Tuesday, May 27, 2025

Teva Brings In European Trastuzumab With Prestige BioPharma Agreement

(5/27, Dean Rudge, Generics Bulletin) ...Teva will now market biosimilar Herceptin in both the US and Europe, after penning an agreement with Singaporean firm Prestige BioPharma for its Tuznue rival to the monoclonal antibody to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer...Commented Teva's CEO, Richard Francis: "I think it's important to understand that our biosimilar portfolio will become more global as the years go on. And it's an extensive biosimilar portfolio, hence the reason why we believe that can actually drive some good growth between now and 2027."... Global Sub. Full

Prestige Biopharma Inks European Licensing Deal with Teva for Herceptin Biosimilar

(5/26, Lee Han-soo, Korea Biomedical Review) ...The agreement grants Teva exclusive commercialization rights for Tuznue across 31 European markets, including the United Kingdom, Germany, France, Italy, Spain, Portugal, Switzerland, and Sweden... Full

Teva, Biolojic Design Initiate IND-Enabling Studies of BD9

(5/27, The Fly) ...Teva has an exclusive license to develop BD9 for the treatment of TH2-driven inflammatory diseases such as atopic dermatitis and asthma. Teva's development of BD9 demonstrates the company's commitment to applying cutting-edge science to address unmet medical needs... This progress exemplifies Teva's focus on advancing transformative therapies that expand access and impact through innovation... Full

Biopharma Leaders Connect to Advance Development and Manufacturing at Veeva R&D and Quality Summit Europe

(5/27, Veeva Systems) ...Biopharma professionals will convene to learn how the industry is advancing across clinical, regulatory, safety, and quality. The opening keynote will also highlight Veeva AI, a major initiative to add AI to the Veeva Vault Platform and Veeva applications to help automate critical functions and improve productivity...Teva, highlighting how innovation, agility, and a data-driven mindset are helping it navigate regulatory change and drive efficiency... Full

Through Expanded Mental Health Services, Free Clinics Provide "A Light at the End of the Tunnel"

(5/27, Olivia Lewis, DirectRelief) ...The free clinic began offering counseling and therapy sessions to low-income and unhoused people at the start of the year, with funding from the Community Routes: Access to Mental Health Care program, a partnership with Teva Pharmaceuticals, the National Association of Free and Charitable Clinics, and Direct Relief. Eleven free and charitable clinics/pharmacies across Alabama, Mississippi, and Texas received support to expand mental health programming to patients... Full

Advanz Allies With Pharmathen On Long-Acting Injectable

(5/26, Dave Wallace, Generics Bulletin) ...Advanz Pharma and Pharmathen have allied for an exclusive license and supply agreement on a long-acting injectable. Through the deal, Advanz will gain exclusive commercialization rights to the product in select European countries, including the UK, as well as in Australia. The collaboration comes after Pharmathen recently struck another LAI co-development deal with Neuraxpharm... Global Sub. Full

Lupin and SteinCares Ink License and Supply Agreement for Ranibizumab in Latin America

(5/26, Pharmabiz.com) ...Global Pharma major Lupin Limited announced that it has entered into a license and supply agreement with SteinCares, a leading specialty healthcare company in Latin America, for commercialization of Lupin's biosimilar ranibizumab across Latin America excluding Mexico and Argentina. Under the terms of the agreement, SteinCares will handle all regulatory filings, registrations and commercialization of ranibizumab in LATAM, while Lupin will be responsible for manufacturing the same... Full

Bio-Thera Solutions And Hikma Pharma Say FDA Approved STARJEMZA Injection

(5/27, RTT News) ...Bio-Thera and Hikma reached a license and commercialization agreement for STARJEMZA in August 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Hikma is responsible for the commercialization of STARJEMZA in the United States... Full

Biocon Biologics Receives UK MHRA Marketing Approval for Yesintek, Biosimilar of Ustekinumab

(5/26, Pharmabiz.com) ...Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon received the approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to market Yesintek, a biosimilar of ustekinumab in the United Kingdom... Full

FDA Grants Expanded Interchangeability Designation to Yuflyma

(5/23, Ashley Gallagher, Drug Topics) ...The FDA granted an expanded interchangeability designation for adalimumab-aaty (Yuflyma) to include prefilled syringes and autoinjectors, which are now fully interchangeable with the reference product, adalimumab (Humira), across marketed dosage forms and strengths. Adalimumab-aaty is a high-concentration, citrate-free biosimilar to Humira... Full

Roche Moves Antibiotic Against Superbug into Phase 3 of Testing

(5/26, Ludwig Burger, Reuters) ...Roche said in a statement that the experimental antibiotic zosurabalpin, jointly developed with Harvard University, would be tested against acinetobacter baumannii, relying on a new mode of action that bacteria have not developed resistance against... Full

