Monday, November 3, 2025

Teva Launches 'The Other TD' Disease Education Campaign

(11/3, The Fly) ...Teva Pharmaceuticals announced the launch of 'The Other TD,' a disease education campaign leveraging the broad recognition of football touchdowns to raise awareness and understanding of a lesser-known TD - tardive dyskinesia. The goal of the campaign is to help undiagnosed Americans living with TD, and their care partners, recognize symptoms and take action by having conversations with their healthcare provider. Terrell Davis, known for his iconic initials, "TD," and for scoring dozens of touchdowns in his career, is partnering with Teva to shine a light on 'The Other TD'... Full

Net Zero Tax ‘Will Drive Up NHS Medicine Prices'

(10/31, Hannah Boland, The Telegraph) ...Teva, which provides products including non-branded antibiotics and painkillers to the NHS, said the tax risked forcing it to redesign medicine packets and invest in changes to its machines. It said this threatened to lead to price rises of up to 20p per pack, "impacting NHS affordability". The company said the levy will also make it more difficult to keep delivering packs of medications where it marks days of the week on the foil cover to help elderly people keep up with their dosage...Teva Pharmaceuticals called for drugmakers that produce large amounts of low-cost medicines for the NHS to be exempt from the new tax, which is expected to add £1.2m annually to its costs. It said: "This would alleviate the disproportionate burden on high-volume, low-margin medicines, protecting NHS affordability."... Full

FDA: Once Again a Blood Pressure Medication Recall for Cancer Concerns

(10/31, Bruce Y. Lee, Forbes) ...Teva USA has determined that the overall harm to the patient population will be "medium," according to a memo from the Califonia Board of Pharmacy Having limited exposure to relatively small amounts of a carcinogen over a short amount of time may have little effect. However, the risk of getting cancer does increase as you get exposed to more and more of the carcinogen over longer and longer periods of time... Full

Blood Pressure Medicine Recalled After Drug Makers Say It Was Tainted with Cancer-Causing Chemical

(11/1, Charlotte Phillipp, People) ...The FDA announced that Teva Pharmaceuticals USA and Amerisource Health Services issued voluntary recalls for blood pressure medication prazosin hydrochloride...The drug makers said the pill capsules may have nitrosamine impurities — or "No-nitroso Prazosin impurity C" — that are considered potentially cancer causing. About 580,000 bottles of various strengths have been recalled for having the impurities... Full

Drugmakers Recall Blood Pressure Pills Contaminated with Cancer-Causing Chemical, FDA Says

(10/31, David Unyime Nkanta, International Business Times UK) ...While the immediate health risk from prazosin contamination remains low, the recall underscores persistent gaps in pharmaceutical manufacturing oversight. Patients are urged to verify their medication, consult healthcare providers for alternatives, and report any adverse reactions. The FDA continues to monitor Teva's corrective actions and evaluate long-term safeguards to prevent future contamination... Full

Drugmakers Continue ‘Thought-Provoking' Price Talks with White House After Pfizer, AstraZeneca Deals

(10/31, Alexis Kramer, Endpoints News) ...The Trump administration's negotiations with large pharma companies are making gradual progress, according to top drugmaker CEOs, though none suggested that a new deal was imminent. On quarterly earnings calls in recent days, executives from Bristol Myers Squibb, Novartis, and others said they're having productive and frequent dialogue with the administration, after Pfizer and AstraZeneca reached "most favored nation" deals in the past month... Sub. Req’d

AbbVie Says Trump Pressing for Larger Medicare Drug Price Cuts

(10/31, Patrick Wingrove and Puyaan Singh, Reuters) ...AbbVie said on Friday the Trump administration was pushing for steeper cuts in this year's Medicare drug price negotiations, which in 2024 yielded discounts of as much as 79%. AbbVie's irritable bowel syndrome drug Linzess and antipsychotic medication Vraylar were among the 15 drugs targeted this year for Medicare price negotiations that end on Saturday. The company said these cuts, which have yet to be made public and will take effect in 2027, would not affect its long-term guidance... Full

