Tuesday, June 24, 2025

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

(6/23, Michael McCaughan, Pink Sheet) ...US Food and Drug Administration Commissioner Martin Makary's favorite solution for high drug prices is to stop using so many. "The best way to lower drug prices is to stop taking drugs we don't need," he told the recent Food and Drug Law Institute annual conference, a line he has used many times. The approach technically would reduce drug spending, not drug prices... Global Sub. Full

Price Inflation Rebates: Biden Policies Add Teeth To Trump's Pharma Tariff Threat

(6/23, Cathy Kelly, Pink Sheet) ...Eli Lilly CEO David Ricks alluded to the issue in a recent interview with the BBC. He said because some US prices are "capped," companies would have to consider offsetting the higher cost with internal spending cuts. Lilly's "biggest payers are Medicare and Medicaid" and to "make up a 25% tariff, you'd have to raise your prices 50% and that's not sustainable," health policy expert Deborah Williams, the founder of Health Policy Insights, told the Pink Sheet... Global Sub. Full

IRA Poised To Raise Drug Costs For Most Seniors, USC Study Finds

(6/23, Gabrielle Wanneh, Inside Health Policy) ...A white paper published this month zeroes in on how standalone prescription drug plans (PDPs) in Medicare have been adjusting to the IRA's drug pricing provisions, specifically how PDPs are adapting now that out-of-pocket drug spending is capped at $2,000 annually and the Part D benefit has been redesigned to increase the percentage of drug coverage PDPs are responsible for at different phases of the benefit... Sub. Req’d

Dr. Rand Paul Introduces the Restore Prescription Drugs Discount Act

(6/23, U.S. Senator Rand Paul) ...U.S. Senator Rand Paul (R-KY) today introduced the Restore Prescription Drugs Discount Act, a bill to eliminate an outdated antitrust law that hinders insurers and employers from negotiating upfront discounts for better prices on prescription drugs... Full

Supreme Court Asks DOJ to Weigh in On Hikma ‘Skinny Label' Fight Against Amarin

(6/23, Alexis Kramer, Endpoints News) ...Hikma says the Federal Circuit's decision to let the case move forward would expose all generic drugmakers to lawsuits and discourage market entry. Amarin said in a response brief that the case is "not about a ‘skinny label' alone," but rather is more fact-intensive and would have limited applicability to other drugmakers... Sub. Req’d

Corrigan-Curay Announces Retirement from CDER

(6/23, Ferdous Al-Faruque, Regulatory Focus) ...On June 23, Jacqueline Corrigan-Curay, acting director of the Center for Drug Evaluation and Research (CDER) and its principal deputy director, announced that she will retire from FDA in July... Full

The FDA's Biosimilar Burden—and How Congress Can Lift It

(6/23, Jeffrey A. Singer, Cato Institute) ...As I explain in my book, Your Body, Your Health Care, when Congress passed the Kefauver-Harris Amendment to the FDCA in 1962, it required drug makers to convince the agency that a new drug was effective as well as safe. This arduous FDA approval process increases drugmakers' research and development costs while reducing the time remaining on their patents, allowing them to recoup those costs. This is one major contributor to high prescription drug prices. It creates the phenomena of "drug lag" and "drug loss."... Full

FDA Finalizes Guidance On Requesting Post-Warning Letter Meetings

(6/23, Joanne S. Eglovitch, Regulatory Focus) ...According to FDA, no significant changes were made to the finalized version; only minor revisions were implemented for clarity. This guidance finalizes the draft version released in September 2023. In the GDUFA III commitment letter, FDA agreed to establish a post-warning letter meeting process for facilities to obtain preliminary feedback from FDA on the adequacy of corrective action and preventive action (CAPA) plans to resolve the inspectional deficiencies identified in the warning letter... Full

Revised Q1 Draft Stability Document Issued by FDA

(6/23, Bob Pollock, Lachman Consultants) ...This draft guidance represents "a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July 1996, respectively." In addition, it "provides stability related guidance for product categories such as advanced therapy medicinal products, vaccines, and other complex biological products including combination products that were not previously covered under the existing stability guidances"... Full

