Wednesday, May 7, 2025

Teva Pharm First-Quarter Profit Rise Tops Estimates

(5/7, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries reported a slightly larger than expected rise in first-quarter profit, helped by strong sales gains in a trio of its branded drugs to treat migraines, Huntington's disease and schizophrenia...Teva said that confirmed U.S. tariffs were expected to have an immaterial financial impact... Full

Teva Reports Q1 EPS 52c, Consensus 46c

(5/7, The Fly) ...Richard Francis, Teva's President and CEO, said, "Teva had a solid start to the year, with its ninth consecutive quarter of revenue growth, delivering global revenues of $3.9 billion, an increase of 5% in local currency terms compared to the first quarter of 2024. Our key innovative growth drivers continue to show strong momentum, collectively generating revenues of $589 million while each growing more than 25% year over year. We also achieved solid generics performance across all regions with biosimilars rounding out the portfolio."... Full

Teva Pharma Boosts FY25 Adj. EPS Outlook - Update

(5/7, RTT News) ...For the first quarter, the company reported net income attributable to Teva of $214 million or $0.18 per share, compared to a net loss of $139 million or $0.12 per share in the prior-year quarter... Full

Teva Pharmaceutical's Q1 Non-GAAP Earnings, Revenue Rise; 2025 Guidance Updated

(5/7, MT Newswire) ...Teva Pharmaceutical Industries reported Q1 non-GAAP earnings Wednesday of $0.52 per diluted share, up from $0.48 a year earlier...The company said its updated full-year 2025 guidance considered the tariff and trade environment as of Wednesday. Teva now expects 2025 non-GAAP diluted EPS of $2.45 to $2.65, compared with its previous guidance of $2.35 to $2.65... Full

Teva Pharma (TEVA) Tops Q1 EPS by 4c; Offers Guidance

(5/7, StreetInsider.com) ...Teva Pharma reported Q1 EPS of $0.52, $0.04 better than the analyst estimate of $0.48. Revenue for the quarter came in at $3.9 billion versus the consensus estimate of $3.98 billion... Sub. Req’d

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

(5/6, Dave Wallace, Generics Bulletin) ...The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements..."The FDA's confirmation of full interchangeability for Selarsdi is an important development for patients and providers seeking to expand access to this important treatment," commented Teva's senior vice president for US biosimilars, Thomas Rainey... Global Sub. Full

Stelara Biosimilar Yesintek Gains Coverage On Leading Formularies

(5/6, Denise Myshko, Managed Healthcare Executive) ...Seven biosimilars that reference Stelara have been approved. In addition to Yesintek, five others have launched: Teva/Alvotech's Selarsdi (at an 85% discount off Stelara); Amgen's Wezlana (only available through Optum Rx with both a high- and low-list price); Celltrion's Steqeyma (at an 85% discount); Fresenius Kabi's Otulfi; and Sandoz' Pyzchiva (at an 80% discount)... Full

Trial Helps Unravel Migraine-Depression Knot

(5/6, Judy George, MedPage Today) ...Fremanezumab (Ajovy) reduced depression symptoms and monthly migraine attacks in people with episodic or chronic migraine and major depressive disorder, the phase IV UNITE trial showed..."Migraine and major depression are frequently comorbid, so it is useful to have a study looking specifically at the outcomes of migraine treatment in this population," observed Elizabeth Loder, MD, MPH, of Brigham and Women's Hospital in Boston, who wasn't involved with the UNITE study... Full

Potential U.S. Tariffs On Pharmaceuticals Expected to Have Minimal Impact On Alvotech's Product Revenues in 2025

(5/7, Alvotech) ...Alvotech expects that potential U.S. tariffs on imported pharmaceuticals should have minimal impact on the Company's product revenues in 2025. Alvotech manufactures its biosimilars in Iceland, a country which currently faces the minimum tariff of 10% on goods imported to the U.S. A 10% tariff on pharmaceuticals would raise the cost of biosimilars from Alvotech imported to the U.S. for customers by less than 1% of Alvotech's expected total product revenues in 2025. Furthermore, according to contracted terms, customers are responsible for all costs of transport and import duties to the U.S., and these costs are therefore not expected to be paid by Alvotech... Full

