Tuesday, October 21, 2025

Teva Reaches License Deal With Prestige Biopharma for Cancer Medication in Europe

(10/20, Dean Seal, Dow Jones) ...Teva Pharmaceuticals International said Monday that Prestige received marketing authorization last year from the European Commission for Tuznue, a biosimilar to Herceptin approved for the treatment of breast cancer and metastatic gastric cancer... Full

Teva to Commercialise Tuznue for Prestige Biopharma Across Europe

(10/20, Elijah Dale, Alliance News) ...Under the terms of the agreement, Teva, a Tel Aviv-based pharmaceutical company, will leverage its commercial network and proven expertise in biosimilars to market and distribute Tuznue in the majority of Europe. "Our deep commercial experience in biosimilars and broad sales and marketing reach across Europe enables us to bring critical medicines to patients," said Richard Daniell, executive vice president, European Commercial, Teva... Full

Formycon, Teva Pharma Launch FYB201/Ranivisio Biosimilar In Pre-filled Syringe In Europe

(10/21, RTT News) ...Formycon AG, Bioeq AG and Teva Pharmaceutical Industries Ltd. on Tuesday announced the launch of FYB201/Ranivisio or ranibizumab in Europe as the first Lucentis biosimilar available in pre-filled syringe presentation or PFS approved by European Medicines Agency for ophthalmic treatments...As per the deal, Bioeq's partner Teva will commercialize FYB201/Ranivisio pre-filled syringe across Europe... Full

Teva to Commercialize Prestige's Herceptin Biosimilar in Europe

(10/21, The Pharma Letter) ...Approved by the European Commission in September 2024, Tuznue is indicated for HER2-positive breast and gastric cancers. Teva plans to leverage its extensive commercial infrastructure to accelerate launches across Europe, expanding its biosimilar portfolio and oncology presence. The deal underscores Teva's ongoing shift away from generics toward higher-value specialty and biosimilar products... Sub. Req’d

Exclusive: Dems Look to Roll Back Drug Pricing Exemption

(10/21, Peter Sullivan, Axios) ...The bill, first shared with Axios, would repeal a provision Republicans passed in their reconciliation law in July that expands an existing exclusion for drugs that treat rare diseases from the price talks. Sponsors Peter Welch (D-Vt.), Ron Wyden (D-Ore.) and Catherine Cortez Masto (D-Nev.) cite a new Congressional Budget Office analysis finding the widened exemption will now cost $8.8 billion over 10 years, up from $4.9 billion. The new analysis takes into account that three blockbuster cancer drugs — Merck's Keytruda, Johnson & Johnson's Darzalex and Bristol Myers Squibb's Opdivo — would be cut out from price talks between manufacturers and the government, increasing the lost savings... Full

CBO Nearly Doubles Cost Analysis for Big Pharma's Blockbuster Bailout, Finding Seniors and Taxpayers Will Pay $8.8 Billion Due to Higher Drug Prices

(10/20, The Campaign for Sustainable Rx Pricing) ..."The updated analysis from CBO confirms the ORPHAN Cures Act will saddle seniors and taxpayers with billions more in higher prescription drug spending by exempting blockbuster brand name drugs and helping Big Pharma keep prices high on their biggest money makers," said CSRxP executive director Lauren Aronson. "Earlier this year, Congress passed this Big Pharma-backed rider without the right information on which brand name drugs would be impacted – or its true cost to the American people."... Full

Insight: Novo Nordisk Fights to Keep Medicaid Paying for Weight-Loss Drugs

(10/21, Dan Levine; Chad Terhune, Reuters) ...Novo's lobbying efforts helped to convince 14 U.S. states to cover Wegovy for low-income patients under their Medicaid health insurance programs. The Danish drugmaker argued that governments would save money on healthcare as more Americans lose weight and reduce their risk of diabetes, heart disease and other conditions. Instead, several states found their spending surged due to Wegovy's cost and widespread demand. California, North Carolina, Pennsylvania and Connecticut have said they'll cut weight-loss drug coverage or seek to scale it back... Full

TrumpRx Won't Change the Economics of Pharmaceuticals

(10/20, Kimberlee Josephson, The Washington Times) ...As many families on a budget know, acetaminophen is the same regardless of whether it is sold as Tylenol or as a generic brand at Costco. Quality health care is multifaceted, and price point is only one part of the equation for patients. More options for drugs often lead to lower costs, but lowering costs for drugs doesn't mean more drug options. As the saying goes, you get what you pay for... Sub. Req’d

