Monday, July 28, 2025

EU Reaches Tariff Deal With US to Avert Painful Trade Blow

(7/27, Alberto Nardelli, Suzanne Lynch and Hadriana Lowenkron, Bloomberg) ...The US and European Union agreed on a hard-fought deal that will see the bloc face 15% tariffs on most of its exports, including automobiles, staving off a trade war that could have delivered a hammer blow to the global economy. The pact was concluded less than a week before a Friday deadline for President Donald Trump's higher tariffs to take effect and was quickly praised by several European leaders, including German Chancellor Friedrich Merz and Italian Prime Minister Giorgia Meloni, who called it "sustainable."... Sub. Req’d

Trump, EU's Von Der Leyen Cite Conflicting Details On Trade Deal

(7/27, Richard Bravo, Bloomberg) ...After he met with von der Leyen Sunday, Trump said that the deal would not include pharmaceuticals, a contentious point in the negotiations, seeming to imply they would be subject to a higher tariff. In a separate news conference, von der Leyen said, "The EU agreed we have 15% for pharmaceuticals." But she added, "Whatever decisions later – by the president of the US – that's on a different sheet of paper." Senior US officials later said that the two sides agreed on a 15% tariff level for the EU's pharmaceutical exports. A separate Section 232 probe on pharmaceuticals is still coming over the next three weeks, but the EU tariff level will remain at 15%, the officials added... Full

US and EU Avert Trade War with 15% Tariff Deal

(7/27, Andrew Gray and Andrea Shalal, Reuters) ...While the tariff applies to most goods, including semiconductors and pharmaceuticals, there are exceptions. The U.S. will keep in place a 50% tariff on steel and aluminum. Von der Leyen suggested the tariff could be replaced with a quota system; a senior administration official said EU leaders had asked that the two sides continue to talk about the issue. Von der Leyen said there would be no tariffs from either side on aircraft and aircraft parts, certain chemicals, certain generic drugs, semiconductor equipment, some agricultural products, natural resources and critical raw materials... Full

US Tariffs Will Not Have ‘Debilitating' Impact On Pharma Industry: Cipla Global MD & CEO

(7/25, The Hindu BusinessLine) ...As the shadow of US tariffs loom large over the pharmaceutical industry, Cipla's top executive said, it would have an impact, but that would not necessarily be "debilitating". "We don't see a debilitating effect on account of tariffs. We do think that there will be an impact...But it's not a debilitating effect that will derail the way that we've thought of our business," said Umang Vohra, Cipla MD and Global CEO, in a post-results media interaction... Full

FTC, DOJ Engage Panelists On PBM Practices In Need Of Federal Reform

(7/25, Gabrielle Wanneh, Inside Health Policy) ...At a listening session held by the Federal Trade Commission (FTC) and antitrust division of the Justice Department Thursday (July 24), stakeholders acknowledged the intended usefulness of pharmacy benefit managers in the supply chain while still urging policymakers to crack down on business policies that lead to opacity, overcompensation, patient steering and other practices that result in consumers paying more for prescription drugs than the prices PBMs initially negotiate with drug companies... Sub. Req’d

Decoding the Biosimilar Paradox: Policy Reforms, Increased Transparency and Patient Education

(7/25, Nicole Faucher, Medical Economics) ...Patients, providers, payors, and employers benefit from biosimilars through reduced costs and expanded access, but barriers like PBM influence and market strategies persist... Full

Follow the Science: Bridging the Biosimilar Gap With Dr Hillel Cohen

(7/27, Skylar Jeremias, Giuseppe Randazzo and Hillel P. Cohen, PhD, The Center For Biosimilars) ...In this insightful podcast episode, host Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), welcomes former Sandoz executive and biosimilar expert Hillel Cohen, PhD, to discuss the evolving world of biosimilars. The conversation covers the scientific and regulatory landscape, touching on the progress in streamlining biosimilar development, the importance of following scientific advancements, and the potential for harmonization in global health regulations... Full

