Tuesday, October 28, 2025

Teva Agrees to Pay $35 Million to Settle Asthma Inhaler Antitrust Lawsuit

(10/27, Mike Scarcella, Reuters) ...Teva Pharmaceuticals has agreed to pay $35 million and withdraw six patents from a U.S. regulatory list to settle claims that the drugmaker delayed generic competition for its QVAR asthma inhalers, causing consumers and others to pay inflated prices. The proposed class action settlement was filed in federal court in Massachusetts on Friday and requires a judge's approval... Full

‘Sufficiently Large To Act As An Incentive': Teva's EU Provigil Antitrust Fine Upheld Again

(10/27, Dean Rudge, Generics Bulletin) ...The European Court of Justice (CJEU) has upheld a €60.5m antitrust penalty against Teva and its subsidiary Cephalon regarding a 2005 settlement that delayed the market entry of a generic version of Provigil (modafinil). The court rejected their final appeal, ruling that the agreement constituted an unlawful ‘pay-for-delay' arrangement under EU antitrust laws. Both companies had argued that the settlement was a legitimate resolution to patent disputes. However, the court found that the financial transfers between Teva and Cephalon were significant enough to incentivize Teva to avoid market competition, thereby restricting competition by object... Global Sub. Full

GRx+Biosims Day 1 Recap: Bringing Passion to Purpose

(10/27, AAM) ...In the breakout session "Elevating the Patient Voice in Generic and Biosimilars Development," experts including Dr. Sarah Ibrahim (FDA CDER), Dr. Nimi Chhina (Teva Pharmaceuticals), Dr. Sarah Ikenberry (FDA OTBB), and Dr. Kimberly Maxfield (Biocon Biologics) explored how integrating patient perspectives can improve adherence, design, and real-world outcomes...Dr. Chhina noted that patients often raise practical concerns about flavors, colors, or tablet size – details that influence whether they actually take their medicines. Incorporating those insights early can prevent discontinuation and improve compliance... Full

AAM Meeting Tidbits from Day 1 – OGD

(10/27, Bob Pollock, Lachman Consultants) ...Dr. Iilun Murphy, Director of the Office of Generic Drugs presented on the State of OGD. Some interesting numbers presented include the fact that OGD received only 600 new ANDAs in FY 2025. She acknowledged that the pace of ANDA submissions was way down (from 740 in FY 2024). OGD on the other hand approved 689 new ANDAs just a bit under the 694 that were approved in FY 2024, but much lower than in previous years. OGD approvals and tentative approvals totaled 939 ANDA in FY 2025, however, when taking into account the total number of other ANDA submissions or receipts including supplements, new ANDAs, amendments and controlled correspondence, the workload was actually greater than any time in the last 6 fiscal years... Full

Policy Considerations for the Development, Regulation and Adoption of Biosimilars

(10/27, IFPMA) ...Biosimilars can play a role in expanding patient access to biological medicines and in supporting the sustainability of healthcare systems. To fully realize this potential, IFPMA recommends the adoption of the following policy recommendations. Strengthen regulatory alignment and capacity building...Promote clear and science-based substitution policies...Ensure robust pharmacovigilance and traceability systems...Ensure transparency for healthcare providers and patients... Full

Why Indian Pharma Giant Dr Reddy's is Unfazed by Trump's Tariff Threats

(10/28, CNBC) ...Dr Reddy's CEO Erez Israeli says the pivot is already visible - India and Europe growth is now driven by innovation, consumer health and branded products, not just U.S. generics... Full

What Makes TrumpRx Different from Other Government-Run Health Programs?

(10/27, Mike Hollan, PharmExec.com) ...Chris O'Dell, SVP of market solutions at Turquoise Health, details the ways that the President's new program differs from previous programs... Full

Former W&M Aide: Another Plus To 340B Reform May Be Lower ACA Premiums

(10/27, Gabrielle Wanneh, Inside Health Policy) ...A former House Ways & Means staffer told Inside Health Policy that as Senate lawmakers craft a 340B reform bill, they should consider that the current drug discount program is contributing to higher Affordable Care Act (ACA) premiums and the way they craft the reforms could allow a possible extension of the expiring ACA enhanced subsidies to be more cost-effective. At issue are misaligned program incentives that encourage covered entities, primarily 340B hospitals, to prescribe more drugs and more expensive drugs to patients than is necessary... Sub. Req’d

PBM Reform Debate: Panelists Clash Over Spread Pricing and Rebates | AMCP Nexus 2025

