Tuesday, November 25, 2025

Teva Receives EC Approvals for PONLIMSI, DEGEVMA

(11/25, The Fly) ...Teva Pharmaceuticals International, a subsidiary of Teva Pharmaceutical Industries, announced that the European Commission, EC, has granted marketing authorizations for its two denosumab biosimilar candidates - PONLIMSI, a biosimilar to Prolia and DEGEVMA, a biosimilar to Xgeva, following the positive opinion of the Committee for Medicinal Products for Human Use, CHMP, earlier this year. Teva plans to launch both products in key European markets in the coming months. The approval represents an important step in advancing Teva's Pivot to Growth strategy, reinforcing the company's dedication to broadening access to biosimilar medicines for patients... Full

Pro Football Hall of Famer Terrell Davis, Teva Call Attention to ‘The Other TD'

(11/24, Kyle O'Brien, MM+M) ...That goal, according to Heather DeMyers, VP of U.S. innovative medicines marketing at Teva, led to the touchdown dance. "When you get excited after your team scores, everyone does some sort of movement or jumps up and down," DeMyers says. "We thought this was a good opportunity to catch people right there and then quickly shift to some of the other movements, like The Other TD."...The decision for Teva to leave the campaign mostly unbranded — save for a small logo on the site and the hero spot — was intentional, according to DeMyers. She notes that since so many still live with the condition without a proper medical diagnosis, the company wanted the focus to be on the messaging rather than the brand... Full

UK-US Drug Pricing Deal Could Come as Early as This Week, Sources Say

(11/24, Anna Brown, Endpoints News) ...The two governments have been in talks since at least October in an effort to boost the UK's investment in the pharma sector and lower drug prices in the US. Under the deal, the UK is expected to agree to pay more for some medicines in exchange for relief from tariffs, according to the sources, who spoke on condition of anonymity...On Monday, US trade envoy Jamieson Greer met with the UK government to negotiate the deal, according to the sources. The UK government may choose to announce a deal before releasing the country's autumn budget on Wednesday, but it will also depend on the White House's schedule, they added. The UK's annual autumn budget outlines government spending for the year ahead... Sub. Req’d

US Negotiated Medicare Prices for 15 More Drugs to Test Cost Savings Promise

(11/25, Patrick Wingrove and Deena Beasley, Reuters) ...The U.S. government is expected this week to announce negotiated prices for 15 of the highest-cost prescription drugs under its Medicare health plan, a potential signal of the Trump administration's commitment to bring down healthcare costs...Other drugs up for price negotiation this year include GSK's asthma and COPD inhaler Trelegy Ellipta and AbbVie's irritable bowel syndrome medicine Linzess. The new prices will take effect in 2027. Analysts said they will be looking at how the prices compare to Medicare's recent net prices after accounting for confidential rebates and discounts. They will also be comparing them to prices negotiated by other high-income countries, a concept President Donald Trump has fought for, sometimes referred to as most-favored-nation pricing... Full

US Court Rejects Teva's Challenge to Medicare Negotiations

(11/24, The Pharma Letter) ...The US District Court for the District of Columbia has rejected Israel-headquartered Teva Pharmaceuticals Industries' challenge to the Medicare Drug Price Negotiation Program - marking the 16th defeat against the industry's nationwide legal campaign to prevent the law from lowering prices... Sub. Req’d

D.C. Court Rejects Teva's Challenge to Medicare Negotiation, Finding No Property Interest in Patent Exclusivity

(11/24, Rose Esfandiari, IPWatchDog) ...Teva Pharmaceuticals USA brought the lawsuit against various officers and employees of the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) who implement the Drug Price Negotiation Program. Teva alleged that CMS's guidance governing program selections is contrary to law and that the program itself violates the Fifth Amendment's Due Process Clause. Teva manufactures AUSTEDO and AUSTEDO XR, which are used to treat involuntary movements associated with Huntington's disease and tardive dyskinesia, and are included in the second round of negotiation... Full