Lawmakers Press FDA to Target Knockoff Weight-Loss Drugs

(7/25, Madison Muller, Bloomberg Law) ...On Friday, a group of more than 80 bipartisan lawmakers asked the US Food and Drug Administration to stop counterfeit and copycat versions of GLP-1 drugs like Wegovy and Zepbound from flooding the market — a problem that emerged over the last year. "We are concerned about recent reports revealing a surge in illegal and counterfeit anti-obesity medications," they wrote in a letter to FDA Commissioner Marty Makary. "Undoubtedly, illegal counterfeit medications pose an increased risk to patient safety with sometimes fatal consequences."... Sub. Req’d

Experts Question Legality Of FDA Using CNPRV To Enter Drug-Pricing Space

(7/25, Maaisha Osman, Inside Health Policy) ...FDA's new offer to accelerate approvals for companies agreeing to lower drug prices brings the agency for the first time directly into a national drug-pricing role -- a move industry lawyers suggest is on shaky legal ground given long-standing drug law restricts FDA reviewers to only assessing efficacy and safety when approving drugs... Sub. Req’d

Drug Pricing Just One Point of Confusion Over New FDA Vouchers

(7/28, Dan Samorodnitsky, BioSpace) ...The Commissioner's National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps including a low price-tag. But the policy is vaguely defined and was announced without public input, going against the FDA's own published practices, experts say... Full

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

(7/25, Sue Sutter, Pink Sheet) ...Details of the plan to expand unannounced foreign inspections are still being worked out at the FDA but will apply to multiple commodities and could extend beyond India and China. A pilot program underway since 2022 is approximately 56% complete and has encountered staffing, logistical and cost challenges. The Office of Human and Animal Drug Inspectorate has 210 investigators and is currently recruiting, Acting Director Ivy Sweeney said... Global Sub. Full

Arkansas Governor Leads Charge to Break Up US Pharmacy Companies

(7/28, Patrick Temple-West, Financial Times) ...In an interview with the Financial Times, [Arkansas governor Sarah Huckabee Sanders] said the law was necessary because people in her state had sometimes struggled to get medicines from the big three pharmacy companies, and "in some cases it can be life threatening"... Sub. Req’d

GSK Strengthens COPD Offering Via $12B Biobucks, 12-Program Deal with China's Hengrui Pharma

(7/28, James Waldron, Fierce Biotech) ...GSK is paying $500 million upfront to China's Hengrui Pharma in a deal spanning up to 12 drugs. The companies only name-checked one of these medicines in their July 28 release—a PDE3/4 inhibitor dubbed HRS-9821...The addition of HRS-9821 "supports GSK's ambition to treat patients across the widest spectrum of COPD by including those who face continued shortness of breath or who are unlikely to receive inhaled corticosteroids or biologics, based on their disease profile," according to the Monday release. Beyond HRS-9821, the collaboration will encompass up to 11 other programs... Full

Roche to Investigate Whether New Drug Can Delay or Prevent Alzheimer's Disease

(7/27, Angela Christy and Rishabh Jaiswal, Reuters) ...Swiss drugmaker Roche Holding plans to investigate whether an experimental medicine can delay or prevent Alzheimer's disease symptoms, it said on Sunday, as a part of the company's growing development programme for the disease. The clinical trial of the drug, Trontinemab, will target people who are at risk of cognitive decline and will aim to delay or prevent the symptoms of Alzheimer's, Roche said in a statement... Full

The Generics Bulletin Top 50, Part One: German Giants Rise Up The Ranks

(7/28, Dave Wallace, Generics Bulletin) ...Second-placed Teva, meanwhile, has been pushing forward with its "pivot to growth" strategy that has seen it focus as much on innovative assets as its off-patent business. Having said that, the firm's $16.5bn sales total in 2024 – representing 4% growth – and near-$10bn Generics/Biosimilars/APIs/OTC figure were still nothing to be sniffed at, with assets such as its generic lenalidomide rival to Revlimid and its Uzedy (risperidone) long-acting injectable helping to boost its fortunes. Uzedy sales – which came to $117m in 2024 – were incorporated into Teva's Generics/Biosimilars/APIs/OTC figure for the purposes of the Top 50, given the product's status as a value added medicine. And Teva clearly sees value in more complex products, with continued investments in complex generics and biosimilars set to support continued top-line growth in 2025 and 2026, according to the firm... Global Sub. Full