(10/27, Denise Myshko, Managed Healthcare Executive) ...What started out as a session on federal reform of pharmacy benefit managers became a debate among panelists about spread pricing and rebates tat the inaugural pharmacy policy summit of the Academy of Managed Care Pharmacy...There is broad consensus in Congress about the need for PBM reform, but disagreements about what that should look like at the federal level, said Sujith Ramachandran, Ph.D., associate professor at the University of Mississippi School of Pharmacy...But even the panelists couldn't agree on what the issues were or how to bring down costs for patients without causing healthcare costs and premiums to rise for employers and patients... Full

Rebates Play a Major Role in Whether Health Plans Restrict Access to Specialty Drugs | AMCP Nexus 2025

(10/27, Briana Contreras, Managed Healthcare Executive) ...Medications with higher rebates may be less likely to face insurance coverage restrictions, while those with higher net prices could be more likely to be limited, according to a poster presentation shared at the annual AMCP Nexus conference analyzing 161 specialty drugs...Certain types of drugs analyzed in the study were also less likely to face restrictions. These included oncology drugs, orphan drugs, drugs with expedited FDA approval, self-administered drugs and those intended for later-line treatment. Older drugs and those in crowded therapeutic classes were more commonly restricted... Full

Dose of Reality: New ICER Report Finds Big Pharma Continues Setting Increasingly Out-of-Control Launch Prices Unjustified by Clinical Value

(10/27, The Campaign For Sustainable Rx Pricing) ...According to ICER's 2025 "Launch Price and Access Report," the inflation-adjusted median annual list price for newly launched drugs increased 24 percent between 2022 and 2024 — from $249,257 in 2022 to $308,749 in 2024. The report found that list prices increased across several major drug categories, including orphan drugs, biologic drugs, small molecule drugs, oncology drugs and endocrine/metabolic drugs, as the pharmaceutical industry remains committed to a business-as-usual approach of putting profits over people with egregious pricing on brand name products... Full

Senators Propose Sweeping Changes to Generic Drug Oversight

(10/27, Debbie Cenziper, Megan Rose and Melissa Dai, ProPublica) ...Citing a recent ProPublica investigation, the senators said the Food and Drug Administration should alert hospitals and other group purchasers when foreign drugmakers with serious safety and quality failures are given a special pass to send their products to the United States...In a recently released investigative report, the committee chair, Sen. Rick Scott, R-Fla., and ranking member Sen. Kirsten Gillibrand, D-N.Y., criticized the FDA for failing to notify Congress "in any way" about the practice, calling it a "failure on the FDA's part to protect public health."... Full

US FDA's Tidmarsh: Marginal Treatments Do More Harm Than Good

(10/27, Sarah Karlin-Smith, Pink Sheet) ...CDER Director George Tidmarsh called for industry to raise the bar on drug candidates, saying marginal treatments may do more harm than good. Tidmarsh said he wants to investigate endpoints used for accelerated approval to determine whether they are still appropriate. He also warned against using crossover designs for confirmatory studies... Global Sub. Full

‘Simple Reform' Not A Step Back From Program Alignment, US FDA's Elizabeth Miller Argues

(10/27, Derrick Gingery, Pink Sheet) ...Elizabeth Miller said the "Simple Reform" will enhance the program alignment initiative rather than undo it. Miller also said the agency is considering ways to streamline inspections, including cutting the time investigators spend in a facility. Many of the changes are in part due to the staffing losses earlier this year... Global Sub. Full

Pharmas Hope FDA PreCheck Can Help Avoid Facility-Related Drug Rejections

(10/28, Nick Paul Taylor, BioSpace) ...Executives from Eli Lilly, Merck and other companies foresee the FDA's new onshoring proposal being anything from a bureaucratic waste of time to a transformative program that will eliminate inspection-related complete response letters. The FDA's recent meeting to discuss plans for PreCheck has revealed what the program will need to achieve to be ruled a success—or a failure—by the biopharma industry. The best- and worst-case scenarios spanned a wide range, with meeting attendees voicing hopes that PreCheck will end facility-related drug rejections as some shared fears that the program will just mean more paperwork... Full

FDA's Top Generic Drug Official Urges Firms to Complete Nitrosamine Risk Assessments

(10/27, Joanne S. Eglovitch, Regulatory Focus) ...Iilun Murphy, the director of the US Food and Drug Administration's Office of Generic Drugs (OGD), issued a warning to manufacturers regarding a recently identified leachable nitrosamine in certain drug products that are packaged in infusion bags. She stressed that manufacturers of affected products must conduct thorough risk assessments to confirm that their bags do not contain this substance. These risk assessments are required to be completed by November 16, 2025... Full

