Tuesday, February 17, 2026

Sanofi Experimental Drug Helps Patients With Bowel Disease

(2/17, Marthe Fourcade, Ashleigh Furlong, Bloomberg) ...Sanofi said an experimental medicine it's developing with Teva Pharmaceuticals Inc. helped patients with inflammatory bowel disease. The benefits after treatment with the drug, duvakitug, were maintained over 44 weeks, Sanofi said in a statement. The 130 patients enrolled in the intermediate trial had ulcerative colitis or Crohn's disease... Sub. Req’d

Moderna Blames FDA for Threatening US Leadership in Medicine

(2/13, Gerry Smith, Bloomberg) ...In a call with analysts on Friday, Chief Executive Officer Stephane Bancel said the agency had become unpredictable. If the FDA keeps it up, it "threatens US leadership in innovative medicines."... Sub. Req’d

Moderna CEO Worries About Drug Development Overall After US FDA mRNA-1010 Refusal-To-File

(2/13, Alaric DeArment, Pink Sheet) ...Moderna CEO Stéphane Bancel opened Moderna's Feb. 13 fourth-quarter and full-year 2025 earnings call stating, "I want to express our disappointment with the FDA for the refusal-to-file letter on our flu program, MRNA-1010."..."The current uncertainty in the US FDA regulatory environment creates real challenges for businesses, patients and the broader innovation ecosystem," Bancel said. "When expectations and review timelines are unpredictable, companies face greater risk and can hesitate to invest, slowing the development of breakthrough medicines."... Global Sub. Req’d

Complex Challenges Arising From Pricing Reforms: Q&A With Jesse Mendelsohn

(2/17, Mike Hollan, PharmExec.com) ...Pharmaceutical Executive recently spoke with Jesse Mendelsohn, SVP at Model N, about the complications that can arise from companies entering into drug pricing agreements with the government. This comes as major pharma companies work directly with the government to provide discounts on select medications... Full

After PBM Reform, Time to Stop Drugmakers' War Against Lower-Cost Medicines

(2/13, PCMA Blog) ...As part of a hearing on affordability this week at the House Energy and Commerce Committee, PCMA laid out several important areas that demand lawmaker attention. At their core is stopping Big Pharma's war against lower-cost medicines. When there is competition among drugs, prices come tumbling down. Which is why drugmakers employ so many shifty tactics to block generic and biosimilar medicines from coming to market... Full

US FDA Proposing White House-Aligned Policies For User Fee Agreements

(2/16, Derrick Gingery, Pink Sheet) ...As the prescription drug and generic drug user fee talks have progressed, multiple references to Trump Administration initiatives have emerged in proposed changes offered by the FDA. The developments seem to confirm concerns leading up to the talks that Trump officials could influence the negotiations, which historically have not been policy-related...The FDA did not respond to questions about whether the White House or the Office of Commissioner Martin Makary were dictating "America First" user fee proposals to the negotiating team... Global Sub. Req’d

‘It's Time For The Biosimilar Program To Evolve‘ – Biosimilars Forum's Reed Sees Need For Change

Streamlining, Interchangeability, PBMs, And OTBB Signatory Authority

(2/17, Dave Wallace, Generics Bulletin) ...Speaking to Julie Reed, executive director of the Biosimilars Forum industry association, it is clear that this sense of intensive activity is being felt throughout the sector. "Every year is busy for biosimilars," Reed said. It's not a sleepy industry."... Global Sub. Req’d

HHS Seeks Info as It Weighs Second Attempt at Drug Rebates

(2/13, Nyah Phengsitthy, Bloomberg Law) ...The request for information issued Friday weighs whether the US government should implement a rebate system under the 340B Drug Pricing Program—a federal plan that historically has required drugmakers to offer up-front discounts to health providers that treat low-income and uninsured patients... Sub. Req’d

A Top FDA Scientist Who Quit Warns of Politicized Drug Approvals

(2/13, Liz Essley Whyte, The Wall Street Journal) ...[Dr. Richard] Pazdur said that under Makary, fast-track drug approvals had been politicized in a way he had never experienced in his 26 years at the agency. Past FDA commissioners carefully avoided interfering in individual drug approvals, instead letting the scientific reviewers have sway. "This wall between the commissioner's office and the review staff has been breached," Pazdur said... Sub. Req’d