Dr. Makary, Dr. Oz: People Talk About Lowering Health Care Costs, But the Trump Administration is Doing it

(11/3, Dr. Marty Makary, Dr. Mehmet Oz, Fox News) ...We are choosing to enact meaningful reforms now that will bring a generation of fair prices to health care. Generic drugs have saved Americans trillions of dollars over the years, making important medical treatments affordable and within reach for many. Let's do the same with biosimilars... Full

Pink Sheet Podcast: US FDA Cuts Biosimilar Requirements, Clarifies Inspection Reform

(10/31, Derrick Gingery, Sue Sutter, and Nielsen Hobbs, Pink Sheet) ...Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its "Simple Reform" of the inspection staff... Global Sub. Full

Stakeholders Emphasize Pharma's Role After ICER Launch Price Report

(10/31, Luke Zarzecki, Inside Health Policy) ...Views are mixed on a report from the Institute for Clinical and Economic Review (ICER) released last Thursday (Oct. 23) that found drug launch prices are rising at higher rates than inflation, gross domestic product growth (GDP) and health care costs, with the pharmacy benefit manager and insurance lobbies saying drugmakers are responsible for rising prices and a pharmaceutical industry group critiquing the report... Sub. Req’d

PDUFA: Essential to America's Edge in Drug Development and Patient Access

(10/31, Lucy Vereshchagina, PhD., PhRMA) ...PhRMA recently participated in the U.S. [FDA's] public meeting to discuss the reauthorization of the Prescription Drug User Fee Act (PDUFA), where we shared how the program continues to benefit countless patients by ensuring they are afforded timely access to safe and effective innovative medicines... Full

Changes for Biosimilar Product Approvals – A Flash from AAM Meeting

(10/31, Bob Pollock, Lachman Consultants) ...The perhaps the next guidance document that the FDA will issue will be on biosimilar interchangeability and perhaps it will be coupled with a revision of the Biologics Price Competition and Innovation Act (BPCIA) to amend its interchangeability language to better protect the FDA's revised thinking on how it views interchangeability of biosimilars with their reference products... Full

More from AAM's GRx+Biosims Meeting

(10/31, Martin Shimer, Lachman Consultants) ...Johnny Young, M.S., Director for the Division of Filing Review, noted that currently about 4% of ANDAs were determined to be incomplete at filing, resulting in the issuance of refuse-to-receive letters. Of these ANDAs, about 21% were refused due to incomplete stability, 19% were refused for non-Q1/Q2 determinations, and 16% were refused for issues related to incomplete or improper 356h forms. The statistic that jumps out to me here is the 16% related to a sponsor's 356h... Full

Novel US FDA Approvals Could Heat Up November, But Will Annual Count Beat 2024?

(10/31, Bridget Silverman, Pink Sheet) ...The US FDA's November 2025 calendar include at least 16 user fee goals, including eight new molecular entities. The 2025 novel approval count at the end of October is only slightly behind novel approvals at the same point in 2024, but to remain in parity at year-end the FDA must approve most of the 21 novel agents remaining with 2025 user fee goal dates or approve some 2026 candidates early. Rare disease drugs dominate the November calendar, but many target orphan markets with existing competition, including Immunoglobulin A nephropathy, achondroplasia, familial chylomicronemia syndrome, and non-small cell lung cancer with HER2 activating mutations... Global Sub. Full

FDA's Top Drug Regulator Resigns Amid Investigation

(11/2, Lizzy Lawrence, Adam Feuerstein, STAT+) ...In an interview with STAT, Tidmarsh confirmed he was placed on leave from his role as the director of the FDA's Center for Drug Evaluation and Research. Makary informed him about Tang's complaint on Friday, but Tidmarsh did not find out he had been placed on leave until he was locked out of his agency email account on Saturday. Tidmarsh denies any wrongdoing. In a statement, a spokesperson for the Department of Health and Human Services, which oversees the FDA, said Tidmarsh resigned Sunday morning "effective immediately."... Sub. Req’d