Acute Headache Treatment Brekiya Launches in United States

(10/27, Logan Lutton, Managed Healthcare Executive) ...Migraine and cluster headache autoinjector treatment Brekiya (dihydroergotamine mesylate) is now available by prescription through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy, according to a news release from its manufacturer, Amneal Pharmaceuticals, Inc...Commercially insured patients may pay as little as $40 for a carton of Brekiya, which includes 4 single-dose autoinjectors... Full

GSK Pens $745M Deal for Phase 1 Drug That Hits Sweet Spots of COPD, Oligonucleotides

(10/28, James Waldron, Fierce Biotech) ...The drugmaker is paying $85 million upfront to Empirico for the rights to a siRNA oligonuceleotide dubbed EMP-012 that's already in a phase 1 study for chronic obstructive pulmonary disease (COPD). The candidate has "best-in-class" potential, according to GSK, which hopes to broaden EMP-012's use to other inflammatory respiratory diseases...The aim is to focus the asset on patients with non-type 2 inflammation, which the pharma described as a "key patient sub-group where treatment options are limited."... Full

Eylea's Dominance Shaken by Biosimilars, Next-Gen Treatments

(10/28, Yeom Hyun-a, ChosunBiz) ...The dominance of ‘Eylea (ingredient name: aflibercept)' in the macular degeneration treatment market, which has lasted over a decade, is now wavering. As biosimilars (biopharmaceutical generics) begin to enter the market in earnest, and next-generation drugs with new treatment methods are emerging one after another, a rapid shift in the market is anticipated...According to market research firm Grand View Research, the global macular degeneration treatment market size is projected to grow from $9.84 billion (13 trillion Korean won) in 2021 to $13.2 billion (18 trillion Korean won) by 2028... Full

Novartis Hits Profit Target as New Drugs Offset Drag From Generics

(10/28, Ludwig Burger and Bhanvi Satija, Reuters) ...Swiss drugmaker Novartis met third-quarter profit forecasts on Tuesday, as fast growth of newer drugs offset a sharp slowdown in blockbuster heart drug Entresto as it comes under pressure from generics in the U.S. market. The results underscore why Novartis is on an aggressive deal-making spree this year, with a push for acquisitions and licensing deals worth up to $30 billion so far to bolster its drug pipeline as established treatments lose patent protection... Full

Novartis Looking to Add More Medicines to Direct-to-Patient Platform, CEO Says

(10/28, Bhanvi Satija, Reuters) ...Swiss drugmaker Novartis is exploring options to add more medicines to its direct-to-patient platform that is expected to launch in the U.S. on November 1, CEO Vas Narasimhan told Reuters in an interview on Tuesday. "We're certainly looking to see if we can add other medicines to the platform," Narasimhan said, while cautioning that "no concrete plans" were yet confirmed... Full

Novartis CEO Says Pharma Giant Has the Firepower for Big M&A Deals: ‘Can Never Be Done'

(10/28, Carolin Roth, CNBC) ...Novartis "can never be done" when it comes to major acquisitions in its sector as it always needs to look for the next "great asset," CEO Vas Narasimhan told CNBC. In order to offset the hit from generics competition Novartis has been on a buying spree, acquiring more than 35 companies over the last year. The Swiss drugmaker announced its biggest deal in a decade on Sunday, when it announced it has agreed to buy U.S. biotechnology company Avidity Biosciences for about $12 billion...Novartis said two of Avidity's three leading drugs that are expected to be launched before 2030 have the potential to generate billions of dollars in sales... Full

Samsung Biologics Reports Highest-Ever Quarterly Revenue

(10/28, Heo Ji-yoon, ChosunBiz) ...Samsung Biologics recorded its highest-ever quarterly revenue in the third quarter of this year since its founding. The company attributed this result to increased productivity from operating all four factories (1–4), expanded sales of biosimilar, a biopharmaceutical generic drug, products, and favorable exchange rate effects...Samsung Biologics expects to achieve its annual revenue growth guidance of 25–30%, which it previously announced, for both consolidated and separate standards this year... Full

Kemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing

(10/28, Kemwell Biopharma Pvt Ltd.) ...Kemwell Biopharma Pvt Ltd...announced today that its drug-product manufacturing facility in Bengaluru has successfully completed a U.S. Food and Drug Administration (FDA) pre-approval inspection (PAI) and is now cleared for the commercial manufacturing and testing of injectable products destined for the U.S. market. This milestone marks the approval of the first product to get U.S. FDA clearance for commercial supply from Kemwell's Bengaluru drug-product facility since the site became a dedicated biologics campus eight years ago... Full

