Wednesday, October 8, 2025

Pharma Companies Scramble to Make Deals With Trump After Pfizer Scored White House Praise

(10/7, Daniel Payne, STAT+) ...Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations. "They have to now," said one lobbyist of their clients' thinking, noting the "anger" with Pfizer for effectively adding to their pressure to come to an agreement with the administration... Sub. Req’d

Fifth Circuit Wrestles Again With US Drug Price Negotiation Plan

(10/7, Nyah Phengsitthy, Bloomberg Law) ...The industry has long fought the agency's definition of a "qualifying single source drug," or a drug or biologic that has no generic or biosimilar competition. The definition guides the agency on which medicines are eligible for price cuts. Novo Nordisk A/S challenged the agency when it deemed six of its insulins as a single product subject to price controls, and Teva Pharmaceuticals Inc. sued the CMS when it grouped two of its drugs that treat movement disorders as one product. "If you say six drugs are one drug, it kills all the incentive to basically say, ‘hey, this is a very useful drug. What else will this molecule do?'" said John Elwood, head of Arnold & Porter's appellate and Supreme Court practice, representing the health groups. "If it's all going to be swept together, you aren't going to put the additional billions of dollars of research."... Sub. Req’d

Pharma Group Asks Fifth Circuit to Ax Medicare Drug Price Negotiation

(10/7, Christina Van Waasbergen, Courthouse News Service) ...A lobby group for drug manufacturers asked a U.S. Fifth Circuit Court of Appeals panel Tuesday to block Medicare's ability to negotiate drug prices under the Inflation Reduction Act, arguing the negotiation scheme violates the Constitution by blocking judicial review and imposing excessive fines. Pharmaceutical Research and Manufacturers of America, a trade group that represents U.S. pharmaceutical companies, brought suit in the Western District of Texas, challenging the scheme in 2023 along with the National Infusion Center Association and the Global Colon Cancer Association. Senior U.S. District Judge David Alan Ezra, a Ronald Reagan appointee, rejected their arguments, finding the negotiation program wasn't unconstitutional... Full

Court Ruling Allows Medicare to Negotiate Prices for Larger Number of Drugs

(10/7, John Wilkerson, STAT+) ...The court's ruling could have a big impact because, although the lawsuit focuses on insulin products from the first year of the program, Medicare also lumped together three of Novo's blockbuster diabetes and weight loss products — Ozempic, Rybelsus, and Wegovy — in the second round of negotiations. Semaglutide is the active ingredient in all of them. The ruling also might bode well for a policy the Trump administration is considering that would build on the Biden administration's legislation... Sub. Req’d

The Art of the Underwhelming Drug Deal

(10/7, Brandon Novick, CEPR) ...Aside from the extremely limited nature of the negotiated deal between the Trump Administration and Pfizer, the entire discourse from the government leaves out the reason other countries pay far less than the US for the same products: they negotiate drug prices for the population at large... Full

Trump Wants to Overhaul Drug Sales. A Company Tied to His Son Stands to Benefit.

(10/7, Annie Linskey and Josh Dawsey, The Wall Street Journal) ...The host: BlinkRx, an online prescription drug delivery company that this year installed Trump Jr. as a board member...BlinkRx stands to benefit from a shake-up of how patients buy drugs after President Trump urged pharmaceutical companies to sell their medicines directly to consumers. BlinkRx helps drugmakers do exactly that with a service that promises to set up direct-to-patient sales programs in as little as three weeks. TrumpRx, a new government website set to launch in early 2026, would funnel patients to direct-sale sites... Sub. Req’d

Broadening the Reach of Prescription Drug Inflation Rebates

(10/7, Christen Linke Young, Brookings) ...To help avoid constitutional challenges, states should base their rebate on state data from a state All–Payer Claims Database or other source of claims data, and as long as payments must be made by pharmaceutical manufacturers, the structure should not be considered an impermissible provider tax in Medicaid... Full

Why Are America's Prescription Drugs So Expensive — And Can TrumpRx Fix It?

(10/7, Kelli Wessinger and Sean Rameswaram, Vox) ...So, why do Americans pay more for prescription drugs than anyone else in the world? And what exactly is "most favored nation status?" To get a grasp on last week's big news, Today, Explained co-host Sean Rameswaram talked with Stacie Dusetzina, professor of health policy at Vanderbilt University Medical Center... Full

PBMs Say They Want Lower Priced Medicines, So Why Don't They Cover Them?

