Wednesday, October 29, 2025

HHS Sec. Robert F. Kennedy & FDA Commissioner Marty Makary on Drug Prices

(10/28, C-SPAN) ...Health and Human Services Sec. Robert F. Kennedy Jr., FDA Commissioner Dr. Marty Makary, and Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz make announcement on Drug Prices... Full

US Set to Speed Up Generic Biological Drug Approvals

(10/29, Patrick Temple-West, Financial Times) ...The US Food and Drug Administration is expected to take measures on Wednesday that include reducing the number of certain human clinical studies and cutting costs of medicines engineered with living cells. The changes would come despite fierce lobbying by the industry's top representatives in Washington, who have spent millions of dollars to derail less-expensive biological options...The cheaper versions "could negatively impact our volumes and prices", New Jersey-based BMS said in its annual regulatory filing this year. Generics companies Teva, Dr Reddy's and Sandoz have lobbied in favour of biosimilar reforms... Sub. Req’d

Novartis CEO Says Trump's Drug Pricing Deals Don't Address Root Problem

(10/28, Annalee Armstrong, BioSpace) ...Speaking on the company's third quarter earnings call, [Novartis CEO Vas Narasimhan] said several key factors are not addressed by the agreements reached by his company's peers, including pharmacy benefit managers, the 340B drug pricing program and low prices in other nations. "From an industry wide perspective, I think the pharma industry's view is that the proposed negotiations or proposed actions are not going to address the underlying issues here," the CEO said as the company reported third quarter earnings... Full

Pharma Must Unite On MFN Launch Prices To Boost Rates Abroad, CMS' Brooks Says

(10/28, Cathy Kelly, Pink Sheet) ...Manufacturers must work together to align US and foreign launch prices and narrow the gap between geographies, CMS' John Brooks said. Brooks conceded the launch price commitment is a big "ask," but is key to the Trump Administration's Most Favored Nation policy. Other commitments avoid a significant price hit in the most important US market segments for existing products to preserve investment in innovation, he said... Global Sub. Full

South Korea, U.S. Conclude Tariff Talks With $20 Billion Cap

(10/29, Lee Jong-hyun, ChosunBiz) ...Tariffs on automobiles and automotive parts will be reduced from 25% to 15%. For semiconductors, tariffs will be set at a level not disadvantageous compared to competing country Taiwan. Director Kim added, "Among itemized tariffs, pharmaceuticals and wood products will receive most-favored-nation treatment, and aircraft parts, generic drugs, and natural resources not produced in the U.S. will be duty-free." The reduced tariffs are expected to take effect as early as November... Full

Dem Senators Object To Commerce Section 232 Tariff Processes

(10/28, Margaret Spiegelman, Jessica Karins, Inside Health Policy) ...A group of Democratic senators is demanding greater transparency and "accountability" from Commerce Secretary Howard Lutnick on the administration's use of a national security statute to impose duties on an expanding number of sectors, including pharmaceuticals and medical devices, charging that those measures have undermined the law's purpose... Sub. Req’d

How Trump and RFK Jr. Are Enabling Anti-Pharma Lawsuits

(10/29, Caitlin Owens, Axios) ...A lawsuit Texas filed Tuesday against the makers of Tylenol foreshadows a wave of legal warfare enabled by the Trump administration - and authorities fear it could eventually drive vaccine manufacturers out of the U.S... Sub. Req’d

Bausch Health Leaves Medicaid and 340B Programs as Drugmakers Face Changing Calculus on Pricing

(10/28, Ed Silverman, STAT+) ...Bausch disclosed its decision in a brief statement on its website but did not offer an explanation. A spokeswoman said the company "remains fully committed" to patients who are prescribed its medicines and to compensate a patient assistance program was "enhanced" with zero out-of-pocket costs for covered medicines and free home delivery... Sub. Req’d

CSRxP: Help Committee Should Reject Big Pharma's Debunked Innovation Rhetoric, Focus on Improving Competition to High-Priced Biologic Blockbusters