After Keytruda Combo Win, Gilead's Trodelvy Meets the Mark in Solo Breast Cancer Trial

(5/23, Fraiser Kansteiner, Fierce Pharma) ...In the late-stage Ascent-03 trial, Trodelvy bested standard-of-care chemotherapy at extending the time before disease worsening or death in certain patients with previously untreated metastatic triple-negative breast cancer (TNBC). The study specifically assessed the TROP2-targeted ADC in patients who aren't candidates for PD-1 or PD-L1 inhibitors, either because their tumors don't express the PD-L1 protein or because the patients are ineligible for immunotherapy treatment, Gilead said Friday... Full

Zydus To Continue Mirabegron Sales

(5/26, Vibha Ravi, Generics Bulletin) ...Zydus Lifesciences is optimistic about continuing its mirabegron sales despite upcoming litigation. FY26 performance in the US is forecast to be strong with new launches and base business growth compensating for a drop in margins on a few key products. The vaccines segment, notably through a unique dual vaccine against shigellosis and typhoid, is a focus area of growth moving forward. Zydus plans to launch saroglitazar for the primary biliary cholangitis (PBC) indication on its own in the US... Sub. Req’d

Bayer Says Aurobindo's Launch of Xarelto Copies Defied Pact

(5/23, Christopher Yasiejko, Bloomberg Law) ...Aurobindo Pharma Ltd.'s April launch of its copy of the blockbuster blood thinner Xarelto violated a confidential patent settlement it reached last year with Bayer AG and Johnson & Johnson's Janssen unit, according to a federal lawsuit... Sub. Req’d

Dr Reddy's Gets 2 Observations from USFDA for Telangana API Plant

(5/25, Press Trust Of India) ...Dr. Reddy's Laboratories received a Form 483 with two observations following a GMP inspection by the USFDA at its API manufacturing plant (CTO-5) in Miryalaguda, Telangana. The inspection, conducted from May 19 to May 24, 2025, identified potential violations of the Food Drug and Cosmetic Act. The company plans to address the concerns within the given timeframe... Full

US Patients Struggle as Weight-Loss Drug Discounts Fall Short

(5/23, Sriparna Roy, Reuters) ...After years of easily available, cheap copies of Eli Lilly's and Novo Nordisk's highly effective weight-loss drugs, some U.S. patients say they are unwilling to pay more and are pursuing alternatives to get around the regulatory deadline for compounding pharmacies to stop making them... Full

The Cost of Weight Loss Drugs is Finally Dropping. How Low Can Prices Go?

(5/27, Berkeley Lovelace Jr., NBC News) ...Wegovy and Zepbound, which both sell for a list price of more than $1,000 a month, have long been out of reach for people without insurance or whose insurance refused to cover them. Among adults who take the medications, about half say it's difficult to afford the cost, according to a May 2024 survey by the health policy group KFF. Over the past several months, however, drugmakers Novo Nordisk and Eli Lilly have introduced lower-cost options. There are some caveats — people must pay out of pocket, or the medication is sold in a vial rather than a prefilled injector pen — but doctors and patients say the changes are long overdue... Full

A Long Talk With Mark Cuban

(5/27, Benhamin Hart, Intelligencer) ...Cuban's main business these days is Cost Plus Drugs, a drug distributor and manufacturer, with which he is hoping to bring transparency to the notoriously opaque health care industry. I spoke with Cuban last week in a wide-ranging conversation that touched on his battle against the health care industry, basketball (we talked a day after Tyrese Haliburton's Game-One buzzer beater against the Knicks); why he thinks AI is the future of everything, and more... Full

Trump's Drug Price Plan Seeks Leverage With FDA Withdrawal Power

(5/27, Nyah Phengsitthy, Bloomberg Law) ...One way the administration may seek to persuade manufacturers to negotiate is through a provision that directs the FDA to review, modify, or revoke approvals for drugs that may be unsafe, ineffective, or improperly marketed if there isn't "significant progress" toward reaching a pricing agreement. It's unclear what legal authority the Food and Drug Administration has to carry out the directive, which the pharmaceutical industry may perceive as a threat. The agency has the power under federal statute to remove or modify drug approvals if they're no longer considered safe or effective, but it lacks authority to pull medicines over pricing... Sub. Req’d

Trump's Drug Price Plan May Hinge On Congress

(5/27, Caitlin Owens, Axios) ...Yes, there's a very strong case for why MFN is going nowhere on the Hill. And yet, stranger things have already happened during Trump's tenure, as the GOP's populist streak overtakes traditional free-market conservatism. "Before the end of this Congress, I feel pretty confident betting that MFN will end up as the law of the land. And as a human consumer of pharma, do I think that's a disaster? Yes," said one former senior GOP Senate aide. "But politically it's a no-brainer."... Full

On US And Foreign Drug Prices, ‘Most Favored Nation' Policy Is An Unreasonable Answer To A Reasonable Question

