Thursday, June 25, 2026

 

 

Innovation Incentives Among Senate Democrats' Menu Of Drug Pricing Options

(6/24, Laura Helbling, Pink Sheet) ...A 42-page request for information on "commonsense policy options to lower drug prices for patients" released June 16 by Senate Finance Committee Ranking Member Ron Wyden, D-OR, is a policy agenda outline should Democrats reclaim the majority next year. The RFI states that listening sessions have been held with "more than 70 external organizations" since the process began with a Feb. 3 Dear Colleague letter to the Senate Democratic caucus. Written comments on the RFI are due Aug. 17 and will "help inform future legislative drafting."... Global Sub. Full

 

China, US to Hold Further Talks on Reciprocal Tariff Cuts

(6/25, Wang Keju, China Daily) ...China and the United States will hold further consultations on reciprocal tariff reductions under the mechanism of the trade council, the Ministry of Commerce said on Thursday. He Yadong, a spokesman for the ministry, said at a news conference that the two sides agreed to set up the council and to discuss tariff cooperation, including reciprocal reductions... Sub. Req'd

 

US Decries the 'Free Ride' Countries With Public Health Systems Are Getting by Negotiating Deals for Prescription Drugs - And Wants Germany to Pay Up

(6/24, Vawn Himmelsbach, Moneywise) ...So, while the U.S. does, in fact, pay much more for prescription drugs - and those high prices do help fund R & D - the pharmaceutical sector "has systematically fought efforts to negotiate or lower prices for Americans," according to CGD..."The United States has deliberately chosen a system permitting manufacturer pricing autonomy, protected by patent laws and regulatory exclusivity provisions, subject to relatively weak constraints from government negotiation and market competition," notes the nonpartisan educational site GovFact... Full

 

Administration Releases Medicare Drug Price Negotiation Program Proposed Rule For 2029

(6/24, Kristi Martin and Rachel Sachs, Health Affairs) ...In this article, we describe how CMS's procedural transition from guidance to rulemaking may impact the functioning of the program. Then, we describe and analyze the substantive policies that CMS added or changed from previous negotiation cycles. Most of the changes CMS proposed to make for the 2029 cycle are relatively modest in scope. Of note, we do not attempt to describe all such changes, particularly putting aside operational changes. Finally, we place these policies in context with the current administration's broader drug pricing reform efforts... Full

 

House E&W To Mark Up Bill Boosting PBM Health Data Transparency

(6/24, Gabrielle Wanneh, Inside Health Policy) ...A bill to increase the scope of health data employer-sponsored group health plans receive from network service providers, including pharmacy benefit managers, is slated to be marked up Thursday (June 25) by the House Education & the Workforce Committee. The bill would build on PBM transparency reforms enacted earlier this year when Congress passed the Consolidated Appropriations Act (CAA)... Sub. Req'd

 

US FDA Rewrites Effectiveness Playbook, Positions Single-Pivotal-Trial Pathway As New Normal

(6/24, Maaisha Osman, Pink Sheet) ...A US [FDA] guidance revision positions a single adequate and well-controlled trial with confirmatory evidence as a broadly available pathway rather than a carve-out for rare or life-threatening conditions, fundamentally reshaping how drug sponsors demonstrate effectiveness... Global Sub. Full

 

Industry Asks FDA for Harmonization, Clarification in Fermentation, Semi-Synthetic Antibiotics Guidance

(6/24, Ferdous Al-Faruque, Regulatory Focus) ..."The draft guidance is very general and lacks specific recommendations regarding establishing specific thresholds for impurities in the products covered by the guidance," said AAM. "In contrast, the European Medicines Agency ("EMA") has issued more specific guidance on acceptance criteria that includes thresholds for reporting, identification, and qualification for certain categories of active substance... Full

 

US FDA Officials Say Hiring Picks up Speed with More than 2,000 Jobs to Start

(6/25, Deena Beasley, Reuters) ...The U.S. Food and Drug Administration, which cut more than 3,000 employees last year, has been authorized to hire 2,200 people, Lowell Zeta, acting chief of staff for the FDA commissioner, said on Tuesday at the BIO International Convention... Full

 

Florida Launches Probe Into CVS for Alleged Anticompetitive Pharmacy Practices

(6/24, Emily Olsen, Healthcare Dive) ...The probe will examine claims of anticompetitive conduct, including whether the healthcare giant steers patients toward its own pharmacies at the expense of independent operators, reimburses affiliated stores more than other pharmacies for the same prescriptions and imposes burdensome audits on small pharmacies, Florida Attorney General James Uthmeier said Tuesday... Full

 

Utah's 'AI Doctor' Prescription Pilot Spurs Oversight Concerns

(6/25, Ian Lopez, Bloomberg Law) ...The approach has triggered calls for accountability and oversight from health providers and policy experts concerned the programs don't fully address patient safety. Some analysts say the program shirks federal law by creating a precedent for delegating prescription powers to unsanctioned AI bots... Full

