Tuesday, November 4, 2025

Teva Jumps Ahead of Q3 Results

(11/3, Shiri Habib-Valdhorn, Globes) ...According to the Wall Street Journal, out of 10 analysts covering Teva stock, nine are positive and one is negative, and the average price target is $25.57 - a, 24.9% premium on the current share price. Last week, Jefferies analyst Dennis Ding published a review ahead of Teva's report and addressed the issue of the IRA legislation designed to lower drug prices in the US, among other things, in the pharmaceutical sector. Ding notes that investors will focus on what Teva management said about the impact on the drug Austedo (a branded drug for movement disorders) and estimates that the company's forecast for $2.5 billion in Austedo sales in 2027 will likely not change. This even though the price of the drug is expected to fall... Full

Teva To Delist QVAR Patents, Pay $35m In End-Payor Antitrust Deal

(11/4, Dean Rudge, Generics Bulletin) ...Teva has agreed to pay $35m and withdraw six patents associated with its QVAR asthma inhalers to settle allegations of blocking generic competition. The settlement, pending court approval, aims to conclude a two-year class action lawsuit initiated by health funds on behalf of consumers. As part of the deal, Teva will delist specific patents from the FDA's Orange Book, while admitting no wrongdoing... Global Sub. Full

FDA Announces Recall 580,000 Bottles of Prazosin Over Potential Carcinogenic Impurity

(11/3, Alexandra Gerlach, Pharmacy Times) ...Teva Pharmaceuticals USA is recalling prazosin due to contamination with a carcinogenic impurity, N-nitroso Prazosin impurity C. The FDA classified the contamination risk as class 2, with levels above acceptable intake limits... Full

The Workers Left Out of Trump's Drug-Manufacturing Renaissance

(11/4, Rebecca Robbins and Annie Flanagan, The New York Times) ...But the president's drug-manufacturing renaissance in America is largely leaving out the production of generic medicines, which account for 90 percent of Americans' prescriptions...Over four decades, the factory manufactured generic drugs that are staples in Americans' medicine cabinets, like the pain relievers ibuprofen, aspirin and Tylenol, as well as treatments for burns and allergies. The factory's owners have been trying to sell it for years, but no one has bought it — even as Mr. Trump has been calling for drug manufacturing to return to the United States. The plant is a vivid example of the decades-long decline of generic drug manufacturing in the United States and the hard realities that would make it difficult to revive... Sub. Req’d

Tariffs, Pricing, Backroom Deals — How Pharma Can Navigate Wildly Shifting Policies

(11/3, Kelly Bilodeau, Pharma Voice) ...While broad policy measures like tariffs generate headlines, plenty of behind-the-scenes and more granular proposals are causing pharma compliance headaches. One that's prompted numerous questions from the life sciences industry is a draft revision to the definition of bona fide service fees under the Medicare program, [Catherine Starks, a partner at law firm Sidley Austin] said... Full

Senate Witnesses Discuss Reshoring and Making China's Massive Biotech Ecosystem Less Attractive for Big Pharma

(11/3, Kenneth Rapoza, Coalition For A Prosperous America) ...China has made itself an indispensable partner of Big Pharma. Their labs are becoming more innovative and are expected to be the main rival for Western pharmaceutical companies at home, and throughout Asian markets. Here at home, biotechnology drives more than $3 trillion in annual economic output. The sector employs at least 2.3 million people directly in labs and research centers and indirectly supports more than 8 million jobs in areas such as pharmaceutical sales and as a market for lab equipment manufacturers. Witnesses called U.S. leadership in biotechnology a national security imperative... Full

PhRMA Says 340B Rebate Pilot Helps With PFS Data Repository; CMS Advances ASP Changes

(11/3, Gabrielle Wanneh, Inside Health Policy) ...Starting Jan. 1, 2026, CMS is establishing a repository where covered entities participating in the 340B drug discount program can voluntarily submit Medicare Part D claims data related to 340B drugs -- a policy brand drug industry representatives say could be populated with the help of the upcoming pilot program permitting drug companies to issue rebate payments for 340B drugs instead traditional upfront discounts. The data in the repository will be used by CMS to remove 340B units from the Part D inflation rebates... Sub. Req’d

