Monday, June 23, 2025

PBM Delinking Policy Scrapped By SFC Could Resurface Post-Reconciliation

(6/20, Gabrielle Wanneh, Inside Health Policy) ...The Senate's draft reconciliation text scrapped a Medicare pharmacy benefit manager (PBM) "delinking" reform included in the House-passed bill even though senators included several Medicaid PBM reforms, but sources expect the delinking policy to resurface in a future health package... Sub. Req’d

Pharma Companies are Weighing How a Drug's IP Location Could Impact Tariffs

(6/20, Anna Brown, Endpoints News) ...There's still uncertainty if a drug's IP will be included in the pharma tariffs because this is an intangible asset, said Alexandra Pygall, an IP lawyer at the UK firm Stephenson Harwood. Normally, a tariff would apply to a physical good, like an API or drug, she said...But [Mark Sitkowski, trade and customs lawyer at US firm Sandler, Travis & Rosenberg] pointed out that forthcoming tariffs could still concern both the physical product and its intangible elements, like its IP. A drug product and its IP are intertwined — the drug cannot be made without its patent, she explained... Sub. Req’d

The MFN Executive Order: A Global Reset for U.S. Pharma

(6/22, Glenn Hunzinger, MedCity News) ...The MFN Executive Order is a bold attempt to recalibrate global drug pricing — with U.S. patients at the center. But without clear enforcement, legal grounding, or international cooperation, its future remains very uncertain. Pharmaceutical companies must prepare for litigation, potential trade friction, and a fluid regulatory landscape that may evolve through CMMI pilots or agency rulemaking... Full

Thanks to Imported Drugs, America Has Lost Control of its Medicine Cabinet

(6/22, Andrew Rechenberg, The Hill) ...America urgently needs full transparency in drug labeling to disclose where drugs and their ingredients are made. The FDA must step up — with stronger enforcement abroad and a ban on imports from repeat safety violators. And to secure critical ingredients during market disruptions, Washington must pursue a long-term vision that includes a "strategic pharmaceutical reserve."...For decades, we were told that offshoring production would make things cheaper, smoother and more efficient. But America can no longer depend on unstable foreign suppliers. It's time to restore our pharmaceutical independence and take back control of our medicine cabinet... Full

Health Care Costs: One of the Biggest Obstacles to Reshoring American Industry

(6/23, Kevin A. Schulman and Wasan Kumar, STAT+) ...Rebuilding domestic manufacturing requires more than tariffs and tax credits; it requires making it feasible, even attractive, to employ American workers. That means reducing the financial penalties employers incur when hiring domestically and confronting the economic footprint of the health care system. Health care reform has long been framed as a moral imperative, a public health issue, or a political battleground, but it is also an industrial policy that must be addressed to ensure reshoring of jobs... Sub. Req’d

Inside the FDA's ‘Listening' Tour: Officials Agree US Lags Behind China On Drug Development

(6/20, Max Bayer, Endpoints News) ...Competition with China has been a recurring theme on the FDA's national tour, which has now included stops in San Diego, San Francisco, Boston and Silver Spring, MD. More than 100 company execs were at the Boston meeting on Tuesday, the largest so far, according to one source. The meetings have been behind closed doors. Endpoints News spoke to multiple attendees who said the FDA appeared receptive to changes that could expedite early drug development, rivaling other nations that have become popular Phase 1 hubs. Sources were granted anonymity to describe the private meeting... Sub. Req’d

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

(6/20, Mcihael McCaughan, Pink Sheet) ...Under Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary, informal communications are very much back in fashion. Indeed, the Federal Register now seems to be the last place to look for FDA policy ideas... Global Sub. Full

AAM Celebrates Court Backing Over Minnesota Pricing Law

(6/23, Dave Wallace, Generics Bulletin) ...John Murphy, president and CEO of the AAM, said the association was "very pleased that the Eighth Circuit, like the district court in Minnesota and every other court that has confronted this question, has ruled that states may not control prices charged outside their borders."... Global Sub. Full