 

 

The Curse of Being Israel's Most Valuable Company

(6/25, Netanel Ariel, The Jerusalem Post) ..."Globes" began its examination with Teva - once nicknamed "the people's stock," because every Israeli held it in their investment portfolio...Teva's stock is currently enjoying a resurgence. It has soared 250% over the past 3 years, but is still a long way from returning to its heyday... Full

 

Israeli Companies Shutting Down Turkish Operations

(6/25, Dean Shmuel Elmas, Globes) ...Teva Pharmaceuticals also includes the Turkish market as part of its international operations. The company's Turkish headquarters are in Istanbul, which is the center for commercial drug marketing activities in the country, alongside collaborations with local organizations to improve access to medical care... Full

 

 

Teva Submits NDA for Ecopipam for Pediatric Tourette Syndrome

(6/24, Morgan Ebert, Contemporary Pediatrics) ...Teva's NDA for ecopipam rests on phase 3 data showing a 50% relapse-risk cut, potentially the first new pediatric Tourette mechanism in a decade... Full

 

FDA Clears Pfizer's Ibrance for 'Double Positive' Breast Cancer

(6/24, Elizabeth S. Eaton, FirstWord Pharma) ...The US regulator on Wednesday expanded Ibrance's label to include its use in combination with anti-HER2 therapy - comprising Roche's Herceptin (trastuzumab) with or without Perjeta (pertuzumab) - plus endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment. According to Pfizer, about 10% of all breast cancers are double positive... Full

 

Novel Breast Cancer Drugs Show Promise --- New Treatments for Aggressive Form Are Able to Surpass Chemo's Results

(6/25, Xavier Martinez, The Wall Street Journal) ...Gilead Sciences won Food and Drug Administration approval Wednesday to sell its drug Trodelvy as a first treatment for newly diagnosed patients with the advanced form of a type of breast cancer known as "triple negative" because it has characteristics that render common treatments ineffective... Sub. Req'd

 

 

Pfizer Dismissed From US States' Drug Price-Fixing Lawsuit

(6/24, Jonathan Stempel, Reuters) ...In a decision on Tuesday, Chief Judge Michael Shea of the federal district court in Connecticut said the states failed to show that Pfizer and its former Greenstone unit conspired with rivals between 2010 and 2014 to rig bids and allocate customers for six drug products...The dismissal came in a lawsuit brought by 45 U.S. states, the District of Columbia and four U.S. territories, accusing 36 defendants of conspiring to fix prices of 80 generic drugs, primarily for skin ailments... Full

 

Indian Drugmakers Line Up for Keytruda Biosimilar Race as Patents Near End

(6/25, Anjali Singh, Business Standard) ...Biocon, Zydus Lifesciences and Dr Reddy's Laboratories have all outlined their strategies over the past financial year. Several other companies, meanwhile, including Intas Pharmaceuticals and Sun Pharma, are seen as potential contenders as the market prepares for biosimilar competition... Full

 

India's Generics Giants Could Ease US Cancer Shortage

(6/24, Dean Rudge, Generics Bulletin) ...Viranchi Shah of the Indian Drug Manufacturers' Association said India has sufficient manufacturing capability, naming Zydus, Alkem and Aurobindo among companies with the ability to produce the drug, although no supply contracts have yet been confirmed... Global Sub. Full

 

Price Erosion, High Compliance Costs Force Indian Generic Drug Exits in US, Leading to Shortages

(6/24, Viswanath Pilla, Moneycontrol) ...While Indian companies have the regulatory approvals to supply several critical drugs, many have stayed away because of weak economics, razor-thin margins and the high compliance costs. That dynamic is now contributing to persistent drug shortages across the US, according to the latest US Pharmacopeia's (USP) 2025 Annual Drug Shortages Report... Full

 

[BIO USA 2026] PanGen Biotech Eyes Europe as Next Market for EPO Biosimilar

(6/25, Lee Han-soo, Korea Biomedical Review) ...PanGen Biotech is preparing Europe as the next major market for its erythropoietin (EPO) biosimilar while expanding its biologics business into antibody biosimilars and CDMO services, building on overseas sales in eight countries and fresh distributor interest generated during BIO USA 2026... Full

 

Global Biosimilar Rules Diverge Across WHO Regions, Limiting Patient Access

(6/24, Skyler Jeremias, The Center for Biosimilars) ...A scoping review published in JAMA Health Forum examined biosimilar regulatory frameworks across all 6 World Health Organization (WHO) regions, finding persistent inconsistencies in how countries approach comparability requirements, clinical study waivers, interchangeability designation, and pharmacovigilance-differences that may complicate the approval process and limit medication availability... Full

 

