Monday, October 20, 2025

Teva Vs. Viatris: Who Will Dominate In President Trump's America?

(10/17, Seeking Alpha) ...In this article, I'll determine which of Viatris and Teva Pharmaceuticals has a stronger position in the generic drugs market, and which, more importantly, has a more promising long-term outlook...First, based on the results of their analysis using my model, I continue to cover Teva Pharmaceuticals with a 'Buy' rating and also upgrade Viatris from a 'Hold' to a 'Buy' rating... Full

Cold Chain Technologies, Teva, and Kuehne+Nagel Proves Sea Freight Viable for High-Value Pharma Shipments

(10/17, Nicholas Saraceno, Pharmaceutical Commerce) ...CCT, Kuehne + Nagel, and Teva Pharmaceuticals validated ocean freight for temperature-sensitive pharma shipments as a viable alternative to air cargo. The project involved a demanding sea route from Germany to Australia, requiring rigorous testing to meet quality and compliance standards. CCT's Enshield passive thermal blanket and Koolit Advanced gel maintained the required temperature range despite unforeseen delays... Full

HLTH25 Day 1: Mark Cuban Sounds Off On High Pharma Costs, Calls On Business Leaders to Step Up

(10/19, Heather Landi, Fierce Healthcare) ...The HLTH conference kicked off Sunday with investor and entrepreneur Mark Cuban taking center stage to blast pharmacy benefit managers, drug manufacturers and wholesalers for driving up prices for pharmaceutical drugs. Characteristically blunt, Cuban also called out business leaders for being "complicit" in the broken system... Full

Mark Cuban On Health Care's Failings: ‘We Are Complicit' | HLTH 2025

(10/20, Ron Southwick, Chief Healthcare Executive) ...Cuban was also asked about President Trump's administration's plans to launch TrumpRx, which is designed to let people buy drugs directly from manufacturers. He wryly said, "It is the most beautiful, amazing, brilliant thing that I've ever seen." He described TrumpRx as a "referral site," but he said Cost Plus Drugs would be participating. "As our volumes go up, our costs go down," Cuban said. "The price for patients go down. So for us, it'll be great, right? It just means more people." Cuban said his one worry is that "it'll be possible for people to gain the system." He said companies could initially offer the drugs at a lower price to woo consumers, and then raise prices... Full

Senate Health Committee To Revisit 340B Issues, Solutions

(10/17, Gabrielle Wanneh, Inside Health Policy) ...Months after unveiling the findings of a years-long investigation of the growth of the 340B drug discount program and the impact certain operational issues and covered entity practices have had on patients, the Senate health committee is due to revisit ongoing concerns with the program next week. The press office for the committee did not respond to an inquiry from Inside Health Policy on whether committee chair Bill Cassidy (R-LA) will introduce long-awaited 340B reform legislation... Sub. Req’d

RFK Jr. and the Long Game of Reform

(10/17, Jeff Dornik, RealClearPolicy) ...If Kennedy succeeds, his legacy will be institutional. He will have reestablished a Department of Health and Human Services that serves science rather than suppresses it, that protects citizens instead of corporations, and that operates according to evidence, not propaganda. The attacks he faces, both from power and from impatience, prove just how dangerous his work is to both sides. He's playing the long game, and that's exactly what's been missing in America for far too long. The goal cannot be vengeance. Rather, it must be restoration. And if he stays the course, that restoration may outlast him and finally bring the kind of truth this country has been begging for since 2020... Full

US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence

(10/17, Sue Sutter, Pink Sheet) ...The recent wave of warning and untitled letters targeting violative promotions was generated by Office of Prescription Drug Promotion staff, not artificial intelligence. OPDP's AI tool for reviewing Form 2253 promotional submissions lacks generative capabilities, former staffer Jason Cober said. Industry has not automated the ad/promo submission process because of disagreements over what should be submitted and the need to examine promotions for fair balance and net impression, an Eli Lilly exec said... Global Sub. Full

