Wednesday, February 18, 2026

Sanofi Points to 'Key Opportunity' for Teva-Partnered IBD in Long-Term Data

(2/17, James Waldron, Fierce Biotech) ...Sanofi and Teva have provided 44-week data they claim show "durable clinical and endoscopic efficacy." The extension stage of the study enrolled 130 patients who had responded to duvakitug in the initial part of the trial. These patients were re-randomized to receive a 450-mg or 900-mg subcutaneous dose of duvakitug every four weeks... Full

Sanofi, Teva's Anti-TL1A mAb Shows its Durability in Long-Term IBD Study

(2/17, Elizabeth S. Eaton, FirstWord PHARMA) ...After 14 weeks, 47.8% of UC and CD patients on the high dose of duvakitug responded to treatment. Specifically, patients with UC taking the low and high doses achieved placebo-adjusted clinical remission rates of 16% and 27%, respectively. Endoscopic response rates in patients with CD were 13% and 35% higher than placebo for the two doses... Full

Sanofi and Teva's Duvakitug Phase 2b Maintenance Data Demonstrated Clinically Meaningful Durable Efficacy in Ulcerative Colitis and Crohn's Disease

(2/18, Pharmabiz.com) ..."One of the persistent challenges in treating ulcerative colitis and Crohn's disease isn't just achieving an initial response, but sustaining it," said Eric Hughes, MD, PhD, executive vice president, global R&D and chief medical officer, Teva. "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

Duvakitug Phase 2b Maintenance Data Show Durable Remission in UC and Crohn Disease

(2/17, Sydney Jennings, Patient Care) ...Duvakitug is currently being evaluated in phase 3 clinical trials for UC and CD. TL1A signaling is believed to amplify inflammation and contribute to fibrosis in inflammatory bowel disease through binding to its receptor, DR3. Duvakitug preferentially inhibits TL1A-DR3 signaling over binding to decoy receptor 3 (DcR3), with the potential to reduce inflammation and fibrosis... Full

Teva's Duvakitug Data Puts Ulcerative Colitis And Crohn's Bet In Focus

(2/18, Bailey Pemberton, Simply Wall St.) ...The fact that Teva and Sanofi are moving quickly into phase III, supported by dedicated investor events and conference presentations, signals that management sees this as a program that could eventually matter for revenue mix if later stage trials read out well and regulators approve the drug... 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

Oz Signals Lower Drug Price Legislation Would Favor Pharma

(2/17, Victoria Knight and Nyah Phengsitthy, Bloomberg Government) ..."I think we've established a deep passion to preserve innovation," [CMS Administrator Mehmet] Oz said at an annual forum hosted by the Pharmaceutical Research and Manufacturers of America, as he discussed the Trump administration's most-favored-nation proposal. "If it's not done right, a future administration will take more drastic, draconian steps in ways that would hurt this industry." Oz also said during his fireside chat at the PhRMA forum with Pfizer Inc. CEO Albert Bourla that he wanted to "codify MFN in a way that industry finds is reflective of what was signed in the contracts."... Full

Trump Officials Try to Make Peace With Pharma

(2/18, Peter Sullivan, Axios) ...[PhRMA] CEO, Steve Ubl, told reporters afterward that it unequivocally opposes Congress codifying most-favored-nation pricing, seeing it as "price controls" that will harm innovation... Full

At Drugmakers' Forum, Oz Gets a Friendly Embrace, While Makary Faces Tough Questions

(2/17, Lizzy Lawrence, Daniel Payne, STAT+) ...Asked by [Pfizer CEO Albert] Bourla if the government could work more with industry on vaccine policy instead of making decisions that industry reacted to after the fact, Oz seemed to agree that HHS could do better. "It would be wise to be more collaborative," Oz said... Sub. Req’d

Cassidy Offers Rx for Overhauling FDA

(2/18, Axios) ...Senate health committee chair Bill Cassidy on Tuesday laid out a plan to overhaul the FDA that calls for more predictability in the drug review process and for speeding up development of drugs for rare diseases... Full