CEVR Examines the IRA's Unintended Consequences on Biosimilars

(11/24, CEVR) ...According to new CEVR research, this may unintentionally reduce long-term savings. In new research published in Health Affairs Scholar, CEVR's Molly Beinfeld, Priyanka Ghule, Fariel LaMountain, and James Chambers modeled three scenarios, using ustekinumab (Stelara) as a case study: Savings from biosimilar competition alone for ustekinumab; Savings from IRA negotiations alone for ustekinumab, assuming no biosimilar competition; Savings if Medicare negotiated a price for palbociclib (Ibrance), a drug not nearing loss of exclusivity, instead of ustekinumab plus savings due to ustekinumab biosimilar competition... Full

Myth vs. Fact: How Government Price Setting Impacts Innovation

(11/24, Brianna Allen, PhRMA) ...The bottom line: The IRA's price-setting policies are actively reshaping drug development decisions in ways that harm patients. Policymakers must fix the IRA's flaws and reject any expansion of government price controls. Reforms must protect access and preserve the incentives that have made the U.S. the world leader in medical innovation... Full

Health Providers Race to Navigate Pharma's New Drug Rebate Plan

(11/25, Nyah Phengsitthy, Bloomberg Law) ...Health providers are now preparing for the pilot—grappling with nine unique drugmaker models, weighing operational changes, and analyzing the financial risks with purchasing drugs at commercial prices. "A lot of entities are trying to figure out what reports they can build internally and what resources they need," said Madeline Wallack, co-founder of Rx|X Consulting, which provides 340B compliance services. "They're scrambling to figure out if they can adapt or customize for these manufacturers."... Sub. Req’d

Safety Label Guidance: Commenters Want Clarity, Transparency, and Assurances

(11/24, Ferdous Al-Faruque, Regulatory Focus) ...Industry, patient groups, and academics seek more clarity from the US Food and Drug Administration (FDA) regarding its plans to require drug and biologic manufacturers to update their labeling after detecting safety signals. Several industry and research advocacy groups have written to the agency regarding a recent draft guidance that outlines its process for requiring safety labeling changes (SLC), asking for more details on how the agency arrives at its decisions and what information it will disclose publicly... Full

CBER Poised for Research Shakeup As Prasad Makes Unproven Claims About ‘Polluted Science'

(11/24, Sarah Karlin-Smith, Pink Sheet) ...Most CBER research efforts may be temporarily paused as Director Vinay Prasad ensures he approves of them. In a scathing email to staff, Prasad made unproven claims about the quality of CBER's research and questioned whether the center's focus areas fit a regulatory agency using taxpayer funding. Two former CBER directors suggested Prasad's assessment may be misinformed... Global Sub. Full

GDUFA IV: US FDA Wants to ‘Streamline' Formal Meeting Structure

(11/24, Derrick Gingery, Pink Sheet) ...The FDA could change the formal meeting structure in GDUFA IV to increase its efficiency. Industry also wants to discuss programs that could be reduced, including pre-submission facility correspondence. All FDA and industry proposals remain within the scope of the user fee program discussions, including incentives for domestic manufacturing... Global Sub. Full

FDA's Pazdur Questions Legality of Voucher Program, Sources Say, In Latest Internal Disagreement

(11/24, Zachary Brennan, Endpoints News) ...Less than two weeks since appointing Richard Pazdur to lead the FDA's drug center, Commissioner Marty Makary is already finding himself in disagreement with his new deputy, according to two people familiar with the situation and who spoke on condition of anonymity to Endpoints News. Since taking the job running the FDA's Center for Drug Evaluation and Research on Nov. 11, Pazdur has pushed back on Makary's National Priority Voucher pilot program, saying that it may be illegal, according to the sources. He has also questioned Makary's requests for label changes and to pull certain unspecified drugs, the people said... Sub. Req’d