California Aims to Curb Medicaid Coverage for Weight-Loss Drugs

(6/24, Andrew Oxford, Bloomberg Law) ...California lawmakers are moving to cut Medicaid coverage for some expensive weight-loss drugs, such as Novo Nordisk's Wegovy and Eli Lilly's Zepbound, in a bid to reduce the state's $12 billion budget deficit. Lawmakers eliminated Medicaid coverage for such drugs when prescribed for weight loss—though they would still be covered when used for diabetes treatment—in a budget passed earlier this month. The move is expected to save the state $85 million in the fiscal year that starts July 1, a savings that is estimated to grow to $680 million annually by mid-2029... Sub. Req’d

Ajovy's Effectiveness Reinforced in Real-World Migraine Prevention Study

(6/23, Jon Napitupulu, The Clinical Trial Vanguard) ...This comprehensive, real-world data strengthens the position of fremanezumab as a viable long-term treatment option for migraine prevention. The positive results, coupled with the high adherence rates, suggest continued growth in the adoption of fremanezumab, benefiting both patients and Teva. Further research could explore the impact of this preventive treatment on quality of life measures, healthcare resource utilization, and overall economic burden of migraine... Full

AstraZeneca Faces New Allegations Over Trial Data for Blood Thinner Brilinta: BMJ

(6/23, Kevin Dunleavy, Fierce Pharma) ..."The (new) findings raise even deeper questions over the approval and decade-long use of the drug," the BMJ wrote in an article Thursday...The BMJ questioned the competence of several trial sites involved in Onset/Offset and the integrity of the data they provided, pointing to some missing patient baseline data and unusual platelet aggregation patterns that appeared to be "an improbable effect for an anti-platelet drug."...AZ did not respond to a request for comment from the BMJ during its investigation, but a spokesperson did tell Fierce Pharma on Monday that "we are confident in the integrity of the trials and its evidence in support of Brilinta/Brilique."... Full

Viatris Targets Gilead's Odefsey HIV Blockbuster In Europe With CHMP Recommendation

(6/24, Dean Rudge, Generics Bulletin) ...Viatris emerged victorious at the June meeting of the European Medicines Agency's Committee for Medicinal Products for Human Use, picking up a pair of positive opinions for new generic medicines, including one for a rival to Gilead Sciences' Odefsey triple-combination antiretroviral tablets, which is a core medication in global HIV treatment strategies... Global Sub. Full

Novo Nordisk Launches Blockbuster Weight-Loss Drug Wegovy in India

(6/24, Rishika Sadam and Kashish Tandon, Reuters) ...Wegovy, a once-a-week injection, will be in pharmacies by the end of the month, Novo said, as the drug looked poised to erode some of Lilly's market share. Mounjaro's sales jumped 60% between April and May, industry experts said. "One in three patients achieve 20% weight loss (with higher dose of Wegovy)," Novo Nordisk India Managing Director Vikrant Shrotriya said on Tuesday, adding the company had conducted late stage trials of injectable semaglutide on 3,500 individuals in India... Full

Novo Nordisk Ends Deal with Hims & Hers Over Sales of Wegovy Copycats; HIMS Drops 34%

(6/23, Annika Kim Constantino, CNBC) ...Novo Nordisk said it is ending its collaboration with Hims & Hers due to concerns about the telehealth company's sales and promotion of cheaper knock-offs of the weight loss drug Wegovy... Full

Diabetes and Obesity Boom Will Propel Lilly, Novo to Front of Pharma Sales Pack by 2030: Evaluate