New England Senators Reintroduce Bill Aimed at Lowering Drug Costs

(10/21, Jon Fetherston, The Maine Wire) ...The bipartisan bill would give the Food and Drug Administration stronger authority to reject citizen petitions filed to delay approval of generic drugs. The lawmakers said some companies misuse the petition process to extend patent protections and block competitors. "We know that increasing generic drug competition is key to lowering prescription drug prices for individuals and reducing drug spending overall," said Collins, Maine's senior senator. "On average, generic drugs cost 80 to 85 percent less than their brand-name equivalents."... Full

Chairman Rick Scott, Ranking Member Kirsten Gillibrand Release Investigative Report Exposing America's Dangerous Overreliance On Foreign-Made Generic Drugs, Proposing Bipartisan Policy Recommendations

(10/20, United States Senate Special Committee On Aging) ...Today, Chairman Rick Scott and Ranking Member Kirsten Gillibrand of the U.S. Senate Special Committee on Aging released an investigative report titled "Protecting Seniors' Access to Essential Medications: Securing the Foreign Generic Pharmaceutical Supply Chain." The report focuses on America's dangerous overreliance on foreign-made generic drugs, which are largely imported from India and China... Full

Direct Purchase Programs Can Lower Costs for Patients

(10/20, Caroline Dunne, PhRMA) ...Some PhRMA member companies are rolling out new platforms so patients can buy medicines directly from manufacturers – at a lower cost. Why it matters: Insurers and pharmacy benefit managers (PBMs) make millions of Americans pay full price for medicines – even when they get big discounts. Direct purchase programs (DPPs), often referred to as direct-to-consumer, allow patients, caregivers and employers to buy prescription drugs at a transparent price, and without markups that can result in patients paying more out of pocket. The current problem: Millions of Americans are paying higher cost sharing and facing new barriers that slow or prevent access to medicine... Full

Anuzis: Purchasing Directly from Manufacturers is the Real Fix for High Drug Prices

(10/20, Saul Anuzis, The Detroit News) ...Innovative companies like Mark Cuban's Cost Plus Drugs, which offers transparent cash prices for dozens of medicines, have already proven that bypassing PBMs can deliver real savings at the pharmacy counter. Major manufacturers, such as Eli Lilly and Novo Nordisk, have recently launched direct-sales programs for their blockbuster weight-loss drugs. Others are considering following in their footsteps. Unsurprisingly, this solution is popular. Surveys show that 86% of Americans in battleground congressional districts support allowing manufacturers to sell medicines directly to patients and local pharmacies...President Trump doesn't need to import socialist price controls - along with all the negative consequences they bring - to make medicines more affordable. He merely needs to pursue his excellent idea of making it easier for patients to purchase discounted medicines directly from manufacturers, so that middlemen don't siphon off savings that could otherwise go to patients... Full

Most Americans Are Concerned About Higher Health Care Costs Next Year, An AP-NORC Poll Finds?

(10/21, Ali Swenson and Linley Sanders, Associated Press) ...About 6 in 10 Americans are "extremely" or "very" concerned about their health costs going up in the next year, the survey from The Associated Press-NORC Center for Public Affairs Research finds — a worry that extends across age groups and includes people with and without health insurance. Many Americans have other health care anxieties, too. The poll found that about 4 in 10 Americans are "extremely" or "very" concerned about not being able to pay for health care or medications they need, not being able to access health care when they need it, or losing or not having health insurance... Full

FDA Review of Drugs Is Slowing While Application Delays Are Growing, Analysis Finds

(10/20, Ed Silverman, STAT+) ...There was a significant drop in drug approvals in the recently ended third quarter, more marketing applications were rejected than in previous months, and the agency delayed more reviews of those applications, the analysis by RBC Capital Markets analysts found. To wit, the rate of drug approvals was 73%, which was down from an average of 87% in the six previous quarters. The analysts also found the rate of rejected marketing applications reached 15%, up from what they termed an "historical average" of 10%. And the delay rate in meeting deadlines for completing application reviews hit 11%, up from an average of 4%... Sub. Req’d

Will US FDA's Missed Hiring Goals Impact Upcoming User Fee Negotiations?

