Wednesday, June 25, 2025

HSRA Conditions Health Center Awards To Lower Insulin, Epinephrine Pricing

(6/24, Gabrielle Wanneh, Inside Health Policy) ...Health centers funded by the Health Resources and Services Administration (HRSA) have been asked to swiftly adhere to updated award terms requiring them to ensure insulin and injectable epinephrine are made available to low-income Americans at discounted prices paid by the center through the 340B drug discount program or even lower. The new requirement announced Tuesday (June 24) falls in accordance with President Donald Trump's April 15 executive order demanding the administration take action to ensure affordable access to the two critical medications... Sub. Req’d

HHS Limits Insulin, Epinephrine Prices in Drug Discount Plan

(6/24, Nyah Phengsitthy, Bloomberg Law) ...The new requirement "aims to improve access and affordability for two of the most vital medications in emergency and chronic care: insulin, used by millions of Americans to manage diabetes, and injectable epinephrine, critical for the treatment of severe allergic reactions," the agency wrote. HRSA encourages health centers to begin implementing the updated award terms immediately to ensure full compliance and maximize patient benefit... Sub. Req’d

Oz Hints at Impending CMS Rule to Force Drug Price Transparency

(6/24, Rebecca Pifer, Healthcare Dive) ...The CMS could issue a rule this year requiring healthcare companies to share more information on drug costs, as the Trump administration continues to push for more price transparency in the sector, Administrator Dr. Mehmet Oz said Tuesday...Oz also said Tuesday that he hopes PBMs will become more transparent voluntarily, and cut back on controversial business practices like retaining rebates they negotiate with drugmakers instead of passing those savings through to health plan and employer clients... Full

Washington Must Close a Loophole That Allows Insurers and PBMs to Profit Off Patients

(6/24, Larry Bahr, RealClearHealth) ...The Trump Administration must act to protect Americans from this deceptive insurer and PBM practice that leads to skyrocketing out of pocket costs. If this loophole is closed, patients like me could see thousands of dollars returned to our pockets each year. Washington has an opportunity to help patients across the country, and it involves acting quickly to close the EHB loophole in federal law that allows this to happen... Full

House Approps Advances Bill That Cuts FDA Funding

(6/24, Jessica Karins, Inside Health Policy) ...The total funding amount is $6.79 billion for FDA, the same amount as the Trump administration's request. That's a cut of about 11.5% in budget authority, a less steep cut than the White House is proposing for HHS as a whole, and a 4% increase in user fee funding. Mirroring the president's budget request, the House bill includes decreased appropriations for FDA's drugs and biologics centers, while appropriations for food and medical devices would increase... Sub. Req’d

FDA Extends Deadline for Nitrosamine Testing Submissions

(6/24, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) has announced that it will give drugmakers more time to conduct testing for nitrosamine drug substance-related impurities (NDSRIs) in approved pharmaceuticals if they cannot meet the August 1, 2025, deadline. Manufacturers will need to submit progress reports during this extended period... Full

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

(6/24, Sue Sutter, Pink Sheet) ...Michael Davis, chief medical officer of the Usona Institute, is CDER's new deputy director. He is a former team leader in the FDA's Division of Psychiatry Products. Davis' background in psychedelic drug development aligns with the priorities of Commissioner Martin Makary and HHS Secretary Robert F. Kennedy Jr... Global Sub. Full

Lawmakers Bet Millions On Pharma Stocks as Trump Targets Industry

(6/24, Amanda Chu, Politico) ...Amidst the turmoil, pharma stocks have taken a hit. But a POLITICO review of stock trading by lawmakers found that many, including Republicans, are buying - suggesting they don't think the Trump administration's attacks on the industry are going to do lasting damage. Members of Congress are allowed to trade stocks, so long as they disclose their purchases... Full

Iowa Business Groups Challenge State Law Regulating Pharmacy Benefit Managers

(6/25, Diana Jones, Reuters) ...The Iowa Association of Business and Industry, which represents Iowa employers, filed the lawsuitin federal court in Des Moines on Monday, saying the law was meant to regulate pharmacy benefit managers, or PBMs, but will harm the community of health insurance plan providers in the state. The suit claims that the law is preempted by a federal law governing health insurance plans and places unconstitutional restrictions on speech for health benefit plans, private employers and PBMs... Full

Louisiana Attorney General Sues CVS for Unlawful Practices

(6/24, Sneha S K and Siddhi Mahatole, Reuters) ...Louisiana Attorney General Liz Murrill said on Tuesday she had filed three separate lawsuits against CVS for unfair, deceptive and unlawful practices "that have harmed Louisiana patients, independent pharmacies, and the public at large." The state is seeking both injunctive relief and restitution, Murrill said on a post on social media platform X... Full

