Tuesday, September 1, 2026

 

 

Trump Administration Reaches Most-Favored-Nation Drug Pricing Deals With 9 Companies

(8/31, Elias Schisgall, Dow Jones) ...The Trump Administration reached agreements for most-favored-nation drug pricing with nine pharmaceutical companies, including Teva Pharmaceuticals, Astellas Pharma, and BridgeBio. The agreements provide for all state Medicaid programs to pay prices for prescription drugs that match the lowest prices paid by other developed nations, the White House said Monday, adding that the agreements also guarantee MFN pricing for all new medicines the companies bring to market... Sub. Req'd

 

Trump Administration Announces Drug Pricing Deals With Teva, Astellas and Others

(8/31, Reuters) ...The White House did not release details of the agreements and companies in separate press releases described some terms as private. The administration and some of the companies said there would also be future savings on innovative drugs, and agreements to manufacture more products in the US... Full

 

Trump Announces Drug Pricing Deals with Teva, 8 Other Companies

(8/31, Catherine Dunn, Barron's) ...When asked which medicines are subject to the deal, a Teva spokesperson told Barron's: "Conditions of the negotiation to reach a final agreement remain confidential; Teva remains in active discussions with the Trump Administration." The company said a final agreement on related Medicaid pricing would apply to "select medicines."..."The agreement also would include a prospective Most-Favored-Nation (MFN) commitment for applicable future innovative product launches," the spokesperson added... Full

 

Trump Administration's MFN Deal With Small, Mid-Size Firms Still A Work In Progress

(8/31, Cathy Kelly, Pink Sheet) ...An announcement from Teva indicated some aspects of the agreements are still to be determined and not finalized... Global Sub. Full

 

Teva in Talks with Trump Administration on Medicaid Drug Pricing

(8/31, StreetInsider.com) ..."Teva built its business around delivering affordable medicines to Americans, and we share the Administration's commitment to improve access to more affordable medicines while investing in scientific innovation and domestic manufacturing capabilities in the U.S.," said Chris Fox, President of Teva USA. No final agreement has been reached. Teva described the announcement as a "shared commitment" and said discussions are ongoing... Sub. Req'd

 

Trump Strikes Medicaid Drug Price Deals With Nine Pharma Firms

(8/31, Rachel Cohrs Zhang, Skylar Woodhouse, Bloomberg) ...The companies will provide discounts on outpatient drugs to state Medicaid programs so that the prices states pay align with what the companies charge in foreign countries. Participation by state Medicaid programs is optional... Sub. Req'd

 

Trump Strikes Nine More Deals With Drugmakers to Lower Prices

(8/31, Daniel Payne, Elaine Chen, STAT+) ...UCB, Sun Pharma, Teva, and Astellas will, together, contribute 290 metric tons of active pharmaceutical ingredients to the country's strategic reserves as part of the deals. All of the new companies except BridgeBio are headquartered outside of the US... Sub. Req'd

 

Direct Relief Medical Aid to U.S. Safety Net Tops $3 Billion

(9/1, Direct Relief) ...Teva Pharmaceuticals is providing inhalers for uninsured patients with asthma and COPD through a program launched with Direct Relief in December 2024... Full

 

 

Nine More Drugmakers Cut Pricing Deals with Trump

(8/31, Adriel Bettelheim, Axios) ...Critics like Public Citizen said there's no evidence that drug companies have followed through on commitments to lower U.S. launch prices to MFN levels. "The new deals are a distraction from the administration's failed plan to lower U.S. drug prices to the levels paid in other wealthy countries," said Peter Maybarduk, Access to Medicines director for Public Citizen. "Trump is cozying up to Big Pharma and keeping American drug prices high."... Full

 

White House Strikes New Drug-Pricing Deals

(8/31, David Lim, Cheyenne Haslett, Politico) ..."A more serious approach would build international reference pricing into Medicare drug price negotiation," Peter Maybarduk, Access to Medicines director for Public Citizen, said in a statement. "The Centers for Medicare and Medicaid Services has not announced any state participants in a pilot to test MFN-based prices in Medicaid."... Full

 

Trump Unveils New Drug-Price Deals with Nine Pharmaceutical Companies

(9/1, Dan Diamond, The Washington Post) ...PhRMA, the pharmaceutical industry's chief lobbying group, has also criticized Trump's efforts to tie U.S. drug prices to foreign prices. "Our industry shares the Trump administration's commitment to ensuring patients can access and afford the medicines their doctors prescribe," Alex Schriver, senior vice president of PhRMA, said in a statement Monday. "Today's announcement reflects companies making their own, individual pricing decisions based on their unique circumstances and patient populations."... Full

 

