Tuesday, September 9, 2025

Japan Follows EU With Generics Exemption From US Tariffs

(9/8, Dave Wallace, Generics Bulletin) ...Meanwhile, a day after the executive order on Japan was signed, Trump issued another executive order modifying the scope of the worldwide reciprocal tariffs first announced back in April by suggesting that generics could be generally considered exempt from US trade deals around the globe. The order establishes the Potential Tariff Adjustments for Aligned Partners (PTAAP) Annex, which "contains the list of products for which the president may be willing to apply only the MFN tariff upon the conclusion of any future reciprocal trade and security deal." Among the categories were "certain generic pharmaceuticals and their ingredients."... Global Sub. Full

Washington is Listening to Brussels When it Comes to Pharma, Says Health Commissioner

(9/9, Brenda Strohmaier and Thomas Mangin, Euractiv) ...Donald Trump's administration is coming round to the idea that the pharmaceutical industry is a unique sector, Health Commissioner Olivér Várhelyi told Euractiv – prompting hopes for stronger EU-US teamwork and tariffs under 15%. "I think we are increasingly convincing our friends and colleagues in Washington that the pharmaceutical industry is completely different from the automotive industry and anything else," Várhelyi said in an interview at his Berlaymont office... Full

Ditch Drug Price Controls for Commonsense Trade Policy

(9/8, William S. Smith, RealClearHealth) ...The USTRx Act represents an avenue that could lead to European nations paying something closer to market prices for prescription medicines without defying the laws of economics and threatening the health of U.S. patients. As the Trump Administration and Congress consider polices to address foreign freeloading and ensure American patients can access innovative treatments, this is an approach worth supporting... Full

Can Congress Revive PBM Reform?

(9/8, Sophie Gardner and Kelly Hooper, Politico) ...Now that lawmakers have returned from their summer break, PBM reform faces new obstacles, including a looming fight over how to fund the federal government, the pending expiration of enhanced Affordable Care Act tax credits and simmering anger from Democrats over Medicaid cuts in the One Big Beautiful Bill Act that President Donald Trump signed into law in July. "We are ready to lower costs and increase transparency, but our colleagues seem laser-focused on taking a hatchet to our health care system and economy," said Rep. Richard Neal (D-Mass.), top Democrat on the House Ways and Means Committee... Full

NCPA Leads Huge Coalition in Letter Asking Congress to Pass PBM Reform Act

(9/8, NCPA) ...The groups are asking House Speaker Mike Johnson (R-La.), Senate Majority Leader John Thune (R-S.D.), House Minority Leader Hakeem Jeffries (D-N.Y.), and Senate Minority Leader Chuck Schumer (D-N.Y.) to pass the PBM Reform Act (H.R. 4317) and two companion bills in the Senate, the Protecting Pharmacies in Medicaid Act (S. 927), and the Patients Before Middlemen Act (S. 882)... Full

AHA Urges FTC, DOJ to Investigate Anticompetitive Activity by Drug Companies On 340B Rebate Models

(9/8, AHA) ...The AHA Sept. 8 urged the Federal Trade Commission and Antitrust Division of the Department of Justice to investigate several drug companies' concerted efforts to impose rebate models within the 340B Drug Pricing Program, saying the actions may violate antitrust laws...The AHA letter details a timeline of many actions taken by several drug companies over a six-month period highlighting a potential antitrust conspiracy to limit 340B discounts... Full

Official OGD July 2025 Statistics Released

(9/8, Bob Pollock, Lachman Consultants) ...Here are some of the highlights of the recently issued Generic Drugs Program Monthly and Quarterly Activities Report for July 2025... Full

FDA Issues Two Biosimilar Final Guidances to Industry

(9/9, The Pharma Letter) ...The US Food and Drug Administration (FDA) yesterday issued two final guidances for industry related to biosimilar development. These guidances will help maintain a predictable and efficient review process for biosimilars, the agency noted... Sub. Req’d

California Wins State Remand of Opioid Case Involving PBM Role

(9/8, Lauren Clason, Bloomberg Law) ...Express Scripts Inc. and OptumRx Inc. must face allegations in California state court that they improperly dispensed opioids, a federal appeals court ruled. The US Court of Appeals for the Ninth Circuit on Monday rejected the pharmacy benefit managers' appeal to move the case to federal court, saying California sufficiently narrowed its case to focus on actions within the state. The decision affirms a lower court's ruling... Sub. Req’d

