Wednesday, August 6, 2025

US FDA Approves Teva's Ajovy for Migraine Prevention in Children

(8/5, Padmanabhan Ananthan, Reuters) ...The U.S. Food and Drug Administration on Tuesday approved Ajovy, an injection made by Israeli drugmaker Teva Pharma, to help prevent migraines in children aged six and older who weigh 45 kilograms or more. This is the first time a drug has been approved for preventing migraines in children... Full

US to Initially Impose 'Small Tariff' On Pharma Imports, Trump Says

(8/5, Patrick Wingrove, Andrea Shalal and Bhargav Acharya, Reuters) ...President Donald Trump said on Tuesday that the United States would initially place a "small tariff" on pharmaceutical imports before hiking it to 150% within 18 months and eventually to 250% in an effort to boost domestic production. "In one year, one and a half years maximum, it's going to go to 150% and then it's going to go to 250% because we want pharmaceuticals made in our country," Trump told CNBC in an interview... Full

Trump Says Pharma Tariffs Could Eventually Reach Up to 250%

(8/5, Annika Kim Constantino, CNBC) ...President Donald Trump told CNBC's "Squawk Box" that planned tariffs on pharmaceuticals imported into the U.S. could eventually reach up to 250%, the highest rate he has threatened so far...On Tuesday, Trump told CNBC that he "invoked" the "most favored nations" policy and that it will have a "tremendous impact on the price of medicine." But Trump has not officially implemented any changes from the executive order... Full

Trump: Pharma Tariffs Coming Within Next Week, Could Climb To 250% In 18 Months

(8/5, Maaisha Osman, Inside Health Policy) ..."We want pharmaceuticals made in our country," Trump said during a CNBC interview Tuesday (Aug. 5). "Initially [it'll be a] small tariff on pharmaceuticals, but in one year, one and a half years max, it's going to go to 150%, then 250%." The goal, he said, is to reduce reliance on foreign suppliers -- particularly China and Ireland -- and bolster domestic production in the United States... Sub. Req’d

Pfizer CEO Touts 'Extremely Productive' Talks With Trump Administration as MFN Pricing, Tariff Threats Close In

(8/5, Fraiser Kansteiner, Fierce Pharma) ...The company and others in the industry have also broached the topic with Department of Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., and, at least on Pfizer's end, those talks have been "extremely productive," [Pfizer CEO Albert Bourla, Ph.D.] said. "I think we understand where the president comes from, and we are engaging in a productive way to find the solution," he explained... Full

Pharma Cooperating With Trump On Direct Sale To Consumers, Pfizer CEO Says

(8/5, Jessica Merrill, Pink Sheet) ...Pfizer CEO Albert Bourla said industry leaders are collaborating on opportunities to sell drugs directly to consumers in an effort to lower drug prices. Direct-to-consumer sales are one request from the Trump Administration that industry is enthusiastic to meet. MFN pricing discussions are underway, Bourla said, addressing the industry overhang during the company's second quarter sales and earnings call... Global Sub. Full

Public Citizen: Foreign Nations Not To Blame For U.S. Drug Prices

(8/5, Maaisha Osman, Inside Health Policy) ...Public Citizen is pushing back hard against the Trump administration's suggestion that foreign nations are "freeloading" on American pharmaceutical innovation, arguing in its filed comments to the U.S. Trade Representative (USTR) that the real culprit behind soaring U.S. drug costs is domestic policy that allows drugmakers unchecked monopoly pricing power... Sub. Req’d

Editorial: The Political Race for Fewer Cures

(8/5, The Wall Street Journal) ...Mr. Trump claimed last week that drug manufacturers receive "generous research subsidies." Not true. Universities do, and some of their research can lead to future drugs. But the pharmaceutical industry spent $141 billion on research and development in 2022, nearly 40 times as much as the National Institutes of Health did on research directly related to drug development. Browbeating companies, as Mr. Trump is doing, could spur them to move more intellectual property to China, where Xi Jinping is rolling out the red carpet. And it will likely result in fewer new drugs developed and sold in the U.S., especially in riskier research fields like neurologic and rare genetic diseases... Sub. Req’d

Cuban: Drugmakers Are More Afraid of PBMs Than Trump

(8/5, Leslie Small, Pink Sheet) ...The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate...Disrupting the PBM space is difficult because the Big Three have too much leverage, Mark Cuban of Cost Plus Drug Co. said recently. Cuban suggested President Trump tell the Justice Department and FTC to go after pharmaceutical companies if they do not implement most favored nation pricing. Cuban also said changing the rebate system will not fix the incentives in the drug supply chain... Global Sub. Full

