Wednesday, September 10, 2025

Teva Gets FDA Fast Track Status for Multiple System Atrophy Drug

(9/9, Seeking Alpha) ...Teva Pharmaceuticals said that the U.S. FDA has granted fast track designation to its experimental therapy TEV-56286 (emrusolmin) for treating Multiple System Atrophy... Full

Teva Received Fast Track Designation from the U.S. Food and Drug Administration for Emrusolmin (TEV-56286), An Investigational Treatment for Multiple System Atrophy (MSA) in Phase 2 Development

(9/9, Indian Pharma Post) ...Emrusolmin is part of a strategic collaboration with MODAG GmbH, a privately held German biotech company, and is currently being evaluated in a Phase 2 trial to assess its efficacy and safety. The U.S. FDA granted Orphan Drug designation to emrusolmin for MSA in 2022. "Multiple System Atrophy is a devastating and rapidly progressive neurodegenerative disorder with no cure," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "The promising potential of emrusolmin is a testament to what we are building at Teva – a pipeline that truly meets patients' needs and strategic partnerships that drive innovation."... Full

Emrusolmin Fast Tracked for Multiple System Atrophy

(9/9, Diana Ernst, Rph, MPR) ...In patients with MSA, abnormal deposits of the a-synuclein protein in oligodendroglial cells and in certain nerve cells result in slowed movement and/or rigidity, autonomic instability, and impaired balance and/or coordination. Emrusolmin is expected to improve symptoms of MSA by targeting alpha synuclein oligomers...There are currently no FDA-approved treatments that address the underlying disease progression of MSA... Full

Trump Weighs Crackdown On Medicines From China

(9/10, Rob Copeland and Rebecca Robbins, The New York Times) ...At the heart of the possible clampdown is a drafted executive order that threatens to cut off the pipeline of Chinese-invented experimental treatments. Major pharmaceutical companies have been buying the rights to drugs created in China for cancer, obesity, heart disease and Crohn's disease. The prospect of the order, a draft of which was obtained by The New York Times, has set off furious behind-the-scenes lobbying efforts by two diametrically opposed groups - each with billions of dollars at stake... Sub. Req’d

US FDA Stepping Up Enforcement of Pharma Ad Rules, Sends Letters to Companies

(9/9, Ahmed Aboulenein, Michael Erman, Jeff Mason, Reuters) ...The U.S. Food and Drug Administration will send out around 100 cease-and-desist enforcement notices and thousands of letters warning pharmaceutical companies that direct-to-consumer ads must comply with regulations that are already on the books, senior administration officials said on Tuesday...They did not disclose which companies had been sent the enforcement or warning letters. They said they were not only concerned about ads from drugmakers, but also ads from online pharmacies "that are not following the same rules that many pharmaceutical companies follow."... Full

Limited Detail In MAHA Strategy Report Could Catch Pharma Off Guard

(9/9, Sarah Karlin-Smith, Pink Sheet) ...The 20-page document reads more like a list of administration priorities than a recipe to achieve them. And it does not include much new detail the administration has not already discussed... Global Sub. Full

PhRMA Statement On The "Make Our Children Healthy Again Strategy"

(9/9, PhRMA) ..."It's concerning however that the report casts doubt on the very things that have helped protect and improve health for generations. Americans should have access to every option at their disposal to safeguard the well-being of children—including medicines and vaccines that prevent and treat disease. Undermining these advances risks reversing decades of progress. That's why we need a comprehensive approach to make America healthier: one that prioritizes prevention, early intervention and the continued availability of safe, effective treatments when people need them."... Full

Dozens of Lawmakers Urge HHS to Abandon a Pilot Initiative for the Controversial 340B Program

(9/9, Ed Silverman, STAT+) ...More than 160 U.S. lawmakers have urged the Trump administration to abandon a newly announced pilot program that would allow pharmaceutical companies to offer rebates for a small number of therapies to hospitals that participate in a federal drug discount program... Sub. Req’d

AHA To HHS: Drug Makers Must Fully Cover Extra Costs From 340B Pilot

(9/9, Gabrielle Wanneh, Inside Health Policy) ...The American Hospital Association (AHA) says if HRSA is serious about ensuring "no additional administrative costs of running the rebate model are passed onto covered entities," the agency must clarify this involves drug companies reimbursing all the additional costs many hospitals and health systems will be at risk of having to bear to support the program, especially those in rural and other underserved areas... Sub. Req’d

PhRMA Stresses Importance of 340B Rebate Model Pilot

(9/9, Eliza Shutzer, PhRMA) ...The Health Resources and Services Administration's (HRSA) rebate model pilot marks an important first step in bringing greater transparency and accountability to the 340B hospital markup program which has limited oversight. PhRMA underscores this point in a letter submitted in response to HRSA's request for feedback on the 340B Rebate Model Pilot Program. PhRMA stands ready to engage with all stakeholders and HRSA to ensure the successful implementation of the pilot program in an effort to improve program integrity... Full

Can Biosimilar Prices Afford to Stay So Low?