US Court Agrees To Throw Out Viatris Wegovy Infringement Case

(7/28, Dean Rudge, Generics Bulletin) ...A US district court in Delaware has dismissed a patent infringement lawsuit filed by Novo Nordisk against Viatris' Mylan regarding its proposed generic version of Wegovy. The court ruled that Mylan's proposed labeling does not encourage infringement of Novo's method-of-treatment patent 9,764,003, which claims a particular method for treating obesity with semaglutide. Wegovy has seen substantial sales growth, reaching approximately $9.2bn last year... Global Sub. Full

Alembic Pharma Gets USFDA Nod for Carbamazepine

(7/28, Press Trust Of India) ...Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic version of Carbamazepine extended-release tablets indicated for treatment of seizures, and relieving nerve pain. The approval by the US Food & Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) of Carbamazepine extended-release tablets of strengths 100 mg, 200 mg, and 400 mg, it said in a statement... Full

Alteogen's Eylea Biosimilar Wins EMA Panel Backing

(7/28, Lee Han-soo, Korea Biomedical Review) ...Alteogen, a Korean biotech company, said it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Eyluxvi, its biosimilar to Eylea (ingredient: aflibercept), jointly developed with its subsidiary Alteogen Biologics... Full

Korean Biosimilar Firms Pursue European Market as Eylea Patent Nears Expiration

(7/28, Yeom Hyun-a, ChosunBiz) ...According to the industry on the 28th, Samsung Bioepis and Celltrion received final approval from the European Medicines Agency in November last year and February this year, respectively, and recently, Sam Chun Dang Pharm and Alteogen also received positive recommendations for product approvals from the EMA's Committee for Medicinal Products for Human Use (CHMP)... Full

Humira Biosimilars Found to Be as Effective as the Original

(7/25, Scott Harris, MedPage Today) ...Amjevita and Imraldi, two biosimilar agents for adalimumab (Humira), were just as effective in treating psoriasis as the original drug for both new users and patients who switched from adalimumab to biosimilars... Full

‘By Most Measures A Failure': Ten Years On From Teva-Actavis

(7/27, Dean Rudge, Generics Bulletin) ...But Teva, under [CEO Richard Francis], is more focused and realistic than it has been in years. The coming decade will determine if the company’s hard-earned lessons translate into durable, growth or whether the Actavis legacy will continue to define its trajectory... Global Sub. Full

Novo Nordisk Faces 'Show Me' Moment to Boost Wegovy Growth After US Copycat Ban

(7/28, Maggie Fick, Reuters) ...New Wegovy prescriptions up 33% since US ban on compounders-IQVIA data. Total Wegovy scripts narrow gap versus Eli Lilly's Zepbound. Novo expects Wegovy prescriptions to rise in second half of year. Novo CEO ousted in May, in place until successor named... Full

Indian Drugmaker Torrent Pharma's Quarterly Profit Jumps On Strong Demand

(7/28, Kashish Tandon, Reuters) ...India's Torrent Pharma reported a 20% jump in its first-quarter profit on Monday, driven by demand for drugs used to treat long-term conditions. The firm's consolidated net profit rose to 5.48 billion rupees ($63.2 million) for the quarter ended June 30, from 4.57 billion rupees year ago...Diabetes, which is one of Torrent's key therapy areas, led demand in the Indian pharmaceutical market, which grew 8% in June, according to data from India Ratings and Research... Full

Dr Reddy's Prioritises Branded Assets for Strategic Acquisitions: CFO Narasimham

(7/28, Viswanath Pilla, Moneycontrol) ...Dr. Reddy's Laboratories' mergers and acquisitions strategy will prioritise financially sound branded assets within the pharmaceutical and consumer health segment, the company's Chief Financial Officer, M V Narasimham, told Moneycontrol...This shift underscores a strategy that values the longevity of branded assets, which can thrive for decades over the price-erosion-prone generics business common in the US and Europe. Narasimham said the company would steer clear of new verticals like medical devices or diagnostics, focusing instead on opportunities that strategically fit its portfolio in key geographies like India, Europe, and other emerging markets... Full

