Thursday, September 11, 2025

Teva's Emrusolmin Granted Fast Track Designation for Multiple System Atrophy

(9/10, Marco Meglio, NeurologyLive) ...According to a new announcement, the FDA has granted fast track designation to Teva Pharmaceuticals' emrusolmin, a small-molecule modulator of protein aggregation, as a potential treatment for multiple system atrophy (MSA), a movement disorder with no approved therapies. The agent is currently being assessed in a phase 2 study (NCT06568237) that is expected to conclude in early 2027... Full

US Tariffs, Pricing Risks to Be Manageable for Big Pharma, Morningstar Says

(9/10, Mariam Sunny, Reuters) ...The impact of U.S. President Donald Trump's plan to levy import duties on pharmaceutical products and his push to lower drug prices are likely to be manageable for big U.S. and European drugmakers, according to an analysis by brokerage Morningstar. The report said the near term risk from the push to slash prescription drug prices to match those paid overseas would be "exceedingly low" as it could harm patient access to drugs...The report looked at ten major pharmaceutical firms in the U.S. and Europe - AstraZeneca , Novartis, Sanofi, GSK, Novo Nordisk, AbbVie, Amgen, Eli Lilly, Merck, and Pfizer... Full

Big Beautiful Bill Reduces Drugs Eligible for Price Negotiations

(9/10, Denise Myshko, Managed Healthcare Executive) ...Two new papers in Health Affairs argue that the One Big Beautiful Bill creates a loophole that reduces Medicare's ability to control costs for the highest-spending medications. "We have a very large number of drugs that are actually blockbusters — they'll generate billions of dollars in revenue a year — that are orphan drugs or that have an orphan designation," Anna Kaltenboeck, a health economist and president of Vendant Research, said in an interview... Full

Cigna Exec Says Express Scripts Poised to Weather Eventual PBM Reform

(9/10, Paige Minemyer, Fierce Healthcare) ...Chief Operating Officer Brian Evanko spoke at the Morgan Stanley Global Healthcare Conference Wednesday morning. The Cigna Group operates Express Scripts, one of the three largest PBMs. Evanko said there is room for the industry to evolve, but the company ultimately believes its business model will be "durable" as clients sign on with Express Scripts for its focus on affordability, clinical programs that promote safety and benefits administration services... Full

340B Rebate Model Pilot: Dispute Over Providers' Administrative Burden, Costs

(9/10, Cathy Kelly, Pink Sheet) ...Hospitals maintain the 340B rebate model will impose extensive administrative costs that pharmaceutical manufacturers should cover. Pharma disagreed and urged HRSA to clarify that manufacturers are not responsible for data collection activities because they already should be completed by covered entities to comply with 340B rules. An organization representing AIDS drug assistance programs, which have relied on a 340B claims-based rebate model for years, supported pharma's view and argued the rebate model is manageable... Global Sub. Full

Pharma's 340B Fight Intensifies in Court as Drugmakers Eye ‘Silver Bullet' Resolution

(9/10, Nicole DeFeudis, Endpoints News) ...The pharma industry has been fighting for years to try to rein in a federal drug discount program that it says has grown rife with abuse. Now, more of those cases are reaching the higher courts. At least three appellate courts are mulling key challenges that pit drugmakers and states against each other over the limits of the program, with billions of dollars at stake... Full

CBO Report Confirms 340B Contributes To Higher Federal Spending

(9/10, Gabrielle Wanneh, Inside Health Policy) ...The nonpartisan Congressional Budget Office says in a new report released Tuesday (Sept. 9) the 340B drug discount has faced a skyrocketing increase in federal spending program because it incentivizes the prescription of more and higher-priced drugs, the expansion of services, and the integration of hospitals and off-site clinics. The report could fuel bipartisan congressional efforts to exert more federal oversight of whether 340B safety net facilities pass the drug discounts they receive on to patients... Sub. Req’d

CBO: 340B Program Costs Taxpayers, No Evidence Patients Benefit

(9/10, Molly Jenkins, PhRMA) ...The 340B program has morphed into the second-largest federal drug program and a money-printing machine for big, tax-exempt hospitals. For years, 340B hospitals and clinics have jacked up prices for patients, employers and the government by as much as 1,000% or more. The new CBO report strengthens the call for urgent reform among policymakers, patient advocates, labor and employers. As Congress and the Administration look for areas to cut fraud, waste and abuse in government spending, they should focus their attention on the 340B hospital markup program that is costing the government and patients billions... Full

'Land Mines Everywhere': How Pharma Communications Keep Up Under a Political Spotlight