Why Are Drug Prices So High? PBMs Are Only Part of the Answer, Say GOP Advisers

(8/5, Joyce Frieden, MedPage Today) ...Problems in the prescription drug marketplace such as lack of transparency "are compounded by the labyrinth of regulations and a web of intermediaries," including PBMs, Thomas DeMatteo, chief counsel to Sen. Mike Lee (R-Utah) on the Senate Judiciary Committee, said at the listening session, which was hosted by the Federal Trade Commission (FTC) and the departments of Justice, Commerce, and HHS. "Insurance companies, PBMs, drug wholesalers, and pharmacies are all taking a cut at various stages of the supply chain. The result is a system where patients understandably feel as if everyone has their hand in their pocket when it's functioning as intended."... Full

Ajovy Becomes First Migraine Prevention Drug for Children in the USA

(8/6, The Pharma Letter) ...The decision allows Ajovy to be prescribed to patients aged six and older who weigh at least 45 kilograms. The treatment, given as a once-monthly subcutaneous injection, was already cleared for use in adults in 2018. This latest approval makes it the first calcitonin gene-related peptide (CGRP) inhibitor to be approved in the US for preventing episodic migraines in pediatric patients...The approval arrives as Israeli-based Teva continues its broader shift away from generics toward innovative branded medicines. The company is currently executing a multi-year strategy it refers to internally as its "Pivot to Growth," which aims to establish it as a stronger player in biopharma... Sub. Req’d

FDA Approves Fremanezumab-vfrm for Migraine Prevention in Children Aged 6 Years, Older

(8/5, Joshua Fitch, Contemporary Pediatrics) ...Fremanezumab-vfrm is administered as a 225 mg subcutaneous injection once a month, previously approved in 2018 for adults. The pediatric safety profile was generally consistent with that seen in adult trials. The most frequent side effects included injection site reactions—such as pain, redness, and itching—while serious adverse events like rash, pruritus, and drug hypersensitivity were noted but infrequent... Full

Teva Pharma Announces USFDA Filing Acceptance for Ajovy in Pediatric Episodic Migraine Prevention

(8/6, Ruchika Sharma, Medical Dialogues) ..."Migraine is common among children and adolescents, often disrupting their education, social lives and overall well-being, yet treatment options remain limited," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "As we work to bring the benefits of AJOVY to younger patients, we build upon its proven success in adults. If approved, AJOVY could be an important step toward filling the gap in pediatric migraine care, offering a much-needed solution for this underserved population."... Full

‘Concrete Solutions, Not Big Words' – Samsung Bioepis Suggests European Improvements For Biosimilars

(8/6, Dave Wallace, Generics Bulletin) ...Samsung Bioepis has published a white paper calling for policy improvements in Europe for biosimilars. Adam Levysohn, head of commercial strategy for Europe at Samsung Bioepis, talks about the problems and solutions. Key areas include portfolio strategy, clawbacks, procurement processes, HTAs, and regulatory streamlining. "One thing that was very important for us in this white paper was to have concrete solutions: concrete examples of what actually works and what should change, so it doesn't become just big words."... Global Sub. Full

Celltrion And Arrotex Tie Up For A Pair Of First PBS-Listed Australian Biosimilars

(8/5, Dean Rudge, Generics Bulletin) ...Arrotex has partnered with Celltrion Healthcare Australia to launch two first-to-market biosimilars for chronic inflammatory conditions, now listed on the PBS. While specific details have not been disclosed, reports suggest the biosimilars are Steqeyma (ustekinumab) for various conditions and Omlyclo (omalizumab) for asthma-related issues. Both products are classified as interchangeable with their reference biologics, allowing pharmacists to substitute them without prescriber approval unless indicated otherwise... Global Sub. Full

Polpharma Biologics And Fresenius Kabi Team Up On Entyvio Biosimilar

(8/5, Urte Fultinaviciute, Generics Bulletin) ...The Phase III trial investigating PB016 is expected to be completed in September 2025, positioning the duo in a leading position amongst other vedolizumab biosimilar competitors. However, the originator Takeda feels safe with its blockbuster, which generated $1.58bn during the previous quarter, as no biosimilar rivals are expected to enter the market for the next five years...In the US, Alvotech joined forces with Teva. The firms announced a US biosimilar pact in 2020, but at the time did not identify specific biosimilars covered by the deal. According to Teva's Q2 FY2025 result presentation, the vedolizumab biosimilar is currently in clinical development... Global Sub. Full

Kashiv BioSciences and MS Pharma Enter into MENA License and Supply Agreement for ADL-018, Biosimilar Candidate to XOLAIR® (bOmalizumab)