(10/28, Lauren Aronson, The Campaign for Sustainable Rx Pricing) ..."Big Pharma's egregious pricing practices and anti-competitive tactics are the root cause of out-of-control drug prices," said CSRxP executive director Lauren Aronson. "As Members of the Committee meet to discuss the biotechnology marketplace, we encourage them to add to the bipartisan momentum for market-based solutions to boost competition to high-priced brand name drugs, particularly by fostering greater biosimilar competition."... Full

Old Drugs Usually Go Way Down in Price. Here's Why This One Skyrocketed

(10/29, Naomi Kresge and Sonja Wind, Bloomberg) ...In most cases, older drugs are cheaper than new ones. Patent protection expires after 20 years in most countries, which usually spurs generic competition that drives prices down by an average of 80% within five years. Drug companies, meanwhile, justify high prices early on to recoup their research costs before no-name copies bite into their revenue. And they can stave off rivals by extending patent protections with minor modifications to the initial formula. "The more profitable the product is, the more incentive there is for an originator to litigate and delay," says Sergio Napolitano, legal affairs director at Medicines for Europe, a trade group of generics producers... Sub. Req’d

More From Day 1 AAM's GRx-Biosims

(10/28, Bob Pollock, Lachman Consultants) ...Elizabeth Miller, Associate Commissioner for Inspections and Investigations, provided an update on the FDA's Office of Inspections and Investigations (OII). She noted that the government shutdown has impacted the OII's core activities which include inspections, investigations and imports... Full

GRx+Biosims 2025 Day 2 Recap: From Passion to Progress

(10/28, AAM) ...The day's centerpiece was a candid fireside chat between Dr. Sarah Yim, Director of the FDA's Office of Therapeutic Biologics and Biosimilars (OTBB), and Giuseppe Randazzo, AAM's Senior Vice President for Sciences and Regulatory Affairs. Their dialogue felt less like a regulatory update and more like a strategic check-in for the entire pharma ecosystem...Randazzo guided the conversation toward affordability and access. Yim reaffirmed that the FDA's public-health mission is inseparable from economic reality... Full

Generic Drugs Are The Physical Manifestation Of Democratized Abundance

(10/28, John Tamny, Forbes) ...Ludwig von Mises long ago observed that the notion of luxury is entirely historical. The previous truth is important to remember as Sens. Rick Scott (R-FL) and Kirsten Gillibrand (D-NY) take aim at generic drugs. For the senators to question the safety and quality of generics whether produced stateside or overseas is for them to question the brilliant evolution of all market advances that ultimately expand access to goods formerly inaccessible to all but the richest of the rich, if at all... Full

FDA Official Issues Warning About Looming Biosimilar Void

(10/28, Joanne S. Eglovitch, Regulatory Focus) ...Sarah Yim, director of the FDA's Office of Therapeutic Biologics and Biosimilars (OTBB) within the Center for Drug Evaluation and Research (CDER), indicated that her office is looking to streamline reviews of biosimilars, so they are more like those for generic drugs, during a presentation at the Association of Accessible Medicines (AAM) GRx+Biosim meeting on October 28... Full

FDA's Biosimilars Director Says Agency Seeks to 'Streamline' Development

(10/28, Zachary Brennan, Endpoints News) ...The FDA's top biosimilars expert Sarah Yim said the agency is looking to take "a little less" of an "algorithmic approach" to reviewing applications, with the goal of accelerating the development of the products to look more like generic small-molecule drugs...Yim said the agency doesn't think the interchangeability designation is necessary (a position she first offered Endpoints News last year), arguing that the products are regulated at the same high standard as the original biologics... Sub. Req’d

Tidmarsh's Efficiencies: CDER Director Changes Dispute Resolution, IND Processes

(10/28, Sarah Karlin-Smith, Pink Sheet) ...CDER Director George Tidmarsh discussed ideas to improve drug review process efficiency for industry and his staff at an Oct. 27 BIO meeting. However, whether Tidmarsh has the unilateral authority to change processes like dispute resolution is unclear, and some ex-FDA officials suggested the changes may be more burdensome for FDA reviewers. Tidmarsh also discussed changing communication with sponsors and IND reform, along with FDA hiring challenges... Global Sub. Full