Youngkin Announces $120 Million Pharma Training Center Partnership

(11/1, Mark Gad, CBS19 News) ...Governor Glenn Youngkin on Friday announced a new partnership between the Virginia Innovation Partnership Corporation and three major pharmaceutical companies — AstraZeneca, Eli Lilly, and Merck. Together, they've committed up to $120 million to launch the Virginia Center for Advanced Pharmaceutical Manufacturing, which will serve as the largest training facility of its kind in the country. "This facility will train between two and two-and-a-half thousand professionals every year to take great jobs across the Commonwealth of Virginia," Youngkin said... Full

AI Drug Developer Partners With Big Pharma And Amazon, Expects Korea Collaborations

(11/3, Yeom Hyun-a, ChosunBiz) ...Mati Gill, CEO of AION Labs in Israel, said in an interview with ChosunBiz at Walkerhill Hotel in Seoul on the 28th, "The true value of AI drug development has yet to be proven, but within the next five years the first AI-approved new drug will emerge." Gill visited Korea to attend DIPS Global TechCon, the official business event of the Asia-Pacific Economic Cooperation (APEC)...Gill said, "Teva adopted advanced technologies such as AI, Machine Learning, computational biology, and computational chemistry to find new growth engines after its flagship multiple sclerosis treatment Copaxone, but its internal capabilities were lacking," adding, "To overcome this limitation, we founded AION Labs as an innovation model that collaborates with global pharmaceutical companies."... Full

Bittersweet Simponi Verdict For Alvotech As US FDA Knocks Back Golimumab Filing

(11/3, Dave Wallace, Generics Bulletin) ...The US Food and Drug Administration has issued a complete response letter to Alvotech over its Teva-partnered AVT05 proposed golimumab biosimilar to Simponi and Simponi Aria. While the FDA said the biologics license application could not be approved until deficiencies were resolved at Alvotech's Reykjavik manufacturing facility, the agency did not identify any other deficiencies with the application. The setback for Alvotech and Teva could offer an opportunity for partners Bio-Thera and Intas, which have also filed a golimumab biosimilar with the FDA... Global Sub. Full

FDA Grants Interchangeability Status to Celltrion's Stoboclo and Osenvelt

(10/31, The Pharma Letter) ...South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has designated Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable biosimilars to the reference products Prolia (denosumab) and Xgeva (denosumab) from Amgen, respectively, for all approved indications... Sub. Req’d

Dr Reddy's Knocked Back On Canadian Semaglutide

(10/31, Anju Ghangurde, Generics Bulletin) ...Dr Reddy's had not ruled out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling "all its capacity" for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties... Global Sub. Full

Samsung Biologics Spins Off Samsung Bioepis Holdings to Pivot to Pure CDMO Role

(11/3, Heo Ji-yoon, ChosunBiz) ...The officially launched Samsung Bioepis Holdings will have Samsung Bioepis, a biopharmaceutical development and commercialization company focused on the biosimilar (biopharmaceutical copycat drug) business, as a 100% subsidiary, and plans to promote a bio-technology platform development business by establishing a separate subsidiary. The first CEO role will be concurrently held by Kim Kyung-ah, CEO of Samsung Bioepis... Full

Provider Perspectives on Biosimilars Amid an Evolving Market

(10/31, Naveed Saleh, MD, MS, Dermatology Advisor) ...The introduction of biologics has been revolutionary across the spectrum of inflammatory diseases. However, these medications are not easily accessible for all patients as they are often expensive due to their complex development, manufacturing, testing, and approval processes...To further examine the role of biosimilars among patients with psoriasis, we spoke with 3 board-certified dermatologists about their experiences with biosimilars in clinical practice... Full

AbbVie Boosts Revenue Forecast by $400M Thanks to Booming Sales of Skyrizi, Rinvoq

(10/31, Kevin Dunleavy, Fierce Pharma) ...For the third straight quarter, AbbVie has jacked up its revenue forecast for 2025. The Illinois drugmaker has raised its guidance by $400 million, now expecting sales to reach $60.9 billion. The estimate is $1.9 billion higher than AbbVie's projection from the start of the year, another indication that the company continues to be surprised by the performance of immunology stalwarts Skyrizi and Rinvoq and that it has rebounded from the 2023 loss of patent protection in the United States for Humira, the first drug ever to generate more than $20 billion in annual sales... Full

