Thursday, May 8, 2025
Top News
Teva CEO Richard Francis On Tariffs: Well Positioned to Maintain Guidance Despite Duties
(5/7, CNBC) ...Richard Francis, Teva Pharma CEO, joins ‘Money Movers' to discuss the company's quarterly earnings results, any pharma shortages in the U.S., and much more... Full
Teva Pharm's US Production Will Help to Limit US Tariffs Impact, CEO Says
(5/7, Steven Scheer, Reuters) ...Speaking after Teva issued first-quarter results, Francis said the company has eight manufacturing plants in the United States, and the company is not reliant on China. "That puts us in a strong position," Francis said. He also said that Europe needed drug pricing reform... Full
Teva Will Hike Generic Drug Prices If Trump Imposes Tariffs, CEO Says
(5/7, Josh Nathan-Kazis, Barron's) ...If President Donald Trump imposes drug tariffs that affect the cheap generic medicines Teva Pharmaceutical Industries makes, the company's CEO says he'll have no choice but to raise their prices. "Ultimately, you would pass that cost on to the purchaser," Richard Francis, the company's CEO, told Barron's on Wednesday, shortly after Teva reported first-quarter earnings that beat expectations and raised its full-year guidance. "That's pretty much standard. That happens with every tariff."... Full
Teva On Course for 2027 Targets
(5/8, Shiri Habib-Valdhorn, Globes) ...Leader Capital Markets head of research Sabina Levy...points out in the context of Teva's financial reports concerns tariffs in the US. Levy points out that Teva estimates the company will not be significantly affected. Teva's most important branded product today is Austedo, for treating movement disorders. The company expects $2 billion in sales this year, and over $2.5 billion in 2027. Austedo is manufactured in the US, so it is not "threatened" by new tariffs. Teva also has a significant network of manufacturing facilities in the generics sector in the US... Full
Teva to Cut 3,000 Jobs by 2027 in Drive Toward Higher Profit Margins
(5/7, Sophie Shulman, CTech) ...Teva Pharmaceutical announced it will lay off nearly 3,000 employees—approximately 8% of its global workforce—by 2027, as part of its effort to reach an operating profit margin of 30%... Full
Teva Plans Staff Cuts as it Commits to Accelerating Growth
(5/7, Nicole DeFeudis, Endpoints News) ...The cuts will impact manufacturing and general and administrative roles, CEO Richard Francis told Endpoints News in an interview about the company's first-quarter earnings. Teva first initiated a broader restructuring plan in 2023, which has involved a consolidation of its manufacturing network, a shift away from some lower-margin generics, and plans to sell off its API unit... Sub. Req’d
Teva's Quiet Layoff Announcement Reveals Bold Restructuring Plan
(5/8, Sophie Shulman, CTech) ...Officially, this is part of an "efficiency program" designed to generate $700 million in savings by 2027. But Chief Financial Officer Eli Kalif made clear on Tuesday that the pace of implementation will be faster than the timeline suggests. "We're facing global competition and want to become a biopharmaceutical company, not just a generics player," Kalif told Calcalist. "This plan has been in the works for some time. As early as 2022, we set a goal of achieving 30% operating profit by 2027. Now it's time to execute."... Full
Teva Stock Jumps On Outlook. CEO Touts 'Real Clarity' On Future Profits.
