Thursday, February 19, 2026

Teva Price Target Raised to $38 From $37 at BofA

(2/18, The Fly) ...BofA raised the firm's price target on Teva to $38 from $37 and keeps a Buy rating on the shares after the company and partner Sanofi announced Phase 2 maintenance data from the RELIEVE UCCD long-term extension study of duvakitug in inflammatory bowel diseases. Based on yesterday's update, the firm edged up its multiple, reflecting $1B in higher duvakitug peak sales, now seen at a $3B peak... Full

Teva Pharma (TEVA) PT Raised to $42 at Truist Securities

(2/18, StreetInsider.com) ...Truist Securities analyst Les Sulewski raised the price target on Teva Pharma to $42.00 (from $38.00) while maintaining a Buy rating... Sub. Req’d

Big Pharma Financially Unfazed by Drug Price Deals

(2/19, Caitlin Owens, Axios) ...Although details of the deals involving more than a dozen leading drug companies are confidential, the industry has made concessions on some prices in exchange for more regulatory certainty — with little to no noticeable impact on the bottom line. "If you have engaged in something that materially changed your outlook, you have to communicate that," said Rob Smith, managing partner at Capital Alpha. "The fact that they're not saying much kind of tells you what you need to know."... Full

Pharma Signals It's Done Negotiating as Trump's Drug Pricing Effort Marches On

(2/18, Max Bayer, Endpoints News) ...The CEO of PhRMA, which represents all but two of the companies that received price-cut demands from Trump, told reporters after the forum that the group remains unequivocally opposed to codifying the deals. "We've been clear all along that we believe price controls are the wrong way to lower costs for Americans," Stephen Ubl said... Sub. Req’d

Can Trump Win Over Critics With MFN Drug Pricing Plan? Former Biden Advisor Weighs In

(2/18, Kevin Dunleavy, Fierce Pharma) ...In a letter to Congress, more than 50 leaders of free-market and conservative organizations have urged (PDF) lawmakers to reject Trump's MFN policy, saying it would "import socialist price controls and values into our country." ...Dubbing themselves the Coalition Opposing the Codification of Most-Favored-Nation Prescription Drug Pricing, the group includes leaders from the National Taxpayers Union, the International Technology & Innovation Foundation, the Competitive Enterprise Institute, the Center for a Free Economy and the American Consumer Institute... Full

Fair Drug Pricing Requires Legislation, Not Executive Orders

(2/18, Wendell Primus and Kristi Martin, The Hill) ...Three main provisions that were left on the table in the development of the act would produce substantial savings for the government. The first is applying the Medicare negotiated prices, known as maximum fair prices, to the commercial market...The second would be to let Medicare negotiate prices for more drugs and give it the authority to negotiate drugs sooner if they are unaffordable. Finally, we must extend the Medicare inflation rebate policy, limiting annual price increases on drugs to the commercial market and benchmarking the policy to 2015 prices... Full

CBO: Part D Contributed To Higher Medicare Spending Than Expected

(2/18, Inside Health Policy) ...The Feb. 11 report notes spending on fee-for-service Medicare was 7% greater in 2025 than what CBO had anticipated. That increase resulted from larger-than-expected increases in enrollment and per-enrollee spending, and led CBO to raise its projection of outlays specifically for the fee-for-service program through 2035 by $0.5 trillion. The report notes bids from private health plans that administer Part D anticipate a 35% jump in annual per-enrollee costs in 2026, which was also higher than what the agency expected... Sub. Req’d

The QALY Paradox: An Unintended Consequence Of Most Favored Nation Drug Pricing

(2/18, Dominique Seo, Kenneth E. Thorpe, and T. Joseph Mattingly II, Health Affairs) ...Rather than rely on the economic evaluation methods and patient preferences developed for other nations, the US must define its own principles for measuring value in drug pricing. Doing so will require deliberate policy making—grounded in methods that reflect US ethical standards, legal limitations, and public values. Until then, the QALY Paradox will remain unresolved: a symptom of policy misalignment between what the law prohibits, what the market rewards, and what international benchmarking quietly imports... Full

Senate HELP Committee Chair Pitches Proposals for FDA Reform

(2/18, Zoey Becker, Fierce Pharma) ...A new report, which [Sen. Bill] Cassidy says is backed by input from a collection of stakeholders, offers proposed changes to the FDA review process and touches on the agency's rare disease approach, its use of AI, biosimilar regulations and other topics... Full

GDUFA IV: More ANDA Postmarket Commitments Coming?

