Thursday, June 19, 2025

Pharma's Silver Lining: A Tax Break

(6/18, Shawn Zeller, Politico) ...How so? That's if Republicans in Congress can coalesce around language in the megabill that would allow drugmakers and other companies that invest heavily in research and development to deduct R&D costs immediately. The Senate Finance Committee's version of the megabill - which aims to extend Trump's 2017 tax cuts - would reverse language in the 2017 law and allow firms to permanently take a deduction in the first year they spend on R&D... Full

Trump Tells Supreme Court No Need to Rush to Consider Tariffs

(6/18, Greg Stohr, Bloomberg) ...President Donald Trump's administration urged the US Supreme Court to turn away a request for fast-track review of his sweeping tariffs, saying the justices should give lower courts more time to weigh in...In a seven-page response Wednesday, US Solicitor General D. John Sauer said the companies "have not justified such a stark departure from established practice."... Sub. Req’d

Pharma Tariffs Playbook: How Trump's Tariffs Could Impact the Industry

(6/18, Lecia Bushark, MM+M) ...Pharma tariffs — while intended to encourage greater domestic drug production — could potentially lead to the opposite, experts say. This could mean tighter budgets, higher drug costs and possibly even generic drug shortages..."Some [pharma companies] will be affected heavily and some will not be affected as much," noted Arda Ural, a pharma consultant and life sciences sector leader at EY. "That would create winners and losers, and it would create drug shortages inevitably."...Amid all the uncertainty, drugmakers are creating scenario plans to navigate what many consider to be an unprecedented time... Full

How Proposed Tariffs Could Disrupt US Drug Prices and Supply

(6/18, Marcia Frellick, Medscape) ...Pharmaceutical tariffs, as proposed by President Donald Trump, aim to boost manufacturing jobs in the US, curb foreign profits, and bolster national security. However, such tariffs could increase the price and reduce the availability of both branded and generic medications, according to two health policy experts... Full

HHS Scores Win in Hospitals' Fight of Drug Discount Plan Audits

(6/18, Nyah Phengsitthy, Bloomberg Law) ...A federal judge agreed with the US Department of Health and Human Services to dismiss a case brought by hospitals challenging an agency decision that allowed Johnson & Johnson to audit their systems over utilization of a federal drug discount program... Sub. Req’d

ProPublica Sued the FDA for Withholding Records About the Safety of Generic Drugs

(6/18, Katherine Dailey and Jessie Nguyen, Medill Investigative Lab, ProPublica) ...ProPublica has sued the U.S. Food and Drug Administration in federal court in New York, accusing the agency of withholding information about the safety and availability of generic drugs critical to millions of Americans...The FDA declined to quickly release the documents, including records that would identify drugs made at some of the most troubled factories in India. Inspection reports that describe unsafe manufacturing conditions are public, but the FDA redacts the names of the medications made in those factories... Full

Makary Names Prasad as FDA's Chief Medical and Scientific Officer

(6/18, Ferdous Al-Faruque, Regulatory Focus) ...In an email to US Food and Drug Administration (FDA) staff on Wednesday, FDA Commissioner Martin Makary announced that Vinay Prasad, director of the Center for Biologics Evaluation and Research, will take on a new role as chief medical and scientific officer, in addition to leading the biologics center. In his new capacity, Prasad will be tasked with advising senior agency officials and representing the agency's thinking on medical and scientific matters to external stakeholders... Full

New York Bill On Free Asthma Inhalers Advances to Governor

(6/18, Johan Sheridan, News 10) ...A bill passed by New York lawmakers on June 12 would eliminate out-of-pocket costs for asthma inhalers if signed by Governor Kathy Hochul. Designed to make life-saving medicine affordable, the legislation would make insurers cover two inhalers without deductibles, copayments, or coinsurance. If signed, S1804A/A128A would take effect on Jan. 1, 2027, joining other states like Minnesota, Washington, and New Jersey in capping prices on asthma inhalers. Almost all health insurance plans in the state would have to provide that coverage... Full

Pipeline And Parent: Meitheal CEO Shea Talks Paclitaxel And What's Next

(6/19, Dean Rudge, Generics Bulletin) ...In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company's oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth... Global Sub. Full

Tevogen Will House Generics Unit In Much-Expanded New Headquarters

(6/19, Dean Rudge, Generics Bulletin) ...Fresh from launching its new Tevogen Generics unit as part of a larger focus on producing US-made, affordable pharmaceuticals, Tevogen is continuing growth plans, announcing a major headquarters expansion in Warren, New Jersey, which will consolidate its R&D and cross-functional teams into one location to improve collaboration and operational efficiency. The move, which will more than double its footprint, will centralize teams, including those previously located in Philadelphia... Global Sub. Full

The Results of 40 Weeks of the Global Phase 3 Clinical Trial of Zolaire's Biosimilar "Omliclo"

(6/19, Haena Wang, Maeil Business Newspapaer) ...The results showed a similar trend in all dosing groups based on the observed efficacy and safety data after the end of treatment, supporting therapeutic equivalence. Similar efficacy and safety results were previously announced at the American Allergy and Asthma Immunization Society last year, from CT-P39, Zolaire to 300 mg of CT-P39 conversion groups up to 40 weeks. With such competitiveness, Celltrion plans to dominate the global omalizumab market and accelerate its market targeting... Full

[Bio USA] Samsung Biologics Expands Strategic Focus to Top 40 Global Pharma

(6/19, The Korea Herald) ...Samsung Biologics announced plans Wednesday to further broaden its customer base, aiming to serve the world's top 40 pharmaceutical companies up from the current top 20...Further expanding its value chain integration, Samsung Biologics is now moving upstream into contract research services. This includes the launch of its first organoid-based drug screening platform, Samsung Organoids, a move that marks its formal entry into contract research... Full