(10/20, Derrick Gingery, Pink Sheet) ...User fee negotiations may be impacted by the FDA's missed PDUFA and BsUFA hiring goals and the Trump Administration's downsizing efforts. The FDA missed hiring goals for the first three fiscal years of the latest user fee cycle. Industry and the FDA could decide a more basic agreement that limits spending and does not create new programs could be best... Global Sub. Full

Convergence: New ICH Q1 Guideline is ‘One-Stop Shop' for Stability Testing

(10/20, Jeff Craven, Regulatory Focus) ...The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, expand its scope, and incorporate more than three decades of related stability guidance documents under one umbrella... Full

'Decade of the ADCs' Continues as AstraZeneca, Kelun and Merck Take the Stage at ESMO

(10/21, Ayisha Sharma, Endpoints News) ...While dealmaking has since slowed, the hype around ADCs has not. They're still expected to become the backbone of care for many cancers in place of traditional chemotherapy, thanks to their ability to deliver cytotoxic payloads in a more targeted way. And they're still a hot topic at this year's meeting in Berlin. We've rounded up the most impactful ADC data presented at ESMO this year... Sub. Req’d

Celltrion Secures FDA Approval for Pediatric Indications of Yuflyma

(10/20, Lee Han-soo, Korea Biomedical Review) ...The newly approved indications include pediatric uveitis and hidradenitis suppurativa. Celltrion said it obtained these approvals in line with the expiration of exclusivity for the original drug, enabling the company to enter the pediatric segment swiftly and expand its market share. With limited treatment options previously available, pediatric patients can now access Yuflyma as a more affordable therapy offering equivalent efficacy and safety to the original drug, Humira... Full

Polpharma Biologics Announces Commercial Launch of Europe's First Pre-Filled Syringe Presentation of a Ranibizumab Biosimilar

(10/21, Business Wire Staff, Polpharma Biologics) ...Ranivisio® is the first Lucentis® biosimilar which is offered in a convenient pre-filled syringe presentation in Europe, setting a new standard for affordable biologics in ophthalmic care. This innovative configuration provides precise dosing and ease of use, supporting efficient administration for patients with neovascular (wet) age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. Bioeq AG, a joint venture between Polpharma Biologics Group BV and Formycon AG, is responsible for the development and licensing of Ranivisio® PFS. Teva holds the commercialization rights for France under an exclusive licensing agreement with Bioeq... Full

Regeneron and Celltrion Settle Eylea Biosimilar Patent Fight

(10/20, Christopher Yasiejko, Bloomberg Law) ...The deal would resolve all claims between the companies in litigation consolidated in the US District Court for the Northern District of West Virginia. A stipulation and proposed order filed Monday would dismiss the Celltrion leg of the case, vacate a 2024 preliminary injunction, and release a related bond. Celltrion can launch its biosimilar in the US on Dec. 31, 2026, Regeneron said Monday in a statement, adding that the other terms of the agreement were confidential... Sub. Req’d

Xbrane's US Approval Bid For Ranibizumab Biosimilar Stalls Again After FDA Review

(10/20, Dean Rudge, Generics Bulletin) ...Xbrane Biopharma's pursuit for US approval of its ranibizumab biosimilar, Lucamzi, has encountered yet another delay as the FDA issued a further complete response letter, marking the second such setback within a year. The letter was a result of unresolved manufacturing issues identified during a re-inspection of one of Xbrane's contract manufacturing sites, with no new scientific or safety concerns raised about the product itself. Meanwhile, the firm has been setting up financing measures so that it can continue operating, namely a 1-for-125 reverse share split, and a credit line to cushion potential additional delays... Global Sub. Full

Aspire Builds Out UK Business With Charlwood Acquisition

(10/20, Dave Wallace, Generics Bulletin) ...Aspire Pharma has announced the acquisition of Charlwood Pharma Ltd, a privately-owned UK niche generics developer. The acquisition "marks the culmination of a successful multi-year collaboration between the two organizations," according to Aspire. More broadly, the deal fits with Aspire's stated strategy of expanding through acquisition, both in the UK and internationally... Global Sub. Full

Strides to Market Incepta' Contraceptive Generic in Africa

(10/21, ET Pharma) ...Strides Pharma through its step-down wholly owned subsidiary has announced to market Incepta Pharmaceuticals WHO-prequalified contraceptive generic in Africa. The generic version, branded as 'Medogen SubQ,' is equivalent to Pfizer's subcutaneous depot medroxyprogesterone acetate (DMPA-SC), a three-month contraceptive that can be administered by healthcare workers or self-injected after appropriate training... Full

Merck Grows Again in Va. With $3B Small-Molecule Drug Plant, Part of Planned $70B US Outlay

(10/20, Kevin Dunleavy, Fierce Pharma) ...With the investment spanning active pharmaceutical ingredient and drug product functions, the new plant will support small-molecule production and testing, Merck said. The facility, dubbed as its Center of Excellence for small-molecule manufacturing, could create more than 500 full-time jobs, according to the company. "It's an important milestone. It's important for Merck. It's important for Virginia. It's important for manufacturing in the United States," Merck CEO Rob Davis said at a groundbreaking event on Monday morning... Full

