Thursday, July 17, 2025

Trump Eyes Steep Pharma Tariffs, Threatening Higher Drug Costs and Shortages

(7/16, Austin Littrell, Medical Economics) ...The tariffs, part of the administration's broader efforts to pressure foreign governments and manufacturers to move production to U.S. soil, are expected to disproportionately affect drugs manufactured in Ireland, Germany, Belgium and Italy — among the largest sources of prescription drug medications for U.S. patients...Higher drug prices would likely hit patients directly — especially seniors and those managing chronic conditions. Nearly one in four Americans already report skipping doses or not filling prescriptions due to cost, according to the Kaiser Family Foundation (KFF)... Full

Cooley Attorney: Pharma Should Be "Contingency Planning"

(7/16, Katherine Davis, Axios Pro) ...The cloud of pharma tariffs hangs over biopharma, and companies need to start preparing now, says Cooley partner Amanda Main..."Companies absolutely should be contingency planning, because the last thing you want to do is be caught on your heels with this and this evolving landscape."... Sub. Req’d

CSRxP Statement On U.S. Senate Reintroduction of the ETHIC Act

(7/16, The Campaign for Sustainable Rx Pricing) ..."Anti-competitive tactics, like patent thicketing, enable Big Pharma to extend monopoly pricing on blockbuster products, costing patients, taxpayers and the U.S. health care system billions of dollars each year. Fostering greater competition by cracking down on Big Pharma's patent abuse will bring more affordable alternatives to the market earlier and help lower prices for patients."... Full

Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap

(7/16, Skylar Jeremias, The Center For Biosimilars) ...Government price negotiations for certain products under the Inflation Reduction Act (IRA) that aimed to rein in high drug costs may have had unintended consequences for biosimilar development, according to a new report from Matrix Global Advisors (MGA)...The report highlighted that these delays could impact patient access to affordable biologic therapies. Biosimilars serve as a crucial mechanism to lower treatment costs for complex conditions such as rheumatoid arthritis and certain cancers. Yet, the hesitancy among manufacturers resulting from the policy environment could blunt this potential... Full

MFN Drug Pricing: Risks to Access, Affordability, and Innovation in Health Care

(7/16, Pearl Steinzor, Adam Colborn, JD, AJMC) ...In a written Q&A interview to AJMC, Adam Colborn, JD, associate vice president of congressional affairs at AMCP, shares further insights on the impact of MFN drug pricing when it comes to access, affordability, and innovations in US health care... Full

RFK Jr. Fires Top Aides in HHS Shakeup

(7/16, Adam Cancryn, CNN) ...US Health and Human Services Secretary Robert F. Kennedy Jr. has fired two of his top aides in an abrupt shakeup of the leadership at the nation's sprawling health department, two people familiar with the matter told CNN. Kennedy's chief of staff, Heather Flick, and deputy chief of staff for policy Hannah Anderson left HHS after only a handful of months on the job, following internal clashes that culminated in both of their removals this week...In a statement, an HHS spokesperson confirmed the moves and said the department's White House liaison, Matt Buckham, would serve as acting chief of staff... Full

FDA Drugs Center Sees Sharp Rise in Staff Departures Since January

(7/16, Zachary Brennan, Endpoints News) ...Outside of the FDA-wide firings from April, the FDA's Center for Drug Evaluation and Research has had more than 380 staff departures from January through the end of June and just 18 new hires over the same period, according to the latest update from the agency... Sub. Req’d

US FDA's Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

(7/16, Bridget Silverman, Pink Sheet) ...The US FDA has 45 novel agents under review with second half 2025 goal dates, but less than 20% are cancer therapies, a big shift from the 45% share oncologics claimed of the 25 novel agents approved to date in 2025. Respiratory therapies are unusually plentiful in the second half goal dates, with applications including Insmed's brensocatib, GlaxoSmithKline's depemokimab and Boehringer Ingelheim's nerandomilast. GSK and Sanofi lead the pack in the most novel candidates. GSK is hoping to add depemokimab to its Blujepa and Penmenvy approvals in the first half, while Sanofi wants to add to its Qfitlia approval with rilzabrutinib and tolebrutinib... Global Sub. Full

FDA Invites More Data from Abroad — With a Wary Eye On China

(7/16, Amy Baxter, PharmaVoice) ...While the FDA is approving drugs more frequently without U.S. participants, it has maintained a tougher stance on China and its pledge to not approve drugs based on trials conducted solely within the country. Drugs approved last year without U.S. participants included sites in multiple countries. The U.S. Justice Department also implemented a new rule this year to prevent China and other "countries of concern" from accessing sensitive information like biometric and genomic data... Full

FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers

(7/16, Megan Rose and Debbie Cenziper, ProPublica) ...In Sun's case, more than a dozen drugs were initially excluded from the Halol import ban...Some of the concerns focused on the exempted drugs still being sent to the United States, according to a person familiar with the situation who did not want to be named because they were not authorized to speak publicly. The FDA blacked out the names of the drugs that were potentially compromised on its publicly released inspection report, including a medication made on a manufacturing line in which several batches had to be rejected because they were filled with black particles... Full

PBM State Fights Will Live On After High Court's Petition Denial

(7/17, Lauren Clason, Bloomberg Law) ...The high court recently chose not to grant a petition to review Oklahoma's Patient's Right to Pharmacy Choice Act, which imposed a series of requirements on PBMs that the US Court of Appeals for the Tenth Circuit in 2023 said violated the Employee Retirement Income Security Act for self-insured plans. The overturned language included distance thresholds for in-network pharmacy access and a ban on patient discounts for using PBM-owned pharmacies... Sub. Req’d

FDA Accepts Biologics License for Proposed Biosimilar to Simponi

(7/16, Charlie Sternberg, Contract Pharma) ...The U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is May 16, 2026... Full

Samsung Bioepis Enters into a Partnership with Harrow for Commercialization of Ophthalmology Biosimilars Portfolio in the United States

(7/17, Samsung Bioepis) ...Samsung Bioepis Co., Ltd. announced today that the company has entered into a license, development and commercialization agreement (DCA) with Harrow, for Samsung Bioepis' ophthalmology portfolio — BYOOVIZ® (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab) and OPUVIZ™ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept) — in the United States. The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected to be completed by the end of 2025... Full

White Paper Offers Tips for Sustaining Biosimilar Progress, Avoiding a Market Void

(7/15, Skylar Jeremias, The Center for Biosimilars) ...To avoid a biosimilar market collapse, coordinated action is needed. Industry and policymakers must work together to revise pricing structures, modernize regulatory frameworks, and foster robust pipeline development. As the white paper noted, "A biosimilar market with multiple marketed alternatives could play a significant role in increasing supply security and reducing shortages." By addressing these structural challenges now, European countries can preserve the economic and clinical benefits of biosimilars, ensuring long-term sustainability for health systems and better outcomes for patients... Full

J&J Flexes $15B Quarter for Innovative Drugs as Biosimilars Chip Away at Stelara

(7/16, Fraiser Kansteiner, Fierce Pharma) ...That performance, buoyed by a slate of promising launches in oncology, immunology and neurology, contributed to a total companywide sales haul of $23.7 billion for the second quarter, nearly a 6% increase from the sum J&J recorded for the same period in 2024. J&J logged those gains despite sales of Stelara—which peaked at around $11 billion in 2023—plunging more than $1.2 billion year over year. For the second quarter, the inflammatory med posted worldwide sales of around $1.7 billion, down roughly 43% compared to its performance in 2024's Q2... Full

Krka Passes €1Bn Threshold In Just Six Months

(7/17, Dean Rudge, Generics Bulletin) ...Krka is set to report record half-year results, achieving over €1bn in sales for the first time. The company's EBIT grew by 8%, supported by strong performances in Eastern and Central Europe, particularly in Russia and Ukraine. The company said previously that it plans to maintain revenue growth of around 6% for 2025, aiming to exceed €2bn in sales... Global Sub. Full

Novartis Nudges Up 2025 Earnings Forecast On Strong Second Quarter

(7/17, Miranda Murray, Patricia Weiss, Reuters) ...Swiss drugmaker Novartis nudged up its full-year earnings forecast on Thursday, citing strong revenue growth from products such as breast cancer drug Kisqali during the second quarter...Jefferies analysts attributed share decline to weaker-than-expected sales due to a miss by psoriasis drug Cosentyx, while JP Morgan noted that finance chief Harry Kirsch's retirement announcement may have tempered investor enthusiasm... Full

Novartis Launches Buyback of Up to $10 Billion, Lifts Profit Outlook

(7/17, Adria Calatayud, Dow Jones) ...The Swiss pharmaceutical company is bracing for the patent expiration--and the arrival of generic competitors--for its heart drug Entresto, the group's best-selling medicine. The company said strong performances from recently launched drugs such as Pluvicto for prostate cancer and Scemblix for leukemia and a new indication for breast-cancer treatment Kisqali show the replacement power of its portfolio. A new buyback of up to $10 billion, which runs until 2027, reflects company's confidence in its growth prospects over the medium to long term and its robust balance sheet, Novartis Chief Executive Vas Narasimhan said Thursday... Full