FDA 'Priority Voucher' Program Comes Under Congressional Scrutiny

(11/24, Joyce Frieden, Medpage Today) ...Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program "could undermine public confidence in FDA's decisions and raise safety concerns." "We have significant concerns that this program will enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump," Sen. Bernie Sanders (I-Vt.) and Rep. Frank Pallone (D-N.J.) wrote last Thursday in a letter to Makary. "This program could undermine public confidence in FDA's decisions and raise safety concerns, including rushed reviews by an agency whose staff have been decimated by this administration's cuts."... Full

Achieving More With Less: US FDA Offers ‘Road Map' For AI In Rare Diseases

(11/24, Sue Sutter, Pink Sheet) ...AI applications can address the inherent challenge of small patient populations, but model development and training also must navigate the limitation of small datasets. Public entities, including regulators, could aid rare disease research by integrating data from various sources and creating centralized databases, the paper's authors said. In a separate article in NEJM AI, FDA officials described four hurdles to large-scale adoption of AI in drug development... Global Sub. Full

 

Glenmark Gains After Launching First-Ever Nebulized Triple Therapy for COPD

(11/25, Business Standard) ...The therapies combine three proven medicines Glycopyrronium, Formoterol, and Budesonideto reduce airway obstruction, control inflammation, and improve lung function and symptom management. Designed as a single, easy-to-use nebulized therapy, the products aim to reduce the burden of multiple medications for patients. Glenmark said the launch represents a breakthrough in COPD care, particularly benefiting patients who face challenges using Metered Dose Inhalers (MDI) or Dry Powder Inhalers (DPI). The company expects the therapy to set a new standard of care for managing COPD worldwide... Full

Celltrion Accelerates Europe Rollout of Xolair Biosimilar

(11/25, Lee Han-soo, Korea Biomedical Review) ...Celltrion is accelerating its European market expansion for Omlyclo, a biosimilar referencing Novartis' Xolair, after completing launches in major markets including Germany, Spain, the U.K., and France...The company said Omlyclo is pursuing a first-mover advantage in Europe by securing early adoption through direct distribution and competitive tender strategies tailored to national market structures... Full

STADA Wins Approvals to Bring Denosumab Biosimilars to Patients in Europe

(11/24, The Pharma Letter) ...The EC approvals follow positive opinions adopted in September 2025 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The European denosumab market is valued at around $1 billion across all indications, with growth expected at mid-single digits for Xgeva and high-single digits for Prolia... Sub. Req’d

Formycon Expands European Aflibercept Footprint With NTC Deal In Italy

(11/25, Dean Rudge, Generics Bulletin) ...Formycon has expanded its European presence for its Baiama aflibercept biosimilar by partnering with Italy-based NTC, granting NTC exclusive commercialization rights in Italy. This deal, which includes revenue-sharing agreements, complements previous agreements with other European firms including Horus in France and Teva elsewhere. Sandoz has also announced the launch of its aflibercept biosimilar, Afqlir, across Europe, beginning in the UK... Global Sub. Full

Fresenius Kabi Introduces Dalbavancin for Injection (For Single-Dose Regimen Use Only)

(11/24, Fresenius Kabi) ...Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced Dalbavancin for Injection (for single-dose regimen use only), which is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections caused by designated susceptible strains of Gram-positive microorganisms. It is available in 500 mg vials and approved for single-dose regimen use only... Full

Zydus Lifesciences Gets Final FDA Nod for High BP Drug Verapamil Hydrochloride

(11/25, Jomy Jos Pullokaran, CNBC TV-18) ...Drug maker Zydus Lifesciences Ltd on Tuesday (November 25) said it has received final approval from the United States Food and Drug Administration (FDA) for verapamil hydrochloride extended-release tablets USP in 120 mg, 180 mg and 240 mg strengths. The approved product corresponds to the US reference listed drug Calan SR extended-release tablets in the same strengths. Verapamil hydrochloride extended-release tablets are administered to lower high blood pressure, reducing the risk of serious cardiovascular conditions such as strokes and heart attacks... Full