How Trump Is Reinforcing His Tariff Wall After Legal Setbacks

(8/31, James Mayger, Brendan Murray, Bloomberg) ...Here is a deeper look at how the Trump administration has maintained and expanded its tariff policies despite encountering pushback in the courts... Sub. Req'd

 

Trump Didn't Lower Your Drug Prices — Ozempic Did

(8/31, Fred Roeder, Washington Examiner) ...At the end of the day, however, drug prices are coming down, and this is objectively great news for most patients. Competition, patient choice, and often simple innovations are all it takes to push prices downward over time. When you look at the chart for the prescription drug consumer price index for each administration going back to Nixon, you get that sense that these things do take time - years, not news cycles. All it takes is one breakthrough to send positive ripples through the entire healthcare system... Full

 

Stakeholders Warn Hep C Subscription Model May Not Work For GLP-1s

(8/31, Gabrielle Wanneh, Inside Health Policy) ...Democrats on the Senate Finance Committee are interested in establishing a subscription model to boost access to medicines like GLP-1s, one of many affordability policies lawmakers are considering should the party take back the Senate after the midterms, citing different models implemented in the United States and overseas for conditions like hepatitis C as potential prototypes -- but stakeholders warn these previous models may not translate effectively to the Medicare program and GLP-1 weight-loss drugs... Sub. Req'd

 

Medicare Update: Hundreds of Thousands Get GLP-1 Drugs for Just $50

(8/31, Suzanne Blake, Newsweek) ...More than 600,000 Medicare beneficiaries have signed up for GLP-1 weight-loss medications in the first two months of a new federal program that caps patient costs at $50 per month, Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz said Monday... Full

 

The Private Label Biosimilar Paradox in Medicare Part D

(9/1, Tyler Novotny, Bryce Platt, Drug Channels) ...Below, we follow the incentives that help explain why PBM-affiliated biosimilars remain largely absent from Medicare Part D formularies... Full

 

FDA Sets Sights On Vraylar And Lynparza With Latest PSGs

(9/1, Dave Wallace, Generics Bulletin) ...The latest batch includes 55 new PSGs, comprising 24 new and 31 revised guidances. The FDA pointed out that the latest publication featured more than 30 PSGs for products that currently have no approved abbreviated new drug applications - including 15 for complex products - with the 55 PSGs overall including 18 for complex products, seven of which are new and 11 of which are revised... Global Sub. Full

 

Experts Propose Suggestions to Improve Transparency of FDA Complete Response Letters

(8/31, Jeff Craven, Regulatory Focus) ...The US [FDA] could take additional steps to more successfully implement disclosures of complete response letters (CRLs) to the public, experts argued in a recent paper published in the Journal of Law and the Biosciences... Full

 

Industry, Patient Groups Seek Changes to FDA's Revised Master Protocols Guidance

(8/31, Ferdous Al-Faruque, Regulatory Focus) ...Industry and patient groups have asked the US [FDA] to make several changes to its revised draft guidance on master protocols for drugs and biological products. Additionally, two industry groups pushed for greater harmonization with global regulators, while a group representing clinical trial sites questioned the practicality of the guidance when it comes to site-level operations... Full

 

Senators: The PBM Industry Just Made Our Point

(9/1, State Senators Vin Gopal, Doug Steinhardt, New Jersey Globe) ...If PBMs are producing the savings they claim, prove it. If their pharmacies offer the lowest prices, let them compete and prove it. If their formularies select drugs based on the lowest true net cost, disclose the transactions and prove it. If steering patients to affiliated pharmacies saves taxpayers money, submit that proposition to independent analysis and prove it. But don't ask taxpayers to accept self-serving economic projections at the same time that industry controls the data on which those projections are based... Full

 

 

Novartis Pauses Immunology, Neuro CAR-T Studies after Three Patient Deaths

(9/1, Elizabeth S. Eaton, FirstWord PHARMA) ...Novartis has temporarily paused screening, randomisation and dosing in eight early- and mid-stage studies of its CD19-directed CAR-T cell therapy rapcabtagene autoleucel (rap-cel) after three fatal cases of immune effector cell-associated haemophagocytic syndrome (IEC-HS), a company spokesperson confirmed to FirstWord on Monday... Full

 

Novartis, Bristol Myers Pause Autoimmune CAR-T Trials Due to Safety Concerns

(8/31, Gwendolyn Wu, BioPharma DIVE) ...Bristol Myers has also voluntarily paused enrollment in autoimmune trials evaluating its own CAR-T treatment zolacabtagene autoleucel, or zola-cel. In an email to BioPharma Dive, a company spokesperson said the move was made "out of an abundance of caution" to "review clinical data across our zola-cel program," noting that Bristol Myers detected "transient and reversible inflammatory events" during routine safety surveillance. The company aims to complete the evaluation and resume testing "as quickly as possible."... Full

