Friday, October 17, 2025

Trump Strikes Deal With Merck KGaA On Tariffs, IVF Costs

(10/17, Rachel Cohrs Zhang, Jessica Nix and Sonja Wind, Bloomberg) ...President Donald Trump announced a deal with Germany's Merck KGaA to cut the price of its fertility medicines in exchange for relief from threatened tariffs, a step toward fulfilling his campaign promise of making IVF less expensive and more widely available in the US... Full

White House Announces IVF Drug Pricing Deal for ‘TrumpRx' Site

(10/16, Sarah Owermohle, Meg Tirrell, CNN) ...Under the plan, cost to patients for three in vitro fertilization (IVF) drugs made by EMD Serono, the US arm of German company Merck KGaA, could be reduced by more than 70%, Trump and administration officials said. The drugs, sold under the brand names Gonal-F, Ovidrel and Cetrotide, currently typically cost $5,000 per IVF cycle, the president said. "As part of this agreement, EMD Serono will list their fertility drugs online at TrumpRx.gov at very, very heavily reduced prices — prices that you won't even believe," Trump said, calling the company the largest fertility drug manufacturer in the world... Full

White House Makes New ‘Most Favored Nation' Deal, Shares Updates On FDA Vouchers, GLP-1 Negotiations

(10/16, Max Bayer, Endpoints News) ...EMD Serono also agreed that all future drugs it develops will be sold at "most favored nation" prices. In return, the company's products and ingredients will be excluded from pharma tariffs that the Department of Commerce is still preparing, according to an EMD Serono press release. That structure bears some similarities to deals the White House has made with Pfizer and AstraZeneca. As part of the IVF announcement, officials said that CVS Caremark and Express Scripts agreed to "materially reduce their expenses associated with the handling" of EMD Serono's infertility drugs — the first time in the most favored nation process that PBMs have been brought into a deal... Full

Trump Says Price of Ozempic Will Be Lowered

(10/17, Trevor Hunnicutt and Patrick Wingrove, Reuters) ...U.S. President Donald Trump said on Thursday that the price of Novo Nordisk's best-selling weight-loss drug would be lowered and that negotiations over price changes would be swift...Asked for comment, a Novo spokesperson said: "Novo Nordisk has engaged in discussions with the Administration regarding the Most Favored Nation executive order." The spokesperson said the company was focused on improving patient access and affordability, but did not comment directly on Trump's remarks... Full

Trump: Cost of Ozempic Could Be $150. Dr. Oz: Not Yet.

(10/16, Natalie Andrews, The Wall Street Journal) ...President Trump said in the Oval Office on Thursday that the cost of Ozempic, or "the fat loss drug," could be $150—or "much lower" than the current cost. Dr. Mehmet Oz, the Centers for Medicare & Medicaid Services administrator, jumped in to say the cost of those drugs hadn't yet been negotiated. The administration is negotiating the price of drugs with several pharmaceutical companies and has already struck deals with Pfizer and AstraZeneca... Full

Novo, Lilly Fall as Trump Touts ‘Much Lower' Ozempic Price

(10/16, Madison Muller and Naomi Kresge, Bloomberg) ...Novo's shares fell as much as 5.6% in early Copenhagen trading on Friday, the most since August. The drugmaker has dropped about 58% in the last 12 months amid concerns over its ability to compete in the weight-loss market. Shares of Lilly fell as much as 5.3% in late New York trading on Thursday...Still, the comments "signal aggressive posturing" in the negotiations, Evan Seigerman, an analyst for BMO Capital Markets, wrote in a note. However, the negotiated price may not present a true fundamental change to Novo's business, he said. That's because people with insurance already pay as little as $25 a month, and the true net price of Ozempic after rebates for insurers is probably about 60% to 70% less than the published list price... Full

What Impact Will TrumpRx and Other DTC Programs Have On Drug Availability?

(10/17, Mike Hollan and Jesse Mendelsohn, PharmExec.com) ...Jesse Mendelsohn, executive vice president at Model N, discusses how selling drugs directly to patients differs from traditional government programs... Full

Will TrumpRx Actually Lower Drug Prices?