India's Gland Pharma Posts Higher Quarterly Profit on Cenexi Boost

(11/3, Kashish Tandon, Reuters) ...India's Gland Pharma reported a 12% rise in second-quarter profit on Monday, as recovery at its European unit Cenexi bolstered margins...Indian generic drug makers, including Gland, derive a significant share of revenue from the United States, and have faced pricing pressure in the market following the imposition of hefty U.S. tariffs on goods from India... Full

BioNTech Ups Sales Guidance After Bristol Myers' Bispecific Payment

(11/3, Elizabeth Cairns, Endpoints News) ...The German biotech said in its third-quarter earnings Monday that it now expects to earn between €2.6 billion ($3 billion) and €2.8 billion ($3.2 billion) this year. Three months ago, it forecast its 2025 revenues at €1.7 billion ($2.0 billion) to €2.2 billion ($2.5 billion). BioNTech is working with Bristol Myers on pumitamig. Previously called BNT327, the antibody is in late-stage trials in lung and breast cancers, and in Phase 2 and earlier studies in a range of other tumor types... Sub. Req’d

Pfizer Sues Metsera, Novo Nordisk Over Rival Obesity Drug Bid

(10/31, Kamal Choudhury, Sabrina Valle, Tom Hals, Reuters) ...Pfizer on Friday filed a lawsuit against Metsera and Novo Nordisk, saying Metsera breached its merger agreement obligations in declaring the Danish drugmaker's $8.5 billion bid for the U.S. obesity drug developer to be a superior offer..."Pfizer's claims against Novo Nordisk are meritless, and we will vigorously defend ourselves in any litigation," a Novo spokesperson said. Metsera said in a statement that it disagreed with Pfizer's allegations and would address them in court... Full

Why Pfizer Can Still Prevail in the Obesity Fight With Novo Nordisk

(11/2, David Wainer, The Wall Street Journal) ...Novo's bid to regain its footing has taken a form unthinkable under past leadership: an unsolicited $9 billion offer to pry Metsera, the developer of a monthly injection, away from Pfizer, which had agreed to buy it in a deal valued at up to $7.3 billion. It is a bold move for a company that mostly shied away from dealmaking under past leadership. In this case it also looks like a move born of frustration, one that is now making Novo investors uneasy...If Pfizer wants a foothold in the obesity race, swallowing a higher price for Metsera might be the cost of admission... Sub. Req’d

JB Pharma, USV Recall Drugs in US

(11/3, ETPharma) ...According to the US FDA latest enforcement report, JB Pharma has ordered two separate recalls of 23,376 —'9,936 and 13,440'—bottles of Cetirizine Hydrochloride Tablets due to the imprinting of the wrong ID on the tablets...Meanwhile, USV is recalling 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution due to the identification of an individual unspecified impurity beyond the permissible limit... Full

The Big Flaw in Big Pharma's ‘Patient Advocacy'

(11/3, Will Greene, STAT+) ...Every year, pharmaceutical companies spend millions on "patient advocacy." At its best, this supports families, advances science, and builds genuine partnerships. But too often, those dollars pay for glossy campaigns or photo-friendly projects that do little for the people they're intended to help...This isn't just an empathy problem. What gets labeled as patient advocacy is often shaped by groupthink, complacency, or a lack of imagination inside organizations. These dynamics can drain energy from well-intentioned work. Here are three ways I've seen this happen repeatedly... Sub. Req’d

Q&A: The Economic Forces That Drive Prescription Drug Prices

(10/30, Jake Miller, Harvard Medical School) ...Luca Maini, assistant professor of health care policy in the Blavatnik Institute at Harvard Medical School, studies competition and regulation in pharmaceutical markets...Harvard Medicine News spoke with Maini to understand the stakes and the many factors at play with talk of tariffs on pharmaceuticals, direct-to-consumer sales of prescription medications, and the U.S. federal administration's negotiations with pharmaceutical manufacturers... Full

Global Biosimilars Week 2025 Launches: Advancing Health Equity Through Wise Investment in Access to Medicines

