Tuesday, August 19, 2025

Trump May Push Hard for Lower Drug Prices Using a Tool Created by Democrats

(8/18, John Wilkerson, STAT+) ...Now, with the latest round of Medicare drug price negotiations underway, some Wall Street analysts and Washington insiders say they think the Trump administration's Centers for Medicare and Medicaid Services will press to extract much lower prices from pharma companies. The negotiation program was part of the Inflation Reduction Act, which Democrats passed without a single Republican vote... Sub. Req’d

Pharma Looks To Appease Trump With DTC Sales, But Sidesteps MFN Pricing

(8/18, Maaisha Osman, Inside Health Policy) ...Pfizer CEO Albert Bourla told investors that top drugmakers are "ready to roll up their sleeves" to expand what Trump dubs direct-to-consumer (DTC) sales offerings after the president sent letters to 17 pharmaceutical CEOs demanding they lower drug costs by extending "most favored nation" (MFN) pricing to current Medicaid drugs and to newly launched products across Medicaid, Medicare, commercial plans and DTC sales by Sept. 29. Bourla is the chair of the brand drug lobby Pharmaceutical Research and Manufacturers of America... Sub. Req’d

Why Direct-to-Consumer Sales are Unlikely to Significantly Lower Drug Costs

(8/19, Elaine Chen, STAT+) ...Selling drugs directly to consumers is unlikely to make most of them more affordable, even if doing so boxes out insurers and the "middlemen" known as pharmacy benefit managers, several health policy and drug pricing experts told STAT. The cash prices that pharma companies are willing to offer for their drugs (which currently stand at several hundred dollars per month) will never be as low as the prices patients can get through insurance. And if patients buy their drugs directly from pharma companies, none of their spending contributes to their deductibles or out-of-pocket maximums meant to limit costs over time... Sub. Req’d

The Trump Administration Is Reviving Its Worst Drug Pricing Policies

(8/18, Sally Pipes, Forbes) ...Given that economic reality, it's unsurprising that generics prices in other countries are higher than in the United States. Combine that fact with the huge volume of generics dispensed, and public-sector net drug prices are actually 18% lower, on average, in the United States than in peer countries, according to research from three University of Chicago economists. It's understandable to look at lower drug prices abroad with envy. But those low prices come at significant cost in terms of access. Importing those low prices via Most Favored Nation remains a bad deal for American patients... Full

Repatriating Drug Manufacturing and Lowering Drug Prices

(8/18, Shoshana Shendelman, RealClearHealth) ...Several pharmaceutical companies have recently announced multi-billion dollar plans to reinvest in US manufacturing. Many others are determining whether manufacturing costs could be lowered in order to offer more competitive pricing in the US. At present, it's nearly impossible to do both at the same time, and companies must choose to either onshore manufacturing or lower the price of drugs. But here are three steps the Trump administration can take in order to achieve both objectives, while supporting US pharmaceutical companies and furthering American innovation... Full

Editorial: Pharmacies, and Patients, Continue to be Squeezed by Profiteering Middlemen

(8/19, Pittsburgh Post-Gazette) ...A spate of pharmacy closures in Western Pennsylvania, from corporate chain Rite Aid to the independent compounding pharmacy Stanton Negley Drug Company in Highland Park, should bring renewed attention to the challenging economic environment for these essential businesses. This is particularly problematic in rural Pennsylvania, where the chain Martella Pharmacies is suing pharmacy benefit manager Express Scripts, along with Highmark Health and UPMC Health Plan, for removing the company's stores from its coverage network... Full

Ready, Set, Pay!

(8/18, Bob Pollock, Lachman Consultants) ...The FDA announced today that FY 2026 prescription drug program fee invoices for New Drugs have been sent out to firms via email. The Agency asks firms to review the invoices promptly and report any discrepancies that might arise... Full

Yale Experts Urge Reforming – Not Gutting – PDUFA

(8/18, Emily Hayes, Regulatory Focus) ...The US Food and Drug Administration (FDA)'s industry user fee is critical and could be reformed to boost public engagement and restore trust, Yale University health policy experts wrote in a August 16, perspective piece published in the New England Journal of Medicine. Industry-paid user fees accounted for almost half of FDA's $47 billion budget in fiscal year 2024, 69% of the agency's budget for small molecule drugs, and 53% of the budget for biologics, noted Therese Ziaks, postgraduate associate, and colleagues at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT)... Full

