Monday, February 23, 2026

FDA Accepts Teva's Drug Application for Monthly Schizophrenia Treatment

(2/23, StreetInsider.com) ...The U.S. Food and Drug Administration has accepted Teva Pharmaceutical Industries Ltd.'s New Drug Application for olanzapine extended-release injectable suspension (TEV-'749), a once-monthly subcutaneous treatment for schizophrenia in adults... Full

NDA Accepted: Olanzapine Extended-Release Injectable Suspension for Treatment of Schizophrenia

(2/20, Leah Kuntz, Psychiatric Times) ..."Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine. TEV-'749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-monthly treatment," said Eric Hughes, MD, PhD, the executive vice president of global R&D and chief medical officer at Teva. "For too long, the lack of a viable long-acting olanzapine formulation has limited the options available to these individuals, and we look forward to working with the FDA on the review of this NDA for TEV-'749 to help address this gap in care."... Full

Biopharma Bites: FDA Reviewing NDAs from Roche and Teva, Plus Funding for Candel's Immunotherapy

(2/20, FirstWord PHARMA) ...If the FDA approves Teva's extended-release injectable formulation of olanzapine, Royalty Pharma will receive low- to mid-single digit royalties, per an agreement signed in 2023 under which it provided Teva with up to $125 million in development funding for the candidate... Full

FDA Accepts NDA For Teva And Medincell's Olanzapine LAI In Schizophrenia Treatment

(2/21, RTT News) ...Currently, there is no long-acting olanzapine formulation available without an FDA-required Risk Evaluation and Mitigation Strategy (REMS). The REMS program mandates administration in a certified healthcare facility and requires patients to remain under observation for three hours following injection... Full

How Low Can You Go? MedImpact Offers Adalimumab At 95% Discount To Humira In US

(2/20, Dave Wallace, Generics Bulletin) ...MedImpact is set to offer the cheapest Humira (adalimumab) biosimilar yet in the US market, partnering with Teva and its Anda distribution affiliate to offer an unbranded version of the Alvotech-developed adalimumab-ryvk at a 95% discount to the reference product. The biosimilar will be offered by MedImpact "through its preferred partner, Birdi Inc., to any hospital, plan, or pharmacy nationwide – not just its own clients or affiliates," the firm said. Availability is planned for July 1, 2026... Global Sub. Full

Will Forte Says "SNL" 'Still Makes Me Nervous' Whenever He Returns: 'It's Built into Every Cell of Your Body'

(2/21, Wesley Stenzel, Entertainment Weekly) ...[Will] Forte recently partnered with Teva to launch a campaign raising awareness for Huntington's disease. The actor's brother-in-law, Douglas, was diagnosed with the condition, which is an inherited disorder in which the brain's nerve cells decay over time, affecting movement, cognitive ability, and mental health. "More people have Huntington's than have ALS, but everybody knows ALS, so that's why we're trying to get the word out about it," Forte says... Full

Will Forte Shares the #1 Lesson He's Learned from a Family Health Condition

(2/20, Rachel Maidl, The Healthy) ...In an exclusive interview with The Healthy, Modling and Forte spoke together about their journey navigating the disorder as a family; the lessons they've learned about relationships, humor, and being present; and where people living with Huntington's can find information and resources... Full

Supreme Court Steps In: Trump's Emergency Tariffs Struck Down

(2/20, Eric Sagonowsky, Fierce Pharma) ...Notably, the Friday ruling affects tariffs deployed under IEEPA, not those levied under the industry-specific Section 232 of the Trade Expansion Act, according to the BBC. The administration has started a Section 232 investigation for the pharmaceutical industry, but the probe has yet to yield taxes on drug imports... Full

Trump's Tariffs Are Off — Or Are They? What Pharma Does Next

(2/23, PharmaSource) ...Lindsay Greenleaf, former HHS adviser at ADVI Health, is direct: "The Trump administration may now have new motivation to move forward with Section 232 — to compensate for today's loss in court."... Full