(11/2, IGBA) ...Today marks the launch of Global Biosimilars Week 2025, an international awareness campaign led by the International Generic and Biosimilar Medicines Association (IGBA). This year's theme, "Biosimilars: A Wise Investment for Global Health," highlights the growing importance of biosimilar medicines in improving access to treatment, enhancing healthcare sustainability, and promoting global health equity... Full

New NHS-Pharma Partnership Could Revolutionise Healthcare in Wales

(11/3, National Health Executive) ...Aimed at NHS organisations in Wales, pharmaceutical industry leaders and those leading on partnership and transformation agendas in their organisation or system, the guidance responds to feedback to address barriers such as culture, trust, and operational challenges. It provides step-by-step resources to support partnership planning, contracting, delivery, and measurement, with frameworks suitable for use at all levels... Full

The NHS Drug Price Dilemma

(11/3, Sophie Cousins, Medscape) ...Research published in The Lancet last year found that between 2000 and 2020, new drugs delivered 3.75 million additional QALYs at a cost of £75 billion. Redirecting that money to existing NHS services could have potentially added 5 million additional QALYs. For lead author Huseyin Naci, associate professor of health policy at the London School of Economics and Political Science, the findings were striking. "Every pound spent on a new drug is a pound not spent elsewhere," he told Medscape News UK. "We found that while new medicines delivered real health gains, the same investment in existing NHS services could have delivered even more."... Full

Lucrative Drug Patents in Ireland Threatened By US Tariffs

(11/3, Saim Saeed, Bloomberg Law) ...As tariffs begin to take their toll on Irish exports, some of the world's biggest pharmaceutical companies are assessing whether their decades-long arrangement to house intellectual property in Ireland is still viable. The tariffs are also injecting a new sense of urgency in the Irish government to up its game by making its IP rules and research and development credits more attractive, with the hope of giving companies added reasons to stay put... Sub. Req’d

India's GLP-1 Surge: Domestic Drugmakers Challenge Novo and Lilly

(11/3, The Pharma Letter) ...Though global players like Novo Nordisk and Eli Lilly dominate the branded GLP-1 space, Indian pharma is rapidly gaining ground, both domestically and in export markets, with a potential $20 billion opportunity on the horizon, reports The Pharma Letter's India correspondent. Home to over 100 million obese adults and often dubbed the diabetes capital of the world, India is emerging as a pivotal force in the global metabolic health revolution. With GLP-1 drugs projected to reach $150 billion globally by 2030, Indian pharma companies are preparing to enter with generics and biosimilars... Sub. Req’d

Patent Gridlock Threatens India's GLP-1 Breakout

(11/3, The Pharma Letter) ...Despite surging demand for affordable GLP-1 treatments, India's path to generic semaglutide is far from smooth. Even as IN 275964, the composition patent for (Wegovy) semaglutide was set to expire in September 2024, domestic players like Dr Reddy's Laboratories and Natco Pharma had accelerated development, aiming to undercut Novo Nordisk's $191 - $281 per month Wegovy pricing with sub-$6 generics... Sub. Req’d

Prescribe Generic Drugs, Wear Name Tags, Haryana Tells Government Doctors

(11/1, Ipsita Pati, The Times of India) ...In a move to tighten discipline inside its public hospitals, Haryana ordered doctors at govt hospitals to prescribe only generic medicines and ensure staff wear name tags while on duty. The directives, issued by Haryana State Health Resource Centre (HSHRC), came after field inspections flagged several violations... Full

Tech Link Critical for Pharma Supply Chains to Onboard New Modalities: Experts

(11/2, Prathiba Raju, Abhijeet Singh, ETPharma) ...For the world's pharmacy, the distribution of drugs goes through a complex cycle where every step requires precision, compliance, and strict adherence to quality control measures...To discuss this topic with industry experts at the recently concluded ETPharma's third edition Future Ready Supply Chain Summit convened a panel discussion focusing on Seamless Synergy: Enabling Multi-Modal Integration in Pharma, Medical Device & Bio Pharm Logistics... Full

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