Samsung Bioepis to Commercialize BYOOVIZ® (ranibizumab) in Europe from January 2026

(10/29, Samsung Bioepis) ...Samsung Bioepis Co., Ltd. announced today that the company has entered into an Asset Purchase Agreement with Biogen regarding Samsung Bioepis' two ophthalmology assets: BYOOVIZ® (ranibizumab), a biosimilar referencing Lucentisi (ranibizumab) and OPUVIZ™ (aflibercept), a biosimilar referencing Eyleaii (aflibercept) — in Europe. Samsung Bioepis will have full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026... Full

Alembic Pharma Gets USFDA Nod for Ticagrelor 60 mg Tablets

(10/29, Business Standard) ...The approved ANDA is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP...With this approval, Alembic now holds a cumulative total of 227 ANDA approvals from the USFDA, including 206 final approvals and 21 tentative approvals... Full

Vertex's Cystic Fibrosis Drug Trikafta Challenged By Buyers' Club-Backed Beximco

(10/28, Urte Fultinaviciute, Generics Bulletin) ...Backed by a cystic fibrosis buyers' club, Beximco Pharmaceuticals plans to produce a generic version of Vertex's Trikafta. The generic drug, named Triko, will be available in spring 2026 at significantly reduced prices, making it more accessible for patients. Due to Bangladesh's economic classification by the UN, Beximco is allowed to legally manufacture and export generic versions of patented medicines... Global Sub. Full

GSK Cancer, HIV Drug Sales Lift 2025 Outlook in Boost to Stock

(10/29, Unnamalai L, Yadarisa Shabong and Bhanvi Satija, Reuters) ...GSK raised its 2025 sales and earnings forecasts on Wednesday as its speciality HIV and cancer medicines posted double digit growth, lifting the British drugmaker's shares...GSK's improved outlook comes as CEO Emma Walmsley prepares to hand over to Luke Miels early next year, with the drugmaker navigating U.S. tariffs and seeking new medicines to offset revenue declines as some top-selling drugs go off patent... Full

Regeneron Tops Quarterly Estimates, Plans to Resubmit Eylea Application

(10/28, Christy Santhosh, Reuters) ...Street estimates for third-quarter results on Tuesday, helped by strong demand for its eczema treatment, Dupixent, and cancer treatment Libtayo, sending shares up 10% in afternoon trading. The drugmaker also announced plans to resubmit the marketing application for the pre-filled syringe version of higher-dose Eylea, or Eylea HD, after the U.S. Food and Drug Administration declined its approval on Monday... Full

Dong-A Socio Holdings Posts 47.7% Operating Profit Surge in Third Quarter

(10/29, Yeom Hyun-a, ChosunBiz) ...The company attributed this performance growth to increased sales at major business units and higher profits from its consolidated subsidiaries. Specifically, Dong-A Pharmaceutical saw an 11.5% increase in sales in its Bacchus and general pharmaceutical divisions compared to the same period last year, with operating profit rising by 28.9%. STJenBio, a contract manufacturing organization (CMO) specializing in biopharmaceuticals, reported higher sales due to new orders and commercial production volumes for global biosimilars... Full

Lilly Makes Billions of Weight-Loss Pills Before US Approval

(10/28, Madison Miller, Bloomberg) ..."We've already made, actually, billions of doses preparing for the launch," Chief Executive Officer Dave Ricks said Monday at an event hosted by the Economic Club of Chicago. "That will make this sort of the ‘GLP-1 for all,' and I think really makes a difference in human health at a global level." Lilly hasn't yet submitted the pill, called orforglipron, to US regulators but expects to do so before the end of the year. The drug is part of a new wave of obesity treatments known as GLP-1 receptor agonists, which mimic gut hormones to suppress appetite and improve blood-sugar control... Sub. Req’d

More Than a Third of Lilly's New Zepbound Prescriptions Are Coming from DTC Program