Glenmark Pharmaceuticals Targets 70% Branded Portfolio by 2030, Boosts Focus On Novel Drugs

(7/17, Rica Bhattacharyya and Vikas Dandekar, The Economic Times) ...Glenmark Pharmaceuticals is transitioning into an innovation-driven company over the next 4-5 years, emphasizing its novel drug portfolio and strengthening its branded business. By 2030, the company aims for 70% of its revenue to come from branded products, focusing on dermatology, respiratory, and oncology. A recent deal with AbbVie for its cancer drug ISB 2001 highlights this strategic shift... Full

For Lundbeck and Otsuka's PTSD Filing, FDA Questions Rexulti Efficacy After Failed Phase 3

(7/16, Angus Liu, Fierce Pharma) ...For an upcoming meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, the agency is asking an expert panel to weigh in on whether results from an exploratory phase 2 trial and a positive phase 3 study can overcome negative findings from a second phase 3 of the combination. "Discordant results" from the two phase 3 trials have FDA reviewers worried, especially since the agency said it was unable to identify an explanation for the differing outcomes despite "extensive exploratory analyses."... Full

Britain's Life Sciences Plan Gets Mixed Reception from Pharma Industry

(7/16, Alistair Smout, Reuters) ...Industry figures have voiced dissatisfaction with Britain's tough pricing regime which they say prioritises low costs over investing in innovation and securing access to the latest medicine. While there was still an impasse on drug pricing, the government released the sector plan, which noted "intense competition for investment" and pledged to reform the regulation of medicine so more drugs get to the state-run National Health Service quicker...The government cited supportive comments from pharma firms GSK, Moderna and BioNTech for its plan, even as industry sources said the unresolved drug-pricing talks were an "elephant in the room."... Full

UK's Plan To Become World's Third Top Life Sciences Economy Falls Short, Says ABPI

(7/16, Neena Brizmohun, Pink Sheet) ...The ABPI acknowledged that the plan included "many important and necessary commitments to support the use of data for research, encourage investment in manufacturing, and accelerate the pace and ease of research." However, it said the UK needed to address "the core issue holding back the life sciences sector, the long-term disinvestment in innovative medicines that is increasingly preventing NHS [National Health Service] patients from accessing medications that are available in other countries."... Global Sub. Full

UK Sets Plan to Be Euro Life Sciences Leader by 2030

(7/16, Ferdous Al-Faruque, Regulatory Focus) ...The UK government has announced an ambitious plan to become the leading life sciences economy in Europe in five years and the third most important global life sciences economy by 2035. The plan includes significant reforms to the Medicines & Healthcare products Regulatory Agency (MHRA)... Full

Belgian Drug Cost Crisis Needs Tough Medicine, Vandenbroucke Prescribes Remedy

(7/16, Nicole Verbeeck, Euractiv) ...Rather than cutting in isolation, Health Minister Frank Vandenbroucke is proposing a new multiannual pharmaceutical framework that seeks to stabilise spending by sharing responsibility across the healthcare ecosystem of industry, prescribers, patients, insurers, and pharmacists. Presented in response to parliamentary questions and elaborated in recent remarks to the pharmaceutical sector, the proposal sets a clear boundary; pharmaceutical spending should not exceed 17.3 per cent of the national healthcare budget... Full

Jeong Eun-kyeong Proposes Reforms to Lower South Korea's High Generic Drug Prices

(7/17, Heo Ji-yoon, ChosunBiz) ...The price of generics starts at 72 to 85% of the original drug's price; however, as many companies launch their products and implement price reduction policies, the actual transaction price may drop to 40 to 50% of the original. According to guidelines from the Ministry of Health and Welfare's notices and the Health Insurance Review & Assessment Service (HIRA), the price of generics registered in Korea for the first time is set at 85% of the original drug price, while the price of generics registered thereafter is priced at 85% of the first generic (approximately 72.25%)...The pharmaceutical industry expresses concern that lowering generic drug prices may hinder R&D investment... Full

Number of Patent Disputes Continue to Grow in Russian Pharma Market

(7/16, The Pharma Letter) ...The number of patent disputes in the Russian pharmaceutical industry has almost doubled in the last several years, while these figures continue to grow these days, The Pharma Letter's local correspondent reports. This is mainly in the form of generics, which are launched bypassing patent protection. According to analysts, this reduces the predictability of work in the market and lead to the further exodus of major global players from Russia... Sub. Req’d

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