Actor Will Forte Joins Huntington's Disease Awareness Campaign

(2/17, Les Luchter, Marketing Daily) ...Actor-comedian Will Forte has a brother-in-law, Doug, with Huntington's Disease (HD), and they're both now starring in an awareness campaign about the rare neurological disease from Teva Pharmaceuticals...Teva learned about Forte's connection to HD after he shared his story with Fox 11 Los Angeles in late 2024, Heather DeMyers, Teva's vice president of U.S. innovative medicines marketing, tells Marketing Daily... Full

Roche's Gazyva Notches Another Pivotal Win in Autoimmune Kidney Disease

(2/16, Matthew Dennise, FirstWord PHARMA) ...Monday's readout from the MAJESTY trial, which randomised 142 patients, showed that significantly more people achieved complete remission at week 104 with Gazyva/Gazyvaro versus tacrolimus, meeting the study's main goal... Full

Lilly Seeks to Move RET Inhibitor Earlier in Lung Cancer Treatment

(2/16, Matthew Dennis, FirstWord PHARMA) ..."We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey," said Jacob Van Naarden, president of Lilly Oncology. "The LIBRETTO-432 results support this observation, demonstrating an effect size in line with the most striking data for targeted adjuvant therapy in lung cancer."... Full

Seasonique, Seasonale Birth Control Pills Recalled over Possible Missing Blister Card

(2/13, CBC) ...Teva Canada is recalling two lots of Seasonique and one lot of Seasonale prescription birth control pills as a precaution after the company received a complaint about a package missing an entire blister card of pills, Health Canada says... Full

Complaint Prompts Recall of Birth Control Pills Prescribed in Canada

(2/17, Kendra Mangione, CP24) ...The recall by Teva Canada Inc. followed a complaint from a user who noted a package of the pills was "missing an entire blister card," the notice from Friday said... Full

Medicine Supply Notification: Phenobarbital 30mg and 60mg tablets

(2/16, Community Pharmacy England) ...Phenobarbital 30mg tablets and 60mg tablets (Teva) are out of stock until mid/late March 2026...Phenobarbital 15mg tablets (Teva) remain available but can only support a partial uplift in demand where alternative options are unsuitable... Full

Merck Loses Bid to Nix Monopoly Claims in Zetia Generic Drug Row

(2/13, Katie Arcieri, Bloomberg Law) ...Judge Haywood S. Gilliam Jr. of the US District Court for the Northern District of California on Thursday denied Merck's motion to dismiss patent-based monopolization claims under California's Cartwright Act, saying plaintiff Kaiser Foundation Health Plan Inc. adequately alleged the drugmaker along with Schering were part of a conspiracy to delay the less expensive generic medication... Sub. Req’d

Biocon Aims for Revenue Surge With Rollout of Generic Weight-Loss Drugs

(2/16, Rishika Sadam, Reuters) ...Biocon is aiming for high-double-digit percentage revenue growth as the Indian pharmaceutical firm prepares to launch generic versions of weight-loss drugs globally even as it remains cautious about an early rollout in the home market, a top company executive told Reuters... Sub. Req’d

Aurobindo: Biosimilars Inflection Point Pushed, Pomalidomide Launch Set For Q4

(2/16, Vibha Ravi, Generics Bulletin) ...Satakarni Makkapati, CEO of biologics, vaccines and peptides said FY29 is expected to be an "inflection year" for biosimilars during a third quarter FY26 (period ending Dec. 31, 2025) earnings-related call but during the fourth quarter of FY25, he had pointed to FY28 being the year for the business to reach an inflection point. Indian companies usually have a fiscal year ending March 31... Global Sub. Req’d

Organon Tempers Expectations For Denosumab Biosimilars As Competition Intensifies

(2/16, Dean Rudge, Generics Bulletin) ...Speaking on its fourth-quarter earnings call, Organon's management said investors should model peak revenue for the denosumab opportunity at around $100m in total over roughly five years across both reference products. "Like a lot of the biosimilar partnered opportunities that we have, we'll be competing against highly competitive markets, both from a volume and price perspective," commented Organon's chief financial officer, Matthew Walsh... Global Sub. Req’d