(10/16, Paige Sutherl and Meghna Chakrabarti, WBUR) ...To be clear, any consumer end price dropping more than 100% suggests that not only would a consumer pay nothing for the prescription, but maybe perhaps the pharma companies would be paying patients to take the drugs. It is highly unlikely that this is the case. And that uncertainty around the details of TrumpRx is exactly why we seek to understand as much as we can about the deal. Because two huge companies did in fact come to an agreement with the government after all. So will the realistic parts of the agreement benefit cost burdened Americans? So we're going to begin today with Dr. Jerry Avorn. He's a professor of medicine at Harvard Medical School and author of Rethinking Medications: Truth, Power, and the Drugs You Take... Full

A Market-Based Path to Affordable Medicines

(10/15, Merrill Matthews, DC Journal) ...Trump is right that Americans generally pay more for brand-name drugs, but they also pay significantly less for most generics, which account for more than 90 percent of the prescription drugs in the United States. If Trump wants to see lower drug prices in the United States, there's an easier way to do it than trying to import other countries' government-imposed price controls. In fact, many Americans already have access to much lower drug prices, not through the black market but through the free market... Full

PBM Programs Offer Expanded Payments for Independent Pharmacies

(10/17, PCMA) ...A study by Dennis Carlton, Ph.D., professor emeritus at the University of Chicago Booth School of Business and former chief economist at the U.S. Department of Justice Antitrust Division, shows that for all prescription drugs, PBMs are paying independent pharmacies on average higher rates than pharmacies that are affiliated with PBMs. The study also concludes that PBM-affiliated pharmacies are not a driver of high drug costs... Full

Shaheen, Collins Reintroduce Bipartisan Bill to Lower Cost of Prescription Drugs

(10/16, U.S. Senator for New Hampshire Jeanne Shaheen) ..."We know that increasing generic drug competition is key to lowering prescription drug prices for individuals and reducing drug spending overall. On average, generic drugs cost 80 to 85 percent less than their brand-name equivalents," said Senator Collins. "This bipartisan bill would help address barriers that currently delay market entry for generic drugs, improving competition and saving patients money."... Full

Market Dynamics for Generics Must Change Amid ANDA Pilot Debut

(10/17, Annabel Kartal Allen, Pharmaceutical Technology) ...Upon announcing the scheme, the FDA claimed that its creation would "strengthen the domestic pharmaceutical supply chain," which has seen significant shortages in recent years. While the pilot prioritisation scheme could offer benefits to generics companies with US operations, Giuseppe Randazzo, senior VP of sciences and regulatory affairs at the Association for Accessible Medicines (AAM) told Pharmaceutical Technology that clarifications are needed before the industry can fully utilise this framework... Full

Biosimilar Medicines Save Money. So Why Aren't More Being Made?

(10/2025, John Murphy and Alex Keeton, The Atlantic) ...In this conversation with John Murphy, president and CEO of AAM, and Alex Keeton, executive director of the Biosimilars Council and AAM's senior vice president of policy, we delve into the importance of patient access to affordable medication and the challenge of creating a competitive market for biosimilars and generics... Full

FDA Announces First Nine Recipients of Priority Drug Review Vouchers

(10/16, Lizzy Lawrence, STAT+) ...President Trump highlighted one of the recipients, EMD Serono, at a White House news conference on expanding access to in vitro fertilization on Thursday. EMD Serono agreed to lower the prices of its existing fertility drugs. In exchange, the company received a voucher for Pergoveris, which stimulates egg development and has already been approved in 74 countries...In a video posted by the FDA on social media, FDA Commissioner Marty Makary and deputy chief medical officer Mallika Mundkur discussed their rationale for selecting the first round of vouchers. Each drug review division within the FDA nominated products, and companies also applied to be considered... Sub. Req’d