(9/9, Biosimilars Council) ...Over the last several months, Stanton Mehr of the Biosimilars Review & Report has unpacked the factors that have contributed to this pricing conundrum, starting by closely examining the adalimumab biosimilar market... Full

Zantac Litigation Attorney Suggests ‘Slowing Down' US Drug Approvals

(9/9, Malcolm Spicer, Pink Sheet) ..."I think the framework has to shift from 'we need to protect industry so they can sell their drugs' to 'we need to protect consumers,' and if that means industry has to eat it for an extra year while it gets approval, then they should," [Brent Wisner, a California attorney] added. "I think that would help improve consumer confidence."... Global Sub. Full

FDA to Weigh Switching More Prescription Drugs to Over Counter

(9/9, Nyah Phengsitthy, Bloomberg Law) ...The FDA is planning to call on the health-care industry and consumers to provide information on the benefits of switching a prescription drug to over-the-counter, the agency's drug chief said Tuesday. "What we want people to do is focus on the benefit that we can provide to society by that switch," George Tidmarsh, director of the Center for Drug Evaluation and Research, said at a regulatory conference held by the Consumer Healthcare Products Association... Full

Drugmakers Battle West Virginia Pharmacy Law in Fourth Circuit

(9/9, Ganny Belloni, Bloomberg Law) ...The crux of Tuesday's oral argument in the US Court of Appeals for the Fourth Circuit centered on whether federal law preempted West Virginia from regulating how manufacturers can distribute drugs under a federal discount program known as 340B. The discussion fielded arguments from lawyers representing the West Virginia Attorney General's Office and drug industry players AbbVie, Novartis, and the Pharmaceutical Research and Manufacturers of America... Sub. Req’d

California Assembly Approves New Rules for Drug Price Middlemen

(9/9, Andrew Oxford, Bloomberg) ...Assemblymembers voted 55-1 for the measure (SB 41) that would prohibit spread pricing by pharmacy benefit managers, the practice where those middlemen companies charge a health plan more for a drug than what it paid to a pharmacy. The bill would also bar PBMs from requiring patients use only specified affiliated pharmacies... Sub. Req’d

Miyares' Office Investigating Pharmacy Benefit Managers, Manufacturers Over Insulin Prices

(9/9, Charlotte Rene Woods, Virginia Mercury) ...Virginia Attorney General Jason Miyares announced Tuesday that his office is looking into whether several insulin manufacturers and pharmacy benefit managers artificially inflated costs of diabetic medications... Full

Uzedy, Long-Acting Subcutaneous Injection for Schizophrenia, Wins Korean Approval

(9/10, Kim Kyoung-Won, Korea Biomedical Review) ...Teva Handok announced on Wednesday that Uzedy, an adult schizophrenia treatment administered at one- or two-month intervals, received official approval from the Ministry of Food and Drug Safety last Friday..."Uzedy holds significant meaning as a new treatment alternative that complements the limitations of existing schizophrenia therapies and can reduce the risk of relapse," Teva Handok General Manager An Hee-kyoung said. "Particularly for patients with low adherence who struggle with long-term treatment, Uzedy is expected to improve quality of life. It offers flexible dosing options at one- or two-month intervals, along with rapid therapeutic effects."... Full

Orimed Pharma Announces the Availability in Canada of PrSolufy™, A New Liquid Solution of Aripiprazole

(9/9, Orimed Pharma, JAMP Pharma) ...Orimed Pharma, an affiliate of the JAMP Pharma Corporation, is launching PrSolufyTM, a liquid solution of aripiprazole. This new formulation offers an alternative to current solid forms, which could make it easier to administer treatment to certain patients. PrSolufyTM is the first product in a future portfolio of liquid solutions, underscoring Orimed Pharma and the JAMP Pharma Group's commitment to innovation... Full

Strides Pharma Arm Partners with Kenox Pharma for Nasal Spray Development

(9/9, Business Standard) ...Under the terms of the agreement, Strides will collaborate with Kenox on the development and regulatory filing of multiple nasal spray products for the US market, spanning various therapeutic indications. The partnership aims to leverage Kenoxs specialized expertise in OINDPs and Strides strong presence in regulated markets... Full

J&J Struggles to Sway Court Over Samsung Stelara Biosimilar Copy

(9/9, Nyah Phengsitthy, Bloomberg Law) ..."Why isn't a monetary damage sufficient?" Judge Cheryl Ann Krause for the US Court of Appeals for the Third Circuit asked an attorney for J&J in an oral argument. Judge Arianna J. Freeman, who was appointed by former President Joe Biden, joined Krause's skepticism and questioned the drugmaker's claim that the biosimilar at issue harms the company's market but that calculating that disruption is difficult. At issue before the Third Circuit is whether a district court erred in finding that J&J failed to demonstrate that it would face irreparable injury from Samsung Bioepis's move to launch another biosimilar to Stelara... Sub. Req’d

CVS Sues Takeda, Bora Units Claiming Collusion On Reflux Drug

(9/9, Katie Arcieri, Bloomberg Law) ...CVS Health Corp. on Tuesday sued Takeda Pharmaceutical Co. Ltd. and other drugmakers with antitrust claims that they delayed the generic version of a blockbuster drug to treat gastroesophageal reflux...Takeda is among a string of pharmaceutical companies targeted in "pay-for-delay" lawsuits, in which brand-name companies are accused of paying a generic drug company to delay launching the cheaper version of a medication... Sub. Req’d