Biosimilar Darzalex Progress Caps Busy Few Months For Shanghai Henlius Biotech

(2/13, Dean Rudge, Generics Bulletin) ...The company secured approval from China's National Medical Products Administration to initiate a Phase I clinical trial for its HLX15-SC subcutaneous daratumumab biosimilar, offering potentially improved treatment convenience for multiple myeloma patients... Global Sub. Req’d

‘This Can Be Weaponized' – Sandoz Sounds Alarm Over Cheap Chinese Antibiotics As India Takes Action

(2/16, Dave Wallace, Generics Bulletin) ...Sandoz strategy head Simon Goeller speaks to Generics Bulletin about recent measures taken by India to protect its market from cheap Chinese antibiotics imports, and the potential threat to Europe...Goeller suggests that the concentration of antibiotics manufacturing in China and the potential for a market monopoly risks antibiotics supply becoming "weaponized" as part of a "hybrid warfare" approach... Global Sub. Req’d

How Ozempic Brought a Napster Moment to Big Pharma

(2/17, David Wainer, The Wall Street Journal) ...An aggressive FDA crackdown may finally rein in mass GLP-1 compounding, but history suggests this is only a bridge to a different kind of disruption... Sub. Req’d

Does Organon's Biosimilars Review Point To Deeper Internal Control Challenges?

(2/13, Dean Rudge, Generics Bulletin) ..."Today we're learning of another issue, this time involving biosimilars purchasing. It raises the possibility that five other issues could be brought up," [Umer Raffat of Evercore ISI] suggested. What's more, he proposed, "It almost looks like there's an unwillingness by the board and the leadership to actually solve this and do it the right way."... Global Sub. Req’d

FDA's Abraham Accords Friendshoring Initiative Builds On Rebuild America's Medical Manufacturing

(2/17, Robert Goldberg, The Times of Israel) ...A practical way to understand what this regional architecture could become is to think in "Teva terms." Teva describes its operations as a global supply chain network focused on "operational excellence and network efficiency," spanning 53 manufacturing sites worldwide. (Teva Pharmaceuticals) That's the basic resilience idea: you don't bet everything on one facility, one route, or one country. You build multi-node redundancy—multiple sites, multiple packaging paths, and multiple distribution channels—so the system keeps delivering when something breaks... Full

Sandoz at Munich Security Conference: "Europe must Start to Treat Essential Medicines as Critical Security Infrastructure"

(2/14, Sandoz) ...Speaking at the Munich Security Conference (MSC), Simon Goeller, Chief Transformation & Growth Officer at Sandoz, said that medicines – especially antibiotics, the ‘backbone of modern medicine' – must be treated as strategic security assets, not merely as ‘healthcare commodities'... Full

EU Pharmaceutical Groups Suggest Fixes to ICH E20 Guideline

(2/16, Joanne S. Eglovitch, Regulatory Focus) ...Pharmaceutical companies and EU industry groups pushed back against the expectation for sponsors to justify their choice to use adaptive clinical trial designs in the International Council on Harmonisation's E20 guidance on adaptive clinical trials in comments submitted to the European Medicines Agency... Full

EU Trade Deal Threatens to Undermine Europe's Home-Grown Medicines Ambition

(2/13, Giedre Peseckyte, Politico) ...Critics warn Europe's plan to tackle drug shortages runs counter to the EU-India deal, which will lower trade barriers for Indian medicines. India is one of two countries, along with China, where Europe has a concerning dependency for critical medicines and their ingredients. For many drugs, these supply chains are considered "vulnerable" with any disruptions likely to cause shortages for patients... Full

Indian Pharma Pivots Toward Specialty Therapeutics and AI-Powered Drug Discovery to Reduce Timelines & Costs

(2/14, Nandita Vijayasimha, Pharmabiz.com) ...The Indian pharmaceutical industry is now increasingly demonstrating genuine strengths to offset structural barriers that continue to impede innovation on the global stage. Its innovation pathway focuses on high-value niche positioning rather than competing directly with global pharma giants... Full

Canada Seeks To Transform Clinical Trial Landscape With Flexible, Risk Based Rules

(2/16, Neena Brizmohun, Pink Sheet) ...Stakeholders have over a month to comment on Health Canada's proposal for new clinical trials regulations that are expected to introduce a flexible, risk-based approach to oversight throughout a trial's life cycle, better support innovative trials, reduce regulatory burden on industry, and improve participant access and safety... Global Sub. Full

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