A Bipartisan Fix for the Prescription Drug Market

(2/20, Sen. Mike Crapo, RealClear Health) ...Congress reinforced protections that require PBMs to contract with all pharmacies that agree to their standard terms and conditions, not just their corporate affiliates. Allowing PBMs to set different terms for different pharmacies threatens small and independent pharmacies, forcing them to choose between operating at razor-thin margins (or even at a loss) or simply refusing to accept certain insurers... Full

AFPI Says Pairing HSAs With TrumpRx Could Cut Costs; Critics Warn It Favors Wealthy

(2/20, Maaisha Osman, Inside Health Policy) ...The conservative think tank America First Policy Institute said in a new report pairing the TrumpRx drug purchasing website with health savings accounts could further lower prescription drug costs by allowing patients to use pre-tax funds to buy medicines directly from manufacturers, but some health policy experts cautioned the approach may primarily benefit wealthier patients able to afford high-deductible plans and set aside significant savings... Sub. Req'd

HHS Takes Another Swing at Drug Discount Overhaul

(2/23, Maya Goldman, Axios) ...The drug industry trade group PhRMA sees the rebate model as a way to add needed transparency to federal drug discounts, spokesperson Alex Schriver said in a statement to Axios... Full

FDA Signals Shift Toward OTC, Brings OTC Group Into PDUFA Talks

(2/20, Maaisha Osman, Inside Health Policy) ...AAM also cautioned that full Rx-to-OTC switches could force generic manufacturers out of the prescription market, particularly those without OTC distribution infrastructure, potentially reducing competition and increasing the risk of drug shortages. The group said FDA policies must preserve generic competition and allow simultaneous prescription and OTC availability when appropriate to protect affordability and patient access... Sub. Req’d

Lobbying Firms With Close Ties to Trump Draw Pharma Industry Clients

(2/23, Daniel Payne, Lizzy Lawrence, STAT+) ...Pharmaceutical giants, seeing a wave of new risks and potential rewards in President Trump's second term, are boosting their spending on lobbying firms with connections to the White House. Three firms - Checkmate Government Relations, Miller Strategies, and Ballard Partners - stand out. Each of the three, which were identified by lobbyists working for other firms as growing players in the space, saw a boom in business in the first year of Trump's second term. Most of the 16 companies that have signed drug pricing deals with the White House have contracted with one of the firms... Sub. Req'd

Pharma Lobbyists Focus on a Surprising New Target: The FDA

(2/23, Daniel Payne, Lizzy Lawrence, STAT+) ...Lobbyists involved in the broader FDA influence efforts across the sector say they've seen a marked shift over the last year. Regulatory affairs plans that were once largely technical, focusing on drug trial design and regulatory minutia, have an added political strategy that focuses on an approach to the White House and top levels of the Department of Health and Human Services, according to the lobbyists... Sub. Req'd

Virginia Pushes for Board Tying Drug Costs to Medicare Prices

(2/23, Ian Lopez, Bloomberg Law) ...Virginia lawmakers want a board that could set pay limits on costly drugs and spread federally negotiated discounts on drugs for seniors to the broader state population. In the process, they're learning from the ups and downs of states that have traveled the same path and faced blowback from the drug industry...PDABs "often fail to address the real drivers of patient costs, such as insurers and pharmacy benefit managers," [Tom Wilbur, a spokesperson for the Pharmaceutical Research and Manufacturers of America] said. He said Virginia policymakers "should focus on safeguarding patient access and affordability from the abusive practices of these middlemen."... Sub. Req'd

Louisiana Reaches $45 Million Settlement With CVS Health, Ending Lawsuits

(2/20, Greg Larose, Louisiana Illuminator) ...Louisiana officials have reached a $45 million settlement with CVS Health over a trio of lawsuits the state brought against the national pharmacy chain and its benefits management subsidiary. The state had accused CVS Health of "unfair, deceptive and unlawful" business practices for using customer information to conduct a text message campaign last year against proposed legislation for pharmacy benefits managers... Full