LB Pharmaceuticals Aims for $228M-Plus IPO to Fund Late-Stage Schizophrenia Study

(9/8, Zoey Becker, Fierce Biotech) ...The CNS-focused-biotech aims to rake in approximately $228.5 million, or $263.4 million depending on options, by offering 16.7 million shares at an assumed offering price of $15 per share. The final proceeds will include deductions for "underwriting discounts and commissions and estimated offering expenses," the company explained. LB Pharma plans to use the proceeds to advance its oral schizophrenia candidate LB-102, the company laid out in a Securities and Exchange Commission (SEC) document filed Sept. 8... Full

Orexo Celebrates Pre-clinical Success With Nasal Semaglutide

(9/9, Dean Rudge, Generics Bulletin) ...Orexo has announced successful pre-clinical results for its intranasal semaglutide formulations using its proprietary AmorphOX powder technology. The data indicates a sevenfold increase in exposure compared to the oral formulation Rybelsus, with lower variability in plasma concentration. This innovative delivery method could offer benefits like improved patient convenience and adherence, making it easier for patients to use GLP-1 drugs... Global Sub. Full

With 'Compelling' Effect Size, Eli Lilly's Jaypirca Advances a Step Closer to First-Line Use in CLL

(9/8, Kevin Dunleavy, Fierce Pharma) ...In a study of patients with treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (CLL/SLL) who do not have 17p deletions, Jaypirca topped the chemoimmunotherapy combination of bendamustine plus rituximab...The data were not mature enough for a key secondary endpoint, overall survival (OS), but were trending "strongly in favor" of Jaypirca, Lilly said. The company added that it expects the OS assessment to be ready by the end of this year. The success of the study, which is dubbed BRUIN CLL-313, likely sets up Jaypirca for first-line use in the indications... Full

Sandoz Eyes 2026 Aflibercept Launch With Regeneron Eylea Settlement

(9/9, Dave Wallace, Generics Bulletin) ...Sandoz has settled US litigation over Eylea with Regeneron, providing a Q4 2026 launch date for its Enzeevu biosimilar. An earlier settlement by Biocon Biologics allows an H2 launch next year, although both have been trumped by Amgen's ‘at risk' launch of its own version of aflibercept last October...The potential for US competition on Eylea does not stop there, however, with Alvotech having also submitted its Teva-partnered AVT06 version to the FDA, expecting a decision by the end of this year. Meanwhile Alvotech also has a biosimilar version of the high-dose 8mg variant of Eylea in the works, as opposed to the lower-strength 2mg version that has so far been the subject of biosimilar activity... Global Sub. Full

A.forall Expands US Generics Portfolio

(9/9, A.forall) ...A.forall is pleased to announce the acquisition of four FDA-approved injectable generics and two late-stage pipeline assets from Provepharm's US portfolio. With this acquisition, A.forall considerably extends its marketed portfolio in the US, marking a significant expansion of its US footprint and a key milestone in the company's sharpened focus on high-quality generics worldwide...The acquired portfolio includes four well-established hospital products that address critical therapeutic needs: Dihydroergotamine Mesylate (neurology – for the treatment of migraine and cluster headaches), Piperacillin/Tazobactam (infectious disease – broad-spectrum antibiotic for hospital-acquired infections), Tranexamic Acid (hematology – to control bleeding in surgical and trauma settings), Phenylephrine Hydrochloride (anesthesiology – to manage hypotension during surgery)... Full

Alembic Pharma Gets USFDA Nod for Phytonadione Injectable Emulsion for Hypoprothrombinemia Due to Vitamin K Deficiency

(9/9, Ruchika Sharma, Medical Dialogues) ...The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, of International Medication Systems Limited. Phytonadione Injectable Emulsion is indicated for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference. It is also indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates... Full

How Can Biosimilars Capture Market Share From Biologic Drugs?