(2/18, Derrick Gingery, Pink Sheet) ...The GDUFA IV talks largely have been dominated by FDA efforts to impose domestic manufacturing incentives, which remain pending. Most align with Trump Administration priorities. The agency has proposed fee and other changes to encourage more active pharmaceutical ingredient and finished dosage form production in the US, such as facility fee waivers during manufacturing plant construction and faster reviews of ANDAs using domestic facilities... Global Sub. Full

FDA Chief Marty Makary Says ‘Everything Should Be Over-the-Counter' Unless Drug Is Unsafe or Addictive

(2/18, Annika Kim Constantino, CNBC) ...He said the FDA is going through "the proper regulatory processes" to update OTC monographs – rulebooks that determine which drugs can be sold without a prescription – and is looking at prescription drugs like nausea medications and vaginal estrogen... Full

Pharma Seeks Relaxed FDA Oversight to Move Drugs to Over Counter

(2/19, Nyah Phengsitthy, Bloomberg Law) ...The task is not only complex, costly, and lengthy, but also unpredictable, drugmakers said, requesting the agency provide more clarity and flexibility to meet Makary's demand. "It is as rigorous as a regular new drug application," said Rachel Turow, a former regulatory counsel at the FDA, now an attorney at Skadden Arps Slate Meagher & Flom LLP representing industry. "FDA is going to have to be flexible if they want to aggressively switch things to OTC."... Sub. Req’d

Pharma Groups Pressure FDA to Finalize NDC Rule

(2/18, Joanne S. Eglovitch, Regulatory Focus) ...Due to new labelers constantly coming online, FDA anticipates that it will run out of 5-digit labeler codes by 2032 at the earliest and new NDC formatting will need to be put in place to accommodate longer NDCs. If the new format and system updates necessary to support this new format are not developed and operational across all systems by that time, the delivery of medications to patients could face significant disruptions... Full

F.D.A. Reverses Decision and Says It Will Review the Moderna Flu Vaccine

(2/19, Christina Jewett and Rebecca Robbins, The New York Times) ...The F.D.A. did not provide a detailed explanation on Wednesday as to why it suddenly changed direction. But its initial refusal to even consider Moderna's application drew swift and highly public rebukes, and startled the pharmaceutical industry -- beyond just vaccine manufacturers -- as well as investors... Sub. Req’d

IRS Grants Tech, Pharma a Tax Break Boost From Trump Deduction

(2/18, Caitlin Reilly, Bloomberg) ...The new guidance doesn't necessarily mean companies can avoid triggering the corporate minimum tax if they claim the backlog of deductions, yet it does allow them to reduce their tax burden by subtracting old domestic R&D investments from their income... Full

New Connecticut Law Caps Generic Drug Price Increases

(2/18, Susan Raff, WFSB) ...State Sen. Matt Lesser, who worked on the legislation, said the law addresses a growing problem with generic drug pricing. "A generic drug is supposed to lower the cost of prescription drugs, but what we are seeing over and over is that generics are actually increasing," Lesser said. The law includes enforcement mechanisms, with manufacturers and distributors facing state fines if they fail to comply with the price caps... Full

Teva and Sanofi's TL1A mAb Shows Durability in UC and CD

(2/18, Abigail Beaney, Clinical Trials Arena) ...In the RELIEVE UCCD long-term extension (LTE) study (NCT05668013), patients treated with duvakitug, an investigational human mAb targeting anti-TNF-like ligand 1A (TL1A), who had initially responded in the 14-week induction phase, saw maintained benefit over a further 44 weeks... Full