Generic Drug and API Manufacturers Call for Onshoring Incentives

(11/4, Nick Paul Taylor, BioSpace) ...While industry representatives have welcomed the steps, some are calling for further initiatives to tackle what they see as the core barrier to onshoring: money. "As our volumes are going up, our economic footprint is actually going down. It's decreased about $6.5 billion over the past five years," Kamaal Anas, corporate vice president for regulatory affairs at B. Braun Medical, said at an FDA meeting in September to discuss the agency's proposed PreCheck program. "We're serving more people, but we're getting less return on investment. That limits our ability to innovate and invest."... Full

Reforming Average Sales Price-Based Reimbursement For Infused Biosimilars

(11/3, Ryan N. Hansen Joshua A. Roth Victoria W. Dayer Sean D. Sullivan, Health Affairs) ...Although biosimilars will not be eligible for negotiation, their reference products will have lower ASPs, and thus biosimilars will need to have even lower prices or steeper discounts to enter the market and compete. The inclusion of MFP in ASP will further exacerbate the ASP spiral unless proposed legislation mitigates the impact. Below, we explore three alternative reimbursement policies that can support a more sustainable biosimilar market... Full

The Tests They Are A-Changing: FDA Takes Action on Biosimilars

(11/4, Sara W. Koblitz, FDA Law Blog) ...This guidance builds on FDA's apparent move to increase flexibility in the biosimilar space. In the last few years, the Agency has signaled its intent to eliminate the interchangeability distinction for biosimilars, and this intent was reiterated in the HHS Press Release announcing this Guidance. There, HHS states "The agency through a separate initiative also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily." This has been long-spoken of, but no action has been taken yet. For now, we wait with bated breath to see if this Guidance and any accompanying policy changes will facilitate the kind of entry we've seen on the small molecule generic side on the biosimilar side... Full

Tidmarsh Creates More Instability And Uncertainty For US FDA, Industry

(11/3, Sarah Karlin-Smith, Pink Sheet) ...People inside and outside the agency are worried the potential exit of CDER Director George Tidmarsh could spur a new wave of career staff exits. Industry did not support some of Tidmarsh's plans to change drug approval standards, but his departure could create uncertainty for industry, experts said. Some FDA staffers were told Nov. 3 that Tidmarsh reversed his resignation... Global Sub. Full

Day After Resigning, Tidmarsh Now Says He'll Fight Exit from FDA

(11/3, Zachary Brennan and Max Bayer, Endpoints News) ...Endpoints spoke to Tidmarsh afterward, who said that he was second-guessing his decision to resign. On Sunday, Tidmarsh had said "I'm going to fight it. It's my name and credibility." It wasn't clear how Tidmarsh un-resigning or trying to get his job back would work, or if he would be able to. Tidmarsh previously told Endpoints that he had resigned. And earlier Monday, an HHS spokesperson said that he had been put on leave several days prior, and officially resigned on Sunday, "effective immediately."... Sub. Req’d

Experts Worry FDA's Credibility is Being Shredded by Scandal and ‘Soap Opera'

(11/4, Matthew Herper and Lizzy Lawrence, STAT+) ..."The numerous incidents and allegations at the FDA leave me very concerned about the agency's ability to be a scientific regulator," said Reshma Ramachandran, an assistant professor of medicine at the Yale School of Medicine and a board member of Doctors for America. "Between the firing and departure of technical and expert staff, reported mismanagement of leadership, and decisions that are being made without real transparency and based on politics, I am deeply worried about the impacts this continued chaos will have on patients and clinicians."... Sub. Req’d

Gov. Hobbs Launches Prescription Drug Discount Cards

(11/3, Sara Filips, FOX 10 Phoenix) ...Gov. Hobbs launched the AZRx initiative to help residents save money on prescription drugs through the free ArrayRx discount card. The discount card is available to all Arizona residents, regardless of insurance or income, and can offer savings of up to 80% on FDA-approved medications. Residents can sign up online now to download or print the card, which can then be presented at nearly 1,200 Arizona pharmacies... Full

AbbVie, Novartis Win Block of Oklahoma Drug Discount Law

(11/3, Ganny Belloni, Bloomberg Law) ...Pharmaceutical giants AbbVie, Novartis, and AstraZeneca succeeded in their efforts to temporarily block Oklahoma from enforcing a law requiring drugmakers to offer steeply discounted medicines to an unlimited number of pharmacies. Judge Patrick Wyrick of the US District Court for the Western District of Oklahoma on Oct. 31 approved the drugmakers' motions to preliminarily enjoin key 340B provisions in state law (H.B. 2048). The drugmakers filed the motions in three separate but similar cases... Sub. Req’d

Duvakitug Delivers Strong Early Results in 'Very First' Anti-TL1A Trial for Crohn's