Mark Cuban Corrects Elizabeth Warren As She Slams JNJ, PFE For Higher Prices And Zero Taxes On Big Pharma: 'PBMs Corrupt Healthcare'

(6/21, Rishabh Mishra, Benzinga) ...A heated debate over the U.S. healthcare system erupted on X, pitting billionaire entrepreneur Mark Cuban against Sen. Elizabeth Warren (D-Mass) over the root causes of soaring drug prices...The clash, unfolding as of Friday, has reignited discussions on Pharmacy Benefit Managers (PBMs) and Big Pharma's tax practices, with the Senate poised to address reform amid rising public scrutiny... Full

Don Jr. Joins Mark Cuban in Criticism of Drug Middlemen

(6/21, Jacob Adams, The Daily Signal) ...Donald Trump Jr. expressed agreement with Kamala Harris supporter Mark Cuban on X yesterday on the issue of combating high drug prices. Cuban critiqued Sen. Elizabeth Warren, D-Mass., on social media over her characterization of why drug prices are so high for Americans compared to the rest of the world... Full

Fremanezumab Reduces Monthly Migraine Days in Children and Adolescents

(6/20, Jessica Nye, PhD, Neurology Advisor) ...In a phase 3, randomized, double-blind, placebo-controlled study, researchers assessed the safety and efficacy of fremanezumab for the prevention of headaches due to migraine in children and adolescents with episodic migraine... Full

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

(6/20, Eliza Slawther, Pink Sheet) ...As for the other drugs recommended for approval, these included Ogsiveo (nirogacestat), SpringWorks Therapeutics' treatment for adults with progressing desmoid tumors, Partner Therapeutics' Imreplys (sargramostim), for the treatment for exposure to myelosuppressive doses of radiation, and Teva's Austedo (deutetrabenazine), for the treatment of adults with moderate-to-severe tardive dyskinesia... Global Sub. Full

CHMP Recommends Five New Drugs, Reconsiders Eli Lilly's Kisunla 

(6/20, Nicole DeFeudis, Endpoints News) ...CHMP also voted in favor of Teva's Austedo in adults with moderate to severe tardive dyskinesia, a disorder that can cause involuntary movements. Austedo won approval for tardive dyskinesia in the US in 2017, and was recently selected for the second round of Medicare drug price negotiations under the Inflation Reduction Act... Sub. Req’d

New Data Demonstrates Robust Efficacy of Vyepti® (Eptinezumab) in Otherwise Difficult-to-Treat Patients with Severe Migraine

(6/21, H. Lundbeck) ...The full results of the phase IV RESOLUTION trial were presented at the European Academy of Neurology 2025 Annual Congress, where Vyepti® (eptinezumab) demonstrated statistically significant reductions compared to placebo in mean monthly migraine days (MMDs) within the first 4 weeks, in patients with chronic migraine and medication-overuse headache who also received standardized patient education. Patients treated with eptinezumab reported rapid reductions in pain severity by Week 2, compared to placebo, alongside a significant reduction in the use of acute migraine medication... Full

A Medicine Shortage is Heaping Undue Stress On Schoolkids Like Alon

(6/22, Caroline Schelle, The Age) ...Australia is facing a shortage of ADHD medications, with the Therapeutic Goods Administration warning it is likely to continue until the end of the year. Other medicines in short supply include Ritalin LA, Rubifen and Teva-XR, according to the regulator's website. For Alon, it meant he had to try out a different medication and dosage in a bid to find one that would work and stave off running out or having to ration the pills... Full

Not All Ritalin Is Created Equal: Why Some Generics Fail to Work

(6/20, Anna Edney, Bloomberg) ...Researchers tested how generic Ritalin and other versions of the drug known as methylphenidate dissolve and found some dissipated much more quickly or slowly than they should have, according to a study, the final version of which is set to be published in the Journal of the American Academy of Child and Adolescent Psychiatry...Other versions that had issues with dissolving included those from Granules India Ltd.; Lannett Co.; Actavis Plc, which is part of Teva Pharmaceutical Industries Ltd.; and Mylan, which is part of Viatris Inc... Sub. Req’d