FDA Accepts BMS Protein Degrader for Review; Disc Rare Disease Drug Rejected

(2/18, BioPharma Dive) ...Remission and response rates for the high dose of 900 milligrams improved at the 44-week endpoint for both conditions compared with those seen at the main, 14-week endpoint, Jefferies analyst Dennis Ding wrote in a note to clients... Full

Duvakitug Shows Durable Efficacy in Ulcerative Colitis and Crohn Disease

(2/18, Ashley Gallagher, MA, Drug Topics) ..."One of the persistent challenges in treating ulcerative colitis and Crohn disease isn't just achieving an initial response, but sustaining it," Eric Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva, said in a news release. "These phase 2b results further reinforce TL1A as a compelling target and clearly strengthen the case that duvakitug has the potential to be a best-in-class therapy. They also provide further evidence to support additional indications we anticipate announcing this year, with the goal of bringing meaningful innovation to patients."... Full

Teva and Sanofi's TL1A mAb Shows Durability in UC and CD

(2/18, Abigail Beaney, GlobalData) ...Detailed results from the study will be presented at a forthcoming medical meeting... Full

FDA Starts Review of BMS's 'Celmod' for Multiple Myeloma

(2/18, Phil Taylor, PharmaPhorum) ...The FDA has started a priority review of iberdomide as an add-on to Johnson & Johnson and Genmab's anti-CD38 antibody Darzalex (daratumumab) and dexamethasone, a standard regimen for relapsed or refractory multiple myeloma, and is due to deliver its decision by 17th August... Full

Paragon's Latest Biotech Will Try to Slow Alzheimer's like Roche

(2/18, Kyle LaHucik, Endpoints News) ...Like Roche with trontinemab, Korsana Biosciences is attempting to deliver an antibody that shuttles across the blood-brain barrier to thwart the advancement of the memory-robbing disease. Korsana disclosed its lead asset Wednesday along with the news that it raised a $150 million Series A in September to help get to early clinical data... Sub. Req’d

Dr Reddy ' s Readies Day-1 Launch of Semaglutide Generic

(2/19, Rica Bhattacharyya, The Economic Times) ..."We are planning all formats - including orals and injectables - and all of them will be there in the initial launch," MV Ramana, CEO, branded markets, India and emerging markets, told ET in an interview. "All of them will be competitively priced," said Ramana... Full

Zydus Introduces Biosimilar Aflibercept 2 Mg Anyra for Advancing Ophthalmic Care

(2/19, Pharmabiz.com) ...Zydus Lifesciences Ltd., an innovation-led global life sciences company, announced the launch of Anyra, India's first indigenously developed biosimilar of Aflibercept 2 mg. Zydus has also signed an agreement with Regeneron Pharmaceuticals, Inc. and Bayer... Full

GSK Strikes 5-Year Deal with Jackson Laboratory Focused on Neurodegenerative Disease Research

(2/18, Will Maddox, Fierce Biotech) ...With Alzheimer's disease as a major target, the partnership aims to unite human stem cell research with large-scale research systems to bridge the gap between discovery and drug development, according to a Feb. 17 press release. By fine-tuning new models, Jackson and GSK hope to enable the biologic interrogation of neurodegenerative diseases and potentially support the discovery of potential therapies, the partners said... Full

J&J Fleshes Out US Investment Plan, Telegraphing $1B Cell Therapy Plant and 500 New Jobs in PA

(2/18, Fraiser Kansteiner, Fierce Pharma) ...J&J will spend more than $1 billion to build out a next-generation cell therapy production plant in Montgomery County, Pennsylvania, the company said in a Feb. 18 release. Once up and running, the facility will create some 500 new permanent biomanufacturing positions, not to mention more than 4,000 construction jobs while the plant is being developed, J&J said. J&J did not lay out a timeline for the plant's expected completion, nor did the company specify the types of "cutting-edge cell therapy technologies" it plans to employ at the new site... Full

Recipharm Focuses Footprint With Sale of Israel API Plant, New CDMO Partnership

(2/18, Kevin Dunleavy, Fierce Pharma) ...As Recipharm continues to refine its footprint, the CDMO is selling its development and small-scale active pharmaceutical ingredient (API) manufacturing facility in Yavne, Israel, to Scinai Immunotherapeutics... Full

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