PhRMA Launches Campaign Highlighting the Importance of America's Global Leadership in Medicine Development

(2/17, PhRMA) ...Today, the [PhRMA] launched America Cures, a new campaign underscoring why U.S. leadership in biopharmaceutical innovation matters now more than ever. The campaign highlights how our leadership in medicine development supports the fastest access to breakthrough treatments in the world, millions of high-paying American jobs and stronger national security... Full

Inside the Black Box of Prescription Drug Pricing

(2/18, Lori Chavez-DeRemer, RealClear Markets) ...Trump's Labor Department is taking the fight to PBMs on behalf of all American workers and retirees. We are shining a light on the black box of prescription drug pricing, empowering employers to negotiate better deals that put money back in workers' pockets... Full

The Federal Trade Commission (FTC) Takes Important Action to Highlight and Curb PBM Abuses

(2/17, Jim Stansel, PhRMA Blog) ...Despite the inclusion of these key provisions, we are concerned that ESI and its affiliates, given their history, will seek any loophole possible to escape from the provisions in the proposed consent agreement... Full

FDA Floats WH-Aligned ‘America First' Policies In User Fee Talks, Raising Legal Concerns

(2/17, Maaisha Osman, Inside Health Policy) ...Industry representatives asked questions about how FDA would define and measure efficiency and said they would review the proposal further before taking a formal position, signaling that financial framework changes could become a key issue in ongoing PDUFA VIII negotiations... Sub. Req’d

No More Excuses After Pharma-Backed PBM Reform Becomes Law

(2/17, PCMA) ...Going further, a renewed focus on the way Big Pharma games the patent system to keep drug prices high is more important than ever after PBM reform, given the way it stands to tie the hands of employers as they combat rising drug prices... Full

CSRxP: Congress Must Return Focus To Drug Patent Reform

(2/17, Gabrielle Wanneh, Inside Health Policy) ...To deliver affordable health care and medications for American people, lawmakers must hold Big Pharma accountable for the egregious anti-competitive tactics and price-gouging practices that keep drug prices high," CSRxP Executive Director Lauren Aronson said in a statement... Sub. Req’d

Proliferating Patents, Lawsuits Stave Off Pharmas' Generic Competitors

(2/18, Shawna Williams, BioSpace) ...A four-decade-old framework intended to simplify generic drugmakers' path to market is now "increasingly exploited" to maintain long-term exclusivity for brand-name pharmas, a new analysis finds... Full

Exclusive-California Preparing Lawsuit over Trump Administration Vaccine Changes

(2/17, Dan Levine and Robin Respaut, Reuters) ...In an interview with Reuters on Tuesday, Bonta and Connecticut Attorney General William Tong both expressed disdain for Kennedy's views on vaccines. In terms of new litigation, Bonta said his "team is mobilized" and is "looking at what the complaint looks like, where to file, what our standing is, all the, all the things we have to have locked in."... Full

US Pharmacopeia: Quality Matter Q&A with Matthew Vankowski

(2/17, LinkedIn) ...In Part Two of our Quality Matters Q&A, USP's Matthew Vankoski answers audience questions from our recent webinar with the FDA and the Association for Accessible Medicines (AAM) — exploring global harmonization, data-driven standards development, and how industry can engage with USP's Pending Monograph Process... Full

U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact

(2/18, Mathini Ilancheran, Clinical Leader) ...Entering 2026, the key change is not a rollback of tariff risk but a policy path that reduces exposure through accelerated U.S. manufacturing investment and pricing agreements that provide tariff exemptions. This paper integrates the 2025 tariff framework with late-2025 and 2026 developments and translates them into actionable procurement and outsourcing responses... Full

Federal Authorities Take Big Steps to Rein in Drug Middlemen at Center of Ohio Complaints for Years

(2/18, Marty Schladen, Ohio Capital Journal) ...To end the conflict, a bipartisan bill was filed this month that would prohibit the health conglomerates from owning providers such as pharmacies and doctors' offices at the same time they own insurance companies and PBMs, which control how much consumers have to pay them... Full