U.K. Decision Blocks a Pair of Alzheimer's Drugs from Access Through its National Health Service

(6/18, Andrew Joseph, STAT+) ...A U.K. health agency reiterated on Thursday that the limited benefits of a pair of new Alzheimer's drugs do not justify their high prices, meaning the medicines won't be made available through the National Health Service...In statements, Lilly and Eisai said they planned to appeal the decisions. "If the system can't deliver scientific firsts to NHS patients, it is broken," said Chris Stokes, Lilly's general manager of the U.K. and northern Europe. "If the government is to deliver on its goals to reduce lives lost to the biggest killers and put Britain at the forefront of transforming treatment for dementia, it must keep pace with licensed medical breakthroughs."... Sub. Req’d

NHS Patients Denied First Drugs That Treat Alzheimer's

(6/19, Eleanor Hayward, The Times) ...Nice, the health spending watchdog, announced on Wednesday that NHS patients would be denied access to -lecanemab and donanemab, as their benefits were "too small" to justify the cost. The two drugs are the first to treat the underlying cause of Alzheimer's -disease, by clearing toxic amyloid protein from the brain, delaying cognitive -decline by four to six months. Had they been approved for NHS use, about 70,000 patients in England in the early stages of Alzheimer's would have been eligible for the drugs on the NHS. The treatments — given as a drip — are already available privately in the UK, costing about £60,000 a year... Full

US Judge Upholds FDA's Removal of Ozempic, Wegovy from Drug Shortage List

(6/18, Diana Jones, Reuters) ...A federal judge has rejected a bid by compounding pharmacies to allow them to continue making copies of Novo Nordisk's blockbuster weight-loss drugs Ozempic and Wegovy, upholding the U.S. Food and Drug Administration's decision to remove the drugs' active ingredient from the shortage list... Full

New Biosimilar Pathways – Key Takeaways from the EMA's Draft Reflection Paper

(6/19, Vladimir Murovec, Osborne Clarke, European Pharmaceutical Review) ...Vladimir Murovec, Counsel, Osborne Clarke, discusses the European Medicines Agency (EMA)'s latest draft reflection paper and its scientific rationale, regulatory implications and potential impact on biosimilar drug development and manufacturing in the EU... Full

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

(6/18, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency has stated reviewing the marketing authorization applications for 10 new products from companies seeking to sell their products in the EU. The products include lerodalcibep, diazoxide choline, nerandomilast, sasanlimab, alpelisib and onasemnogene abeparvovec. There are also two biosimilar version of ustekinumab and two generic or hybrid drugs, colchicine and palbociclib. Palbociclib could become the first generic version of Pfizer's CDK 4/6 inhibitor Ibrance in the EU... Global Sub. Full

US Tariffs Could Punch €18Bn Hole in Public Finances, Central Bank Warns

(6/19, Eoin Burke-Kennedy, The Irish Times) ...In a special article published alongside its latest quarterly bulletin, the regulator models the threat to the Republic's tax base from a big change in US trade policy. In the worst-case scenario, involving weaker corporation tax receipts and a slowdown in multinational investment, it predicted the State could end up with a budget deficit of 4 per cent, equivalent to €17.7 billion, by the end of the decade... Full

Brazil Could Look To Germany, UK And Australia For ATMP Drug Pricing Rules

(6/18, Francesca Bruce, Pink Sheet) ...Brazil will soon draft the first dedicated regulations for the pricing of advanced therapies. Responses to a consultation that was intended to inform the new regulations show that there is an appetite to look to other markets, including the UK and Germany, for new pricing models. Risk sharing agreements, annuity payments and pay for performance deals were highlighted as possibilities... Global Sub. Full

Belgian Pharma Sector Wants Agreement ‘Course Correction' in Trilogue

(6/18, Nicole Verbeeck, Euractiv) ...While Belgium's government endorsed the EU's new pharmaceutical agreement, the country's pharmaceutical industry warns that the text weakens innovation safeguards. Belgium's pharma sector has also criticised the government for deviating from its earlier position... Full

Navigating Tariffs and Diplomacy: The Future of India-US Pharmaceutical Trade

(6/18, Leyla Hasanzadeh, Pharmaceutical Technology) ...Several reports indicate that India has made substantial tariff offers and market access concessions to avoid punitive US tariffs. More specifically, the Indian Pharmaceutical Alliance, an organisation representing the country's largest pharmaceutical companies, has urged the government to reduce import tariffs from the current 10% to zero for pharmaceutical imports from the US. The question now is whether India can secure similar terms for its pharmaceutical industry in return, given the close ties between Prime Minister Narendra Modi and President Trump and the critical nature of India's generic drug exports to the US healthcare system... Full

NPPA Releases Calculation Sheet for Nine Scheduled Formulations

(6/19, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority (NPPA) has published the calculation sheets for the ceiling price of nine scheduled formulations under the National List of Essential Medicines (NLEM), 2022, including an antiretroviral drug, anti-inflammatory drug, antibiotic to treat tuberculosis, surface-active agent, among others... Full

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

(6/19, Jung Won Shin, Pink Sheet) ...As artificial intelligence (AI) and the biopharma industry are key sectors that look set to be fostered by the administration of South Korea's new president Lee Jae-myung, companies in the country are expected to accelerate moves to adopt AI technologies related to drug discovery and development. But being a relative latecomer in the area, Korea may need an innovative strategy not seen elsewhere if it is to become a global leader... Global Sub. Full

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