(11/3, Rebecca L. Forand, Healio) ...Duvakitug outperformed placebo at week 14 in endoscopic response and was well tolerated among patients with moderately to severely active Crohn's disease, according to research presented at ACG Annual Meeting. The double-blind, randomized RELIEVE UCCD induction basket trial evaluated the safety and efficacy of duvakitug (TEV-48574; Teva Pharmaceuticals, Sanofi), an anti-TL1A monoclonal antibody, in 138 adult patients with moderately to severely active Crohn's disease who had previous experience with conventional and/or advanced therapies... Full

Xbrane Continues Pivot To Leaner Model As FDA Delay Strains Liquidity

(11/3, Dean Rudge, Generics Bulletin) ...Xbrane Biopharma is adjusting its strategy to a capital-light development model following delays in FDA approval for its ranibizumab biosimilar, Lucamzi. The company plans to fund future projects through existing cash flows from its European biosimilars and strengthen partnerships with top-tier manufacturers to mitigate regulatory risks. Recent delays were attributed to issues with one of Xbrane's contract manufacturers, although the company emphasizes that the product itself is not flawed... Global Sub. Full

Sandoz, Pfizer Fail to Escape Skin Care Drug Price-Fixing Claims

(11/3, Katie Arcieri, Bloomberg Law) ...Sandoz Inc., Pfizer Inc., and Amneal Pharmaceuticals LLC are among 36 drugmakers that will face claims from states that companies colluded to fix the price of generic skin care products and forced consumers to pay higher prices. Judge Michael P. Shea of the US District Court for the District of Connecticut on Oct. 31 denied the drugmakers' joint motion for summary judgment, saying the claims aren't time-barred under the Sherman Act's four-year statute of limitations... Sub. Req’d

Celltrion's Q3 Net Nearly Quadruples on High-Margin Drugs

(11/4, Choi Kyong-ae, Yonhap News) ...Stronger global sales of its flagship biosimilars -- including Remsima SC, Yuflyma and Vegzelma -- buoyed the quarterly results, Celltrion said. These high-margin products accounted for 54 percent of total sales in the third quarter, up from 42 percent a year earlier. Celltrion said it expects solid earnings momentum to continue in the fourth quarter, as its plans to launch five new biosimilars -- Steqeyma, Omlyclo, Avtozma, Eydenzelt and Stoboclo-Osenvelt -- in global markets by the end of this year are progressing smoothly... Full

Celltrion Looks Beyond Biosimilars With $744M Pact For 2 Preclinical Autoimmune Drugs

(11/4, James Waldron, Fierce Biotech) ...Celltrion is paying $8 million upfront for the two drugs, with up to $736 million in potential milestone payments—including $11 million in near-term milestones. In return, the Korean company receives worldwide rights to KG002 and the rights to KG006 everywhere bar greater China and Japan. Kaigene will also receive tiered royalties on net sales should either drug make it to market... Full

India's Alembic Pharma Posts Quarterly Profit Jump on Strong Generics Demand

(11/4, Abhirami G, Reuters) ...Indian drugmaker Alembic Pharmaceuticals posted a 20.4% rise in second-quarter profit on Tuesday, aided by strong demand for its generic drugs as well as new launches in its key U.S. market...Alembic Pharma and several of Indian peers that make generic drugs derive a significant share of revenue from the United States. In October, U.S. President Donald Trump shelved plans to impose tariffs on generic drug imports, providing relief to companies in the sector. In addition, new drug approvals in the U.S., including a hypertension drug and an antidepressant drug, led to strong growth in the geography for the company... Full

Ajanta Pharma Offers Growth Potential Amid US Generic Challenges: Nuvama

(11/4, Kumar Gaurav, Business Standard) ...Analysts at Nuvama Institutional Equities have maintained their positive outlook on Ajanta Pharma, following the company's financial results for the second quarter of FY2025–26. Shrikant Akolkar, Aashita Jain, Gaurav Lakhotia, and Tanay Parab — analysts at Nuvama — believe that, with larger generic companies expected to face growth challenges in the US in FY27E, Ajanta Pharma presents a strong investment opportunity, driven by its growth prospects in branded markets... Full