US FDA Drug, Biologics Centers Lost Nearly 1,000 Employees In FY 2025 Fourth Quarter

(10/17, Derrick Gingery, Pink Sheet) ...New data indicates CBER and CDER lost more than 1,500 people in FY 2025 amid a reduction in force, layoffs and voluntary departures. CDER staffing declined a net 740 people during the FY 2025 fourth quarter, while CBER posted a net loss of 190. The data calls into question FDA hiring efforts, which officials have said remain ongoing... Global Sub. Full

EMA Says Active Substance in Tardive Dyskinesia Drug Not New

(10/17, Sophie Cousins, Medscape) ...The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has confirmed its initial recommendation to not consider deutetrabenazine as a new active substance. In June this year, the CHMP recommended granting a marketing authorization for the medical product Austedo (Teva Pharmaceutical Industries) for the treatment of moderate-to-severe tardive dyskinesia in adults. The CHMP also concluded that the active substance, deutetrabenazine, could not be considered a new active substance — a conclusion that has been confirmed again after re-examination of the initial opinion... Full

FDA Accepts New Drug Application for Single Inhaler Triple Therapy in Asthma

(10/17, Isabella Hornick, Healio) ..."This NDA acceptance is one step forward on the path to providing a new treatment option for clinicians and their patients living with asthma," Martin Marciniak, PhD, vice president of U.S. medical affairs at Chiesi, told Healio...As Healio previously reported, these trials showed that this triple therapy inhaler decreased exacerbations among adults with uncontrolled asthma. The TRIMARAN trial targeted patients who were on medium doses of inhaled corticosteroids plus a LABA, whereas the TRIGGER trial targeted patients on high doses of inhaled corticosteroids plus a LABA... Full

Formycon Secures Two Partners In Australia And Latin America For Eylea Biosimilar

(10/17, Urte Fultinaviciute, Generics Bulletin) ...Formycon has secured partnerships with Actor Pharmaceuticals in Australia and Megalabs in Latin America to market its aflibercept biosimilar FYB203. Under the agreement, Formycon will help manage the supply chain, while commercialization rights holder Klinge will receive upfront and milestone payments. This is one of several partnering deals for Formycon and Klinge for the Eylea biosimilar, with others covering North American and European markets...The European market was split by two partners. First was Teva, which received semi-exclusive commercialization rights in major parts of Europe – excluding Italy – and Israel. The rest of the region was picked up by ophthalmology specialist Horus Pharma... Global Sub. Full

Roche Suffers a Fresh Blow as India's Supreme Court Allows Generic Sales of its Pricey Rare Disease Drug

(10/18, Ed Silverman, STAT+) ...The move came after a lower court earlier this month upheld a ruling that it would be in the public interest to allow Natco Pharma to sell a version of Evrysdi for about $179 a bottle. By comparison, Roche charges $6,982 for its drug, which is used to combat spinal muscular atrophy, a genetic disorder that causes certain muscles to become weak and waste away. One severe form of the disease can lead to death by age 2 if left untreated... Sub. Req’d

Civica Partnership Strengthens Our Commercial Platform and Patient Reach in the US Insulin Market: Biocon Biologics CEO

(10/20, Ekta Batra, Vinnii Motiwala and Mangalam Maloo, CNBC TV-18) ...Speaking to CNBC-TV18, Biocon Biologics CEO and MD Shreehas Tambe called the tie-up "a very significant development—not just for Biocon, but also in terms of how insulins will be made available to patients in the United States." He highlighted that the partnership reflects the company's robust commercial platform, which can deliver medicines through multiple channels, from hospital networks to direct consumer distribution... Full

Amgen, AZ's Tezspire Gains 2nd FDA Nod, Upping the Ante in its Battle with Dupixent