(9/10, Zoey Becker, Fierce Pharma) ...Moderated by Bo Piela, Alnylam Pharmaceuticals' vice president of enterprise and executive communications, the panel discussion saw seasoned industry communications leaders delving into the strategies they've honed while navigating an uncertain policy landscape over the past year. To hear Piela tell it, just some of the themes at the heart of the chaos include mass layoffs at the FDA, proposed tariffs on imported medicines, regulatory threats to vaccine development and more... Full

Medincell: UZEDY® Approved in South Korea Following Successful US Launch

(9/10, Medincell) ...Teva Handok announced today that UZEDY®, Long-Acting Injectable Risperidone for Schizophrenia, has received regulatory approval from the South Korean Ministry of Food and Drug Safety. UZEDY® will be distributed in South Korea by Teva Handok, a joint venture between Teva, Medincell's partner, and Handok, a leading South Korean healthcare company... Full

Lundbeck Showcases New Clinical Migraine Data, Including Long-Term Preventive Effectiveness of Vyepti® (eptinezumab) in Patients Severely Impacted by Migraine

(9/11, H. Lundbeck A/S) ...Lundbeck demonstrates leadership and unwavering commitment to advancing migraine management and supporting patient outcomes with six presentations at the 2025 International Headache Congress (IHC), including three oral presentations on eptinezumab (Vypeti®) and Lu AG09222 (anti-PACAP mAb). New data from the open-label extension of the RESOLUTION trial and the primary results of the SUNSET extension trial will be presented for the first time at IHC. Patients treated with eptinezumab experienced sustained reductions in migraine symptom and burden, including long-term reduction in monthly migraine days (MMDs) and improvements in patient-reported outcomes... Full

‘We Believe We Have The Most Valuable Biosimilars Pipeline' – Alvotech CEO Wessman On The Path Ahead

(9/10, Dave Wallace, Generics Bulletin) ...In the first part of an exclusive two-part interview, Alvotech founder, chairman and CEO Róbert Wessman discusses key aspects of the rapidly-growing biosimilars developer's strategy – while also explaining how the competitive landscape for biosimilars is evolving as originators get out of the game...In terms of how Alvotech sells its biosimilars, the products are commercialized through a broad global network of marketing alliances with a multitude of partners – including but not limited to major players such as Teva, Stada and Dr Reddy's..."The model is classic," he explained. "They basically participate in R&D risk with us through license fees, and we then supply to them on an exclusive basis once the product launches."... Global Sub. Full

‘Everything Is Up For Grabs' – Alvotech's Wessman On Biosimilar Streamlining And Bridging The Void

(9/11, Dave Wallace, Generics Bulletin) ...In the second part of Generics Bulletin's interview with Róbert Wessman, the Alvotech founder, chairman and CEO discusses global moves towards biosimilar streamlining – as well as talking PBMs, price negotiation, US trade tariffs and the push towards reshoring manufacturing... Global Sub. Full

Biocon Eyes Generic Semaglutide Market for 2026

(9/10, Anna Brown, Endpoints News) ..."Ozempic is coming off-patent next year. So there's a huge opportunity to play in the GLP-1 market," Biocon founder Kiran Mazumdar-Shaw said in a Wednesday interview with Endpoints News...The drugmaker is filing its generic semaglutide application "where market formation is expected in 2026 and beyond," a Biocon spokesperson said, noting that it expects approval next year. Meanwhile, competitor Sandoz has already filed an application for generic semaglutide in Canada and expects approval in the first quarter of 2026... Sub. Req’d

Lupin Receives FDA Nod for Generic Risperdal Consta

(9/10, Sandra Levy, Drug Store News) ...Lupin has received approval from the Food and Drug Administration for risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial and 50 mg per vial, single-dose vials...This is Lupin's first product using Nanomi technology and has a 180-day CGT exclusivity. Nanomi, a Lupin subsidiary, is focused on the development of long-acting injectable medicines to improve health outcomes for patients, the company said... Full

Medicines and Healthcare Products Regulatory Agency (MHRA) Approves Bio-Thera Solutions' Qletli® (adalimumab), A Biosimilar Referencing Humira®

(9/11, Bio-Thera Solutions) ...Bio-Thera Solutions Inc...today announced that the MHRA has approved Qletli® (adalimumab), a biosimilar of Humira®, for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, crohn's disease, ulcerative colitis, uveitis in adults, and polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis and uveitis in paediatric... Full

Viatris Investors Face Skeptical Judges On Biosimilars Unit

(9/10, Martina Barash, Bloomberg Law) ...Viatris Inc. investors encountered tough questions Wednesday at the Third Circuit in their quest to revive a proposed class action over the drugmaker's statements about its commitment to its biosimilars segment...At issue is the pharmaceutical giant's 24% stock drop after allegedly surprising the market with a decision to sell off its key biosimilars division in February 2022. The investors alleged that earlier statements expressing a commitment to biosimilars were false and misleading... Sub. Req’d