(5/7, Allison Gatlin, Investor's Business Daily) ...Chief Executive Richard Francis noted Teva exited its business in Japan during the first quarter. He noted Teva divested that business to divert its capital to more profitable businesses. Minus that, underlying sales are expected to grow this year. "I think right now the analysts see the guidance as really favorable because the one thing they were looking at was, can Teva drive profitability in '25, '26 and '27," he told Investor's Business Daily. "I think we gave real clarity on our ability to drive our EBITDA (earnings before interest, taxes, depreciation and amortization)."... Full
CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance
(5/8, Urte Fultinaviciute, Generics Bulletin) ...Given that pharmacovigilance activities can be manual, time-consuming, and error-prone, but have predefined rules, it is a great candidate for AI and automation, explained Miriam Kaminietsky, director and head of the pharmacovigilance project management and innovation team at Teva...This year, the Israeli firm is focusing on Teva ChatGPT, a tool to summarize literature articles, with plans to launch it over the next month. Given Teva's large product portfolio and the need to summarize over 250 articles a month, the firm saw potential in easing the manual labor of its workers... Global Sub. Full
H-E-B, Other Major Retailers Sue Over Drug Monopolies
(5/7, Patrick Danner, San Antonio Express-News) ...H-E-B, Walgreen Co., the Kroger Co. and Albertsons Companies Inc. filed suit March 25 in federal court in San Francisco alleging that Japanese drug maker Takeda Pharmaceutical Co. Ltd., TWi Pharmaceuticals Inc. of Taiwan and related defendants have conspired to restrain competition for the drug Dexilant and generic equivalents. They treat acid reflux. Nine days later, the same four retailers sued Israel's Teva Pharmaceuticals Industries Inc. and subsidiaries in federal court in Vermont over the alleged suppression of generic competition for Copaxone, an injectable drug that treats a type of multiple sclerosis... Sub. Req’d
Texas Grocery Giant Joins Antirust Suit Against Global Drug Maker
(5/7, Zachary-Taylor Wright, My SA) ...Essentially, the pharmacy companies say Teva manipulated the market by upping its dosage as soon as a competitor hit the market (despite Teva scientists allegedly saying the increase had no benefit), engaging in exclusive contracts with doctors' offices to prescribe Teva-branded medicine and by prompting a misinformative marketing blitz that suggested generic versions of the medication were less effective... Full
Industry News
Gilead Boosts Planned US Investments by $11 Billion Amid Tariff Threat
(5/7, Christy Santhosh, Reuters) ...Gilead Sciences announced $11 billion in new planned investment in the U.S. to add to its domestic manufacturing and research heft, becoming the latest company to announce spending plans in reaction to President Donald Trump's tariff policy. The new investments, unveiled on Wednesday, will supplement an already planned spending of $21 billion to boost U.S. manufacturing and research and development through 2030, the drugmaker said... Full
Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case
(5/7, Dean Rudge, Generics Bulletin) ...Viatris will be able to launch generic versions of Heron Therapeutics' Cinvanti and Aponvie for nausea and vomiting beginning June 2032, after striking a patent-litigation settlement agreement with the originator... Global Sub. Full
US Judge Sides with FDA's Removal of Lilly's Weight Loss Drug from Shortage List
(5/7, Patrick Wingrove, Reuters) ...A U.S. federal judge has sided with a U.S. regulator's decision last year to take Eli Lilly's blockbuster weight loss and diabetes drugs Zepbound and Mounjaro off a list of medicines in short supply, a ruling that could dash patients' hopes of regaining access to cheaper copies of the popular therapies...A Lilly spokesperson said the court's decision confirms that Mounjaro and Zepbound are not in shortage, and that "continuing to sell mass compounded products, including when referring to them as 'personalized', 'tailored' or something similar, is breaking the law"... Full
Lupin Launches Seizure Drug Eslicarbazepine Acetate in US After FDA Approval
(5/7, Jomy Jos Pullokaran, CNBC TV-18) ...Drug firm Lupin Limited on Wednesday (May 7) said it has launched eslicarbazepine acetate tablets in the US after securing approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application. The product, available in 200 mg, 400 mg, 600 mg, and 800 mg strengths, is the generic equivalent of Sumitomo Pharma America's Aptiom and is indicated for the treatment of partial-onset seizures in patients aged four years and above... Full
