Monday, November 24, 2025

Teva Launches 'Teva Rise' to Harness Global Innovation and Transform Healthcare

(11/21, Indian Pharma Post) ...The initiative -- Teva Rise encompassing digital health and biotech -- aims to connect startups and tech companies with its business units, to tackle real-world pharmaceutical challenges while driving patient impact and accelerating Teva's Pivot to Growth strategy...Richard Francis, Teva's President and CEO, said, "Teva Rise is a powerful example of our Pivot to Growth strategy in action. By bringing together the best minds and technologies, we're not just modernizing our operations—we're transforming the future of healthcare for patients everywhere."... Full

Teva Loses IRA Drug Pricing Challenge in DC Federal Court 

(11/21, Nicole DeFeudis, Endpoints News) ...US District Judge Sparkle Sooknanan said Thursday that Teva's constitutional and statutory claims against the negotiation process "either fail on the merits or are unripe." Teva has already filed a notice of appeal, and a company spokesperson said it "stands behind the merits" of the case... Sub. Req’d

DC Court Shuts Down Teva Suit On IRA Negotiation Process, Guidance

(11/21, Gabrielle Wanneh, Inside Health Policy) ...Teva has filed an appeal in the case. The verdict comes days before the Trump administration's Nov. 30 deadline to reveal the new maximum fair prices for selected drugs following the second cycle of negotiations between CMS and participating drug companies. The slate will include a lower negotiated price for Teva's two Huntington's Disease treatments Austedo and Austedo XR...Despite several blows to the drug industry's many attempts to challenge the IRA's legality, Duane Wright, senior analyst at Bloomberg LP, says he doubts the industry will give up on its litigation efforts... Sub. Req’d

Pharma Loses for 16th Time: DC District Court Rejects Teva Pharmaceuticals' Challenge to Medicare Negotiation

(11/20, Patients for Affordable Drugs) ..."Patients have triumphed again with a 16th victory over Big Pharma: this time over Teva Pharmaceuticals, the only corporation that filed after its drug was included in the second round of negotiations," said P4AD Executive Director Merith Basey. "Despite their expensive legal assault, their unfounded and unimaginative arguments were rejected in court. Americans overwhelmingly support Medicare's right to negotiate lower drug prices, and the courts continue to affirm that this program is constitutional and here to stay."... Full

Through the Line Podcast: Teva Proves Sea Freight for Temperature-Sensitive Medicines

(11/21, Elisabeth Cuneo, Through The Line) ...How can strict temperature control be maintained over sea routes, while ensuring full compliance and product integrity? Teva Pharmaceuticals, in partnership with Kuehne + Nagel and Cold Chain Technologies (CCT), successfully validated the global transportation of temperature-sensitive medicines by sea... Full

Breast Care International and Partners Deliver Essential Medicines as Lifeline to Patients Across Ghana

(11/21, Mahmud Mohammed-Nurudeen, My Joy Online) ...Dr. Wiafe Addai expressed heartfelt appreciation to Direct Relief USA and Teva Pharmaceuticals for their consistent and compassionate support, noting that the donation strengthens Ghana's national response to cancer and other chronic conditions. The impact of the donation was immediately felt by those on the frontlines of patient care. A clinical psychologist at Willingway Rehab and Recovery Center, Dr. Aaron Prosper Kuubagr, described the intervention as "a huge relief."... Full

HHS Aims Anew at Discount Drug Program for Safety-Net Hospitals

(11/21, Ganny Belloni, Bloomberg Law) ...The Medicare outpatient prescription drug acquisition cost survey was announced by the Centers for Medicare & Medicaid Services in July and finalized Friday in the hospital outpatient prospective pay rule (RIN 0938–AV51). The survey is expected to start in late 2025 to early 2026. The results will then be used to set drug payment rates in 2027 in the 340B Drug Pricing Program, which requires drugmakers to offer outpatient drugs at significant discounts to hospitals and facilities that treat a disproportionate share of low-income and uninsured patients... Sub. Req’d

Dems, Watchdogs See Favoritism, Drug Safety Risks In FDA's CNPRV

(11/21, Maaisha Osman, Inside Health Policy) ...Democratic leaders in Congress and public-interest watchdogs are sounding alarms over FDA Commissioner Marty Makary's new Commissioner's National Priority Voucher program, warning the initiative, which was not authorized by Congress, invites political favoritism, risks corruption and could undermine drug safety by diverting scarce staff and delaying reviews for medicines that genuinely warrant priority status. The program offers drug makers that promote the president's national goals, such as lowering prices and producing domestically, accelerated FDA reviews... Sub. Req’d

FDA Review Staff Was Excluded from Voting on Whether to Approve First Priority Voucher Drug