Sawai And Nichi-Iko Trim Overlap To Stabilize Japan's Generics Supply

(9/11, Dean Rudge, Generics Bulletin) ...Sawai and Nichi-Iko, two Japanese generics firms, are collaborating to enhance productivity and stabilize the supply of generic drugs. This partnership aims to streamline production for 15 active ingredients, translating to 30 drug products, with plans to begin implementation in 2026. Encouraged by government measures, the firms will reduce duplication by consolidating manufacturing sites... Global Sub. Full

FDA Allows First Biosimilar Without Clinical Efficacy Trials

(9/10, Briana Contreras, Managed Healthcare Executive) ...For years, CESs have been a required step when approving biosimilars. According to Sarfaraz K. Niazi, a professor at the University of Illinois at Chicago, he said in a news release, these studies are expensive and time-consuming and typically can cost hundreds of millions of dollars while rarely uncovering meaningful differences from the reference product. The FDA's acceptance in this case applies to a biosimilar of Stelara (ustekinumab), an immunosuppressive drug used for conditions such as Crohn's disease and psoriasis. Instead of requiring CESs, the agency agreed that analytical similarity testing and immunogenicity studies were sufficient to demonstrate biosimilarity... Full

A Key Ingredient to Biosimilar Adoption: Communicate and a Date-Certain, 'Hard Transition' to the Biosimilar | PBMI 2025

(9/10, Peter Wehrwein, Managed Healthcare Executive) ...Scripius formulary executive Cody Olsen, Pharm.D., discusses some of the key ingredients to a successful switch to biosimilars. Some pharmacy benefit managers have hesitated about giving biosimilars preference on their formularies. Cody Olsen, Pharm.D., says Scripius is all in on them... Full

GTCR is Said to Near $4.8 Billion Deal to Buy Advent's Zentiva

(9/11, Bloomberg) ...GTCR emerged as the likely buyer of Advent International-owned Zentiva after outbidding rivals including private equity firms and drugmakers, the people said, asking not to be identified because the information is private. An announcement could come as soon as Thursday, the people said... Full

Strong Danish Economy Can Ride Out Novo Nordisk Downturn, Finance Minister Says

(9/10, Jacob Gronholt-Pedersen, Reuters) ...Denmark's economy remains robust despite job cuts at Novo Nordisk, the finance minister told Reuters on Wednesday, dismissing concerns that the pharmaceutical company's financial troubles could further impact the country's economic outlook..."I do not see today's announcement as something that changes the economic estimates that the government has made," Nicolai Wammen said in an interview. "The Danish economy is extremely strong, and we have the highest employment ever in Denmark, very low unemployment, and very little debt. We have had a surplus on the public finances for nine years in a row," he said... Full

Biocon Shares in Focus as it Opens Manufacturing Facility in New Jersey

(9/11, Amit Mudgill, BusinessToday.In) ...Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc in 2023 and has since invested over $30 million to transform it into a plant with an annual capacity of 2 billion tablets. A few products have already been commercialised, with more in the pipeline, Biocon noted in a filing to stock exchanges. The investment strengthens Biocon's supply chain, diversifies its manufacturing base, and accelerates its global expansion... Full

DHL Targets Specialty Pharmacies, Radiopharmacies in Deal

(9/10, Alexandra Murphy, Becker's Hospital Review) ...DHL Supply Chain is acquiring SDS Rx, a U.S.-based provider of final-mile delivery and specialized transportation services for long-term care and specialty pharmacies, radiopharmacies and health system networks...The acquisition will also enhance DHL's reach in specialty pharmacy services, which now account for around half of total prescription drug spending in the U.S., the release said... Full

US Drugmaker Merck Scraps £1Bn London Research Centre and Cuts 125 Science Jobs

(9/10, Julia Kollewe, The Guardian) ...The US drugmaker Merck has scrapped a £1bn London research centre and is laying off 125 scientists in the capital this year, in a big blow to the UK's important life science sector...Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI), said: "This is a real blow to the UK's life sciences ambitions. No one wants to hear that successful and innovative companies like MSD are reducing their investment and footprint in the UK."... Full

Britain Defends Investment Record as Merck Scraps Labs Over Pharma Environment

(9/11, Alistair Smout and Sarah Young, Reuters) ...The news has added to a sense of anxiety around Britain's life sciences sector after the country's biggest drugmaker AstraZeneca scrapped plans for a new UK vaccine plant, and the government became caught up in a row over drug pricing. Merck said in its statement its decision "reflects the challenges of the UK not making meaningful progress towards addressing the lack of investment in the life science industry and the overall undervaluation of innovative medicines and vaccines by successive UK governments". It will also have likely factored in the threat of tariffs and other pressures from U.S. President Donald Trump who wants more manufacturing to return to the United States... Full