(6/23, Kevin Dunleavy, Fierce Pharma) ...In its "World Preview 2025" report, Evaluate projects that Lilly's prescription drug sales will reach $113 billion, well ahead of second-place Novo Nordisk, which has drawn an $84 billion estimate for 2030. The common thread between Lilly and Novo, of course, is their dominance of the diabetes/obesity market, which Evaluate figures will grow at a 20% annual clip between 2024 and 2030. Evaluate sees Lilly taking more advantage of the growth, increasing its prescription drug sales from $41 billion last year, while the analysts expect Novo will double its sales over the period from $42 billion in 2024... Full

Pharma M&A Remains Quiet as China's Industry Influence Grows

(6/23, Lecia Bushak, MM+M) ...Evaluate's annual World Preview Report, which examines the state of the pharma industry through the next five years, found that demand for prescription drugs globally remains high — enough to buoy the industry forward amid such turbulence...Pharma products sourced from China will account for 40% of all licensing deals in 2025, the report found, compared to 3% just five years ago. This represents a massive shift towards China holding more dominance as a global leader in pharma, given it can produce best- and first-in-class molecules more quickly and cheaply than the U.S... Full

Trump's Trade War Will Lead to Drug Shortages in Canada, New Report Warns

(6/24, David Reevely, The Logic) ...America's global trade war is breaking up delicate supply chains for essential drugs and Canadians should expect shortages, says Mark Lievonen, a co-chair of Canada's COVID-19 vaccine task force and veteran pharma executive. All the instability has created pandemic-level risks to health security already, Lievonen, a former president of the Canadian arm of French pharma giant Sanofi, told The Logic. "It's not disease, but it's underlying infrastructure," he said... Full

Pharma Reform Should Provide for More Timely Patient Access in Europe

(6/24, Medicines for Europe) ...Speaking at Medicines for Europe's Legal Affairs Conference, General Counsel Sergio Napolitano said: "This is a key moment that will shape the future of the EU pharmaceutical sector. From the pharmaceutical legislation reform to the SPC reforms, there is one common denominator: timely access of generic and biosimilar medicines. This can be achieved by carefully balancing the incentive system, stopping IP abuses and supporting an industrial policy for off-patent medicines."... Full

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

(6/23, Eliza Slawther, Pink Sheet) ...The EU is in the final phase of reforming its pharmaceutical legislation, with the European Commission, European Parliament and Council of the EU each having adopted their respective positions on the draft text, paving the way for negotiations. One lawyer says the council's version is favorable for industry, while another highlights the shortcomings of this version. Both lawyers explain that the commission's version is probably the least favorable for companies due to its low regulatory data protection offering... Global Sub. Full

UK Government Blueprints Ambition to Be a Key Life Sciences Hub 

(6/24, Anna Brown, Endpoints News) ...In a 160-page report published Monday, the Department for Business and Trade outlined investment strategies to boost eight industry sectors in the UK, including the life sciences, which covers pharmaceuticals. The UK government is focused on boosting its global competitiveness in the pharma industry after the country has "underperformed in recent years," the report said... Sub. Req’d

Ireland Warns Thousands of Jobs at Risk From Pharma Tariffs

(6/23, Olivia Fletcher, Laura Noonan and Stephen Carroll, Bloomberg) ...Ireland plans to use its budget cushion to pump money into infrastructure to protect competitiveness as global trade turmoil and tariffs threaten thousands of jobs in the multinational hub. The small, open economy has a strong fiscal position for now, with a huge budget surplus thanks to corporate tax income from US corporates such as Apple Inc. and Pfizer Inc. But with some of that revenue at risk, Finance Minister Paschal Donohoe said Monday that the government must use that money with an eye on the longer term... Full

Donohoe: Pharma Tariffs Could Cost Ireland 75,000 Jobs

(6/23, Bloomberg) ...Irish Finance Minister Paschal Donohoe said US pharmaceutical tariffs are a key concern as they could cost thousands of pharma jobs in Ireland. "The macroeconomic modelling we've done for the Irish economy would indicate that there could be approximately 75,000 jobs that could be affected by it across the medium term," Donohoe told Stephen Carroll at Bloomberg's Future of Finance in Ireland event in Dublin... Full

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