AstraZeneca's Fixed-Duration Calquence Combo Wins FDA Nod as BeOne CLL Rivalry Heats up

(2/20, Angus Liu, Fierce Pharma) ..."The continuous regimens frequently used to treat chronic lymphocytic leukemia often come with side effects that may become burdensome to patients over time," Jennifer Brown, M.D., Ph.D., from the Dana-Farber Cancer Institute, said in a Feb. 20 statement, adding that the Calquence combo gives doctors greater flexibility to tailor treatment plans... Full

Biohaven Charts Comeback Path After FDA Blow, Placing Bets on Obesity

(2/20, Gabrielle Mason, Fierce Biotech) ...With no "near-term revenue opportunity" from the ataxia program, the company has pivoted strategy, said CEO Vlad Coric, M.D. "You have to focus on your closest near-term value inflection points," Coric told Fierce last week. For Biohaven, that means prioritizing assets stemming from three late-stage platforms: myostatin-activin inhibitors, extracellular protein degraders and Kv7 ion channel activators... Full

Dr. Reddy's Secures First-Mover Advantage With FDA Review of Orencia Biosimilar

(2/23, Indian Pharma Post) ..."We are proud to be the first to submit a BLA for an abatacept biosimilar which marks a significant milestone in our mission to increase patient access to critical, high-quality biologic therapies," said Milan Kalawadia, CEO, North America, at Dr. Reddy's. "We look forward to working with the FDA to bring this in-house developed biosimilar to market as a cost-effective alternative for patients and healthcare providers in the United States."... Full

Biosimilars & Innovation Are Dr. Reddy's Growth Pill: Generics to Remain Core Business, Says Co-Chairman & MD GV Prasad

(2/23, Rica Bhattacharyya, The Economic Times) ...Dr Reddy's Laboratories is looking to sharpen focus on biosimilars and innovation while continuing to fetch majority of revenues from generics and active pharmaceutical ingredients, said GV Prasad, co-chairman and managing director. Speaking to ET's Rica Bhattacharyya, Prasad said the Hyderabased-based company is accelerating capital allocation to biosimilars, expecting it to reach meaningful scale in five years... Full

Sandoz Confirms European Commission Approval for Ranluspec® (Ranibizumab), Further Strengthening Overall Biosimilars Leadership and Position in Ophthalmology

(2/23, Sandoz) ...Sandoz...today confirmed that the European Commission has granted marketing authorization for Ranluspec1. Ranluspec is developed, manufactured and registered by Lupin and was approved based on the review of a comprehensive data package... Full

Sandoz Mulls Appeal As US Court Dismisses Amgen Enbrel Antitrust Complaint

(2/20, Dave Wallace, Generics Bulletin) ...Sandoz has told Generics Bulletin that it is mulling further options, including an appeal, after a US court dismissed its antitrust complaint against Amgen over Enbrel. Currently, Sandoz's Erelzi etanercept biosimilar - approved almost a decade ago - is blocked from launch for a further three years... Global Sub. Full

Organon Says Audit Review of Biosimilar Purchases Finds No Issues

(2/23, FirstWord PHARMA) ...Organon's audit committee completed an independent review - conducted with outside counsel - of the timing of certain biosimilar purchases and found no evidence of wrongdoing, according to Fidelity... Full

Merck Creates Separate Cancer Business. The Stock Is Rising Ahead of Patent Cliff.