(10/28, Lydia Ramsey Pflanzer, Endpoints News) ...As of the second quarter of 2025, LillyDirect, including sales that come from cash-paying patients, makes up 35% of new prescriptions of Zepbound, Jennifer Mazur, SVP, Lilly USA Consumer Services and LillyDirect told Endpoints News...For now, the GLP-1 business is the only one with pricing aimed at self-paying patients. While Lilly has other conditions like migraine and Alzheimer's disease on its website, those are aimed at linking patients to virtual care options. Insurance coverage and other factors determine which approach Lilly takes when reaching patients directly. But it's a priority for the company, Mazur said... Sub. Req’d

Lilly Keeps Up Legal Fight Against GLP-1 Compounders 

(10/28, Nicole DeFeudis, Endpoints News) ...The pharma giant told Endpoints News on Tuesday that it plans to refile its complaint against the telehealth company Mochi Health after a California federal judge dismissed the case on Friday for lack of standing. Lilly also filed two new lawsuits last week against Texas compounding pharmacies, bringing the total number of cases filed against compounders, telehealth companies and med spas to 34... Sub. Req’d

Eli Lilly, Nvidia to Build Supercomputer, AI Factory for Drug Discovery

(10/28, Annika Kim Constantino, CNBC) ...Eli Lilly and Nvidia are partnering to build what the companies call the pharmaceutical industry's "most powerful" supercomputer and so-called AI factory to help accelerate drug discovery and development across the broader sector. It's the latest stride by Nvidia and the pharmaceutical industry to harness AI to try to shorten the time it takes to bring cures to patients, while reducing costs at every stage of the drug discovery and development process. The supercomputer will power the AI factory, a specialized computing infrastructure that will develop, train and deploy AI models at scale for drug discovery and development... Full

Mark Cuban Cost Plus Drugs and Medchat•ai Deploy AI to Scale Affordable Medication Access

(10/28, Mark Cuban Cost Plus Drugs Company and Medchat•ai) ...Medchat•ai, a leader in AI-powered healthcare automation, and Mark Cuban Cost Plus Drugs Company, today announced a strategic partnership to enhance customer support and accelerate consumers' access to safe, affordable medicines. The collaboration introduces AI customer care agents that deliver instant, personalized support for pricing questions, order status, real-time delivery tracking, and more... Full

Big Pharma's Scramble Over Patent Cliff Will Be Costly

(10/28, Financial Times) ...For companies on the edge of that cliff, the options are limited. Organic growth from in-house development takes too long to compensate for the immediate losses caused by the patent expiry. So, too, do the smaller, earlier-stage deals that Big Pharma has engaged in over the past few years...That leaves companies facing patent expiries seeking mature biotech bolt-ons, with either late-stage or already approved products... Sub. Req’d

US Appeals Court Revives $2.5 Billion Opioid Lawsuit in West Virginia

(10/28, Dietrich Knauth, Reuters) ...The 4th U.S. Circuit Court of Appeals ruled that a lower court incorrectly concluded that Cencora, McKesson Corp and Cardinal Health did not create a "public nuisance" by supplying a flood of addictive pills to pharmacies in Cabell County and the City of Huntington...A Cencora spokesperson said the company was disappointed in the ruling and considering next steps, including a further appeal... Full

Pharmalittle: We're Reading About Rising GLP-1 Use, A Psychedelic Therapy for Depression, and More

(10/28, Ed Silverman, STAT+) ...Teva Pharmaceuticals agreed to pay $35 million and withdraw six patents from a U.S. regulatory list to settle claims that the drugmaker delayed generic competition for its QVAR asthma inhalers, causing consumers and others to pay inflated prices, Reuters writes...As part of the settlement, Teva agreed to the withdrawal of six patents listed for QVAR from the FDA's Orange Book, which lists patents protecting drugs the agency has deemed safe and effective. Teva denied any wrongdoing in agreeing to settle... Sub. Req’d

‘Generics Manufacturers Are Central To Our Mission' – International Health Partners On Collaboration