OpenAI Lands New Pharma Deals with Thermo Fisher and Lundbeck

(10/27, Marta Rybczynski, FirstWord Pharma) ...OpenAI announced new collaborations with Thermo Fisher Scientific and Lundbeck on Monday, extending its reach into drug development. The announcements mark one of OpenAI's broadest steps into biopharma as companies look to apply large language models to improve research productivity and trial efficiency...Lundbeck said the rollout follows a successful pilot showing how ChatGPT improved research speed and analysis quality. The initiative will extend across R&D and commercial teams, supported by strict ethical and data governance frameworks. "By integrating AI into our daily processes, we're unlocking new levels of efficiency and innovation," said Claus Thomsen, Lundbeck's head of global IT... Full

Cigna's End to Drug Rebates Spurs Questions on Premiums, Impact

(10/28, Lauren Clason, Bloomberg Law) ...Cigna's pharmacy benefit manager subsidiary Express Scripts—one of the nation's largest PBMs—plans to phase out rebates for its fully insured plans by 2027. The company also plans to phase them out with self-insured employer plans by 2028. Bloomberg News first reported the announcement Monday...Cigna's new approach will pass on manufacturer discounts to the patient at the point-of-sale, rather than distributing them evenly across all enrollees to keep premiums down. Insurers and PBMs have previously said this strategy would increase premiums, but Adam Kautzner, president of Express Scripts pharmacy benefits division, told Bloomberg News he didn't think that would happen... Sub. Req’d

NHS Faces ‘Stark Choice' if Britain Caves to Donald Trump's Drug Pricing Threats

(10/27, Martin Bagot, Mirror) ...The NHS Confederation and NHS Providers, representing trusts and other health organisations, said in a joint statement that the cost of covering redundancies and strikes, along with paying more for medicines was not included in the budget this year. Labour 's NHS recovery is on a knife edge just as ministers are negotiating a US trade deal which could force it to pay billions of pounds more for drugs. A proposed deal to increase drug "value for money" thresholds by 25% will leave a black hole in the NHS budget and mean patients wait longer to be treated... Full

Danish Rejection of US Price Comparison

(10/27, The Pharma Letter) ...Henrik Vestergaard, acting chief executive of Lif, the Danish Pharmaceutical Industry Association, has taken aim at the USA's most-favored-nation (MFN) drug pricing policy that would tie US prices of prescription drugs to the lowest prices paid in other developed countries...He describes a tumultuous year for the pharmaceutical industry, both globally and in Denmark, with a 100% tariff on US pharma imports agreed after months of rumors, and lingering uncertainty about how these will be implemented... Sub. Req’d

UK Watchdog Slams AstraZeneca, Organon for Marketing Breaches

(10/27, Nick Paul Taylor, Fierce Pharma) ...The Prescription Medicines Code Of Practice Authority (PMCPA) case against AstraZeneca centers on a claim the company made on a website for Symbicort. The website said U.K. guidelines recommend all newly diagnosed asthma patients aged 12 years and up should receive a certain regimen. However, a complainant noted that another regimen is recommended for some patients. Symbicort is approved in both populations. AstraZeneca accepted that it made "an unintentional error" by failing to accurately reflect the full U.K. guidelines. Yet the drugmaker denied that the error constituted a patient safety risk, arguing that there was no theoretical risk of an overdose... Full

An Important Milestone: Canada Approves Expensive New Drug That Can Slow Alzheimer's Disease

(10/27, Daniel Otis, CTV News) ...While existing medications treat Alzheimer's symptoms, lecanemab is the first drug authorized in Canada that targets the disease's underlying cause in order to reduce the rate of cognitive and functional decline. "This is an important milestone," neurologist Dr. Sharon Cohen told CTVNews.ca. "What this does is slow down the disease at an early stage where people are still living at home and functioning quite well."... Full

German Pharma Grows on Trump Tariff Fears, Industry Says

(10/27, DPA) ...Germany's pharmaceutical industry is anticipating strong growth in production and sales in 2025, even as the broader economy struggles, industry figures showed on Monday. The Association of Research-Based Pharmaceutical Companies (VFA) forecasts a 3.2% rise in production this year, compared with a 1.7% decline across German industry overall. Pharma investment is expected to grow by 2.7% and sales by 3.4%... Full

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