AstraZeneca, Daiichi Sankyo's Enhertu Rings Up Success in Another Breast Cancer Trial
(5/7, Kevin Dunleavy, Fierce Pharma) ...The Destiny-Breast11 trial has shown that Enhertu followed by the chemotherapy pacliotaxel, and targeted cancer drugs Herceptin and Perjeta (THP) provides a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) versus standard of care (SOC) when used before surgery in patients with high-risk, locally advanced HER2-positive early-stage breast cancer... Full
Merck's New Keytruda Shot Is a Rare Real-Time ‘Product Hop'
(5/7, Christopher Yasiejko, Bloomberg Law) ...Merck & Co.‘s planned debut this fall of an injectable form of its breakthrough cancer treatment Keytruda will simplify care, expand access, and save more lives, the company says. But by shifting patients to a version protected by newer patents, it will also extend Merck's control over the world's best-selling drug. Merck is performing a sleight-of-hand known as a "product hop" by tweaking how the drug is delivered. The pivot will preserve its exclusivity and could box out lower-cost rivals for Keytruda, which last year made $29.5 billion globally... Sub. Req’d
Hikma Pharmaceuticals Agrees USD50 Million Settlement for Xyrem Claims
(5/8, Emily Parsons, Alliance News) ...The London-based pharmaceutical group, alongside wholly-owned subsidiary Hikma Pharmaceuticals USA Inc, said the agreement resolved the majority of class action antitrust lawsuits brought against the company by third-party payors in the US who have purchased or been billed for Xyrem, or sodium oxybate. Hikma noted that the settlement was not an admission of wrongdoing or liability, and said it would continue to defend itself "vigorously" against any litigation not resolved by this settlement... Full
Rite Aid to Sell Customer Prescriptions to Rival Pharmacies
(5/7, Jonathan Randles, Bloomberg Law) ...Rite Aid won court approval to run an expedited process to sell customers' prescription information to rival pharmacies as the bankrupt firm prepares to unload or close its stores...Rite Aid has said prescriptions are the company's most valuable asset and that a sale must be completed quickly "to ensure an uninterrupted supply of medications to pharmacy-care customers who need them."... Sub. Req’d
Expert: Navigating the Next Decade of Market Growth and Innovation for Biosimilars
(5/7, Kennedy Ferruggia and Dracey Poore, Pharmacy Times) ...In an interview with Pharmacy Times®, Dracey Poore, director of biosimilars at Cardinal Health, discussed the critical need for increasing biosimilar adoption to ensure market sustainability and manufacturer viability, highlighting that only 10% of biologics losing patent protection have biosimilars in the pipeline. She proposed innovative solutions like integrating payer formulary data into electronic medical records and developing AI-driven tools to streamline benefits investigations and reduce administrative burdens... Full
The State of Antibiotic Development: ‘Deplorable Comes to Mind'
(5/7, Ed Silverman, STAT+) ...Four years ago, an ambitious pharmaceutical industry venture to tackle antibiotic resistance launched to invest in small companies that can develop two to four novel antibiotics by 2030 — and replenish the global supply chain with needed treatments...Since then, the AMR Action Fund has closed 10 investments and hopes to complete as many as 10 more by the end of next year. Despite the progress, though, antibiotic development otherwise remains meager. We spoke with Henry Skinner, who has headed the AMR Fund since it began, about the outlook for taming antibiotic resistance... Sub. Req’d
U.S. Policy & Regulatory News
Trump to Pitch Sweeping Medicare Drug Price Plan
(5/7, Jake Traylor and Adam Cancryn, Politico) ...President Donald Trump plans to revive an effort to dramatically slash drug costs by tying the amount the government pays for some medicines to lower prices abroad, three people familiar with the matter told POLITICO. Trump early next week is expected to sign an executive order directing aides to pursue the initiative, called "most favored nation," for a selection of drugs within the Medicare program... Full
Editorial: Trump's Worst Idea Since Tariffs
(5/7, The Wall Street Journal) ...Some Republicans see this as a path of less political resistance to achieve some $880 billion in Medicaid savings that is the target of their reconciliation outline. But savings from Mr. Trump's drug plan would be negligible, and the scheme would harm innovation and raise prices for Americans with private insurance... Sub. Req’d
From Deal to Disaster: Drugmakers Face a Changed Washington as Trump Embraces ‘Most Favored Nation' Prices