'Now is Not the Time to Retreat': BMS CEO Blasts Trump Admin Tariffs, Health Reforms Amid $40B US Investment Pledge

(5/6, Fraiser Kansteiner, Fierce Pharma) ...Monday, Bristol Myers Squibb helmsman Chris Boerner joined a growing list of life sciences leaders announcing major U.S. investments in the face of potential pharmaceutical import tariffs. At the same time, however, the CEO took the opportunity to strike back against the Trump administration's trade policies, federal health layoffs and funding cuts that have dominated the industry's attention in recent months... Full

Amgen Biosimilars Continue Surge Ahead Of Imminent Denosumab Competition

(5/6, Dean Rudge, Generics Bulletin) ...Recent biosimilar launches including aflibercept, eculizumab and ustekinumab pushed sales of Amgen's biosimilars up by more than a third to $735m in the first quarter of 2025. Amgen is gearing up for the US loss of exclusivity for its denosumab brands, Prolia and Xgeva, in May. Together, the two products had worldwide sales of more than $6.5bn last year. Proposed biosimilars to Ocrevus, Keytruda and Opdivo are continuing to advance in Phase III clinical trials, as Amgen looks to the next wave of launches... Global Sub. Full

Fresenius Profit Rises On Biopharma Growth, Turnaround Gains

(5/7, Sonja Wind, Bloomberg) ...Fresenius SE posted higher profit on growth at its biopharma unit and cost-savings from the Germany healthcare group's turnaround plan. First-quarter earnings rose 12% in constant currency terms to €0.74 a share before special items, the company said Wednesday, broadly in line with the 79-cent average of analyst estimates compiled by Bloomberg. Fresenius also confirmed its outlook for the year...Having streamlined the group, Chief Executive Officer Michael Sen is looking to increase the profitability of the two remaining divisions: the hospital business Helios and its drug- and medical device-supplier arm Kabi... Sub. Req’d

Novo Nordisk Shares Up On Hopes for US Wegovy Recovery

(5/7, Jacob Gronholt-Pedersen, Maggie Fick, Reuters) ...Drugmaker Novo Nordisk expects a recovery of Wegovy weight-loss drug sales in the United States once a ban on compound copycats is enforced this month, its CEO said on Wednesday, boosting the shares. Booming sales of Wegovy helped to make Novo the most valuable listed company in Europe, worth $615 billion at its peak. But prescriptions in the United States, its biggest market, have not grown since February despite Novo having increased supplies of Wegovy to meet demand... Full

Cencora Raises Annual Profit Forecast On Strong Demand for Specialty Drugs

(5/7, Sneha S K, Reuters) ...The company now expects its annual adjusted profit to be between $15.70 and $15.95 per share, up from its previous expectation of $15.30 to $15.60 per share. Analysts, on average, were expecting a profit of $15.46 per share, as per data compiled by LSEG. The increasing U.S. demand for high-margin medicines that treat complex conditions, such as rheumatoid arthritis and cancer, has prompted Cencora and its peers Cardinal Health and McKesson to expand their footprint in the sector... Full

Drugmakers Fight Trump Price Plan Said to Cost Them $1 Trillion

(5/6, Rachel Cohrs Zhang, Bloomberg) ...The pharmaceutical industry estimates President Donald Trump's new drug pricing proposal could cost drug companies as much as $1 trillion over a decade, its largest trade group is telling members of Congress...The brand-drug lobby PhRMA held an emergency call with its board members on Sunday to discuss its opposition strategy, some of the lobbyists said. The pressure will only ramp up this week as industry executives at some of the world's largest pharmaceutical companies converge on Washington for a previously scheduled in-person board meeting... Full