(10/17, Kevin Dunleavy, Fierce Pharma) ...The U.S. regulator has endorsed Amgen and AstraZeneca's Tezspire as an add-on maintenance treatment for patients age 12 and older. The first-in-class monoclonal antibody, which is injected monthly, inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine which triggers inflammation..."Tezspire is the only biologic that is able to target these cytokines upstream, next to the epithelium, and that gives you unique and broad coverage of that inflammation," Pablo Panella, AstraZeneca's senior vice president for global respiratory and immunology, said in an interview with Fierce Pharma... Full

ESMO: AstraZeneca Believes Latest Data 'Validate' Going it Alone On Next-Gen ADCs

(10/18, James Waldron, Fierce Biotech) ...Europe's leading cancer conference may be swimming in antibody-drug conjugate data, but AstraZeneca remains convinced that its in-house pipeline sets the pharma apart. The U.K.-based drugmaker earned its ADC credentials through the blockbuster Enhertu and then sealed the deal with the approval of Datroway at the start of the year. Both of those therapies emerged from a collaboration with Daiichi Sankyo, but AstraZeneca executives told Fierce Biotech earlier this year that the next chapter of the pharma's ADC story involves "a conscious effort to invest significantly" in its internal pipeline... Full

ESMO: AZ, Daiichi Unleash Enhertu's 2-Fisted Power, Aiming to Reshape Early Breast Cancer Landscape

(10/18, Angus Liu, Fierce Pharma) ...First, in another major head-to-head win against Roche's rival antibody-drug conjugate Kadcyla, Enhertu significantly pared down the risk of invasive disease recurrence or death by 53% when used as an adjuvant therapy after surgery in HER2-positive early breast cancer. The patients had residual invasive disease following neoadjuvant treatment and are considered at high risk of recurrence... Full

ESMO: Lilly Reveals Scale of Survival Win with Verzenio

(10/17, Phil Taylor, Pharmaphorum) ...Eli Lilly's CDK4/6 inhibitor Verzenio reduced the risk of death by 15.8% when used as adjuvant treatment for early-stage HR-positive, HER2-negative breast cancer, according the reveal of data from the monarchE trial. The results – presented at the ESMO cancer congress and simultaneously published in Annals of Oncology – come after seven years of follow-up of patients in monarchE and show a clear overall survival (OS) benefit of adding two years of Verzenio (abemaciclib) treatment to standard endocrine therapy in this population... Full

Novo Nordisk Hires US Pharma Veteran as Trump Pricing Pressure Mounts

(10/17, Maggie Fick and Stine Jacobsen, Reuters) ...Novo Nordisk has appointed U.S. pharmaceutical executive Greg Miley as its new global head of corporate affairs, as the obesity drugmaker faces growing pressure from U.S. President Donald Trump on drug pricing...A Novo spokesperson said on Saturday that Miley would join the company in early November, overseeing global communication and global public affairs. Novo is turning to an American executive with deep U.S. pharmaceutical experience to help navigate political risks under the Trump administration in the United States, its largest market... Full

Celltrion Expected to Surpass 1 Trillion Won in Operating Profit This Year

(10/20, Choi Mun-hee, Business Korea) ...According to a report released by Korea Investment & Securities on Oct. 20, Celltrion's 2025 revenue is forecast to reach 4.24 trillion won, up 19% from a year earlier. Operating profit is projected at 1.12 trillion won, a surge of 127% during the same period, with an operating profit margin estimated at 26.3%. Although the outlook for sales of existing products and Zymfentra was slightly lowered, the rapid improvement in cost ratios is expected to push the company's gross profit margin to 56.4%, up 9.2 percentage points from last year... Full

WeightWatchers Partners with Amazon for Easy Weight-Loss Drug Delivery

(10/20, Amina Niasse, Reuters) ...WeightWatchers said on Monday it will partner with Amazon to deliver medications including injectable GLP-1 obesity treatments for its members, a move the telehealth provider said will make it easier for some customers to receive prescriptions. WeightWatchers customers will be able to check whether their medications are in stock and have the refrigerated drugs delivered more efficiently by using the Amazon Pharmacy option on its website, said WeightWatchers Chief Operating Officer Jon Volkmann... Full