(5/7, Max Bayer and Drew Armstrong, Endpoints News) ...As a sign of the industry's inroads, Trump described at the White House event how [Eli Lilly CEO David0 Ricks "sweet-talks" him about the role middlemen play in drug pricing. "By the time I leave the meetings, I was telling my people, I say, 'Gee, he's giving us a great bargain,'" Trump said... Sub. Req’d
Trump Order On Domestic Manufacturing Wins Plaudits From Industry
(5/7, Dave Wallace, Generics Bulletin) ...The AAM applauded the efforts to promote and streamline regulatory programs to boost incentives for increased domestic manufacturing. While reshoring production has been seen as a key policy objective for the Trump administration, industry chiefs have cautioned that building up manufacturing capacity will take time and it is not realistic for the US to manufacture all of its critical medicines domestically... Global Sub. Full
PhRMA Warns Tariffs Won't Boost U.S. Drug Manufacturing, Cites Global Trade Benefits
(5/7, Maaisha Osman, Inside Health Policy) ...Instead of tariffs, PhRMA also urged the government to strengthen international supply chains by working more closely with allies and using trade agreements to improve resilience. The industry's current model, the group argues, delivers both economic security and national security...The group warned that cutting off global partners would create dangerous chokepoints, not resilience. "The security of the U.S. drug supply depends on both robust domestic production and trusted global trade," PhRMA wrote... Sub. Req’d
Pharma Warns Tariffs Mean Less R&D
(5/7, Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech, The Hill) ...In a comment submitted to the Department of Commerce, PhRMA Executive Vice President of International Advocacy Jay Taylor advised against enforcing tariffs, saying trade barriers in market should be addressed through "negotiation and enforcement of robust bilateral and sectoral agreements."... Full
Pharma Industry Argues Tax, Other Incentives Better Than Tariffs
(5/7, Jessica Merrill, Pink Sheet) ...AAM painted a dire picture and tried to set generic and biosimilar manufacturers apart from their brand counterparts..."While tariffs may not reduce the availability of branded drugs, and may even incentivize investments in the United States, they will exacerbate generic shortages and hamper the ability for US producers of generics to make investments," AAM said...PhRMA and BIO argued that a complicated and global supply chain would be at risk from tariffs and pushed for policies that could reinforce an already strong US sector... Global Sub. Full
NACDS Comments On Potential Pharmaceutical Tariffs
(5/7, NACDS) ...Should the Administration move forward with tariffs on pharmaceuticals and pharmaceutical ingredients, NACDS is advocating for carefully designed structure that leverages incentives, building U.S. manufacturing capacity without jeopardizing patients' access to essential medications... Full
Public Citizen Comments On Section 232 Investigation On Pharmaceuticals
(5/7, Public Citizen) ...Our comment focuses specifically on generic drug supply and access, as these are especially threatened by potential import restrictions. Maintaining the availability of and access to medicines should be a central consideration in any government action that targets pharmaceuticals... Full
US FDA's Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops
(5/8, Anju Ghangurde, Pink Sheet) ..."We've been supporting all inspections, unannounced or otherwise; we have been doing it for the last few years," Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance, which represents frontline domestic firms, told the Pink Sheet. Jain also dismissed any suggestion of leniency or differing regulatory standards when it comes to the agency's foreign versus domestic facility inspections, underlining that currently there's lot of "rhetoric" that's playing out... Global Sub. Full
US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped
(5/7, Derrick Gingery, Pink Sheet) ...FDA reviewers and scientists continue to write guidances, but publication has slowed substantially since the Trump Administration took office. Product-specific guidances, used for generic drug development, have not been published since November, in part because of cuts to the policy staff in the Office of Generic Drugs. Sponsors are concerned that multiple publication deadlines could be missed because of the cuts... Global Sub. Full
FDA's ODAC Will Review Drugs for Four Different Cancers at Meeting in May
(5/7, Zachary Brennan, Endpoints News) ...The FDA announced a two-day meeting of its Oncologic Drugs Advisory Committee (ODAC) later this month to review four cancer drugs from Genentech, Pfizer, J&J and UroGen Pharma, with potential new treatments for different forms of large B cell lymphoma, prostate cancer, multiple myeloma and bladder cancer... Sub. Req’d