UK Company Selects HRN001 as its Lead Huntington's Therapy Candidate

(2/17, Marisa Wexler, MS, Huntington's Disease News) ..."The nomination of HRN001 represents a pivotal milestone for Harness and underscores our commitment to the Huntington's disease community," Jan Thirkettle, PhD, CEO of Harness, said in a company press release..."By precisely [increasing] FAN1, a target with compelling genetic validation in delaying disease onset, HRN001 represents a differentiated, first-in-class therapeutic approach for addressing somatic expansion, a fundamental driver of disease progression," Thirkettle said. Harness plans to continue preclinical development of the therapy this year, with the goal of moving HRN001 into clinical testing next year... Full

Compass Pathways Soars as Psilocybin Depression Treatment Hits Second Phase 3 Trial Goals

(2/17, Elizabeth Cairns, Endpoints News) ...The study, called COMP006, had an unusual design. Unlike the first pivotal trial, which compared COMP360 with placebo, the second pitted different doses against each other. Roughly half the patients in the trial took two 25 mg doses of the drug three weeks apart. A quarter of the trial's subjects received two doses of 10 mg, and another quarter two doses of 1 mg... Sub. Req’d

FDA Approves Filkri, Filgrastim Biosimilar Referencing Neupogen for Cancer Treatment-Related Indications

(2/17, Gillian McGovern, Pharmacy Times) ...Filkri is available in 2 injection presentations: 300 mcg/0.5mL and 480 mcg/mL, both of which come in a single-dose prefilled syringe. Exact dosing depends on the patient and the reason for treatment. The most common adverse events reported by patients include pain, pyrexia, rash, cough, dyspnea, epistaxis, anemia, diarrhea, hypoesthesia, and alopecia... Full

Biocon To Explore Further Possibilities For Fully Acquired Humira Biosimilar

(2/18, Urte Fultinaviciute, Generics Bulletin) ...Despite the challenging adalimumab biosimilar experience in the US, Biocon Biologics continues to see value in its Hulio (adalimumab-fkjp) on the global stage, particularly now that the firm is the full asset owner...The biosimilars business grew by 9% year-on-year and brought in revenues of INR25bn ($275.7m) in the fiscal third quarter ending Dec. 31, 2025... Global Sub. Full

Gotenfia Approval Sets Stage For Multi-Player Competition On EU Golimumab

(2/17, Dean Rudge, Generics Bulletin) ...The approval positions the partners as the second entrants into a market that only recently opened to biosimilar competition, following Alvotech and Advanz Pharma's debut of their Gobivaz version late last year. Stada said preparations were already under way to bring Gotenfia to patients across Europe, with the firm responsible for commercialization in the EU, the UK, Switzerland and selected other territories, while Bio-Thera will handle development, manufacturing and supply... Global Sub. Full

Sandoz Receives US FDA Approval to Expand Enzeevu® (Aflibercept-abzv) Label for Multiple Retinal Indications

(2/18, Sandoz) ...The most recent approval expands the Enzeevu® label indications to include macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR) and diabetic macular edema (DME), along with the previously approved indication of nAMD. This expansion offers retina specialists a clinically-proven aflibercept biosimilar option to treat more patients across these retinal diseases... Full

Esperion Reaches Settlement Agreement With Fifth ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) & NEXLIZET® (bempedoic acid & ezetimibe) Prior to April 19, 2040

(2/17, Esperion) ...Esperion today announced that it has entered into a settlement agreement with Alkem Laboratories Ltd.. This agreement resolves the patent litigation brought by Esperion against Alkem in response to Alkem's Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of NEXLETOL and NEXLIZET prior to the expiration of the applicable patents. Pursuant to the agreement, Alkem has agreed not to market a generic version of either NEXLETOL or NEXLIZET in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur... Full

Merck and Mayo Clinic Announce New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine

(2/18, Merck and Mayo Clinic) ...The new Mayo Clinic Platform_Orchestrate program provides Merck direct access to Mayo Clinic's world-class clinical and scientific expertise; platform data including de-identified clinical and multimodal data sets, registries and biorepositories; advanced AI tools and analytics; and the ability to scale solutions... Full