EMA Greenlights Give Eylea And Stelara Biosimilars Momentum Across Europe

(6/23, Dean Rudge, Generics Bulletin) ...Advanz Pharma's Mynzepli and Stada's Afiveg, along with Polpharma's Vgenfli and Eiyzey, have received favorable opinions as Eylea biosimilars...Sandoz and Samsung Bioepis followed with positive opinions for their respective Afqlir and Opuviz versions in September, with both now also formally approved. And partners Formycon and Klinge recently received European Commission approval for their Ahzantive and Baiama versions that were endorsed by the CHMP in November. Teva will market the product in Europe under a commercial alliance... Global Sub. Full

Bio-Thera Receives Positive CHMP Opinion for Usymro, A Biosimilar Referencing Stelara

(6/23, Pharmabiz.com) ...Bio-Thera Solutions Inc., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Usymro (ustekinumab), a biosimilar monoclonal antibody referencing Stelara. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for Usymro... Full

Celltrion Reinforces Commitment To UK Biosimilars Market With New HQ

(6/20, Dave Wallace, Generics Bulletin) ...Celltrion UK has opened its new UK headquarters at the Charter Building in Uxbridge. The Korean biosimilars giant said the move reinforces its "dedication to long-term growth and partnership in the UK market." Speaking to Generics Bulletin, the firm acknowledged however that it still had "major questions over the attractiveness of the market" that needed to be addressed to ensure a sustainable operating environment... Global Sub. Full

Accord And Sandoz Remain Frustrated As Dutch Xtandi Patent Is Latest To Hold Firm

(6/23, Dean Rudge, Generics Bulletin) ...The Hague court's judgment on the ‘196 patent follows the UK High Court in October last year also shooting down an invalidity challenge to the UK part of the patent from Accord and Sandoz, as well as Teva. Though the UK court sided with Astellas, it at times offered credit to Accord, Sandoz and Teva for coming close to proving a charge of obviousness... Global Sub. Full

12 Drugs in Shortage

(6/21, Alexandra Murphy, Becker's Hospital Review) ...Scopolamine transdermal system: Baxter and Teva have reported shortages of scopolamine transdermal patches in 1.3 mg and 1.5 mg presentations, used to prevent nausea and motion sickness. Neither manufacturer has provided a reason for the shortage... Full

Lilly Expects Orforglipron Obesity Results in Third Quarter

(6/21, Deena Beasley, Reuters) ...Lilly expects to submit the non-diabetes Phase 3 data to global regulatory agencies by the end of the year, said Ken Custer, head of cardiometabolic health at the company. The U.S. Food and Drug Administration typically makes new drug approval decisions 10 months after a manufacturer's submission. Lilly said it plans to file for regulatory approvals for orforglipron as a diabetes treatment in 2026... Full

Data On Novo Nordisk Experimental Weight-Loss Drug Show Mostly Mild Side Effects

(6/22, Deena Beasley, Reuters) ...Novo Nordisk said it plans to file for regulatory approvals for CagriSema in the first quarter of 2026. "We expect to see approval maybe around the beginning of 2027," Martin Holst Lange, head of development at Novo Nordisk, told Reuters. The company is conducting several other trials of CagriSema, including measuring its impact on cardiovascular outcomes... Full

GLP-1 Reduced Migraine Frequency by Nearly Half, In a Pilot Study

(6/20, Veronica Paulus, STAT+) ...Though GLP-1 drugs have been on the market for years, they have recently gained significant popularity for treating obesity. Researchers are also studying their effectiveness for managing other diseases including hypertension, heart failure, sleep apnea, and Alzheimer's. Now migraine could join that growing list of conditions where the drug could play a role. A GLP-1 drug for treating chronic migraines could offer hope for patients who don't respond to existing medications... Sub. Req’d