Pfizer Raises 2025 Profit Forecast for Second Time in a Row

(11/4, Mrinalika Roy and Christy Santhosh, Reuters) ...Pfizer on Tuesday lifted its full-year profit forecast for the second time in a row as robust demand for its blockbuster heart treatment and blood thinner helped it post third-quarter earnings above expectations...The upbeat results and outlook come as Pfizer is engaged in a public legal fight with Novo Nordisk over obesity-drug developer Metsera. Novo Nordisk recently launched an unsolicited, higher bid for Metsera, which had already agreed to an acquisition by Pfizer. Pfizer's September deal had valued Metsera at up to $7.3 billion... Full

Pfizer Accuses Novo Nordisk of Anticompetitive Plot to Stall Metsera Deal in Lawsuit

(11/4, Sabrina Valle, Mrinalika Roy, Tom Hals, Reuters) ...Pfizer filed a second lawsuit on Monday accusing Danish drugmaker Novo Nordisk of structuring its $9 billion bid for Metsera to stall the entry of the biotech firm's treatments into the obesity drug market rather than being aimed at closing a deal. Novo and Metsera on Monday rejected Pfizer's claims, which were a dramatic escalation in the fight for control of the biotech startup. A judge will analyze the complaints on Tuesday... Full

Novo Nordisk CEO Faces Baptism of Fire Amid Board Shakeup, Pfizer Fight

(11/4, Maggie Fick and Bhanvi Satija, Reuters) ...Novo has cut its guidance three times so far this year and analysts said that the high end of its full-year outlook of 8%-14% sales growth looks challenging and could be lowered. BMO analyst Evan Seigerman said he was looking for comments on how Novo plans to get past its restructuring and revive growth in its obesity business. Jefferies analyst Michael Leuchten said Novo's outlook is constrained by its dependence on semaglutide, the active ingredient in its obesity and diabetes drugs which underpins about 60% of future revenues, given signs of market slowdown... Full

Novo Sharpens India Focus with Bigger Bets On Niche Hospitals

(11/4, Rishika Sadam, Reuters) ...Novo Holdings, which had 142 billion euros ($165.60 billion) in assets under management by 2024-end, is in talks with several Indian companies, Amit Kakar, managing partner and head of Asia, told Reuters in an interview this week. The life sciences investment powerhouse that manages assets for the Novo Nordisk Foundation, one of the world's biggest philanthropic bodies, holds 77% voting control in Novo Nordisk, the maker of obesity drug Wegovy and diabetes treatment Ozempic... Full

Lilly To Build $3 Billion Dutch Plant To Boost Weight-Loss Pill Production

(11/3, Mariam E Sunny, Reuters) ...Eli Lilly said on Monday it plans to build a new $3 billion manufacturing plant in the Netherlands to expand the production capacity for its keenly watched experimental weight-loss pill, orforglipron, and other oral medicines. Lilly, the world's most valuable pharmaceutical company by market capitalization, has invested billions of dollars in recent months to scale up the production of orforglipron... Full

Hims & Hers in Talks With Novo Nordisk to Sell Wegovy Injections, New Obesity Pill

(11/3, Heather Landi, Fierce Healthcare) ...Hims & Hers stock jumped 6% in post-market trading Monday after the company said it was in active discussions to make Wegovy injections and Novo Nordisk's forthcoming obesity pill available through the company's online platform. Novo Nordisk expects to launch an oral obesity drug in the U.S. next year, once the Food and Drug Administration approves it... Full

Cigna ‘Rebate-Free' Pharmacy Model Will Test Employer Reliance On Revenue Stream

(11/3, Cathy Kelly, Pink Sheet) ...Adoption of Cigna's rebate-free pharmacy benefit model could be slow, but should reach the majority of its plan sponsors by the end of 2028. Industry watchers believe the plan will lower costs, but were skeptical about adoption rates, in part because payers rely on rebate revenue. Eli Lilly Chairman David Ricks said the Cigna model could make pricing more reflective of a drug's value... Global Sub. Full

Microdosing Aims to Extend the Lifespan of the GLP-1 Compounding Market

(11/4, Katie Palmer. STAT+) ...Noom, Found, and Hims & Hers have all launched programs to prescribe "microdosed" GLP-1s in the last three months, following in the footsteps of many smaller direct-to-consumer telehealth companies. Microdosing is getting a shot of promotion from Hollywood, too: Noom has promoted its program alongside a new celebrity spokesperson, actor Rebel Wilson, and TV host Andy Cohen has been doing the rounds talking about his microdosing habit... Sub. Req’d

Could GLP-1 Drugs Help Migraine Sufferers?