(2/23, Nate Wolf, Barron's) ...The drugmaker is splitting its Human Health business into an oncology unit and a specialty, pharmaceuticals, and infectious diseases unit. The move is designed to ensure strong execution of new drug launches across a broad range of therapeutic areas, the company said in a Monday announcement... Full

Gilead to Acquire Cancer Therapy Developer Arcellx for up to $7.8 Billion

(2/23, Reuters) ...Gilead will pay $115 per share in cash at the deal's closing, which is at a premium of 79% to the stock's last close. Kite Pharma, a unit of Gilead Sciences, was partnering with Arcellx to jointly develop and sell anito-cel, an experimental CAR-T therapy for multiple myeloma, a type of blood cancer... Full

Roche Looks to Divest Its Former Blockbuster Antibiotic Amid EU Generics Woes

(2/20, Kevin Dunleavy, Fierce Pharma) ...Roche is seeking a partner to take over the plant and continue production of the drug, also known as ceftriaxone sodium, which has faced generic competition over the last two decades. Local outlet AWP Financial News reported the effort earlier this week... Full

Sanofi Appoints Specialty Care Head; Biogen Chair to Retire in June

(2/20, Alex Hoffman, Kyle LaHucik, Max Bayer, Endpoints News) ...As Sanofi looks ahead to the Belén Garijo era, the French pharma will also have a new head of specialty care on March 1... Full

Israel's 2026 Public Health Basket: Cancer Treatment Leads, More Mental Health Drugs

(2/20, Ido Efrati, Haaretz) ...Israel's Public Committee for the Expansion of the Health Care Services Basket on Thursday submitted its 2026 recommendations to Health Minister Haim Katz, proposing new drugs and medical technologies worth a total of 650 million shekels (about $208 million) for inclusion in the country's universal health coverage... Full

EMA Kicks Off Process To Find Its Next Chief

(2/20, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency has begun the recruitment process for its next executive director, who will take over from its current chief, Emer Cooke, when she leaves the role to retire on April 30, 2027... Global Sub. Full

Medicines for Europe Response to The Decision by The CJEU to Deny Legal Standing Based on Procedural Matters of Admissibility and Whether There Is an Individual Concern.

(2/20, Medicines for Europe) ...Whilst we are disappointed that the first instance Court denied the applicants' legal standing, this is a decision on mere procedural matters of admissibility of the action and whether there is an individual concern, with a very conservative approach taken by the Court. This is not a judgment on the substantive question of whether the EPR Scheme violates EU laws and principles and threatens the secure supply of medicines and affordable healthcare... Full

Medicines Shortages in the EU: The Impact, Cost, and Cause

(2/19, Jack Henry Colby, BioPharm International) ...A 2024 report from the Pharmaceutical Group of the European Union (PGEU) showed that pharmacists across the EU spend more than one working day per week resolving medicine out-of-stock issues with their suppliers. PGEU found that most out-of-stocks were reported for antimicrobials, followed by painkillers, and then anaesthetics... Full

Nearly 100 EU Biologics to Lose Patents by 2032, 79% Lack Biosimilars

(2/23, Ko Jae-won and Minu Kim, Pulse) ...A report released Sunday by the Korea Biomedicine Industry Association (KoBIA), citing IQVIA and other market data, found that nearly 100 biologics will lose patent protection in Europe by 2032. Of those, 79 percent currently have no biosimilars under development, raising concerns over delayed competition and missed savings opportunities... Full

Pharma Industry Aims for Double-Digit Growth in 2026-27, Says Ministry of Commerce

(2/23, Pharmabiz.com) ...The interaction also took note of the direction set in the Union Budget 2026-27, which places biopharma and biologics at the centre of India's future healthcare and manufacturing priorities. The proposed Biopharma Shakti initiative, with an outlay of Rs.10,000 crore over five years, aims to strengthen India's end-to-end ecosystem for biologics and biosimilars, reduce import dependence and enhance competitiveness in global supply chains, aligned with the objective of capturing 5 per cent of the global biopharmaceutical market share... Full

Brazil Pitches Greater Cooperation in Pharma Sector With India, Eyes Production Partnership

(2/22, ANI) ...Brazil is seeking to deepen pharmaceutical cooperation with India as Health Minister Alexandre Padilha accompanies President Luiz Inacio Lula da Silva on an official visit aimed at securing agreements for local production of generic medicines and technology transfer to national laboratories, as reported by brasil 247... Full

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