DoseSpot Study: Many Patients Are Overpaying for GLP-1s

(6/23, Paige Minemyer, Fierce Healthcare) ...E-prescribing company DoseSpot released a study Monday that analyzed more than 100,000 prescriptions for GLP-1s and found they likely overpaid by a collective $10.2 million. Most (92%) of prescriptions included at the study could have been obtained at a lower price. The data were provided exclusively to Fierce Healthcare. The report said that the $10.2 million in savings extrapolated across the approximately 32 million individuals who currently take GLP-1 ones mean there's an opportunity here for potentially billions in savings... Full

Granules India Receives Form 483 with 1 Observation from USFDA for Bonthapally API Unit 1

(6/23, Indian Pharma Post) ...Granules India Ltd's API Unit-I facility located at Bonthapally Village, Sangareddy District, Hyderabad, Telangana, India has completed a US FDA inspection from June 16, 2025 to June 20, 2025 with 1 (one) 483 observation. The Company will respond to this observation within the stipulated time. Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume... Full

Donald Trump's Drug Plan Risks Higher Medicine Prices in Europe

(6/22, Hannah Kuchler, Peter Foster and Patrick Temple-West, Financial Times) ...Experts say the US president's plan risks significant consequences for European healthcare systems, as both the Trump administration and pharmaceutical companies are likely to seek price increases in Europe to allow for cheaper costs in the US...Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said Most Favoured Nation was a "validation of what we have been saying for a long time": that the UK will miss out on investment because it pays so little for drugs... Sub. Req’d

Medicines For Europe Sets Out Trade Priorities

(6/20, Dave Wallace, Generics Bulletin) ...Medicines for Europe has set out trade policy recommendations to the European Commission and member states representatives. Key requests include removing supply chain barriers, promoting fair market access, balancing intellectual property frameworks and advancing regulatory convergence. The European off-patent industry association is set to host its annual and legal affairs conferences in Brussels next week... Global Sub. Full

Stars Align for Drugmakers in Final Straight of EU Pharma Package

(6/23, Giedre Peseckyte, Politico) ...With today's geopolitical and economic cards considerably more in industry's favor, the sector is hoping for the best possible outcome from the three texts. "Europe should certainly not move backward from what is offered today," Lars Fruergaard Jørgensen, president of Europe's branded drugs lobby EFPIA, and outgoing chief of Novo Nordisk, told POLITICO. "Instead of sticking to policy ideas born out of a different context, I urge EU policymakers to align with the new reality."... Full

How Denmark Could Struggle to Separate its Interests in EU Pharma Reform

(6/23, Emma Pirnay, Euractiv) ...A spokesperson for the EU pharma lobby EFPIA, currently led by Lars Fruergaard Jørgensen, CEO of Denmark's Novo Nordisk, told Euractiv that they want to "support an environment that fosters medical innovation and improves patient access across Europe." The director of the EU generics industry group Medicines for Europe, Adrian van den Hoven, was diplomatic, stating that the negotiations should aim to find a balance that can support both the innovative and generics industry... Full

Private ADHD Clinics Have Led to ‘Two-Tier' System in England, Warns Task Force

(6/20, Amy Borrett, Financial Times) ..."Significant growth" in the use of private clinics had created "one [system] for those who can pay and another for those who cannot", the body set up by the NHS said in its interim report published on Friday. The task force said the NHS needed to "shift rapidly" to a new "accessible, regulated and generalist" model of care for ADHD — or attention-deficit hyperactivity disorder — a neuro-developmental condition characterised by persistent inattention, hyperactivity and impulsivity... Sub. Req’d

Innovative Medicines: Where Does the Netherlands Stand?

(6/23, The Pharma Letter) ...Geopolitics, medicines and European legislation – it all came together during a special AXON-Bruggink session on the position of the Netherlands as a location for innovative medicines, according to the Dutch trade group VIG. The pharmaceutical sector operates internationally. An outline of the European context could not be missing from the program. VIG colleague Richard Kempen, advisor European Affairs, explained the status of the renewal of the European pharmaceutical legislation and what the proposed Pharma Package entails... Sub. Req’d

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