FDA Proposes Guidance On Using Overall Survival Endpoints in Cancer Drug Trials

(8/18, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration (FDA) on Monday issued draft guidance to assist sponsors in assessing overall survival in randomized clinical trials for oncology drugs and biologics. The agency cautions that while cancer treatments can improve overall survival, sponsors should look out for potential toxicity from the treatments that may have the opposite effect... Full

7 Drugs in Shortage

(8/18, Alexandra Murphy, Becker's Hospital Review) ...Celecoxib capsule: Apotex and Teva Pharmaceuticals have discontinued manufacturing multiple presentations of celecoxib capsules, an analgesic used to manage pain and inflammation. The discontinued strengths are 50 milligram, 100 milligram, 200 milligram and 400 milligram capsules... Full

MedImpact Offers Low Cost, Unbranded Ustekinumab-aekn Biosimilar to Any Specialty Pharmacy in the US

(8/18, MedImpact Holdings) ...MedImpact Holdings Inc. today announced that it will have access to an unbranded biosimilar ustekinumab-aekn at a significantly lower cost than the reference Stelara® (ustekinumab). The biosimilar, distributed by Anda, an affiliate of Teva Pharmaceuticals USA, Inc., will be available for direct purchase from MedImpact's preferred partner, Birdi, Inc., by any licensed specialty pharmacy... Full

Accord Takes On Ustekinumab Rivals In US With Steepest Discount Yet

(8/18, Dave Wallace, Generics Bulletin) ...Accord BioPharma has launched its Imuldosa (ustekinumab-srlf) biosimilar pre-filled syringes in the US at a 92% discount to Stelara. The price compares to discounts of around 80%-90% from suppliers that launched Stelara biosimilars in the US earlier this year. Accord is positioning Imuldosa as one of the cornerstones of its US biosimilars business, along with Udenyca (pegfilgrastim-cbqv) and Hercessi (trastuzumab-strf)... Global Sub. Full

Formycon's Search For Keytruda Biosimilar Partner Is Key To Deliver FY2025 Guidance

(8/18, Urte Fultinaviciute, Generics Bulletin) ...Formycon is in active discussions with potential partners for its FYB206 biosimilar to Keytruda (pembrolizumab), which will play a pivotal role in achieving revenue guidance for FY2025...The identity of Formycon's mysterious FYB208 biosimilar candidate has still not been disclosed, with CEO Stefan Glombitza asking for patience for the next few months... Global Sub. Full

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

(8/18, Vibha Ravi, Generics Bulletin) ...Zydus is set to launch a US generic version of Ibrance by late 2027 or early 2028, partnering with Synthon for a possible 180-day exclusivity. Palbociclib generics, loss of Ibrance's market share to competitor brands, Pfizer's own lifecycle management tactics and IRA negotiations set the ground for an interesting price dynamic...Meanwhile, Teva Pharmaceutical Industries, Natco Pharma and partner Alembic Pharmaceuticals, Sun Pharmaceutical Industries, Dr. Reddy's Laboratories and Lupin Ltd are among those waiting in the wings, hoping for a slice of the generic pie... Global Sub. Full

Alembic Pharma Shares Gain After Receiving USFDA Nod for Hypertension Treatment Drug

(8/19, Shloka Badkar, CNBC TV-18) ...Alembic Pharmaceuticals Ltd. on Tuesday, August 19, said it has received the final approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) Macitentan Tablets, 10 mg. The company said the approved ANDA is therapeutically equivalent to the reference listed drug product Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc... Full

Glenmark Pharma USA to Launch Micafungin Injection

(8/19, Moneycontrol) ...Glenmark Pharmaceuticals Inc., USA is set to launch Micafungin for Injection USP, available in 50 mg/vial and 100 mg/vial (Single-Dose Vial) formulations. The company will begin distribution in September 2025. Glenmark's Micafungin for Injection USP, 50 mg/vial and 100 mg/vial (Single-Dose Vial) is bioequivalent and therapeutically equivalent to Mycamine® for Injection, 50 mg/vial and 100 mg/vial, of Astellas Pharma US, Inc. NDA-021506... Full

Extrovis AG and Dr. Reddy's Announce the Launch of the Authorized Generic of Carac