Pharma Imports to US Surged in March as Drugmakers Look to Avoid Tariffs

(5/6, Michael Erman, Reuters) ...Pharmaceutical imports to the U.S. surged in March as drugmakers stocked up ahead of potential U.S. tariffs on their products, which have historically been exempt from such fees. Total imports of pharmaceutical products exceeded $50 billion in the month - the equivalent of 20% of all pharmaceutical imports in 2024, according to data from a U.S. Commerce Department report on Tuesday... Full

Pharma Shipments Surge as Trump Tariff Threat Looms

(5/7, Tina Reed, Axios) ...Imports from Ireland, a manufacturing hub for pharma giants like Pfizer and Johnson & Johnson, not only hit a record in March, but were double the previous high. "The race is on. Everyone wants to get in before they can't get in anymore," said Marc Busch, an expert in international trade policy from Georgetown University... Full

Trump, Congress Look at Matching Some US Drug Prices to Costs Abroad

(5/6, Zachary Brennan, Endpoints News) ...House and Senate lawmakers from both parties are working with the Trump administration on proposals that would use drug prices paid by other developed countries as a reference for the US, an idea that would upend American drug economics and that could have a huge impact on the pharmaceutical industry... Sub. Req’d

Trump EO Aims To Boost U.S. Drugmakers, Crack Down On Foreign Facilities

(5/6, Sigi Ris, Jessica Karins, Inside Health Policy) ...President Donald Trump issues an executive order late Monday that aims to boost domestic drug manufacturing by directing FDA to provide early support to new U.S. drug facilities and the Environmental Protection Agency (EPA) to streamline requirements for companies building such facilities, while also ordering increased inspections and enforcement for foreign drugmakers. But increased surveillance and enforcement may be difficult for an agency shedding staff and with a reduced budget... Sub. Req’d

Trump Throws Curveball with International Drug Pricing Plan

(5/6, Peter Sullivan, Victoria Knight, Axios Pro) ...The "most-favored nation" plan, which would peg Medicaid drug prices to the generally lower prices paid abroad, runs counter to free-market orthodoxy. But it could be hard for GOP lawmakers to say no if President Trump puts his weight behind the idea... Sub. Req’d

Trump, FDA Zero in On Foreign Factories to Give Domestic Sites An Edge  

(5/6, Anna Brown, Endpoints News) ...With several large pharma companies promising billions of dollars to reshore manufacturing to the US, President Donald Trump and the FDA have started on plans that would give current and future domestic factories a leg up. The FDA on Tuesday said it is planning on doing more surprise inspections of foreign factories, a day after Trump signed an executive order designed to "streamline" FDA facility inspections and shrink factory construction timelines in the US... Sub. Req’d

Novo Nordisk's CFO Sceptical Trump Executive Order On Drug Manufacturing Can Cut Timelines

(5/7, Maggie Fick, Jacob Gronholt-Pedersen, Reuters) ...Novo Nordisk Chief Financial Officer Karsten Munk Knudsen said in an interview it takes years for a pharmaceutical company to build a factory in compliance with the quality protocols set and enforced by the U.S. Food and Drug Administration. "We would welcome if there are more pragmatic ways through it, but I'm sceptical that it will markedly change timelines in our industry," he said... Full

Editorial: Global Drug Supply Chain Is Actually a Good Thing

(5/7, Bloomberg) ...Available data appear to support what should be an obvious conclusion: The US is highly reliant on drug imports. According to a large database of public and proprietary records, 90% of the top 30 brand-name drugs sold in the US are manufactured abroad. The US imported more than $200 billion worth of medications last year. Whether this mismatch constitutes a national-security threat is another matter. Pharmaceutical supply chains started winding their way around the globe in the 1980s, in search of cheaper labor and materials, less encumbered construction, and lower taxes. The result has been a boon for patients, who've gotten less expensive medications... Sub. Req’d

Trump Is Threatening Big Pharma With Tariffs. Tax Changes Might Work Better.