(11/21, Lizzy Lawrence, STAT+) ...STAT has learned that when the agency voted on whether to approve the first product from a voucher recipient in October, the voting members did not include the review team. Instead, the voting panelists were leaders from the top of the agency, according to three agency sources. It is not clear what the outcome was. The agency has not yet publicly announced the approval decisions for any of the voucher recipients. That's a major departure from the agency's typical practice of investing this power in career officials, to avoid the perception of politics influencing the approval process. It's the latest example of how political influence is shaping FDA's scientific decision-making... Sub. Req’d

Study: FDA Finds Competitive Generic Therapies Launch Faster Than Other Generics

(11/21, Joanne S. Eglovitch, Regulatory Focus) ...A study by US Food and Drug Administration (FDA) officials published in JAMA Internal Medicine earlier this week found that competitive generic therapies (CGTs) approved by the US Food and Drug Administration (FDA) were launched faster than traditional generics. This swift launch enables these products to compete more quickly with brand-name drugs, the authors said. The study authors attributed the faster CGT entry "to the use or lose" nature of CGT exclusivity... Full

In Letter to Makary, Biotech CEOs Push for FDA Stability and Say Volatility Threatens US Innovation

(11/21, Gabrielle Masson, Fierce Biotech) ...Overall, CEOs worry that added volatility in an already high-risk industry will discourage overall investment in biotech innovation or will drive it to other countries, according to the Nov. 20 letter posted by the nonprofit group No Patient Left Behind. The signatories include prominent industry leaders such as Alnylam Pharmaceuticals' founding CEO John Maraganore, Ph.D., and Nkarta Therapeutics CEO Paul Hastings, among many others. The survey was disseminated among biopharma CEOs and regulatory affairs leaders and focused on recent experiences with the FDA... Full

Investment Firm Warns FDA On A ‘Dark And Murky' Path For Innovation

(11/21, Jessica Karins, Inside Health Policy) ...A report from the financial firm Raymond James warns FDA's trajectory under Commissioner Marty Makary imperils biotechnology investment and innovation, alleging Makary could be "the worst Commissioner in decades" if factors like plummeting staffing, regulatory uncertainty and divisive rhetoric from high-level officials don't change. A separate joint message from patient advocates, investors and biotechnology executives warns drug makers are considering sending their investments and clinical trials overseas due to the FDA upheaval... Sub. Req’d

US FDA's Advertising Enforcement Crackdown Expands To Generic Drugs

(11/21, Sue Sutter, Pink Sheet) ...A webpage for PharmaTher's generic ketamine misleadingly suggested the approved indication was different from the reference product, the FDA said in an untitled letter. Lawyers said the letter is a reminder that generic drug makers are subject to the same promotional rules as innovators. The FDA also sent late September untitled letters to SK Life Science and AstraZeneca for violative branded TV commercials... Global Sub. Full

The White House Has Asked for the Resignation of a Top Aide to FDA Chief

(11/21, Lauren Gardner, Politico) ...The White House on Thursday emailed HHS leadership asking for the resignation of a top aide to FDA Commissioner Marty Makary whom he had sought to promote, according to two administration officials granted anonymity to discuss a sensitive personnel matter. Makary pushed back on the request to force policy and research staffer Sanjula Jain-Nagpal out of the agency, officials told POLITICO... Full

US FDA Cancer Office Keeps Hemorrhaging Staff, Most Land At Industry

(11/21, Sarah Karlin-Smith, Pink Sheet) ...The Pink Sheet documented 33 departures from agency oncology roles in 2025, including 17 who took pharma industry roles. Most of the rest moved to roles adjacent to pharma, such as in consulting or contract resource organizations. Many senior leaders with more than a decade of FDA experience departed, along with some reviewers who were so new the agency may have wasted its investment in their training. The losses could impact the FDA's ability to innovate or develop new programs because it will be much more focused on core product review work... Global Sub. Full

Three Global Strategies – Will the Patient Be Better?

(11/21, Patrick Day, Lachman Consultants) ...A quick comparison of these strategies can yield insightful intelligence on not only the direction of the global supply chain but also on how regulators will interact and perform their regional functions to ensure that the safety of patients is always protected. The most recent FDA Report on the State of Pharmaceutical Quality highlights the shift in location of manufacturing sites; this shift will probably continue given the tension in these strategies. A cursory review of these strategies can give insight into the future movement of typical product families... Full