Maryland Gov Expected To Sign Bill Expanding State PDAB Authority
(5/7, Luke Zarzecki, Inside Health Policy) ...Vinny DeMarco, president of Maryland Health Care for All, told Inside Health Policy Moore said he would sign the bill, and DeMarco said Moore's state agencies endorsed the bill. Another source close to the legislation told IHP they were informed the governor plans to sign the bill. Andrew York, executive director of the Maryland Prescription Drug Affordability Board, also told IHP there has been no indication that the governor would not sign the bill. The governor has two more bill signing events scheduled this month, one on May 13 and another on May 20... Sub. Req’d
International News
Europe Must Act Now to Protect Patients and Medicines Supply
(5/7, Medicines for Europe) ...We urge Member States to support the needed reforms on the CMA and UWWTD and importantly, to resist pressure to stall negotiations on the pharmaceutical legislation over transatlantic trade tensions. Europe already grants the longest monopoly protections for medicines globally, yet announced investments in R&D and manufacturing have flowed elsewhere. The Draghi Report evidence is overwhelming that competition stimulates productivity, investment and innovation. Now, some companies are shifting production to the US. That is no reason to delay reforms that serve European patients... Full
European Parliament Report Urges for Reassessment of Urban Wastewater Treatment Directive's Impact On Medicines
(5/7, Medicines for Europe) ...Medicines for Europe therefore welcomes the European Parliament Plenary's call for a new and comprehensive assessment of the impact of EPR on the availability and affordability of medicines. Medicines for Europe calls on the European Commission to pause the implementation of the EPR provisions in the UWWTD, and to conduct a thorough review of its impact on pharmaceuticals to safeguard patient access to medicines... Full
England: HTA Sandbox Helping To Assess ‘Challenging' Drugs And Indications
(5/7, Eliza Slawther, Pink Sheet) ...England's health technology assessment institute, NICE, is using its HTA Lab to test new methods and processes for challenging products, including drugs for MASH and individualized therapies. A senior advisor for NICE discussed the details of ongoing projects and emphasized the importance of industry input. The sandbox environment allows for exploratory assessments without impacting current or future product evaluations... Global Sub. Full
UK Trumpets a Trade Deal with India - But Pharma isn't Happy
(5/7, Phil Taylor, PharmaPhorum) ...The deal has been held up as a way to boost the economies of both nations at a time when tariffs imposed by the US are wreaking havoc with international trade, with UK Prime Minister Keir Starmer saying it would boost British exports to India by an additional £25.5 billion over its 2024 level of $42.6 billion...In particular, the trade organisation is concerned about regulatory data protection (RDP), referring to the extensive data from preclinical and clinical trials to demonstrate the quality, efficacy, and safety of a new medicine... Full
Bulgarian Intelligence Agency Flags Healthcare Crisis as National Security Threat
(5/8, Krassen Nikolov, Euractiv) ...According to a SANS report seen by Euractiv, the agency highlights four key scenarios related to healthcare that pose serious threats to Bulgaria's stability. These include the potential for new epidemics facilitated by the migration of populations from conflict regions and low immunisation rates; the escalating problem of antimicrobial resistance due to widespread antibiotic use; a growing shortage of medical personnel, particularly in state and municipal hospitals; and the periodic lack of essential and high-cost medicines... Full
Brazil To Upgrade Pricing Framework To Keep Up With Market Developments
(5/7, Francesca Bruce, Pink Sheet) ...Brazilian authorities will update the country's medicine pricing framework to bring it up to date with advances in drug technology. A draft resolution setting out the updates will be put out for consultation. The updates will include a new basket of countries for reference pricing and greater recognition of incremental innovation... Global Sub. Full
NPPA Fixes Retail Prices of 84 New Drugs
(5/8, Pharmabiz.com) ...The Authority has fixed price of 36 drug combinations containing empagliflozin, a compound which was patented by Boehringer Ingelheim, based on applications from marketing companies including Corona Remedies, Skymap Pharmaceuticals, Mankind Pharma, MacLeod's Pharmaceuticals, Zuventus Healthcare, German Remedies Pharmaceuticals, Alkem Laboratories, Jagsonpal Pharmaceuticals, Lupin Ltd, and Micro Labs... Full
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