(8/18, Chain Drug Review) ...Extrovis AG, a global pharmaceutical company focused on research-driven innovation, and Dr. Reddy's Laboratories has announced the launch of Fluorouracil Cream, 0.5%, an authorized generic and therapeutic equivalent of Carac (fluorouracil cream) 0.5%, in the US market, approved by the U.S. Food and Drug Administration... Full

Henlius And Organon Sued In US Over Plans To Market Perjeta Biosimilar

(8/19, Dean Rudge, Generics Bulletin) ...Shanghai Henlius Biotech and its US commercialization partner Organon have been sued in a New Jersey federal court by Roche and its Genentech affiliate for allegedly infringing 24 patents shielding the originator's Perjeta (pertuzumab) blockbuster, weeks after Roche said it was expecting biosimilar competition to its blockbuster HER2 inhibitor for breast cancer by the end of 2026... Global Sub. Full

Novo Nordisk Unveils $499 Cash-Pay Ozempic Offering Amid Continued Compounder Competition

(8/18, Andrea Park, Fierce Pharma) ...Eligible self-paying patients with Type 2 diabetes will now be able to purchase their prescribed Ozempic for $499 per month, the Danish pharma announced Monday. The lower-cost doses—coming in at half the med's list price of about $1,000—will be available for home delivery via NovoCare and from traditional pharmacies through a collaboration with GoodRx. The new Ozempic offering was driven by Novo's desire to reach "as many people as possible" and address their unmet needs, Kevin Donahoe, head of the company's diabetes marketing, said in an interview with Fierce Pharma Marketing... Full

GoodRx, Novo Nordisk Partner to Offer Discounted GLP-1s at the Pharmacy Counter

(8/18, Shelby Livingston, Endpoints News) ...GoodRx CEO Wendy Barnes said in an interview with Endpoints News that the company's goal has been to get as many medications as possible on its site. The company's own research shows insurance coverage for GLP-1 weight loss drugs dropped between 2024 and 2025, and that 19 million people in the US lack any coverage for the drugs. Even patients with coverage struggle to afford them, and millions of consumers have been searching GoodRx's site for solutions, she said... Sub. Req’d

Indian Drugmakers Seek Exemption for Generics from US Supplies Probe

(8/19, Vikas Dandekar, The Economic Times) ...Indian pharmaceutical industry representatives met with Union Commerce Minister Piyush Goyal. They requested the US government to exclude generic drugs from its investigation into pharmaceutical imports. The probe, under Section 232, raises concerns about supply chain disruptions. This discussion occurs amidst India-US trade negotiations and potential US tariffs... Full

Pharma Sector Faces Tariff Threats Amid Rising US Trade Actions: Report

(8/19, ANI) ... Pharmaceuticals, one of India's biggest export earners, could come under strain if the United States announces fresh tariffs, Fitch Ratings has warned in a new Fitch Wire report. The rating agency said while Indian corporates generally have low direct exposure to current US tariffs, the pharmaceutical industry remains vulnerable to future trade measures. The US is a key market for Indian drugmakers, and any tariff imposition could ripple across the sector. As per the report, Biocon Biologics Limited, which focuses on biosimilars, is particularly exposed with about 40 per cent of its revenue coming from the US... Full

Indian Pharma's Diversification into EU Markets is Acting as a Buffer Against US Trade Shocks: Parag Bhatia

(8/18, Shardul Nautiyal, Pharmabiz.com) ...Indian pharma industry's diversification into European markets is acting as a buffer against US trade shocks, says Parag Bhatia, director, Laborate Pharmaceuticals. Bhatia informs that Indian pharma companies have steadily diversified into Europe, the UK, Australia and other regulated markets. The European Union's unified yet stringent framework offers two advantages, which are a large, stable demand base due to ageing populations and public health systems, and reduced single market dependence... Full

Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

(8/18, Lisa Takagi, Pink Sheet) ...Japan's cost effectiveness assessment scheme will cut the reimbursement prices of four drugs on November 1, including a 15% reduction for Eisai's Alzheimer's therapy Leqembi. The country aims to continue using CEA to balance rising medical costs, but is also considering possible revisions to the program. A recent official hearing heard opinions from industry groups, which called for changes to comparator selection and cautioned CEA has been used so far as a "cost reduction" tool... Global Sub. Full

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