(11/3, Natalie Faunce, WDBJ) ...A Headache Center in Italy recently did research on glucagon-like peptides (GLP-1) receptors agonist medications used to treat diabetes and obesity. The research revealed they may help cut a person's monthly migraine days by half...Here @ Home sits down with Jamie Brackenrich with Align Neurology about what this research may mean for those who are trying to manage their pain... Full

A Miracle Pill for Parkinson's is 50 Years Old. Why Can't Most of the World Get it?

(11/4, Michael S. Okun and Ray Dorseym, STAT) ...For more than half a century, levodopa has been the gold standard for treating Parkinson's disease, and the treatment is taught to medical students worldwide. Yet in 2025, most of the world's 11.8 million people with Parkinson's cannot reliably get it. Let that sink in. A generic, off-patent medication that costs pennies a dose — one that can restore dignity, mobility, and independence — is out of reach for many people who need it. This is not because we lack the science. It's because we lack the will, the systems, and the plan... Full

INVESTIGATING GENERICS: Decades of Recalls Reveal Flaws in the U.S. Opioid Supply Chain

(11/3, Emma Tasinski, Med Shadow Foundation) ...One physician told MedShadow he considers a patient's request for a specific manufacturer a "red flag," for psychological dependency, but added that he uses the conversation as an opportunity to try and help the patient become more comfortable with drugs from different manufacturers, rather than stopping treatment. The manufacturer can make a bigger difference than most people realize. MedShadow has been investigating what happens when patients receive the same medication from different manufacturers. On paper, the drugs should be identical, but people who rely on certain drugs tell a different story... Full

Pharma's Corporate Reputation Dips Among Neurology Patient Groups, Citing Drug Access Challenges

(11/3, Andrea Park, Fierce Pharma) ...PatientView's latest report found that just 52% of neurology patient groups surveyed said the industry's reputation was "good" or "excellent," down from 55% last year and from a peak of 61% the year before that. The survey was conducted from late 2024 to early 2025 and comprised 365 patient groups, which collectively support more than 4.6 million patients with neurological conditions, with multiple sclerosis, Parkinson's disease and epilepsy among the most highly represented focuses... Full

Company Looks To Cut Into $35 Billion Waste In Pharma Trade

(11/4, Ken Roberts, Forbes) ...Frontier Scientific Solutions last month began flying between Ireland, where nine of the world's 10 largest and better-known pharmaceutical and generic brands are manufactured, and North Carolina's Wilmington International Airport, where it has built a 530,000-square-foot warehouse built for the nation's first "scheduled service" flights for the life-science industry. Backed by $1.5 billion investment from GID, Frontier is called a freight integrator because it is leasing the wide-body jets from ATSG, temperature-controlled 767 wide-body aircraft that it will use exclusively for steroids, vaccines, hormones, blood plasma, a wide range of pharmaceuticals that now includes GLP-1 drugs like Ozempic, Wegovy and Trulicity, and "active pharmaceutical ingredients," or APIs... Full

Eli Lilly Calls On Europe To Ditch Clawback Taxes On Drugmakers

(11/4, Hannah Kuchler, Financial Times) ...Eli Lilly has called on European nations to scrap clawback taxes on drug sales, as the pharmaceutical industry puts pressure on governments to pay more for drugs or risk losing access to new medicines. The US drugmaker, best known for its obesity and diabetes drugs, announced plans on Monday to build a new €2.6bn factory in the Netherlands, expanding its capacity to produce oral medicines including a weight loss pill for which it hopes to win approval next year... Sub. Req’d

Global Biosimilars Week Returns, With A Focus On Wise Choices

(11/4, Dave Wallace, Generics Bulletin) ...The latest annual Global Biosimilars Week awareness campaign has been launched by the International Generic and Biosimilar Medicines Association, with this year's edition focusing on biosimilars as a "wise investment for global health" and "advancing health equity through wise investment in access to medicines."... Global Sub. Full

EMA Partners with Healthcare Professionals and Consumers for #ItTakesATeam Medicine Shortages Campaign

(11/4, European Medicines Agency) ...EMA, in collaboration with European healthcare professional and consumer organisations, has launched a new awareness campaign on medicine shortages. The #ItTakesATeam campaign highlights the shared efforts to prevent and manage shortages across the EU, and the role of each actor in supporting patients faced with these shortages... Full

New Bulk-Buy to Drive Drug Price Cuts

(11/4, Wang Xiaoyu, China Daily) ...China's 11th nationwide centralized drug procurement round has selected 55 medicines, including antivirals and diabetes treatments, which are expected to become available at lower prices from February 2026, the National Healthcare Security Administration said last week... Full

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