(5/7, David Wainer, The Wall Street Journal) ...Tariffs are certainly getting pharma CEOs to listen, and many are already stockpiling imports while expanding production within existing U.S. sites...But changes to the tax code could prove even more crucial to long-term investment. Before the 2017 tax cuts, the U.S. corporate rate was 35%, compared with just 12.5% in Ireland, making the U.S. a tax outlier. Companies responded by setting up complex offshore structures to house intellectual property and book profits in low-tax jurisdictions... Full

The U.S. Drug Supply is Vulnerable. Why Tariffs Are the Wrong Prescription.

(5/6, Geoffrey Joyce, Barron's) ...While onshoring brand-name drugs appears relatively more feasible due to their higher profitability, achieving greater domestic production of essential generic drugs, which constitute the bulk of prescriptions and are often subject to shortages, will require thoughtful and sustained government intervention. If the Trump administration proceeds with imposing tariffs on pharmaceuticals, these lessons and policy considerations will be paramount to mitigating potential negative consequences and effectively building a more secure and resilient domestic pharmaceutical supply chain for the long term... Full

Carter: Medicaid PBM Spread Pricing Ban Expected In Reconciliation

(5/6, Gabrielle Wanneh, Inside Health Policy) ...House Energy & Commerce health subcommittee chair Buddy Carter (R-GA) said a measure to prevent pharmacy benefit managers from charging Medicaid managed care organizations more for prescription drugs than what is reimbursed to pharmacies for dispensing those drugs will likely be included in the upcoming budget reconciliation package -- echoing what lobbyists told Inside Health Policy Monday (May 5)... Sub. Req’d

Lawmakers Warn RFK Jr. of Drug Price Talks' Effect On Pharmacies

(5/6, Nyah Phengsitthy, Bloomberg Law) ...The current implementation pathway for the Medicare Drug Price Negotiation Program is unsustainable for pharmacies by forcing them to purchase drugs at higher prices and then wait to be paid back and made whole again, 26 lawmakers said in a letter sent Tuesday to Health and Human Services Secretary Robert F. Kennedy Jr. and Mehmet Oz, administrator for the Centers for Medicare & Medicaid Services... Sub. Req’d

FDA To Ramp Up Surprise Foreign Inspections As Top Inspector Departs

(5/6, Maaisha Osman, Inside Health Policy) ...FDA announced Tuesday (May 6) it will ramp up unannounced foreign inspections, a major shift in the agency's policy on drug inspections that came alongside the sudden departure of FDA's top inspections official Michael Rogers. FDA Commissioner Marty Makary said Tuesday that Rogers' departure was unrelated to staff cuts at the agency, but HHS' major reduction in force has left stakeholders concerned inspectors won't be able to keep up... Sub. Req’d

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

(5/6, Sue Sutter, Pink Sheet) ...Sources told the Pink Sheet that Makary has repeatedly mischaracterized foreign facilities as being subject to a lower standard than domestic facilities, which may have contributed to Rogers' decision to leave...John Murphy, president and CEO of the Association for Accessible Medicines, said the generic drug trade group applauded the president's efforts to promote and streamline regulatory programs to boost incentives for domestic manufacturing... Global Sub. Full

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

(5/6, Eliza Slawther, Pink Sheet) ...European pharma trade associations argue that transferable exclusivity vouchers (TEVs) for novel antimicrobials proposed under the EU pharma legislation are inadequate to incentivize antimicrobial development. EFPIA warns that changes made to the original TEV framework have weakened the value of the incentive for companies. EUCOPE says the TEV framework risks being overly bureaucratic for small and medium sized companies but could be an interim solution to addressing antimicrobial resistance... Global Sub. Full

Europe's Last Maker of Key Antibiotics Ingredients Shuts Biggest Domestic Factory

(5/6, Andy Bounds, Financial Times) ...Xellia Pharmaceuticals said it could only survive against Chinese competition by moving some of its production to its plant there. Half of Xellia's active pharmaceutical ingredients (APIs) feature on the recent EU list of critical medicines and the World Health Organization's list of essential medicines...Its chief executive Michael Kocher said that unless government-funded health systems were prepared to pay more for generic medicines, more companies based in the EU would move factories. "We are discussing so much about reshoring. I think it's just as important to make sure that what we have in Europe stays in Europe," he told the Financial Times in an interview... Sub. Req’d