(5/23, James C. Robinson, Health Affairs) ...The announcement of the MFN was loud yet vague, and implementation will face innumerable obstacles. The financial markets quickly shrugged it off. Nevertheless, the proposal signals a willingness to ask the questions policy insiders avoid and demand a solution for a problem that many would like to ignore... Full

After MAHA Report Flags Pediatric Drug Harms, PhRMA Pushes Back

(5/23, Maaisha Osman, Inside Health Policy) ...The inaugural report from the Make America Health Again (MAHA) Commission raises alarms about the widespread use of certain medical interventions in children -- alleging many are harmful, ineffective, and in some cases, outright dangerous. The report takes aim at everything from psychiatric drugs and surgeries to overprescribed antibiotics, alleging many are used despite limited or no evidence of benefit. But the pharmaceutical industry is pushing back, accusing the commission of spreading misleading claims that ignore the life-saving value of medicines... Sub. Req’d

PhRMA's Statement On the MAHA Commission Report

(5/22, PhRMA) ...Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement on today's Make America Healthy Again (MAHA) Commission report: "The administration is right to focus on understanding the root causes of chronic disease in children, including food, environmental toxins and other lifestyle factors. But when people get sick, they should have every option available to them to get better – including medicines. Medicines are part of the solution, not the cause of chronic disease. That's why our industry wakes up every day focused on developing new treatments to fight and prevent disease." The report made several untrue or misleading claims... Full

ICER Preps For Inaugural Annual Report On Drug List Prices & Access

(5/23, Gabrielle Wanneh, Inside Health Policy) ...ICER will start developing the new report by identifying all novel agents approved by FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the United States from January 2022 to December 2024, though it will exclude any generic drugs, biosimilars, vaccines, antibiotics, microbiota products, blood or plasma-based products, and imaging or diagnostic agents due to different pricing strategies and market dynamics... Sub. Req’d

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

(5/26, Laura Helbling, Pink Sheet) ...Sen. Gary Peters said the BIOSECURE Act would emerge again, likely with some changes based on adjustments made when the bill moved through Congress last year. Among the issues still to be clarified is a mechanism to prevent targeted companies from shutting down and reopening under a different name. Legislation on gain-of-function research and data privacy also is in the works, Peters said... Global Sub. Full

US Warns Drugmakers Against Misrepresenting Cost of Imported Products

(5/23, Drew Armstrong and Anna Brown, Endpoints News) ...In a statement Thursday, the agency said that "declaring incorrect value on import or export documentation submitted to CBP is considered trade evasion, and CBP will pursue any violations to the fullest extent possible." The statement doesn't specifically mention tariffs but appears aimed at drugmakers who might try to circumvent or limit them. Endpoints News reported Thursday that drug developers may be considering using a principle known as the "first sale" rule, which could let them decrease the value of a drug declared at the border, lowering any tariff duty they would have to pay... Sub. Req’d

Competition Beats Price Controls — and Patients Pay the Price When We Forget It

(5/22, Biosimilars Council) ...Unless policymakers act now to reform the IRA price-setting process, speed the approval of biosimilars, end patent thickets, and support adoption of lower-cost options, they will entrench monopolies, stifle future savings, and deny patients better access to affordable medicines. Let's not undermine the engine that drives innovation, lowers costs, and expands access. Competition works — if policymakers will let it... Full

Rising Drug Prices Add to Healthcare Uncertainties

(5/26, Brenda Destro, RealClearHealth) ...As drug companies face the possibility of increasing costs due to tariffs, there is little doubt that the impact on healthcare will be significant. According to an Ernst & Young analysis, tariffs could increase annual U.S. drug costs by nearly $51 billion and raise prices on some cancer treatments by as much as $10,000 per course. Generic drugs, which account for 90% of prescriptions filled in the U.S., could increase from 82 to 94 cents per pill—an 11% jump with broad system-wide impacts. If drug companies decide to simply pass along those costs to consumers, the shockwaves will ripple throughout the healthcare system and into every home in America... Full

About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds

(5/23, Zachary Brennan, Endpoints News) ...Nearly one out of every 20 staff in the FDA offices that oversee drugs and biologics are gone after the Trump administration cut thousands of agency roles and offered buyouts, according to an analysis by the investment bank Bernstein... Sub. Req’d

Amgen's Enbrel Targeted as Colorado Panel Works On Payment Cap

(5/23, Celine Castronuovo, Bloomberg Law) ...Board members said in their first rulemaking hearing on setting an upper payment limit for Amgen Inc.‘s top-selling drug that they may set a cap that's at or above Medicare's annual maximum fair price of roughly $30,000 per patient for 2026. The Medicare negotiated price for Enbrel set under the Inflation Reduction Act drug price program is set to take effect January 2026... Sub. Req’d