Biotech Leaders Say Uncertainty at FDA Threatens Drug Development

(10/16, Lizzy Lawrence, STAT+) ...Then, amid tumult at the agency as the Trump administration took power, their applications were rejected. The companies' CEOs talked about the importance of a stable FDA at the STAT Summit on Wednesday. "It is going to kill drug development if you don't have consistency and transparency," said Replimune CEO Sushil Patel. "It's really going to make it very difficult for us to bring innovative treatments to patients faster."... Sub. Req’d

US FDA Could Use Shutdown To Improve Amid Growing Foreign Competition

(10/16, Alaric DeArment, Pink Sheet) ...Amid the ongoing government shutdown, panelists at the BioFuture conference saw potential opportunities to make the FDA more flexible and efficient. Staffing shakeups could push regulators to be more open to new ideas than their predecessors. The agency also could streamline operations, which could be important as foreign regulatory agencies look to pick up its slack... Global Sub. Full

Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-October 16, 2025

(10/17, European Medicines Agency) ...Following a re-examination at the request of the applicant for Austedo (deutetrabenazine), a medicine for the treatment of adults with moderate-to-severe tardive dyskinesia, the committee confirmed its initial recommendation to not consider deutetrabenazine, as a new active substance... Full

Samsung Biologics Separates Biosimilars, Becomes Pure-Play CDMO

(10/17, Yeom Hyun-a, The Chosun Daily) ...The company will separate the business unit subject to the split on November 1 and establish Samsung Epi Holdings. The new entity plans to integrate Samsung Bioepis, a biosimilars developer, and a newly established subsidiary specializing in antibody-drug conjugate (ADC) platform technology. Samsung Epi Holdings aims to complete the establishment of the new subsidiary by the 14th of next month... Full

Serve You Rx, Waltz Health Partnership Drives 90% Biosimilar Conversation Rate

(10/16, Paige Minemyer, Fierce Healthcare) ...Serve You Rx has integrated the proprietary Waltz Connect platform, which offers specialty pharmacy savings supported by AI. The partners found that between May and July of this year, they generated an average savings per prescription of $917, a total cost reduction of 14%...Jeff Park, president of Waltz Health, said that the results bolster the case for alternative firms and mid-market players in the PBM space. He told Fierce Healthcare he expects to see "more plans and payers opt out of their traditional, locked-in big three PBM models, and moving more towards this innovation."... Full

Non-Medical Switching Policies Favoring Biosimilars Do Not Increase Health Care Use, Costs

(10/16, Max R. Wursta, Healio) ...Non-medical switching policies that mandate biosimilar use for inflammatory arthritis do not appear to increase the use of other health care services and costs, according to a study published in Arthritis Care & Research. "In many health care systems worldwide, non-medical switching policies have been introduced and have rapidly increased biosimilar uptake," HaoHung Dang, MSc, a health data analyst and researcher at the University of British Columbia, in Vancouver, and colleagues wrote. "In September 2019, British Columbia (BC), Canada, became the first public health care system in North America to announce a non-medical switching (switching for reasons other than effectiveness, safety or adherence) policy (known as the Biosimilars Initiative) to increase the uptake of several selected biosimilars... Full

Roche to Sell Flu Pill for $50 to Cash-Paying US Patients

(10/16, Patrick Wingrove, Reuters) ...The Xofluza cash price, offered by Roche's U.S. biotech unit Genentech at 70% below list price, will be available to insured and uninsured patients from Alto Pharmacy and Mark Cuban Cost Plus Drug Company. Same-day delivery will be available via Alto Pharmacy. Major U.S. pharmacy chains like CVS will not be involved, Roche confirmed...Roche said its new program will not be accessible through TrumpRx, but that it will continue to evaluate its options... Full

Kite Puts $1.6B On the Line to Pair Up with China's Pregene for Another in Vivo CAR-T Deal

(10/16, Gabrielle Masson, Fierce Biotech) ...The companies said the goal of the deal is to deliver potentially life-changing medicines faster and more efficiently. And while the pair didn't disclose what indications they were aiming to enter, Pregene co-founder and Chief Scientific Officer Zhang Jishuai, Ph.D., said the two aim to bring transformative medicines to patients "especially in oncology, autoimmune diseases and other areas where innovation is urgently needed."... Full