Sun Pharma, Lupin, Dr Reddy's Recall Medicines in US Over Quality Issues

(7/27, IANS) ...Indian pharmaceutical companies Sun Pharma, Lupin, and Dr Reddy's Laboratories are recalling some of their medicines from the US market due to manufacturing problems and product mix-ups, as per the US Food and Drug Administration latest enforcement report. Sun Pharmaceutical Industries, headquartered in Mumbai, is recalling 5,448 bottles of a generic drug used to treat Attention Deficit Hyperactivity Disorder (ADHD)... Full

The Patients Forced to Switch From Zepbound to Wegovy

(7/27, Peter Loftus, The Wall Street Journal) ...It is the most high-profile example in recent years of something that critics call "nonmedical switching," in which a PBM ends coverage of one drug and provides more favorable coverage of a similar drug, usually because it has negotiated better pricing... Full

Concerns Raised Over ‘Undermining' of Compulsory Licensing in UK Pact

(7/25, Manu Kaushik, Mukesh Jagota, The Financial Express) ...Concerns emerge over India's UK trade pact prioritising voluntary over compulsory licensing for medicines. Experts warn it could dilute public health safeguards under Indian law, though officials affirm sovereign rights remain intact under WTO rules... Full

Pharma Companies Slow Down Their Manufacturing Projects in Ireland, Data Show

(7/25, Anna Brown, Endpoints News) ...Ireland has been a hub for drug manufacturing for decades, especially for making and supplying raw materials and API, said Rory Mullen, head of biopharma and food at IDA Ireland, in an interview with Endpoints News. But now, pharma companies that are starting their investment projects in Ireland, whether that's an R&D or manufacturing site, are pausing their plans, Mullen said...According to GlobalData, the number of pharma FDI projects in Ireland has decreased each quarter since the start of the year. In the first three months of 2025, there were 67 FDI projects announced. In Q2, there were 44 projects, which is the lowest it's been since the last three months of 2023... Sub. Req’d

Pharma Braces for Critical French Drug Pricing Reforms Pending CEPS's Report

(7/25, Alex Watt, Pharmaceutical Technology) ...Based on a sample of off-patent, generic, and biosimilar prices, these medicines are typically priced between 38% to 68% lower in France, on average, when compared to the other top European markets. Growing budgetary pressure is a central theme in France as the country prepares for the publication of the government's 2026 Social Security Finance Bill (PLFSS). French Prime Minister François Bayrou has requested the Economic Committee for Health Products (CEPS) to create a report, which will be published by the end of July 2025 and released in Q3 2025, outlining its drug pricing policy recommendations... Full

Govt Tightens Oversight On Drugs That Are Outside Direct Price Control

(7/27, Priyanka Sharma, Mint) ...To protect consumers from steep drug price increases, the National Pharmaceutical Pricing Authority (NPPA) has issued a directive to strictly enforce price control measures on non-scheduled drugs—those not subject to direct price caps. This means manufacturers cannot raise the maximum retail price (MRP) of these non-scheduled medicines by more than 10% in a year, as per the Drugs Price Control Order (DPCO). These drugs account for about three-fourths of India's pharmaceutical market by volume... Full

Doctors Not Prescribing Generic, Free Medicines Get Warning

(7/27, Times of India) ...In a startling revelation during a surprise inspection, civil surgeon Dr Sangeeta Jain found that doctors at the Dera Bassi Civil Hospital were not prescribing generic medicines and were directing patients to private chemist shops instead of providing free government-supplied medication... Full

Pharma Exports Seen to Double to $65-Bn by 2030 Despite Headwinds

(7/27, Manu Kaushik, The Financial Express) ...Despite the US tariff threat and regulatory headwinds, India's pharmaceutical exports could double to $65 billion by 2030, owing to a combination of strategies including a thrust to advanced therapeutic areas and complex generics, according to Rubix Data Sciences. "From strategic acquisitions by Indian contract development and manufacturing organisations (CDMOs) in the US and Europe to the increasing share of complex generics in their product mix, Indian companies are proactively mitigating external risks," it said... Full

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