. Full

Eli Lilly Allows Cipla to Sell Weight Loss Drug Under New Brand in India

(10/23, Kashish Tandon, Reuters) ...Under the agreement, Lilly will manufacture the drug and Cipla will market it under the brand name Yurpeak, the drugmakers said. Yurpeak will be available as a once-weekly pre-filled injector pen, same as Lilly's Mounjaro Kwikpen, allowing healthcare providers to personalise treatment plans to individual patient needs. The medication will be available in six dose strengths - 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg and will be priced the same as Mounjaro... Full

Xspray's Hybrid Nilotinib Candidate XS003 Advances To FDA Review Stage

(10/23, Dean Rudge, Generics Bulletin) ...Xspray Pharma has welcomed an "important milestone" after the FDA agreed to review its proposed hybrid version of Tasigna (nilotinib), which the Swedish firm says has shown a markedly reduced food effect compared to the reference product...The agency will review the product submitted via its 505(b)(2) pathway, with a decision expected by June 18, 2026... Global Sub. Full

Biocon Gets Health Canada Nod for Biosimilars Yesintek, Yesintek IV

(10/23, Press Trust Of India) ...Biocon Biologics has made strides in the healthcare sector by obtaining Health Canada's approval for Yesintek and Yesintek IV, its latest autoimmune treatment options. These biosimilars to Stelara have received official clearance on October 17, heralding a new era of affordable treatment in Canada... Full

Glenmark Pharma Set to Launch Ropivacaine Hydrochloride Injection in US

(10/23, Business Standard) ...Glenmark Pharmaceuticals Inc., USA, has announced the upcoming launch of its Ropivacaine Hydrochloride Injection USP in three single-dose vial strengths, 40 mg/20 mL (2 mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL)... Full

Two More Denosumab Biosimilars Approved in the US

(10/23, Nancy A. Melville, Medscape) ...The FDA has approved two new drugs that are biosimilars to denosumab, adding to the ever-expanding field of less expensive options of the popular anti-osteoporosis and cancer-related bone loss drug; however, savings on such drugs so far have been modest...Meanwhile, in Europe, where biosimilars are typically available at a small fraction of the cost seen in the US, the denosumab biosimilars are a very welcome alternative, Muhammad K. Nisar, MD, consultant rheumatologist and physician at Luton & Dunstable University Hospital, Luton, England, told Medscape Medical News... Full

‘Sustainability Could Be In Jeopardy' – Cencora Evaluates The Current Landscape For US Biosimilars

(10/22, Dave Wallace, Generics Bulletin) ...Cencora's director of biosimilar commercialization, Dennis Nelson, speaks to Generics Bulletin for an exclusive Q&A interview. Nelson highlights recent key launches and regulatory developments in the US biosimilars arena, as well as pointing out areas where changes could help to improve the operating environment. The executive also points to moves away from dual high/low WAC pricing, and towards private-label biosimilars, and offers thoughts on why the pipeline of biosimilars in development remains so limited... Global Sub. Full

Some Generic Adderall Medications Are Being Recalled Over Bottle Mislabeling. What to Know

(10/22, 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... Sub. Req’d

Roche Raises Full-Year Earnings Outlook as U.S. Drug-Pricing Talks Continue

(10/23, Billy Gray, The Wall Street Journal) ...Thomas Schinecker, chief executive of the Swiss pharmaceutical giant, said Thursday that Roche is and has been in discussions with the U.S. government about pricing, but that it was too early to comment further. He declined to comment on how a potential agreement between Roche and the White House would compare with those recently made by pharmaceutical groups Pfizer and AstraZeneca. Schinecker said the company had put in place a number of mitigation efforts to protect itself from a tariff hit and that Roche was confident of its U.S. positioning relative to its peer companies... Sub. Req’d

Takeda Boosts Pipeline and Revenue Growth Prospects With $1.2B Deal for Innovent Cancer Drugs

(10/22, Frank Vinluan, MedCity News) ...Takeda Pharmaceutical is bolstering its pipeline in a big way, committing $1.2 billion for rights to two late-stage Innovent Biologics cancer drugs and securing an exclusive option to license an early-stage program, all of which have potential applications for treating a range of solid tumors. The deal is important because like other big pharmaceutical companies, Takeda needs new products to make up for the coming drop-off in revenue as it faces the patent cliff... Full

To Enter Sleep Market, Alkermes Forks Over $2.1B for Avadel

(10/22, Kevin Dunleavy, Fierce Pharma) ...Under the deal, Alkermes will pay $18.50 per share for Avadel and potentially tack on a contingent value right of $1.50 per share if the FDA approves Lumryz for idiopathic hypersomnia by the end of 2028, the companies said in an Oct. 22 press release...Alkermes aims to close the deal in the first quarter of next year. The Avadel purchase is expected to provide an immediate revenue boost for Alkermes, which reported sales of $1.56 billion last year, down 6% from 2023... Full

Merck KGaA to Mothball Operations at Ireland API Plant by End of 2028

(10/22, Fraiser Kansteiner, Fierce Pharma) ...Merck KGaA plans to discontinue operations at its production plant in Arklow, Ireland, "by the end of 2028," a company spokesperson confirmed to Fierce Pharma in a statement Wednesday. The decision follows a strategic review of the products made at the site, which prompted Merck KGaA to "discontinue" its API portfolio there, the spokesperson explained... Full

Anti-Obesity Drug Prescribing Shows Signs of Leveling Off

(10/23, Adriel Bettelheim, Axios) ...The anti-obesity drug boom may be cooling, as overall prescribing of GLP-1 medicines remained relatively flat for the three months ending in September, according to a new analysis of electronic health records...Even with more approved uses for the drugs, the high cost, variable insurance coverage policies and the fact that many patients can't stay on them are tempering some expectations... Full

Challenges, Innovations, and Future Outlook of Biologics Formulations

(10/22, Feliza Mirasol, PharmTech.com) ...The diversity of biologics under development suggests that no single non-parenteral strategy will dominate. Instead, modalities will be tailored: oral delivery for chronic, systemic diseases; inhalation or intranasal delivery for respiratory or mucosal immunity; and transdermal approaches for lower-dose applications. The overarching driver will continue to be the pursuit of patient-centric care—convenient, non-invasive, and accessible therapeutics that reduce healthcare burdens while improving treatment adherence... Full

Belgium Slashes Clinical Trial Review Times In Push To Draw More Studies

(10/22, Neena Brizmohun, Pink Sheet) ...The AFMPS, Belgium's healthcare products regulator, is to start speeding up its review of clinical trial applications. The accelerated timelines will apply to mononational and multinational clinical trials. The AFMPS believes the faster reviews will strengthen Belgium's position as a leading center for clinical trials... Global Sub. Full

Brazil's ‘Milestone' Clinical Research Decree Expected To Double Clinical Trials

(10/22, Francesca Bruce, Pink Sheet) ...A newly published decree in Brazil is aimed at doubling the number of trials conducted in Brazil. It slashes timelines for approving clinical trials and introduces new structures for ethics reviews. The decree also aims to better protect clinical trial participants... Global Sub. Full

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