Tariffs On Medicines Will Make Californians' Lives Even More Unaffordable

(6/24, Ron Nehring, The Orange County Register) ...Imposing pharmaceutical tariffs on imports from an adversary like China is one thing. But penalizing trade with our allies when it comes to life-saving medication just doesn't make sense. It won't shore up national security. But it will punish American patients and businesses. And taxpayers too, since Medicare and Medicaid will inevitably spend more on drugs as a result... Full

TEVA's Phase 4 Study Confirms Long-Term Efficacy of Ajovy in Migraine Management

(6/24, Swagath Bandhakavi, World Pharmaceutical Frontiers) ...Teva Pharmaceutical Industries has announced the conclusive results of the PEARL Phase 4 study, revealing that Ajovy (fremanezumab) effectively reduces migraine frequency and severity over a two-year period... Full

Teva Reports Final Analysis of Migraine Prevention Trial of Ajovy

(6/24, Clinical Trials Arena) ...Teva Pharmaceutical Medical Affairs Europe head and vice-president Pinar Kokturk said: "The final analysis of the PEARL real-world study reaffirms the long-term effectiveness and safety profile of fremanezumab in the preventive treatment of chronic and episodic migraine. "These data provide valuable real-world evidence supporting fremanezumab's sustained clinical benefit, particularly in a population burdened by high disease impact and a need for preventive therapy."... Full

Phase 4 PEARL Study Confirms Long-Term Effectiveness of Fremanezumab in Preventing Chronic, Episodic Migraine

(6/24, Marco Meglio, NeurologyLive) ...Fremanezumab effectively reduces migraine frequency, duration, and severity in chronic and episodic migraine patients over a 2-year period. The PEARL study showed 66% of episodic and 51.6% of chronic migraine patients achieved a 50% reduction in Monthly Migraine Days. High adherence and sustained benefits were observed, with a consistent safety and tolerability profile... Full

Migraine Drug Sales Rebound After Two Years of Decline

(6/24, GxP News) ...In the period from January to May 2025, sales of migraine medications in the Russian retail market reached 1.68 billion rubles, marking a 26.7% increase compared to the same period last year...Of all the migraine medications, Adjovi, a drug produced by Teva Pharmaceutical, showed the greatest growth. Its sales increased threefold over the year. This is an all-time record for sales dynamics in rubles. Analysts added that Teva, with its Sumatriptan product, is a leader with 29% of the entire market... Full

Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (Omalizumab)

(6/25, Alvotech, Advanz Pharma and Kashiv BioSciences) ...The randomized, double-blind, multicenter study assessed the efficacy, safety, and immunogenicity of AVT23 compared to Xolair® in patients with Chronic Spontaneous Urticaria (CSU), who remained symptomatic despite treatment with H1 antihistamines. The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic... Full

U.S. Biosimilar Specialist Valorum Biologics LLC Becomes Commercialization Partner for Formycon's Eylea® Biosimilar FYB203/AHZANTIVE® (Aflibercept-mrbb) in the United States and Canada

(6/22, Formycon AG) ...Formycon AG today announces that Klinge Biopharma GmbH, the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE®1 (aflibercept-mrbb), Formycon's biosimilar to Eylea®, concluded an exclusive license agreement with U.S. biosimilars specialist Valorum Biologics LLC for the commercialization of FYB203/AHZANTIVE® in the United States and Canada... Full

Aurobindo Pharma Arm CuraTeQ Gets UK Regulator's Approval for Dyrupeg

(6/24, Jomy Jos Pullokaran, CNBC TV-18) ...Hyderabad-based drug maker, Aurobindo Pharma Ltd, on Tuesday (June 24) said its wholly-owned step-down subsidiary, CuraTeQ Biologics s.r.o., has received marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Dyrupeg, a biosimilar of pegylated filgrastim... Full

Lupin Gets US FDA Nod for Constipation Drug Prucalopride Tablets

(6/25, Financial Express) ...The product, it added, will be manufactured at the company's Goa facility. "Prucalopride Tablets are bioequivalent to Motegrity® Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc. This product will be manufactured at Lupin's Goa facility in India," Lupin said in a regulatory filing. According to the IQVIA data dated April 2025, Prucalopride Tablets, 1 mg, and 2 mg (RLD Motegrity®) had estimated annual sales of $184 million in the US... Full

Bio-Thera Solutions and SteinCares Expand Partnership to Commercialize Biosimilars for Treatment of Inflammatory Diseases Across Latin America

(6/25, Bio-Thera Solutions) ...This is the fourth product that the two companies agree to collaborate and strengthens their shared commitment to improving access to high-quality, cost-effective therapies in the region. Under the agreement, Bio-Thera will be responsible for product development and supply, while SteinCares will lead the registration and commercialization process throughout Latin America... Full

CivicaScript® Launches Low-Cost Multiple Sclerosis Treatment to Increase Patient Access, Create Significant Savings