UK Closes in On Drug Pricing Deal with White House

(10/17, George Parker, Hannah Kuchler and Aime Williams, Financial Times) ...Sir Keir Starmer's government believes it is closing in on a major drug pricing deal with the White House, in which Britain would pay billions of pounds more to buy some medicines in exchange for the US imposing "low to zero" tariffs for UK pharmaceutical exports...The UK government has proposed increasing the value at which the NHS deems a medicine cost-effective by up to 25 per cent, according to two officials. But pharma industry sources said any deal would also have to include changes to the UK's tax on medicine sales, otherwise any additional upfront spending would be clawed back under the tax, which caps how much the NHS spends on drugs... Sub. Req’d

‘Lessons Have Not Been Learned' On UWWTD Ahead Of Fresh Study By EU Commission

(10/17, Dave Wallace, Generics Bulletin) ...The Urban Waste Water Treatment Directive remains a source of consternation for the off-patent industry given the likely impact on costs and access to medicines. Against a backdrop of industry criticism and member state discontent, the European Commission has promised to review its approach to the legislation. However, Medicines for Europe and other pharmaceutical associations have complained that they have not been consulted over the latest study, and it does not go far enough to constitute a full impact assessment and correction of earlier flawed assumptions... Global Sub. Full

Netherlands is Champion of Cost Control in Medicines, But at a High Price

(10/20, The Pharma Letter) ...A future-proof pharmaceutical policy requires a healthy balance between affordability, availability, and quality. The fact that the MAUG parties, after two years of research, focus almost exclusively on "affordability" is both remarkable and worrying. This is the view of the Dutch Association of Innovative Medicines (VIG) in response to the final report Socially Acceptable Medicine Expenditures"... Sub. Req’d

Sweden Urged to Leverage Research Infrastructure in Drive to Lead Life Sciences

(10/20, The Pharma Letter) ...Sweden's life science sector, now worth an estimated 474 billion Swedish kroner ($50 billion) in annual sales, has become one of the country's most dynamic growth engines. But according to Lif expert Frida Lundmark, the nation's advanced research infrastructure must be more closely connected to healthcare delivery if Sweden is to position itself as a global leader in life sciences... Sub. Req’d

Industry Group: Germany Too Reliant On China for Key Drug Supplies

(10/20, DPA) ...Germany is increasingly reliant on China for key pharmaceutical ingredients, raising the risk of supply disruptions that Beijing could exploit for political leverage, according to a new report by the German generics association Pro Generika. The lobby group's report, released on Monday, warns that China could use its dominant position in pharmaceutical raw materials much like it has wielded export controls on rare earths during trade disputes with the United States. An interruption in deliveries of active ingredients for generic medicines would create major shortages in Germany's drug supply, the group said... Full

Pharma Innovation: Growth of China's Innovative Drugs Market Reflects Global Reach

(10/20, Zheng Songwu, CGTN) ...China's bio-pharmaceutical market is the world's second largest, with licensing deals for what are known as innovative drugs surpassing 60 billion dollars in the first half of 2025. The growth reflects the influence of Chinese-developed drugs worldwide. Zheng Songwu visited pharmaceutical companies in Shanghai to understand how the sector is gaining international traction... Full

Turkey Antitrust Regulator Fines Several Big Drugmakers for ‘No-Poach' Agreements

(10/17, Ed Silverman, STAT+) ...Antitrust regulators in Turkey have fined more than a dozen large pharmaceutical companies — including global drugmakers such as Pfizer, AstraZeneca, and Novartis — for agreeing not to poach employees from one another, a move that disrupted the domestic labor market. The Turkish Competition Authority also found that some of the companies shared competitively sensitive information about future salaries and benefits...Notably, Teva Pharmaceutical, the world's largest purveyor of generic medicines, was fined $503 million last year by European regulators for delaying competition to a blockbuster multiple sclerosis drug. The generic maker artificially extended patent protection for its drug and spread misleading information about a rival medicine... Sub. Req’d

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