Novo Nordisk Says Alzheimer's Drug Trial Fails to Meet Main Goal

(11/24, Stine Jacobsen and Maggie Fick, Reuters) ...Novo Nordisk said on Monday an older oral version of its semaglutide drug failed to meet its main goal in late-stage trials testing whether the medicine can slow cognitive decline in Alzheimer's patients, sending its share price down 10%...The results from the two trials of early-stage patients, called EVOKE and EVOKE+, mark another setback for the Danish drugmaker, which boomed on the success of blockbuster medicine Wegovy before slowing sales growth and a tumbling share price prompted a CEO change and mass layoffs. The setback reinforces analyst scepticism about Novo's Alzheimer's ambitions, with UBS having estimated just a 10% probability of success... Full

Alvotech Receives European Approval for Denosumab Biosimilar AVT03

(11/24, StreetInsider.com) ...AVT03 received approval in two presentations: a 60 mg/mL single-use pre-filled syringe as a biosimilar to Prolia for treating osteoporosis and bone loss, and a 70 mg/mL single-use vial as a biosimilar to Xgeva for preventing skeletal-related events in adults with advanced bone malignancies... Full

Dr Reddy's Gets EU Approval for Osteoporosis Drug AVT03, A Biosimilar to Prolia and Xgeva

(11/24, Sheersh Kapoor, CNBC TV-18) ...Dr Reddy's Laboratories has received approval from the European Commission (EC) for AVT03, a biosimilar version of Prolia and Xgeva—widely used medicines for treating osteoporosis and preventing bone-related complications in cancer patients...Dr Reddy's will commercialise the product and holds exclusive rights for the US and semi-exclusive rights in Europe and the UK. The biosimilar will be sold in Europe under the brand names Acvybra (for osteoporosis) and Xbonzy (for cancer-related uses)... Full

Sandoz Debuts Aflibercept Biosimilar In Europe

(11/24, Dave Wallace, Generics Bulletin) ...Sandoz has launched its Afqlir (aflibercept) biosimilar rival to Eylea in Europe. An initial roll-out in the UK will be followed by launches in major markets such as France and Germany. Meanwhile, Sandoz is also launching Formycon's Lucentis (ranibizumab) biosimilar, Epruvy, in Germany... Global Sub. Full

NTC Becomes Commercialization Partner for Formycon's Eylea® Biosimilar FYB203/Baiama® in Italy

(11/24, Formycon AG) ...As part of the agreement, Klinge is eligible to receive royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge... Full

AstraZeneca to Onshore Rare Disease Portfolio as Part of its $50B Pledge to the US

(11/21, Anna Brown, Endpoints News) ...The UK-based drugmaker will use the funds to onshore its rare disease portfolio to the US for the first time. It plans to expand its biologics facility in Frederick, MD, and nearly double the factory's commercial capacity. AstraZeneca will also build a new factory in Gaithersburg, MD, which will manufacture assets for clinical trials, the UK drugmaker said. Around 300 new jobs will be created across both the Gaithersburg and Frederick sites... Sub. Req’d

Lilly Becomes First $1Trn+ Pharma Company

(11/24, Phil Taylor, Pharmaphorum) ...The 150-year-old company passed the historic milestone on Friday as its share price approached $1,060, fuelled by the breakneck pace of growth of its GLP-1 agonist-based diabetes and obesity drugs in the last few years, and continued to rise after-hours. A decade ago, its shares were trading at less than $100. The new valuation can be directly traced back to the success of Lilly's Mounjaro for diabetes and Zepbound for obesity – both based on the GLP-1/GIP agonist tirzepatide – which generated revenues of nearly $19 billion. It also marks a turnaround for the company after initial clinical data with a follow-up, oral GLP-1 agonist drug, orforglipron, disappointed in the summer... Full

Bayer Reports Positive Results for Blood Thinner After 2023 Setback

(11/23, Joern Poltz, Reuters) ...German pharma company Bayer reported positive study results for its anticoagulant asundexian on Sunday, two years after a research setback for the promising blood thinner candidate. In a Phase III study, a daily dose of 50 milligrams significantly reduced the risk of ischemic stroke compared with a placebo, Bayer said... Full

Taiwan DIR Grants Approval for Lotus' Acquisition of Alvogen US, Aiming 2025 Year-End Closing

(11/24, Lotus Pharmaceuticals) ...The approval from Taiwan DIR represents a significant regulatory clearance required for the transaction. With this milestone now secured, Lotus confirms that the acquisition remains firmly on track for completion by year end, in-line with the Company's expectations. In preparation for closing, Lotus will be undertaking a number of internal procedures over the coming weeks. Certain steps may require public disclosures via the Market Observation Post System (MOPS), as mandated by regulatory requirements. These are necessary procedural steps to ensure a smooth and timely closing of the transaction before the end of 2025... Full

Aurobindo Pharma Incurring Loss at China Plant; Hopes to Achieve Break-Even by Q4