(10/28, Dave Wallace, Generics Bulletin) ...International Health Partners talks to Generics Bulletin about how its work to provide access to vital medicines is growing, and how the generics sector can get involved. IHP outlines the benefits for off-patent companies of collaboration, as well as addressing potential concerns that donors may have about how their medicines are used. Medicines UK chief executive Mark Samuels described IHP as "a trusted and respected brand" with a "long track record of making a significant medical difference in places where it is needed most."... Global Sub. Full

UK Preparing to Meet 'Inevitable' Increased Drug Costs After US Talks

(10/28, Alistair Smout, Reuters) ...The British government is preparing to meet the "inevitable" increase in the cost of some drugs following talks over pharmaceutical sector pricing and tariffs with the United States, Science Minister Patrick Vallance said...Vallance has acknowledged that the country's National Health Service needs to reverse a trend of declining spending on medicines, and on Tuesday he said that the ongoing talks with Washington would mean the costs of certain drugs would go up... Full

UK Gives Drugmakers More Time to Consider Exiting Medicine Rebate Scheme

(10/28, Anna Brown, Endpoints News) ...The new deadline to exit VPAG is Nov. 14, reducing the minimum notice period pharma companies must give from two months to six weeks...The VPAG rate for 2026 is currently unknown and will be based on sales forecast and sales growth up to the third quarter of 2025, according to a Department of Health and Social Care fact sheet. While such extensions are not "unusual," there is "some uncertainty around the future UK commercial environment right now, so providing more time to clarify the situation is helpful," an ABPI spokesperson told Endpoints News... Sub. Req’d

UK: Another Delay To VPAG Deadline For Pharma As Global Uncertainty Continues

(10/28, Eliza Slawther, Pink Sheet) ...This is the second extension to the original September deadline, both of which were made due to ongoing global uncertainties in the life sciences sector. Companies must weigh up whether to join the voluntary scheme or default to the statutory scheme, both of which have been criticized in recent years for setting unexpectedly high rebate rates... Sub. Req’d

Weight-Loss Drugs Are Spreading Across the World

(10/28, The Economist) ...At least ten Indian versions of semaglutide are in late-stage trials. Analysts expect the generics to debut at about a third of the original price, with further decreases as competition intensifies. Cheaper drugs will bring treatment within reach of many more patients. Analysts at JPMorgan Chase, a bank, expect India's GLP-1 market to grow from $179m in 2025 to $1.5bn by 2030. An even bigger prize for India's drugmakers will be exports to countries where semaglutide's patents have lapsed. Dr Reddy's, a local giant, plans to sell a generic Wegovy in 87 countries once the patents expire. Subsidies from the Indian government for makers of GLP-1 drugs will also help... Sub. Req’d

Biosimilars Improve Health System Resilience in Latin American, Caribbean Nations

(10/28, Skylar Jeremias, The Center For Biosimilars) ...Biosimilars possess the potential to drastically enhance patient access and ensure long-term sustainability for regional health systems across Latin America and the Caribbean (LAC), according to a new narrative review published in Current Opinion in Immunology. The analysis, conducted by María Herrán, MS, and Juan-Manuel Anaya, MD, focused on the transformative role of biosimilars in high-cost therapeutic areas like oncology and chronic autoimmune diseases... Full

Russian Drug Prices Continue to Demonstrate Sharp Increases This Year

(10/28, The Pharma Letter) ...According to official data of Russian statistics services, this year prices for drugs in the Russian market grew by about 15%, compared to the same period of last year, however, in reality the growth of price is significantly higher...Accordance to recent data from the Russian analyst agency DSM Group, the average weighted cost of a drugs' package in some leading pharmacy chains of Russia from January to August 2025 was 416 roubles, a 13.6% increase compared to the same period in 2024... Sub. Req’d

Sales of Dementia Drugs Steadily Growing in Russia

(10/29, The Pharma Letter) ...According to official statistics, sales of anti-dementia drugs in the local market have grown by a third in the last three years – both in value and volume terms. In Russia, approximately 2 million people already have Alzheimer's disease and other dementia-related conditions. Due to increased life expectancy and associated brain damage, this number will only increase... Sub. Req’d

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