(10/7, Elise Shutzer, PhRMA) ...The Pharmaceutical Care Management Association (PCMA), which represents PBMs, recently launched a misleading ad campaign saying pharmaceutical companies should just lower the price of medicines. But what they don't say is that PBMs often refuse to cover lower priced medicines and instead charge rebates and fees that drive up medicine costs – often exceeding the total price in other countries... Full

CSRxP: Pera Would Further Enable Big Pharma's Patent Abuse That Keeps Prescription Drug Prices High

(10/7, The Campaign for Sustainable Rx Pricing) ..."PERA would further enable Big Pharma's patent abuse playbook that keeps drug prices high in the United States, by significantly broadening the scope of what is patentable, likely resulting in brand name pharmaceutical companies building new patent thickets early on in the drug discovery process," said CSRxP executive director Lauren Aronson... Full

Pharmaceutical 232 Must Cover Generic Drugs to Fulfill President's Promise of Reshoring Essential Medicine Production

(10/7, Kenneth Rapoza, Coalition For A Prosperous America) ...The Trump administration's Section 232 investigation into pharmaceutical imports is reportedly close to being final. The final investigation's success will depend largely on whether or not the Commerce Department determines that there is a crisis in the generics industry — an issue that President Trump highlighted back in 2023... Full

Express Scripts' Adam Kautzner Becomes PCMA Board Chair

(10/7, PCMA) ...The Pharmaceutical Care Management Association (PCMA) is pleased to announce that Adam Kautzner, PharmD, President, Evernorth Care Management & Express Scripts Evernorth Health Services, has assumed the role of Chair of the PCMA Board of Directors...In addition, PCMA is announcing the creation of a new Affiliates Council to represent the association's mid-market and innovator companies. This segment of the industry has been growing in the PCMA membership, with five new companies joining in the last year. The PCMA board is being expanded to include the chair of the Affiliates Council, ensuring that this critically important market perspective is represented at the table. Jeff Park, President of Waltz Health, is serving as the Affiliates Council's first board representative... Full

DEA Raises Adderall Production Quotas for the First Time

(10/7, Kastalia Medrano, Filter) ...Effective October 2, the DEA increased the 2025 APQ for d-amphetamine, the primary active ingredient in Adderall, from 21.2 million grams to 26.5 million grams. It also increased the APQ for methylphenidate, better known by brand names Ritalin and Concerta, as it has done once before since the shortage began to affect those medications in late 2022... Full

White House Reiterates Concern Kids Overprescribed Psychiatric, Weight-Loss Drugs

(10/7, Luke Zarzecki, Inside Health Policy) ...The White House underscored its concerns that selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers and weight-loss drugs are overprescribed to children, issuing a statement Monday (Oct. 6) for Child Health Day reiterating that stemming the alleged overprescribing is a focus of HHS Secretary Robert F. Kennedy Jr.'s Make America Healthy Again strategy... Sub. Req’d

FDA Generic Pilot Fuels Talk Of All-Out Onshoring Push, Details Unclear

(10/7, Maaisha Osman, Inside Health Policy) ...FDA has launched a new pilot program offering faster reviews for generic drugmakers that conduct testing and manufacturing in the United States, a move aimed at boosting domestic pharmaceutical production and reducing reliance on foreign suppliers. Generic industry experts tell Inside Health Policy the initiative underscores the administration's full-throttle push to onshore every stage of drug development and manufacturing, though they note it remains unclear whether the expedited reviews will apply to pending applications or only to new submissions... Sub. Req’d

The Biosimilars Forum Calls for State Policies that Support Lower-Cost Prescription Drugs Including Biosimilars for Patients that Need Them

(10/7, Biosimilars Forum) ...The Forum is very concerned with the Colorado Prescription Drug Affordability Board's (PDAB) action to place artificial price controls on a biologic with biosimilar competitor, which are often up to 85% less expensive than brand biologics. This action negatively impacts patients that need access to lower-cost medicines. The action could also deter biosimilars manufacturers from continuing their work developing lower-cost biosimilars... Full

MSD Advances On a Broad Front With TL1A Drug Tulisokibart

(10/7, Phil Taylor, Pharmaphorum) ...MSD's confidence in its anti-TL1A antibody tulisokibart in inflammatory diseases has been made apparent by a decision to start trials of the drug in three more indications...TL1A – or tumour necrosis factor-like ligand 1A – has become something of a hot topic in immunology and inflammation R&D, with tulisokibart competing with candidates in development at Teva/Sanofi and Roche to be first to market...Meanwhile, Sanofi licensed rights to Teva's duvakitug in a deal valued at around $1.5 billion, and the two partners have reported positive phase 2b results with the drug in ulcerative colitis and Crohn's and are recruiting for a four-study phase 3 programme... Full

Alvotech And Advanz Celebrate EU Omalizumab Filing

(10/8, Dave Wallace, Generics Bulletin) ...Advanz and Alvotech have successfully filed their Kashiv BioSciences-developed omalizumab biosimilar rival to Xolair with the EMA. The European filing comes shortly after Kashiv's US marketing partner Amneal filed the omalizumab biosimilar with the US FDA. Celltrion has already launched a Xolair biosimilar in Europe and has received approval in the US, where biosimilar competition is yet to begin... Global Sub. Full

Gilead Inks Trio of Biktarvy Patent Settlements, Waylaying US Copycats Until 2036

(10/7, Fraiser Kansteiner, Fierce Pharma) ...Gilead has struck accords with Lupin, Cipla and Laurus Labs to delay the entry of any Biktarvy copycats in the U.S. until April 1, 2036. Gilead inked the settlements after each of the three generic drug makers filed applications for generic Biktarvy with the FDA, according to an Oct. 6 securities filing... Full