Improving EU's Regulatory Framework for Enhanced Pharma Competitiveness

(5/6, Catherine Eckford, European Pharmaceutical Review) ...New research reports that financial barriers, alongside regulatory restrictions and other factors, are making pharmaceutical companies choose the US over the EU market. Overall, this reduces investment in the pharma industry, and thus EU competitiveness with international markets. Additionally, the findings from Bayes Business School, UK, and Merck KGaA, published in Drug Discovery Today, suggests that EU Member States must have closer collaboration, "provide better incentives for the development of new medicines and approve access to medicines quicker than other international regulators, if it is to attract greater investment from pharmaceutical companies"... Full

US-Ireland Trade Deficit at Record On Pre-Tariff Pharma Imports

(5/6, Vince Golle and Mark Niquette, Bloomberg) ...The shortfall with the Emerald Isle more than doubled to a seasonally adjusted $29.3 billion - larger than the US's $24.8 billion goods deficit with China. It was also wider than two other major US trade partners, Canada and Mexico. Overall, the value of imports from Ireland was twice the total brought in a month earlier... Sub. Req’d

Ireland Has Lowest Availability for New Cancer Medicines in Western Europe - IPHA

(5/7, Fergal Bowers, RTE) ...Ireland has the lowest availability for new cancer medicines in Western Europe, according to the Irish Pharmaceutical Healthcare Association (IPHA). Only 25% of 56 new cancer treatments licensed since 2020 are currently available in Ireland, the association said... Full

Trump's New Executive Orders May Hit Indian Pharma Exports, Reshape Global Drug Supply Chains: Report

(5/7, ANI) ...The recent executive orders on pharma issued by President Donald Trump are expected to create significant challenges for Indian pharmaceutical companies, especially those operating in the U.S. generic drug market, according to a report by Nuvama Research.These policy moves aim to prioritize domestic manufacturing of pharmaceuticals in the United States and could reshape global drug supply chains if implemented strictly... Full

India's Next Pharma Revolution: Crushing Patent Games to Dominate the $200B Biosimilars Market

(5/6, Ashwani Mahajan, Fortune India) ...India's biosimilar ambition is not just economic – it is a moral obligation. With 63% of deaths linked to chronic diseases and out-of-pocket expenses dominating healthcare spending, affordable biologics are essential to prevent families from sacrificing education, livelihoods, or dignity for treatment. By streamlining regulations, defending competition, and investing in self-reliance, India can replicate its generics success in biosimilars. The roadmap is clear: revise guidelines, unify approvals, and prioritize domestic innovation... Full

Comments Sought On Biosimilars Guidelines

(5/6, Teena Thacker, The Economic Times) ...India's drug regulator has released draft guidelines for biosimilar drugs, inviting public comments within 30 days. These revised regulations, aligned with international standards, aim to establish stringent quality benchmarks for biosimilar research and manufacturing. The guidelines also emphasize minimizing animal testing, reflecting a commitment to ethical practices in drug development within the rapidly growing biosimilars market... Full

CDSCO Releases Revised Guidelines On Biosimilars, Invites Comments from Stakeholders

(5/7, Pharmabiz.com) ...It also addresses topics such as next generation analytical methodologies for establishing analytical similarity, elaborating use of reference standards and development of in-house reference standards, elaborating list of in vitro studies, and new guidance on determining the need for in vivo animal studies and on the implementation of the 3Rs principles (Replace, Reduce, Refine) to minimise the use of animals in testing... Full

Russian Govt to Take Additional Measures to Avoid Drug Shortages

(5/7, The Pharma Letter) ...The Russian government will consider registering next-in-class drugs based on data from the second phase of clinical trials (CT) as well as will implement other measures in order to avoid a shortage of drugs in domestic market this year, The Pharma Letter's local correspondent reports... Sub. Req’d

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