(8/5, Kashiv BioSciences, MS Pharma) ...Under the terms of the agreement, Kashiv BioSciences is responsible for the development of the product within the agreed territories. MS Pharma will be responsible for the licensing, distribution, and commercialization of ADL-018 in the MENA region, with the option of local manufacturing to be carried out at MS Pharma's state-of-the-art biologics facility in Saudi Arabia... Full

CivicaScript® to Distribute Low-Cost Biosimilar to Treat Chronic Inflammatory Conditions

(8/5, CivicaScript) ...The product will be available starting Jan. 1, 2026. Ustekinumab-aauz is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. Specific information about ustekinumab-aauz can be found here. The company's expansion into biosimilars builds on the steady growth of its specialty generic product portfolio, with four products launched in 2025. CivicaScript will be the exclusive distributor of unbranded ustekinumab-aauz, produced by Fresenius Kabi... Full

Annual Spending On Specialty Drugs Continues to Increase But at a Slower Pace Than Prior Years, Driven in Part by Biosimilar Adoption.

(8/5, Pharmaceutical Strategies Group) ...Notably, cost per claim was meaningfully less of a contributor to trend this year versus recent years. "The data reveals a compelling story regarding what is happening with specialty drugs. Overall costs continue to increase for healthcare payers, but what is driving that cost is changing," stated Morgan Lee, PhD, Senior Director of Research & Strategy at PSG. "Adoption of Humira biosimilars helped pull specialty trend down this year, which is evident throughout the report," Lee added... Full

Markup Madness 2025: Hospitals, Insurers, and the Broken Buy-and-Bill Market for Biosimilars

(8/5, Adam J. Fein, Ph.D., Drug Channels) ...DCI's analysis of four national commercial insurers—Aetna, Anthem, Cigna, and UnitedHealthcare—and 26 hospitals found that: Hospitals still earn significant markups over average sale price (ASP). 340B hospitals earn even more. Insurers pay wildly varying amounts for the same drug. Some hospitals get paid significantly more than others for the same drug. Insurers can pay more for a lower-cost biosimilar than for the higher-cost reference product... Full

Amgen Profit Rises, Weight-Loss Data Expected in 4th Quarter

(8/5, Deena Beasley, Reuters) ...Amgen on Tuesday posted quarterly financial results that beat Wall Street expectations as a 9% increase in product sales offset higher operating expenses due in part to development of experimental weight-loss drug MariTide...The company said its 2025 outlook includes the impact of implemented tariffs, but does not account for any future levies, including potential sector-specific tariffs, or pricing actions that could be implemented in the future...Amgen CEO Robert Bradway, during a conference call with investors, said the company agrees that reform is needed in the U.S. healthcare system, but that it is too early to comment on specific plans. "We expect to work with the administration," he said... Full

Amgen Stands Firm On IV Checkpoint Inhibitor Biosimilars

(8/6, Dean Rudge, Generics Bulletin) ...Amgen remains confident in the commercial and clinical potential of its intravenous biosimilar programs for immuno-oncology agents such as its ABP 234 biosimilar to Keytruda (pembrolizumab) and ABP 206 biosimilar to Opdivo (nivolumab), despite emerging competition from subcutaneous formulations leveraging hyaluronidase technology. The intravenous formulations of both Keytruda and Opdivo have been forecasted to fall to biosimilar competition in 2028, opening up a market worth tens of billions of dollars... Global Sub. Full

Aurobindo Expects Lannett Acquisition To Pass FTC Scrutiny; Q1 US Revenue Falls

(8/6, Vibha Ravi, Generics Bulletin) ...Aurobindo Pharmaceuticals Ltd seems confident its all-cash $250m (INR21.8bn) deal to acquire Pennsylvania-based Lannett Company Inc will pass scrutiny by the US Federal Trade Commission (FTC) even as its revenues in the US come under pressure...Despite the advantages that come with the Lannett acquisition, the stakes are much lower compared to the Sandoz deal which would have made Aurobindo the second-largest generics company in the US by prescriptions and placed it second in the dermatological drugs segment as per Aurobindo's statements at the time... Global Sub. Full

Hungary's Richter Says Some US Exports Face Tariff Challenges, But Flagship Drug Exempt

(8/6, Anita Komuves, Reuters) ...Higher U.S. tariffs may make it challenging for Hungarian pharmaceutical company Richter to export some products to the United States, but they won't apply to its flagship antipsychotic drug Vraylar, CEO Gabor Orban said on Wednesday..."There is no point in moving Richter to the U.S." he said. However, some parts of production, such as filling up syringes, could be shifted to U.S. partners to exempt those drugs from tariffs, he said... Full