Digesting The Clinical Landscape For Biosimilar Keytruda

(9/10, Generics Bulletin) ...In this detailed overview, Generics Bulletin dives into which biosimilar sponsors are currently known to be working towards filings for biosimilars to Keytruda (pembrolizumab), which had sales of around $30bn last year... Global Sub. Full

Australian Study Reveals Significant Cost Savings and Market Impact From Biosimilars

(9/10, Skylar Jeremias, The Center For Biosimilars) ...Researchers conducted the analysis to address a critical challenge facing health care payers: balancing the rapid growth in indications and costs of biologic medicines with finite health budgets. The researchers recognized that once patents for reference products expire, the introduction of biosimilar medicines is a key strategy to provide continued patient access to necessary treatments while ensuring the long-term affordability of funding schemes... Full

Lundbeck, in Major Resource Reallocation, Bows Out of 27 Markets and Lays Off 602 Staffers

(9/9, Angus Liu, Fierce Pharma) ...Lundbeck will transition to a partnership model in 27 markets through collaborations with the Swixx Group, Zuellig Pharma and NewBridge Pharmaceuticals, the Danish pharma said Tuesday...Lundbeck plans to finish the transition in all countries by Dec. 1. In addition, Lundbeck said it will consolidate the majority of its current partnerships into the three major collaborations moving forward. "This step is essential to building the commercial infrastructure that will sustain our long-term strategy and deepen our commitment to serving patients," Lundbeck CEO Charl van Zyl said in a statement... Full

September Deals Freshen Up Novartis's Cardio Franchise

(9/9, Kevin Grogan, Scrip) ...We are not even halfway through September but with the acquisition of Tourmaline Bio, Novartis has taken its second ride on the dealmaking merry-go-round this month alone to boost its cardiology pipeline as it plans for life after Entresto. Analysts have responded positively to the Tourmaline deal which sees Novartis get hold of the Phase III-ready asset pacibekitug. Srikripa Devarakonda at Truist Securities issued a note on Sept. 9 saying that the acquisition was a good fit given the Swiss major's cardiology footprint; the anti-IL-6 antibody is being touted as a potential best-in-class drug for atherosclerotic cardiovascular disease... Full

Glenmark Pharma Subsidiary IGI Gets $700 Million Upfront Payment from AbbVie

(9/9, PT Jyothi Datta, The Hindu BusinessLine) ...Drugmaker Glenmark Pharmaceuticals' wholly-owned subsidiary Ichnos Glenmark Innovation has received an upfront payment of $700 million (about 6,000 crore) from US drugmaker AbbVie...The Mumbai-based drugmaker had in July announced this deal on its drug candidate that was in early Phase-I clinical trials and had shown promising outcomes in patients with relapsed/refractory multiple myeloma... Full

FDA Prohibits Sun Pharma Halol Plant from Exporting Drugs to US

(9/9, Mike Hollan, PharmExec.com) ...The FDA classified Sun Pharma's Halol plant as "Official Action Indicated" due to multiple infractions found during an inspection. The plant is banned from importing products to the US, except for medications facing shortages. Previous regulatory actions have been taken against the Halol facility, indicating ongoing compliance issues... Full

Pricing Group Says Weight-Loss Drugs Becoming More Cost-Effective

(9/9, Deena Beasley, Reuters) ...In a draft report, the Institute for Clinical and Economic Review gave its highest cost-effectiveness rating to both Novo Nordisk's semaglutide, sold as Ozempic and Wegovy, and Eli Lilly's tirzepatide, sold as Mounjaro and Zepbound, for weight loss compared to lifestyle modifications such as diet and increased exercise..."Prices have come down a ton," in the last couple of years, ICER Chief Medical Officer Dr. David Rind told Reuters. But due to high demand, "payers are having a lot of problems with affordability of these drugs," he said... Full

EU Critical Medicines Act: Parliament Clarifies ‘Significant Proportion' Rule

(9/9, Eliza Slawther, Pink Sheet) ...The European Parliament has proposed clearer definitions for companies around the amount of their drug manufacturing that must take place in Europe to benefit from procurement provisions under the planned Critical Medicines Act. One aim of the act is to incentivize companies to manufacture their products in the EU, EEA and Switzerland to reduce the EU's reliance on foreign manufacturers. The parliament has also introduced more detail around strategic projects under the act, which are ventures that create, increase or modernize EU manufacturing capacity... Global Sub. Full

India Proposes Faster Drug Approval Process, Cuts License Timeline to 45 Days

(9/9, The Pharma Letter) ...Under the draft changes, the statutory processing time for test licence applications would be halved - from the current 90 days to 45 days - in a bid to reduce delays in bringing new medicines to market. Companies will now be permitted to initiate certain clinical trials and manufacture the necessary investigational drugs without obtaining prior licenses... Sub. Req’d

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•     FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•     Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.