(11/24, Press Trust Of India) ...The Hyderabad-based drug major remains confident about sustaining its growth momentum and driving value creation across all businesses, he said. "China (plant), as on date in the quarter, I will be incurring a loss of around maybe a million dollars, but, probably, we will be able to achieve the break-even between Q3 and Q4 and after that, China will start moving up in the overall contributing to the growth of the EBITDA growth," Subramanian said in an analyst call... Full

US FDA Investigates Takeda's Blood Disorder Drug After Pediatric Death

(11/21, Kamal Choudhury and Sriparna Roy, Reuters) ...The health regulator said it is investigating the risk of developing neutralizing antibodies, including potential life-threatening outcomes, following treatment with Takeda's Adzynma. Approved in 2023 as the first therapy for congenital thrombotic thrombocytopenic purpura (cTTP), Adzynma works by replacing the missing ADAMTS13 protein to prevent dangerous clot formation. The inherited condition causes blood clots in small blood vessels, which can lead to strokes, kidney damage and other serious complications... Full

Pharma Needs Incentives To Optimize Cancer Drugs, EMA Oncology Chair Says

(11/21, Eliza Slawther, Pink Sheet) ...The chair of the European Medicines Agency's oncology working party, Pierre Demolis, advocates for incentives to encourage pharmaceutical companies to optimize cancer drugs. He explained that safety, rather than optimal efficacy, was the main consideration for companies during registrational trials. Representatives from AstraZeneca and Jazz Pharmaceuticals said that industry could learn from pediatric oncology, where the system for exploring dose optimization was more well-established... Global Sub. Full

Switzerland Becoming the Benchmark for US Drug Prices

(11/24, The Pharma Letter) ...Switzerland is becoming the benchmark for American drug prices, warns the trade body Interpharma. A new US model links pricing to international averages – including purchasing power parity-adjusted Swiss prices. This increases the pressure on the Swiss pricing system and jeopardizes the availability of medications. A comprehensive modernization of the pricing system is urgently needed – this includes a purchasing power parity-adjusted comparison of foreign prices and the introduction of a manufacturer-set provisional price after market approval. Only in this way can the supply of new medications be guaranteed in the future... Sub. Req’d

Danish Plan to Ease Non-EU Medicine Imports Sparks Safety Warnings

(11/24, The Pharma Letter) ...The Danish government's push to let citizens buy medicines from countries outside the EU is drawing sharp criticism from Lif, which represents research-based drugmakers in Denmark. Lif argues the change exposes patients to greater risks, noting that the current ban helps prevent counterfeit products entering the country. Acting chief executive Henrik Vestergaard said it was "very worrying" that savings would come "at the expense of citizens' safety," stressing that buyers would have no guarantee about content, dosage or purity... Sub. Req’d

Kiran Mazumdar-Shaw Advocates Dual-Agency Model for Faster Drug Approvals in India

(11/24, Vikas Dandekar, ETPharma) ...A note from Shaw to Niti Aayog, India's apex public policy think tank, calls for a dual-agency model that bifurcates the examination and approval process for newly researched drugs and devices between the Indian Council of Medical Research (ICMR), the premier medical research agency and the regulator Central Drugs Standard Control Organisation (CDSCO)... Full

Indian Pharma Ramps Up Quality & Compliance Efforts to Meet Evolving Oral Dosage form BA/BE Requirements

(11/24, Nandita Vijayasimha, Pharmabiz.com) ...Indian pharma industry is intensifying its focus on quality systems, regulatory alignment, and scientific rigor as the Central Drugs Standard Control Organisation (CDSCO) continues to strengthen expectations around bioavailability and bioequivalence (BA/BE) requirements for oral dosage forms. With increasing scrutiny on post-approval changes ranging from formulation updates to site transfers, companies are investing in more robust data packages, enhanced dissolution testing strategies, and risk-based change-management frameworks to ensure therapeutic consistency... Full

Chinese Pharma is on the Cusp of Going Global

(11/23, The Economist) ...For much of the past century drug discovery was dominated by Western firms, the companies collectively often called "big pharma". No longer. These companies face some of the steepest "patent cliffs" in their history, as drugs expected to generate more than $300bn in total revenue over the next six years will lose their patent protection by 2030. To plug the gap, big American and European firms are scouring the globe for promising molecules, and increasingly, they are finding them in China. The timing is awkward. America wants to reduce its reliance on Chinese supply chains, since it remains in a trade war that is only temporarily on hold. The government frets already about China's chokehold on active drug ingredients, for example. And rumours fly around that the White House plans to crack down on Chinese pharma, though nothing has happened so far. Yet when it comes to creating the next generation of medicines, America's drugmakers, and its patients, are likely to become more, not less, dependent on Chinese innovation... Full

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.