 

Novartis Shares Climb After Pill Hits Goals in Multiple Sclerosis Trials

(9/1, Adria Calatayud, Dow Jones Newswires) ...The Swiss pharmaceutical company said two trials for relapsing multiple sclerosis met their primary goal by showing its drug, known as remibrutinib and marketed as Rhapsido for the skin condition chronic spontaneous urticaria, reduced relapse rates compared to a rival treatment... Sub. Req'd

 

New Guidelines on Migraine Prevention Reflect Increasing Options for Patients

(8/31, Isabella Cueto, STAT) ...The guidance for health care providers comes from the American Headache Society and the American Academy of Neurology, which last updated their recommendations in 2012...Among the key updates are at least a half dozen medications that were approved for migraine prevention by the Food and Drug Administration since 2012. Many of those focus on blocking the calcitonin gene-related peptide, or CGRP, pathway, which is implicated in migraine... Sub. Req'd

 

'A Neuroscience Revolution': The GLP-Like Race to Keep Us Awake and Make Billions Doing it

(8/31, Darren Incorvaia, Fierce Biotech) ...But experts who spoke to Fierce are virtually unanimous that orexin mimics have much broader potential than narcolepsy, with several referring to them as the "GLPs of neuroscience." Orexin drugs coming down the pike could find use in other sleep disorders as well as in fatigue, cognition and mood—broad societal problems that present potentially massive markets... Full

 

 

Samsung Bioepis Makes A Start On Biosimilar Taltz Trials

(9/1, Dave Wallace, Generics Bulletin) ...Setting out details of the Phase I trial – which is expected to complete midway through 2027 – Samsung Bioepis said the 174-participant trial would be a randomized, double-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB35 to Taltz in healthy participants... Global Sub. Full

 

Civica Portfolio Grows By Three And Prices Fall Up To 98%

(9/1, Anabel Costa-Ferreira, Generics Bulletin) ..."Patients and payers deserve greater transparency and lower-cost treatment options...Our model is designed to improve access to generics and biosimilars at sustainable prices," said CivicaScript president Brent Eberle... Global Sub. Full

 

BCBS Lawsuit Over CVS Generic Drug Prices Moves Forward

(8/31, Allison Bell, BenefitsPRO) ...U.S. District Chief Judge John McConnell Jr. issued an order Friday on a case involving 13 Blue Cross and Blue Shield carriers that have joined to sue CVS Health over what the insurers argue was manipulation of the "usual and customary" prices of the generic drugs included in the $4 drug program. The judge ruled on disputes involving the proposed testimony of just five of the many witnesses that the Blues and CVS may call up at a trial, if the case goes to trial... Full

 

 

Eli Lilly Inks $2.88B Merida Buyout for Autoimmune Drugs Against Rogue Antibodies

(8/31, Nick Paul Taylor, Fierce Biotech) ...Lilly sees promise in Merida's technology. The biotech's approach aligns with the Big Pharma's focus on changing the course of disease, not just its downstream effects, Francisco Ramírez-Valle, M.D., Ph.D., senior vice president at Lilly immunology research and early clinical development, said in a statement... Full

 

Sanofi-Backed Electra Files for IPO to Fund Phase 2/3 Immunology Drug

(8/31, Kyle LaHucik, Endpoints News) ...Electra Therapeutics plans to begin public trading on the Nasdaq after the Labor Day holiday, according to a Friday IPO filing with securities regulators. While the startup hasn't said how much it hopes to raise, it will use the money to fund its late-stage immunology treatment candidate. The Sanofi-backed startup plans to trade under the ticker $ETRA... Sub. Req'd

 

Emergent Re-Ups Narcan Education Push Across US, Canada on Overdose Awareness Day

(8/31, Zoey Becker, Fierce Pharma) ...With opioids linked to nearly 80% of drug-related deaths worldwide, according to the World Health Organization, the company is now returning to college campuses to reinforce the campaign in partnership with Release Recovery and its CEO Zac Clark. Emergent will promote the Ready to Rescue messaging at college campuses across the U.S. this fall, enlisting Clark to share his personal story with opioid dependencies and encourage the younger generation to carry Narcan nasal spray... Full

 

 

Turkish Regulator Sets Drug Naming Rules, Breaking Away From Sole EMA Reliance

(8/31, Eliza Slawther, Pink Sheet) ...The Turkish Medicines and Medical Devices Agency (TITCK) has released its own standalone guidelines on how companies may create brand names for human medicinal products, which are set to come into force from next year... Global Sub. Full

 

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