Drug Trade Group Lobs Latest Challenge to Tennessee Pharmacy Law

(5/23, Ganny Belloni, Bloomberg Law) ...The Pharmaceutical Research and Manufacturers of America, a key trade group representing the interest of companies including Eli Lilly & Co., Novo Nordisk A/S, and Merck & Co., filed a lawsuit Thursday in the US District Court for the Middle District of Tennessee alleging a Tennessee contact pharmacy law violates the Constitution's supremacy clause because it attempts to "rewrite the terms" of the federal 340B drug discount program... Sub. Req’d

NY Bill Targeting Pharmacy Benefit Managers Faces Union Pushback

(5/27, Zach Williams, Bloomberg Law) ...Pharmacy benefit managers—which negotiate prescription drug prices among pharmaceutical companies, insurers and pharmacies—would have to pay independent pharmacies a minimum rate for filling prescriptions under the measure (A.B. 5882). That could lead to higher consumer costs, according to PBMs. Groups representing New York City teachers and municipal workers oppose the bill as written, complicating its chances for passage before the session ends in mid-June... Sub. Req’d

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

(5/26, Bridget Silverman, Pink Sheet) ...Only 12% of novel agents approved in the US in 2025 have previously been approved in Europe, while 64% of EU approvals already had been approved in the US. Contract manufacturing of biologics was the most common reason for US delays for EU-approved products in a Pink Sheet analysis. Disputes with the US FDA over clinical data integrity and comparability also delayed US approval beyond EU action... Global Sub. Full

Swiss President to Hold Talks in Ireland Amid US Focus On Pharma Industry

(5/26, Dave Graham, Reuters) ...Switzerland's President Karin Keller-Sutter will travel to Ireland for high-level talks this week, her government said on Monday, the first visit by a Swiss president to the country since 2012. Both countries are trying to navigate U.S. policy challenges for their major pharmaceutical industries, after President Donald Trump this month issued an executive order directing drugmakers to quickly lower drug prices... Full

Harris Urges US Against Tariff Hikes On Pharma and Microchip Sectors

(5/25, David Young, Independent) ...Simon Harris has written to US Secretary for Commerce Howard Lutnick following the latter's instigation of two investigations examining whether the United States' reliance on foreign imports in those sectors poses a risk to national security. The outcome of the investigations could result in significant tariffs being imposed on pharmaceutical and semiconductors sold into the US from abroad... Full

What New Zealand Could Gain from India's Booming Pharmaceutical Sector

(5/26, Jogai Ghatt, RNZ) ...Generic drugs have been found to be just as safe and effective as brand-name ones and cost significantly less. However, New Zealand has stricter regulations on importing them. Before entering the New Zealand market, generics must be deemed bioequivalent to the original drug - meaning they need the same active ingredients, dosage form, strength and absorption rate - verified through rigorous Medsafe testing. A free trade agreement between the two nations would remove significant barriers to importing generics into New Zealand... Full

Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

(5/26, Lisa Takagi, Pink Sheet) ...Japan's new pricing list took effect on May 21, 2025 includes Camzyos by BMS, BridgeBio/Alexion (AZ)'s Beyonttra. MSD's cytomegalovirus (CMV) antiviral Prevymis had 20% premium awarded for its pediatric formula. Market Expansion Repricing scheme will slash Byer's Eylea (-20%) and BI's Jardiance (-12%) and its competitors from August 1, 2025... Global Sub. Full

China to Revise Drug Procurement Credit Evaluation System to Curb Inflating Prices, Sources Say

(5/27, Guo Jinhui, Yicai) ...The National Healthcare Security Administration will soon release a revised version of the Drug Pricing and Procurement Credit Evaluation System, sources close to the matter told Yicai. This will include guiding documents to standardize the credit evaluation process and the latest lists of untrustworthy enterprises and related projects, they added... Full

AbbVie, Gilead, UCB Collect Korea Nods for June Reimbursement Lineup

(5/23, Kim Ji-hye , Korea Biomedical Review) ...Korea's national health insurance program is expanding coverage across autoimmune diseases, oncology, and inflammation with four major drug additions set to take effect June 1. The update adds UCB's Bimzelx, Gilead's Trodelvy, AbbVie's Rinvoq, and Celltrion's biosimilar to Roche's Actemra to the reimbursement list... Full

Korean Pharma Industry Proposes Policies As Election Nears

(5/25, Jung Won Shin, Pink Sheet) ...With South Korea's presidential election now less than two weeks away, candidates are ramping up their campaigns, but their key pledges remain short on specific biopharma policies. The main domestic biopharma association, the KPBMA, has proposed a wish list of 10 key policies, including acceleration of AI-based digital transformation and predictable policies to support innovation and investment. The group also wants to see a new big data platform to support new drug R&D and a predictable drug price road map... Global Sub. Full

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