Global Biosimilars Market Sees Gains in Access and Pipeline Expansion

(10/7, Skylar Jeremias, Center for Biosimilars) ...The global biosimilar industry experienced significant momentum in early October 2025, driven by a key US product launch, strategic international partnerships aimed at improving affordability, and major regulatory filings for a high-value asthma and allergy treatment. These updates reflect continued efforts by biopharmaceutical companies to increase patient access and reduce the economic burden on health care systems worldwide... Full

Peter Marks, FDA Vaccine Regulator Ousted by RFK Jr., Joins Eli Lilly

(10/7, Lizzy Lawrence, STAT+) ...Marks confirmed his new role at Lilly Research Laboratories to STAT. His first day was Monday. "I am excited about the potential to help benefit people by advancing the development of infectious disease products for public health," Marks told STAT. "Lilly continually evaluates breakthrough science which could benefit patients," said Lilly spokesperson Stefanie Prodouz. "Peter's expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas."... Sub. Req’d

Between Debt and Discovery: Takeda's Uneasy Next Phase

(10/8, The Pharma Letter) ...Now, with leadership set to change in 2026 and late-stage pipeline readouts looming, Takeda stands at a crossroads. The company has spent the past six years trying to prove that its boldest-ever acquisition was not a bridge too far. Shire's assets brought depth in rare disease and gastrointestinal medicine, while Takeda added oncology and vaccines to build a broad portfolio. But the debt overhang and patchy R&D productivity continue to cast a shadow. Whether Takeda can convert its global reach into lasting competitiveness depends on how well it manages this balancing act... Sub. Req’d

Health Rounds: Genetics Play a Role in Higher Depression Risk for Women

(10/8, Nancy Lapid, Reuters) ...The team identified about 7,000 changes in DNA that could cause depression in both sexes, and about a further 6,000 DNA changes that could cause depression in females only...The differences may help explain why females with depression more often experience metabolic symptoms such as weight changes or altered energy levels, they said. The researchers say most drug trials and therapies are tested on males, and they hope their work will also translate to a greater clinical understanding of female depression. "These findings underscore the importance of considering sex-specific genetic (factors) in the study of health conditions, including major depressive disorder, paving the way for more targeted treatment strategies," the researchers concluded... Full

Amazon Launches Prescription Vending Machines at One Medical Clinics in Los Angeles

(10/8, Annie Palmer, CNBC) ...Amazon is launching prescription vending kiosks at select One Medical clinics in the Los Angeles area. The kiosks are operated by Amazon Pharmacy and stock a range of commonly prescribed medications, such as antibiotics, inhalers and blood pressure treatments. The launch comes as pharmacy chains Rite Aid, Walgreens and CVS have closed stores in recent years... Full

Britain Prepares NHS Drug Spending Hike to Stave Off Trump Tariffs

(10/8, Dan Bloom and Caroline Hug, Politico) ...The U.K. government has drawn up proposals to increase the amount the National Health Service pays pharmaceutical firms for drugs, in a bid to steer U.S. President Donald Trump away from his threatened tariffs on the sector... Full

UK Government Prepared to Pay More for Drugs Bought by NHS

(10/8, Hannah Kuchler, Laura Hughes, Jim Pickard, Financial Times) ...A government spokesperson said: "We've secured a landmark economic partnership with the US that includes working together on pharmaceutical exports from the UK whilst improving conditions for pharmaceutical companies here. "We're now in advanced discussions with the US Administration to secure the best outcome for the UK, reflecting our strong relationship and the opportunities from close partnership with our pharmaceutical industry."... Sub. Req’d

Defining Unmet Medical Need: EU Debate Sparks Concern Over Innovation And Access

(10/7, Francesca Bruce, Pink Sheet) ...The European Commission, Parliament and Council will negotiate a definition of unmet medical need (UMN) as part of upcoming trialogues to finalize updates to the EU's pharmaceutical legislation. Experts have warned that a narrow definition could limit access to medicines for some patients and stifle innovation. The designation of UMN could affect pricing and reimbursement decisions at the member state level, as well as access to incentives at the EU level... Global Sub. Full

Japan Continues Toward Self-Reliance with Alfresa-Led Biosimilars Alliance

(10/8, Dean Rudge, Generics Bulletin) ...Alfresa Holdings, Kidswell Bio, Chiome Bioscience, and Taiwan's Mycenax have formed a two-track alliance to accelerate Japan's shift to domestically produced biosimilars... Global Sub. Full

China Biotech Pushes Abroad as Domestic Pricing Tightens

(10/7, The Pharma Letter) ...The industry's response has been swift and increasingly outward. Chinese biotechs are racing to globalize their trials, list shares on investor-friendly exchanges, and ink cross-border partnerships that convert science into cash...China's procurement and reimbursement reforms created a crucible that tests resilience. Price compression now appears baked into market access. That reality is pushing companies to prune portfolios, refocus resources on genuine innovation, and look for growth beyond China. The transition is uneven, but the direction is clear... Sub. Req’d

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