Fresenius Lifts Sales Outlook as Revamp Gains Momentum

(8/6, Sonja Wind, Bloomberg) ...Chief Executive Officer Michael Sen, who took the helm in 2022, has streamlined the company's once-sprawling portfolio and is trying to drive profit by focusing on two units — Kabi, which makes biosimilars, medical devices and intravenous drugs, and the hospital business Helios. During the second-quarter, greater demand for more procedures, especially for patients at hospitals in Germany, and higher prices boosted performance at Helios. A cost-savings program is underway to help offset the end of energy subsidies in Germany, Fresenius said, with more significant benefits expected in the second half... Full

‘We Are Lowering Our Prices' in the U.S. Says Novo Nordisk CFO

(8/6, CNBC) ...Karsten Munk Knudsen, CFO of Novo Nordisk, discusses the prospect of tariffs on pharmaceuticals and the importance of the U.S. market to the Danish drugmaker... Full

Wegovy Maker Novo Nordisk Warns On Continued Copycat-Drug Challenge as New CEO Readied

(8/6, Jacob Gronholt-Pedersen, Maggie Fick, Reuters) ...Novo Nordisk cautioned on Wednesday that it expects continued competition this year from copycat versions of its Wegovy obesity drug, as it battled pressure from compounding pharmacies in the United States and rival Eli Lilly... Full

Novo Nordisk Expands Lawsuits Against Weight-Loss Drug Compounders

(8/5, Kamal Choudhury, Mariam Sunny and Christy Santhosh, Reuters) ...Danish drugmaker Novo Nordisk said on Tuesday it has filed 14 new lawsuits in the United States against the sale of unapproved versions of semaglutide, the active ingredient in its popular weight-loss and diabetes drugs, Wegovy and Ozempic. The new lawsuits target companies producing compounded versions of semaglutide "under the fake guise of personalization", Novo said. Novo told Reuters its filing lawsuits against telehealth firms, compounding pharmacies and medical spas, including Prism Aesthetics, Mochi Health and Fella Health... Full

Mark Cuban and Giant Eagle to Announce Prescription Drug Program Partnership

(8/6, Megan Shinn, Mike Darnay, CBS Pittsburgh) ...Cuban's latest business venture focuses on slashing drug prices through his Cost Plus Drugs company and this afternoon, the Mt. Lebanon native will join Giant Eagle CEO Bill Artman to announce the new partnership. Giant Eagle says the partnership will extend the reach of the Cost Plus Drugs program to customers across the footprint of the regional grocery chain, which currently spans five states... Full

Alternative PBM Navitus Enables Cost-Plus Pricing at Costco

(8/5, Noah Tong, Fierce Healthcare) ...Starting in January, Navitus Health Solutions members will see cost-plus pricing at Costco Pharmacy for select prescriptions. The alternative pharmacy benefit manager (PBM) said the pricing shift will be available for retail and mail-order locations. This model will show, in total, what Costco pays to acquire a drug, a fixed markup and the fee for pharmacy services, a news release explained... Full

Indian Generics Wave Next Year Set to Sink Obesity Drug Price

(8/6, Rica Bhattacharyya, The Economic Times) ...As several leading Indian drugmakers are readying to launch the generic versions of Danish drug maker Novo Nordisk's blockbuster weight-loss drug semaglutide in March next year, its price is expected to crash by as much as 80% from the prevailing rate, analysts told ET...Drugmakers such as Dr Reddy's, Sun Pharmaceutical Industries, Cipla, Mankind Pharma, Torrent Pharmaceuticals, Zydus Lifesciences and Eris Lifesciences are gearing up to enter the market with affordable versions, said senior company executives... Full

Korea Sees Favorable Treatment in New US Levies On Chips, Pharma

(8/5, Heesu Lee, Bloomberg) ..."The US made a commitment to give us top-tier treatment to sectors like pharmaceuticals and semiconductors," Finance Minister Koo Yun-cheol told lawmakers during a parliamentary committee hearing Wednesday. "We're not completely satisfied, but it's still meaningful that Korea won't be at a disadvantage compared to other countries." Koo said South Korea was granted most-favored-nation status in the latest trade deal, placing it on equal footing with countries like Japan and the European Union in upcoming tariff decisions... Sub. Req’d

Russia Experiencing Sales Boom for Ozempic and its Analogues

(8/5, The Pharma Letter) ...Russia is currently experiencing a boom in the sales of Ozempic (semaglutide) and its analogues due to a high demand for such drugs among domestic customers, reports The Pharma Letter's local correspondent. In the first half of the year, pharmacy sales of these drugs exceeded 12 billion roubles ($150 million). Compared to the same period last year, sales have increased four-fold. According to data from the Russian pharma research agency in DSM Group, in total, over 2 million packages of Ozempic and its analogues were sold in Russia for the reporting period... Sub. Req’d

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