SCAN Health Plan, Costco Team Up to Drive Member Cost Savings

(10/20, Paige Minemyer, Fierce Healthcare) ...Costco will become a preferred pharmacy for SCAN, offering competitive prices for drugs and vaccines to SCAN's Medicare Advantage members. SCAN enrollees can also use their eye wear allowance to make purchases at Costco, establishing a new avenue for affordable access to vision care. SCAN is also launching a new rewards program in which members in certain plans can earn up $125 in rewards for completing health-related activities and embracing healthy habits. Those rewards can be used at Costco to purchase healthy groceries, personal care products or fitness equipment... Full

The Emergence of CGRP-Targeted Therapies is Transforming Migraine Care | NCPA 2025

(10/20, Brian Nowosielski, Amaal J. Starling, MD, FAAN, FAHS, Courtney Hahs, PharmD, Drug Topics) ..."CGRP is a neuropeptide that plays a significant role in migraine. We have basic science studies that show that levels of this peptide are elevated during migraine attacks," Amaal J. Starling, MD, FAAN, FAHS, associate professor of neurology at the Mayo Clinic College of Medicine and Science, told Drug Topics. "Triptan medications reduce the level of this. Individuals with more severe forms of migraine have chronically elevated levels of CGRP and animal models have shown, if we can block that CGRP pathway at different levels, that can reduce the animal model of migraine pain."... Full

Trump's Pharma Strategy 'Holds Europe Hostage', Finnish MEP Warns

(10/21, Thomas Mangin, Euractiv) ...As a member of the EU-US delegation, Finnish MEP Maria Guzenina (S&D) has closely followed how Donald Trump has shifted his negotiation tactics with the pharma industry. After initially trying to cut drug prices through executive orders, the US president has started dealing directly with major companies – already striking agreements with Pfizer, AstraZeneca, and Merck. Euractiv sat down with Guzenina, a former Finnish health minister and now serving her second mandate in the European Parliament, to discuss how the new American approach affects Europe and why "the EU could end up on the menu instead of at the negotiating table"... Full

Ministers in Stand-Off After Promising Trump Higher Drug Prices

(10/20, Chris Symth, The Times) ...The US has been offered a deal to pay pharmaceutical companies more by ripping up NHS rules on value for money, but ministers are at odds over finding the billions of pounds needed to fund it. The chancellor wants the NHS to pay more but Streeting, the health secretary, says he cannot foot the bill for costlier medicines without harming efforts to cut waiting lists. Both are said to have rejected a 50-50 cost share proposed by Sir Chris Wormald, the cabinet secretary... Full

EMA Slashes Average Clock-Stop Extensions By 18% To Speed Up Drug Reviews

(10/20, Vibha Sharma, Pink Sheet) ...The European Medicines Agency's tightened approach when it comes to granting companies extra time to respond to questions relating to their drug marketing applications has led to an 18% reduction in average extension durations in the first half of 2025, compared with previous years. This reduction follows a 2024 initiative that saw the EMA return to a strict implementation of its 2009 guideline on clock-stop extensions, resulting in more harmonized and justified extension approvals and the rejection of requests tied to immature dossiers... Global Sub. Full

Czech Pharma Sounds Alarm Over EU Wastewater Directive Costs

(10/21, Aneta Zachová, Euractiv) ...Czech pharmaceutical and cosmetics companies are bracing for a financial hit as the country prepares to implement the European Union's revised Urban Wastewater Treatment Directive, which mandates extended producer responsibility (EPR) for the removal of micropollutants. Under the new rules, manufacturers will be required to co-finance advanced treatment technologies, a move industry leaders warn could carry a significantly higher price tag than Brussels anticipates... Full

Swiss Pharma Exports to Russia Continue Despite War

(10/21, Swissinfo.ch) ...Since the invasion, many Swiss companies have drastically reduced or completely ceased their activities in Russia. Pharmaceutical exports, on the other hand, are legally permitted: the EU sanction measures taken by the Federal Council mainly concern trade in goods, finance and energy, but not the supply of humanitarian or medical products...The big companies in the industry justify their actions with responsibility towards patients. "Novartis is committed to ensuring access to medicines for people all over the world, regardless of where they are," the company stated. Disruption of the supply of essential preparations could have serious consequences for those affected... Full

Pharma Sector Transforms for Growth

(10/21, Li Jing, China Daily) ...China's pharmaceutical sector, once driven largely by generic drug production, is now witnessing a steady rise in innovative drug development, cross-border partnerships, and record research and development spending, signaling a structural transformation toward high-quality growth, experts and industry insiders said... Full

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