Novo Nordisk's Obesity Drug Shows Weight Loss of Up to 14.5% in Mid-Stage Study

(11/25, Mariam Sunny, Reuters) ...Novo Nordisk said on Tuesday its experimental obesity drug, amycretin, showed statistically significant weight loss of up to 14.5% at 36 weeks in patients with type 2 diabetes in a mid-stage study...Novo said the drug appeared safe and well tolerated, with mostly mild-to-moderate gastrointestinal side effects. The company plans to start late-stage trials in 2026... Full

Novartis Was the Sole Bidder in $12B Deal to Buy Avidity

(11/25, Kyle LaHucik, Endpoitns News) ...It took 14 calls between chief executives, four months of negotiations and four hiked proposals for Novartis and Avidity Biosciences to come to their $12 billion agreement in October, according to a Monday financial filing with the background of 2025's second-largest biopharma acquisition. The document shows the power that a seller can have when it's in possession of an asset that a bigger company wants. During the deal process, Avidity's advisors reached out to seven potential counterparties to gauge their interest in a deal, but none of the companies moved forward, according to the filing... Sub. Req’d

Global Pharmaceutical Market Projections Through 2030

(11/24, Nicole Raleigh, Pharmaphorum) ...In Evaluate's recently released annual World Preview Report, including updated global pharmaceutical market projections through 2030, it was projected that worldwide drug sales will grow at a CAGR of over 7% into 2030, with China's biopharma sector rapidly reshaping the market. Indeed, China-sourced assets accounted for just 3% of all licensing deals in 2020, yet in 2025 will make up almost 40%... Full

Public Understanding of Antibiotics is Insufficient, Global Study Finds

(11/24, Chris Dall, MA, CIDRAP) ...In a systematic review and meta-analysis, researchers from Australia, Nigeria, and the United Kingdom identified 227 studies from 98 countries that reported the knowledge of antibiotic use and resistance among the public. They found that 73.2% of the 322,492 participants correctly recognized that antibiotics are effective in treating bacterial infections and 72.5% knew that excessive antibiotic use reduces the effectiveness of antibiotics. But only 42.1% knew that antibiotics were not effective against viruses, and that number was significantly lower in countries such as Laos (7.2%), Myanmar (11.7%), and Bangladesh (12.5%). Similarly, only 35.1% of respondents knew that antibiotics don't speed up recovery from cold and flu... Full

How Dangerous is Trump's Drug Pricing Policy for European Patients?

(11/25, Brenda Strohmaier, Euractiv) ...Last week, Novartis CEO Vas Narasimhan warned that Switzerland's health system could face major disruption. "If authorities do not change their pricing policies, companies will be forced to launch new therapies exclusively on the private market," he told investors. Swiss media noted this would mean mandatory health insurance would no longer cover such drugs... Full

Medicines UK Urges Focus On Five Priorities Ahead Of UK Budget

(11/24, Dave Wallace, Generics Bulletin) ...Medicines UK has made a pre-budget submission to the government under the banner of "better health, better access, better value." The off-patent association identified five key "focus areas": VPAG, community pharmacy, biosimilars, EPR packaging and FTAs. Medicines UK chief executive Mark Samuels says the country's international life sciences reputation has "taken a hit in recent years" but insists that action can be taken to restore confidence... Global Sub. Full

England Becomes First In Europe To Reimburse Autolus' CAR-T Aucatzyl

(11/25, Eliza Slawther, Pink Sheet) ...Autolus's CAR-T therapy Aucatzyl is to be reimbursed in England for treating adults over 26 with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This is the first reimbursement agreement outside of the US for Aucatzyl, which secured conditional marketing authorizations in the UK and EU this year, after it was approved in the US a year ago. England's health technology assessment institute NICE initially said it could not determine whether the drug was a cost-effective use of NHS resources, but reversed this decision after Autolus submitted updated data, updated some of its modeling and changed its commercial arrangement... Global Sub. Full