Big Pharma Will Stop Investing in UK, Warns Eminent Scientist Sir John Bell

(9/11, Julia Kollewe, The Guardian) ...Sir John Bell, a prominent scientist who brought business and government together during the Covid-19 vaccine rollout, has warned that other big pharmaceutical companies will stop investing in the UK, after Merck's decision to scrap its planned £1bn London research centre. Bell, a former regius professor of medicine at the University of Oxford, told the BBC's Today programme that he had spoken to several chief executives of large companies in the past six months "and they're all in the same space, and that is, they're not going to do any more investing in the UK"... Full

Pharma Says UK is 'Tumbling Down' Rankings for Investment

(9/11, Phil Taylor, Pharmaphorum) ...A report on pharma competitiveness, published by the Association of the British Pharmaceutical Industry (ABPI), claims that the UK's position for attracting foreign direct investment (FDI) fell from second in a 2017 report to seventh in 2023, with industry investment in R&D falling by 58% in the six years. Over that period, the ABPI and its member companies have been incensed by steep increases in the rate that they must repay on sales of newer products to the NHS under the voluntary and statutory rebate schemes, which set a yearly cap on the total allowed sales value of branded medicines to the NHS each year... Full

British Pharma Industry Says Drug Pricing Stance Hurts Foreign Investment

(9/10, Alistair Smout, Reuters) ...ABPI said that "high clawback rates on pharmaceutical companies' UK revenues exacerbate... persistent structural barriers to investment", and cited several pharma executives who were critical of the government's approach. "The UK is increasingly being ruled out of consideration as a viable location for pharmaceutical investment," it said...Trump is due to visit Britain next week on a state visit. While Britain and the U.S. have agreed a deal on some tariffs, the treatment of pharmaceutical firms is yet to be finalised... Full

Generic Medicine Industry Join Calls for An Urgent Pause to the Extended Producer Responsibility Scheme for Urban Wastewater, to Avert a Healthcare Crisis.

(9/11, Markus Sieger, Euractiv) ...As the swell of voices calling for a fairer, simpler and more practical solution to the Extended Producer Responsibility scheme in the Urban Wastewater Treatment Directive (UWWTD) builds, we the leaders of the generic medicine industry are calling for an urgent pause in adoption, to protect future patient access and security of supply for critical medicines while the scheme is properly reviewed... Full

Denmark Tackles GCP Inspection Pain Point: Lack Of Direct Access To Patient Records

(9/10, Vibha Sharma, Pink Sheet) ...According to the DKMA, limited or inadequate access to these records is a recurring issue during good clinical practice (GCP) inspections and may result in major, or even critical, deviations. "This is indeed a very frequent finding and an EU issue as well as a deviation seen across sites inspected by EU inspectors in most parts of the world," the agency told the Pink Sheet... Global Sub. Full

Argentina Shakes Up National Traceability System To Include More High-Cost Medicines

(9/10, Francesca Bruce, Pink Sheet) ...Argentina is updating its traceability system for medicines. New regulations expand the number of active pharmaceutical ingredients that are subject to surveillance to include high-cost medicines, such as those that treat complex and chronic conditions. The updates mean that products will be subject to the same surveillance system across the country, rather than regional systems... Global Sub. Full

Trump Might Come After Our Drug Prices. Universities Need to Help Us Play Defence

(9/11, Andrew Kemle, The Globe and Mail) ...Unlike many of Mr. Trump's trade policies, his plan to up drug costs for countries like Canada seems to have the backing of U.S. businesses. The Pharmaceutical Research and Manufacturers of America (PhRMA), the U.S. Chamber of Commerce, and the National Association of Manufacturers are just some of the groups urging the President to use tariffs to punish "freeloaders," Canada included. Lower drug prices help save lives. Our universities might hold the key to protecting our pricing system from Mr. Trump's overtures... Sub. Req’d

Korea to Adopt Compliance Scoring System On Pharma Kickbacks in 2026

(9/11, Kwak Sung-sun, Korea Biomedical Review) ...Starting in 2026, the government is likely to implement a new "rebate scoring system" as part of the criteria for retaining certification as innovative pharmaceutical companies...The new system will allow firms with a history of rebates to maintain their designation as long as their scores remain below a set threshold. Kim Kang-seop, director of the Health Industry Promotion Division at the Ministry of Health and Welfare, explained the progress of the rebate scoring system during a meeting with journalists on Wednesday... Full

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