Biogen Expands Spinraza Patent Fight With Cipla, Somerset Suits

(6/24, Christopher Yasiejko, Bloomberg Law) ...Biogen Inc. is now targeting Cipla Ltd. over proposed copies of the spinal muscular atrophy treatment drug Spinraza while expanding its fight with Somerset Therapeutics Private Ltd. to three newly asserted patents. Cipla's generic version of Spinraza infringes US Patent Nos. 9,926,559, 10,436,802, and 12,013,403, Biogen alleged. Its complaint was docketed Tuesday in the US District Court for the District of Delaware... Full

 

What Parents Should Know About Generic Drugs

(6/24, Ritu Goel, MedShadow Foundation) ...We often tell families that a generic is identical to its brand-name counterpart. It's an easy shorthand, and is almost true. But the more precise term regulators use is bioequivalent, and the difference is worth understanding without the jargon... Full

 

 

Germany's Merck Boosts Life Sciences Business with $11 Billion Bio-Techne Deal

(6/25, Reuters) ...With this deal, Merck will gain access to Bio-Techne's expertise and supplies of research reagents, proteins, antibodies, analytical instruments and other tools that are used by scientists and drug developers... Full

 

Takeda Sees Return to Growth Within Three Years, New CEO Says

(6/25, Eru Ishikawa, Bloomberg) ...Takeda is planning three major launches, including narcolepsy drug Oveporexton and psoriasis medication Zasocitinib in the next 12 months, while advancing a pipeline of five additional late-stage assets. It will ensure resiliency of its core therapeutic and business areas, which makes up more than half of its revenue... Full

 

How GSK's New CEO Lined Up a Major Buyout to Start His Time at the Top

(6/24, Kyle LaHucik, Endpoints News) ...The SEC filings give an inside look at how previous CEO Emma Walmsley handed control over to Miels, who began negotiating the deal in the fall of 2025, and who pushed hard to try to complete the deal before officially taking over... Sub. Req'd

 

Eli Lilly Dives into Hair Loss Treatments with Investment in AI Startup Absci

(6/24, Allison DeAngelis, STAT) ...On Wednesday, Absci announced that it raised $100 million from a group led by Eli Lilly. Lilly brought the lion's share of the funding, handing over $40 million in exchange for equity in Absci, which is publicly traded on the Nasdaq... Sub. Req'd

 

US Health Spending to Top $6 Trillion in 2026 on the GLP-1 Wave

(6/24, Annika Inampudi, Bloomberg) ...The nation's total healthcare tab - the collective expenditures by governments, businesses and households - is projected to surpass $6 trillion in 2026, fueled in large part by prescription drug outlays, according to a report from the Centers for Medicare and Medicaid Services released Wednesday... Full

 

Shortage of Chemotherapy Drugs Brings Rationing Fears

(6/24, Christina Jewett, The New York Times) ...The shortages stem from manufacturing problems, shipping delays and decisions by some companies to stop producing the medications, according to the Food and Drug Administration... Sub. Req'd

 

New Report: CivicaScript Saved Patients & Payers More Than $16 Million in Generic Medicine Costs in 2025

(6/25, CivicaScript) ...CivicaScript's transparent, nonprofit business model saved patients and payer members more than $16 million in 2025 after they switched to its low-cost generic medicines, the company's new Annual Savings Report shows...The 2025 savings were driven by CivicaScript's first product, abiraterone acetate tablets USP, 250 mg, and four additional specialty generics launched that year. The new report shows that while conversion to CivicaScript's newer products is still in early stages, the products are already driving significant per claim savings... Full

 

 

Swiss Healthcare Costs Rise Faster Than Patients Can Keep Up

(6/25, Aylin Elci, Swissinfo.ch) ...With system finances under pressure, the government began a national cost containment package in January 2022. Phase one includes sending invoice copies to patients, simplifying imported drug packaging, and encouraging generics by doubling co-payment for some brand-name drugs from 20% to 40%, while keeping generics at 10%. The second phase covers 16 measures approved by parliament in March 2025. Key changes include overhauling drug pricing, requiring manufacturers to repay a portion of revenue to the health system when sales of some expensive drugs reach a certain volume... Full

 

'It's Important That We Evolve' - IGBA's Gaunt On Being The Voice Of The Global Off-Patent Industry

(6/25, Dave Wallace, Generics Bulletin) ...Speaking to Generics Bulletin on the sidelines of Medicines for Europe's annual conference in Athens earlier this month, [Ana Gaunt, secretary general of the IGBA,] set out her four key focus areas in her new IGBA role - sustainability, supply chain resilience, regulatory harmonization and balanced intellectual property systems - as well as acknowledging that the association needs to evolve as an organization to ensure that it best represents the off-patent industry's voice on the global stage... Global Sub. Full

 

India Pharma Sector Shifts From Generics to High-Value Innovation and Biologics

(6/24, The Hindu Businessline) ...Backed by $30 billion in annual exports and the highest number of USFDA-approved facilities outside the US, the industry is rapidly moving into complex generics, biosimilars and AI-driven smart manufacturing... Full

 

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