Veeva Summit Europe: Future-Proofed AI Set to Bolster Commercial Pharma Operations

(11/25, Annabel Kartal Allen, Pharmaceutical Technology) ...At the 13th Annual Veeva Commercial Summit Europe, experts touted the benefits of AI but stressed the importance of data and future-proofing in its long-term success...However, as AI becomes a mainstay tool, speakers at the Veeva summit stressed that decision-makers must figure out the best use cases for the technology on a day-to-day basis. They were also sure to acknowledge AI's current pitfalls, which became an important talking point as industry members look to ensure trust, accuracy and future-proofing are at the forefront of the AI revolution... Full

J&J MedTech Bolsters Stroke R&D Programs in Ireland

(11/24, Conor Hale, Fierce Biotech) ...Johnson & Johnson MedTech is expanding its stroke-focused R&D in Ireland, building on previous investments and coming on the heels of a new innovation center that was completed earlier this year in Galway. The move coincides with the location hosting a meeting of J&J's neurovascular global scientific advisory board, which includes physician leaders from the U.S., Europe, Middle East, Africa and Asia-Pacific regions... Full

Russian Govt to Create Temporary List of Innovative Drugs

(11/25, The Pharma Letter) ...According to recent statements made by some senior Russian state officials in the field of healthcare, the launch of innovative drugs in the Russian market is carried out too slowly, while the main reason is regulatory gaps. Still, there is a possibility that the introduction of the new initiative will ensure their more stable procurements. As part of these plans, the drug, which is proven effective and registered in Russia will first be included in the temporary list, and then added to the list of vital and essential drugs... Sub. Req’d

Russia's Akselpharm Defends its Patent for Osimertinib, Sparking AstraZeneca Criticism

(11/24, The Pharma Letter) ...The Presidium of the Russian Intellectual Property Rights Court (IPC) has reinstated the Eurasian patent of Akselpharm for the crystalline form of osimertinib. This dispute is part of a long-term battle between Akselpharm and the British company. AstraZeneca manufactures the original osimertinib-based drug Tagrisso at its Russian site. According to Russian research agency DSM Group, government procurements of drugs containing this active ingredient amounted to 5.2 billion roubles ($65.8 million) from January to September 2025, which is an increase of 13% year-on-year... Sub. Req’d

Policymakers-Industry Collaboration Vital for Healthcare Delivery: Dr Reddy's

(11/24, Press Trust Of India) ...Dr Reddy's Laboratories chairman Satish Reddy emphasized the need for collaboration between government and industry. This partnership is crucial for creating a healthcare system ready for the future. Reddy shared his views at a pre-budget consultation in New Delhi. He highlighted risk-based innovation funding to boost India's pharmaceutical sector. This aims to accelerate breakthroughs and improve patient access and affordability... Full

Piyush Goyal Meets Pharma Stakeholders to Discuss Growth, Regulation Amid Global Tariff Concerns

(11/25, ANI) ...Union Minister Piyush Goyal met with Indian pharmaceutical stakeholders. Discussions focused on strengthening regulatory frameworks and accelerating growth. The government is committed to a future-ready, innovation-led pharma sector. This meeting occurs as the global pharmaceutical industry assesses potential US tariff implications. Indian industry representatives express confidence that proposed tariffs will not significantly affect exports... Full

Can India's Pharma Thrive Amid US Tariff Threats? Union Minister Piyush Goyal Meets Industry Leaders

(11/25, Gunjan Rajput, Republic) ...Industry experts believe that India's strong presence in the global generics market provides resilience against such policy changes. The government's ongoing focus on innovation, manufacturing scale, and regulatory efficiency is also expected to support long-term growth. As per government data, the US is the largest importer of India's pharmaceuticals, accounting for over 31 per cent of the total and 47 per cent of its generic exports... Full

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