(6/24, CivicaScript) ...CivicaScript will offer dimethyl fumarate 240 mg capsules for sale to pharmacies for $47 per bottle of 60 capsules – typically a month's supply. CivicaScript recommends that pharmacies charge patients no more than $68 per bottle (CivicaScript's maximum retail price, or MaxRP TM). CivicaScript's MaxRP policy provides a way for healthcare providers, caregivers, patients and others to compare prices; consumers can confirm they are being charged no more than the MaxRP by scanning the QR code featured on the CivicaScript product label. CivicaScript will offer the 120 mg and 240 mg strengths of dimethyl fumarate capsules for sale... Full

Sun Pharma's European Partner Withdraws Application for Skin Cancer Treatment Therapy

(6/25, Meghna Sen, CNBC TV-18) ...India's largest drugmaker, Sun Pharmaceutical Industries Ltd., announced on Wednesday that its European biotech partner Philogen has voluntarily withdrawn the marketing authorisation application (MAA) for its investigational therapy Nidlegy from the European Medicines Agency (EMA). Nidlegy, a biological investigational medicinal product, is being developed for the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma... Full

Cigna Sues Bristol Myers for Alleged Monopoly Over Blockbuster Cancer Drug

(6/24, Jonathan Stempel, Reuters) ...Cigna sued Bristol Myers Squibb on Tuesday, accusing the drugmaker of violating U.S. antitrust law by keeping generic versions of its blockbuster blood cancer drug Pomalyst off the market so it could retain a monopoly. In a complaint filed in Manhattan federal court, Cigna said Bristol Myers' Celgene unit filed sham lawsuits to protect its patents for Pomalyst, whose chemical name is pomalidomide, and paid off several generic drugmakers to end legal challenges... Full

Study Confirms Interchangeability of Hulio, Biosimilar of Humira, in Severe Chronic Plaque Psoriasis

(6/24, Gillian McGovern, Pharmacy Times) ...Adalimumab-fkjp (Hulio; Biocon Biologics, Inc) had similar pharmacokinetics, efficacy, safety, and immunogenicity profiles compared to its reference product, Humira (adalimumab; AbbVie), in patients with severe chronic plaque psoriasis, according to new data. The authors noted that these results support the FDA-granted interchangeability status of Hulio... Full

Many Patients Switching to Humira Biosimilars Eventually Switch Back

(6/24, Briana Contreras, Managed Healthcare Executive) ...More than one in eight patients who switched from Humira (adalimumab) to a lower-cost biosimilar eventually returned to the original drug—at times within a month—highlighting the challenges to biosimilar adoption despite growing uptake, according to new research from Truveta... Full

Exclusive-New Data Show Most US Patients Now Stay On Wegovy, Zepbound After a Year

(6/25, Chad Terhune, Reuters) ...That level of persistence is higher than what prior analyses have shown, suggesting that more patients might be staying on the popular GLP-1 drugs for obesity as product shortages ease, insurance coverage expands and doctors manage side effects better, health experts say...Patrick Gleason, Prime's assistant vice president for health outcomes and a co-author of the analysis, said he was surprised to see persistence rise above 50%. "It's a near doubling from one-third persistent to roughly two-thirds now," Gleason said. "This is a dramatic change, and I believe this is more reflective of what we will see going forward."... Full

Hims ‘Won't Cave' to Novo Demands Over Copycat Weight-Loss Shots, CEO Says

(6/25, Madison Muller and Devin Leonard, Bloomberg) ..."We're upset that Novo is feeling the pressure and not comfortable, but ultimately, I think us holding strong to fighting on behalf of customers is just who we are," Hims CEO Andrew Dudum said Tuesday in his first interview since the news broke. "There's just no way in hell we're going to cave on that, no matter who the pharma company is or what the partnership looks like."... Sub. Req’d

New Drug Procurement Rules Aim To Drive Pharma Investment In Mexico

(6/24, Pink Sheet) ...A newly published decree aims to use public procurement of medicines and medical devices to stimulate local industry and reduce reliance on foreign imports. Under the decree, procurement practices will favor companies that operate a factory or conduct research activities in Mexico. Guidelines with more detail on how procurement processes will work are to be published by the health ministry in the near future. Legal experts warn that the decree will bring uncertainty for companies and that it could face legal challenges... Global Sub. Full

China+1 Strategy Gains Momentum in Pharma, But Full Monetisation Still 2-3 Years Away: Goldman Sachs

(6/25, ANI) ...Indian pharmaceutical and biotech sectors have started witnessing tangible benefits from the global shift away from China, as early signs of the China+1 strategy materialising emerge, according to a recent Goldman Sachs report... Full

AbbVie's Rinvoq Expands Reimbursement in Korea for Psoriatic Arthritis

(6/25, Lee Han-soo, Korea Biomedical Review) ...AbbVie's JAK inhibitor Rinvoq (ingredient: upadacitinib) has become the first drug in its class to receive reimbursement for the treatment of adult patients with active and progressive psoriatic arthritis (PsA) in Korea, signaling a major expansion of treatment options in a therapeutic area historically dominated by injectable biologics... Full

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