(9/9, Ge Bai, Forbes) ...The streamlined direct transaction process, combined with biosimilars' lower net prices, could open a promising pathway for biosimilars to capture market share among price-sensitive patients and plan sponsors. As Americans' dissatisfaction with health insurance grows and high-deductible plans become more prevalent, patients are increasingly seeking affordable cash-pay options, creating an opportunity for biosimilars... Full

Samsung Biologics Signs $1.29 Billion CMO Deal with US Pharma Company

(9/9, Lee Han-soo, Korea Biomedical Review) ...However, Samsung Biologics did not identify the name of the partner citing contractual reasons. The disclosed deal, worth $1.29 billion, will run through December 2029. The latest agreements bring up the company's cumulative contract value for this year to more than $3.6 billion... Full

Novartis to Acquire Tourmaline Bio for $1.4 Billion

(9/9, Miranda Murray, Reuters) ...Novartis will acquire Tourmaline Bio for $48 per share, valuing the New York-based biopharmaceutical company at $1.4 billion on a fully diluted basis, the Swiss pharma giant said on Tuesday. Tourmaline is focused on developing pacibekitug, a promising targeted therapy with the potential to reduce systemic inflammation, as a treatment option for atherosclerotic cardiovascular disease, Novartis said in a statement... Full

USAntibiotics Working with Walmart and McKesson to Support U.S. Manufacturing of Amoxicillin

(9/8, Bill Schiffner, Chain Drug Review) ...The collaboration will see USAntibiotics supply millions of life-saving doses of amoxicillin directly to Walmart pharmacies and to McKesson for distribution to pharmacies, health systems and healthcare providers nationwide beginning in August 2025. This collaboration aligns with McKesson's commitment to continue to fortify the U.S. supply chain and strengthen healthcare access through its digitally connected distribution network across the U.S. and builds on Walmart's pledge to invest an additional $350 billion in products made, grown, or assembled in the United States by 2030... Full

Lilly Will Let Small Biotechs Use its AI Models at No Cost

(9/9, Brittany Trang, STAT+) ..."These are the same models that Lilly scientists use every day," said Lilly Catalyze360 vice president Aliza Apple, who is also the new head of TuneLab. The models are available at no cost and without any intellectual property stipulations to "selected biotech partners." The criteria for selection include having a preclinical-stage small-molecule or antibody program, a Lilly spokesperson told STAT. The new offering could be a boon for small biotechs that don't have the data or cash resources to develop their own models... Sub. Req’d

Healthcare Tourism into India Can Offset Tariff Impact On Generic Drugs: Suneeta Reddy

(9/9, Abhimanyu Sharma, CNBC TV-18) ...Speaking to CNBC-TV18 on the sidelines of the 52nd National Management Convention of the All India Management Association (AIMA), Reddy said India has a $100 billion opportunity in healthcare tourism over the coming years. Even if the country captures 20% of this opportunity - worth $20 billion by 2030 - it could offset losses from tariffs through gains in medical value travel... Full

Clinical Trial Approvals In Spain Now 30% Faster For Eligible Phase I Studies

(9/8, Francesca Bruce, Pink Sheet) ...Spain has expanded the eligibility for its fast track process for evaluating Phase I clinical trial applications. All Phase I clinical trials involving a biological medicine for treating cancer or rare diseases are now eligible. The move is intended to make Spain a more attractive destination for conducting clinical research... Global Sub. Full

WHO Adds GLP-1s To Essential Drugs List For Informing Global Procurement And Funding

(9/8, Eliza Slawther, Pink Sheet) ...A spokesperson for Novo Nordisk told the Pink Sheet that the inclusion of GLP-1 receptor agonists on the EML "highlights the proven health benefits of these innovative treatments for people living with diabetes and obesity."...Eli Lilly also expressed support for the inclusion of its GLP-1 products Trulicity and Mounjaro on the EML. A spokesperson for the company told the Pink Sheet that this was "testimony to their potential to help people living with type 2 diabetes and obesity (Mounjaro only)."... Global Sub. Full

WHO Adds GLP-1s And Pembrolizumab To Essential Medicines List

(9/8, Dave Wallace, Generics Bulletin) ...The WHO's latest model list of essential medicines has been updated to include "key cancer and diabetes treatments" that reflect upcoming generic and biosimilar opportunities. Pembrolizumab – sold as Keytruda – and various GLP-1 molecules have been newly added to the latest list. The Medicines Patent Pool reaffirmed its commitment to using voluntary licensing, technology transfer, and manufacturing to enable access to generic versions of these essential medicines... Global Sub. Full

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