Sandoz Says UK Should Prioritize Uptake And Competition Over Rebates

(10/17, Dave Wallace, Generics Bulletin) ...At a UK conference, Sandoz public affairs lead Declan Mullaney has discussed the benefits biosimilars bring to the NHS but argued that to generate savings more focus should be placed on driving uptake and competition and less on rebates. Praising the NHS for its efforts to drive biosimilar uptake, Mullaney said however that VPAG rebates could be having a chilling effect on the market. Given the limited number of biosimilar suppliers and the impact of VPAG on biosimilars, he argued that biosimilars should be exempt from the scheme... Global Sub. Full

UK Must Make ‘Strategic Choices' To Free Up Money For Medicines, ABPI Chief Says

(10/16, Eliza Slawther, Pink Sheet) ...A fundamental transformation of the UK's approach to funding medicines and healthcare is required to address long-standing challenges faced by pharma companies, the Association of the British Pharmaceutical Industry's chief executive Richard Torbett says. Some of the key challenges highlighted by Torbett include high and unpredictable rebate rates and reimbursement restrictions on medicines. He said that the gains to the economy from making these changes would outweigh the initial costs... Global Sub. Full

Record Number of Prescriptions Dispensed by Community Pharmacies in England

(10/17, The Pharma Letter) ...The UK's NHS Business Services Authority has released its latest General Pharmaceutical Services report. The report shows the services provided by community pharmacies and appliance contracts in England over the last ten years, along with their associated costs. The figures show that community pharmacies across England dispensed 1.16 billion prescription items in 2024/25, representing a 4% increase from the previous year and continuing an upward trend that has lasted for four consecutive years... Sub. Req’d

EU Policy Reforms and Pharma Investments Highlight Shifting Industry Priorities, Says GlobalData

(10/16, GlobalData) ...The European Parliament's rapporteur has recently presented draft reforms to the proposed EU Critical Medicines Act, emphasizing stronger investment in domestic manufacturing while expanding stockpiling measures to secure medicine supply across member states. The draft broadens the definition of "medicines of common interest" and extends investment incentives beyond critical medicines. It also proposes multi-winner procurement, minimum supply commitments, and an EU coordination mechanism to manage shortages, highlighting shifting industry priorities, says GlobalData, a leading data and analytics company... Full

'Factories Will Close' Without Wastewater Directive Revision, Says Greek Health Minister

(10/17, Vasiliki Angouridi, Euractiv) ...Speaking to Euractiv on the sidelines of a conference on vaccines, Health Minister Adonis Georgiadis said that if the directive is enforced as planned, "factories will close." During his address at a conference organised by the Panhellenic Pharmaceutical Association on vaccination, Georgiadis criticised the directive's approach, adopted by the EU Environment Council in 2022. He explained that while wastewater from pharmaceutical production already undergoes three stages of treatment, the directive introduces a mandatory fourth purification level for remaining substances, with 80% of the cost to be borne by the pharmaceutical industry... Full

Indian Pharma Eyes Russian Market: Firms Explore Localised Production; Target to Build Largest API Hub

(10/17, The Times of India) ...Indian pharmaceutical companies are exploring opportunities to establish production facilities across Russia, with productive negotiations underway for joint ventures. This move aims to leverage India's expertise and Russia's market potential, fostering self-sufficiency in pharmaceuticals and other key sectors through complementary strengths... Full

Exclusive: India to Force Drugmakers to Upgrade Plants After Fatal Cough Syrup Crisis

(10/16, Rishika Sadam and Krishna N. Das, Reuters) ...Jagdeep Singh, secretary of the SME Pharma Industries Confederation, has warned that nearly half of the manufacturing units in the pharmaceutical hub state of Himachal Pradesh would shut if an extension was not forthcoming. "I can guarantee there will be shortages, unemployment, and massive national losses," he said, adding that some firms have already discontinued products as customers refuse to bear the upgrade costs...The deadline "cannot be extended again and again - people are dying," the person said, adding that major drugmakers which have already upgraded their facilities could meet any shortfall... Full

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