Dr Reddy's Says Wegovy Copycat to Be Priced Competitively, with 50–60% Discounts Feasible

(2/17, Rishika Sadam and Sriparna Roy, Reuters) ..."Fifty to 60% (lower than the innovator) is very comfortable," said G V Prasad, co-chairman and managing director of Dr Reddy's, in an interview on the sidelines of the BioAsia conference in Hyderabad. "That is not bad on the innovator drug."... Full

Express Scripts Accused of Hiding Drug Rebates by Plumbers Union

(2/17, Lauren Clason, Bloomberg Law) ...The Plumbers' Welfare Fund, Local 130 U.A., filed a class action against Express Scripts and parent companies Evernorth Health Services and The Cigna Group in the US District Court for the Northern District of Illinois on Tuesday, arguing the pharmacy benefit manager's negotiation tactics amount to "kickback payments" that limit patient access and raise the union's drug costs... Sub. Req'd

Pricing and Reimbursement Delays Continue to Impact Biopharma Revenue Streams

(2/17, Annabel Kartal Allen, Pharmaceutical Technology) ...Delays in obtaining pricing and reimbursement (P&R) have been identified as key hurdles holding back the pharmaceutical industry, according to market analysis. This trend is highlighted through responses to a survey taken from GlobalData's State of the Biopharmaceutical Industry report, which reveals that industry professionals rate the impact of P&R processes among the top five leading factors currently impacting the sector... Full

Pharma Companies Venture Further Afield in Search of R&D

(2/17, Robert Barrie, Pharmaceutical Technology) ...According to a survey of pharma executives by consultancy firm Ayming UK, nearly half (47%) of the respondents said they offshored R&D last year. Companies cited collaboration opportunities with partners and proximity to new markets and customers as two of the primary motivating factors for their strategy. Firms also pointed to enhanced access to R&D talent, along with lower wage costs in certain territories... Full

As China's Drug Industry Races Ahead, its GLP-1 Race Is Accelerating Too

(2/18, Brian Yang, STAT+) ...It's still unclear whether China's homegrown GLP-1s can really threaten Novo's or Lilly's interests in China. Not everyone is convinced they can... Sub. Req’d

The China factor: US Pharma Group Campaigns for Increased Competitiveness

(2/18, Manasi Vaidya, Pharmaceutical Technology) ...The chief topic on the agenda for all was China; with PhRMA and others ringing alarm bells that China's healthcare industry is quickly moving ahead on key metrics like the pace and cost of Phase I trials, and share of innovative therapies in development... Full

Time for Innovative Medicines Fund 2.0 in England: Industry and Patients Want Change

(2/17, Leela Barham, Pink Sheet) ...England's £340m ($460.2m) a year Innovative Medicines Fund for promising non-cancer drugs should be made more commercially attractive by removing onerous obligations for companies and opened to costly-combination therapies that struggle through the health technology assessment (HTA) process. These are just some of the suggestions that pharmaceutical companies and patient representatives have made to the Pink Sheet following its investigation into the fund... Global Sub. Full

January Brings A Slew Of Price Spikes For UK Generics

(2/17, Dave Wallace, Generics Bulletin) ...The new year brought a slew of triple-digit percentage price rises across a host of UK generics, according to the latest figures from market researcher WaveData. Based on trade prices to UK independent pharmacists, WaveData calculated that every single presentation in our table of Biggest Risers saw its average price at least double in January 2026... Global Sub. Full

'This Requires More Than Isolated Policy Interventions' - Centrient Urges EU To Bolster Supply Chain

(2/18, Dave Wallace, Generics Bulletin) ...Centrient has joined in calls for Europe to strengthen its supply chain and bolster local manufacturing - particularly in the area of antibiotics - after India's Directorate General of Foreign Trade recently took the step of restricting imports of certain antibiotics and key starting materials below a certain value, effectively setting a price floor for products that are increasingly produced at low costs in markets outside of India, notably in China... Global Sub. Full

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