Wednesday, July 30, 2025

Teva Pharm Q2 Profit Beats Estimates as Branded Drugs Gain

(7/30, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries reported a higher than expected rise in second-quarter profit, helped by strong sales gains of its branded drugs to treat migraines, Huntington's disease and schizophrenia... Full

Teva Again Raises Profit Guidance

(7/30, Shiri Habib-Valdhorn, Globes) ...Teva Pharmaceutical Industries Ltd. beat the analysts on profit in the second quarter of 2025 but missed on revenue. Non-GAAP earnings per share was $0.66, above the analysts' forecast of $0.62 and the company has raised its annual net profit guidance for 2025 for the second time this year. Teva expects annual earnings per share of $2.50-2.65, up from the bottom range of $2.45... Full

Teva Returns to Profit in Q2 But Misses On Revenue

(7/30, Sophie Shulman, CTech) ...The standout performer was Uzedy, Teva's newest brand-name drug for schizophrenia, which delivered 120% growth and reached $54 million in quarterly revenue. Based on this performance, Teva raised its full-year sales forecast for Uzedy to $190–200 million...CEO Richard Francis noted, "The rapid progress of our transformation plans is already generating annual savings at a rate of $140 million by 2025, an important milestone toward our target of $700 million by 2027." This refers to Teva's recent restructuring plan, including an 8% workforce reduction announced three months ago... Full

Teva Pharmaceuticals Swings to 2Q Profit But Narrows Full-Year View

(7/30, Josee Rose, Dow Jones) ...Teva said its key drugs Austedo, Ajovy and Uzedy all performed well in the quarter and it raised its full-year revenue outlook for Ajovy, which treats migraines, and Uzedy, which is used to treat schizophrenia. Austedo is used to treat certain movement disorders. The company said its generics business "continues to provide a stable foundation despite headwinds" and expects continued momentum behind its over-the-counter and biosimilars, and is on track to double its biosimilar revenue from 2024-2027. The company said it's entering its second phase of its "Pivot to Growth" strategy... Sub. Req’d

Teva Says 'On Track' for 30% Operating Profit Margin by 2027

(7/30, The Fly) ...The company said, "In Q2 2025, we continued to execute on the four key pillars of our Pivot to Growth strategy, announced in May 2023, and entered into its second phase - 'Accelerate Growth.' During this phase we expect to focus on growing our innovative portfolio, aligning capital allocation to invest in higher value activities, reinforcing our commitment to patients, and optimizing our organization and operations. Delivering on our Growth Engines - on the first pillar, we continued to demonstrate strong performance of our key innovative products - AUSTEDO, AJOVY, and UZEDY. Collectively, these products grew ~26% in Q2 2025 YoY in local currency..."... Full

Why Drugmaker Teva Pharmaceutical Narrowed Full-Year Guidance After Beating Q2 Earnings

(7/30, Kit Norton, Investor's Business Daily) ..."Teva's performance this quarter stands as a testament to the exceptional strength of our innovative portfolio, which remains the primary engine driving our revenue growth," Teva CEO Richard Francis said in the earnings release. Analysts forecast Teva Pharmaceutical profit for the year growing 1.6% to $2.53 per share with revenue increasing 2% to $16.89 billion, according to FactSet. Notably, Teva said at the beginning of the second quarter that current U.S. tariffs will have an "immaterial impact" on 2025 metrics. The company has eight production facilities in the U.S., and says its supply chain is centered in the U.S., Israel and Europe... Full

Teva Pharma (TEVA) Tops Q2 EPS by 3c, Misses On Revenue; Offers FY25 Revenue Guidance

(7/30, StreetInsider.com) ...Teva Pharma reported Q2 EPS of $0.66, $0.03 better than the analyst estimate of $0.63. Revenue for the quarter came in at $4.2 billion versus the consensus estimate of $4.28 billion... Sub. Req’d

Teva Reports Q2 Adjusted EPS 66c, Consensus 62c

(7/30, The Fly) ...Reports Q2 revenue $4.2B, consensus $4.27B. Mr. Richard Francis, Teva's President and CEO, said, "Teva's performance this quarter stands as a testament to the exceptional strength of our innovative portfolio, which remains the primary engine driving our revenue growth. Our key innovative products delivered a 26% increase in local currency, demonstrating their impact on our financial trajectory and value to patients. As we execute our Pivot to Growth strategy, our focus on innovation is unwavering, placing us firmly on track to achieve a 30% operating profit margin by 2027..."... Full

Teva Pharma Posts Profit In Q2, Adj. EPS Beats Market, While Revenues Miss; Lifts FY25 Earnings View

(7/30, RTTNews) ...Teva Pharmaceutical Industries Ltd reported Wednesday a profit in its second quarter, compared to prior year's loss, with slightly higher net revenues. Adjusted earnings beat market estimates, while top line missed the view. Further, the company raised the lower end of its fiscal 2025 adjusted earnings outlook range, and maintained revenue view. The company added that it is on track for 30 percent operating profit margin by 2027 in line with Pivot to Growth Strategy... Full

Merck, AstraZeneca Downplay Impact of European Tariffs Despite Timing Uncertainties

(7/29, Cathy Kelly, Pink Sheet) ...Merck and AstraZeneca discussed why the 15% EU tariffs on pharmaceuticals won't be too challenging in the near term, suggesting company efforts to move more manufacturing to the US has paid off. There are uncertainties remaining about how and when the tariffs will be implemented, which could change forecasts, the firms acknowledge. At the same time, President Trump is not giving up on his campaign to 'rebalance' drug pricing disparities between the US and wealthy markets abroad... Global Sub. Full

Commerce Secretary Lutnick: The Key to Why the EU Did the Deal is Autos and Pharmaceuticals

(7/29, CNBC) ...Commerce Secretary Howard Lutnick joins ‘Squawk Box' to discuss the state of U.S. trade negotiations, details of the U.S.-EU trade deal, U.S.-China trade talks, and more... Full

Trump Gets Tariffs; Americans Get Price Hikes

(7/29, David Gaffen and Marleen Kaesebier, Reuters) ...Many companies shipped more goods and raw materials into the U.S. before tariffs hit. Economists and analysts reckon that hoarding has helped some delay hiking prices until later in the year and explains why tariffs have not yet shown up in U.S. inflation data. Andrew Wilson, International Chamber of Commerce deputy secretary general, estimates inflation will be felt once companies have run down inventory, but that might not be until the fourth quarter or first quarter of next year... Full

How Will Trump's EU Tariffs Affect Drug Prices?

(7/29, Berkeley Lovelace Jr., NBC News) ...In the short term, drug companies might increase the list prices of these products to account for the higher cost, said Rena Conti, an associate professor at Boston University's Questrom School of Business. "U.S. consumers will pay more at the pharmacy counter for these drugs," Conti said. "What patients pay at the pharmacy counter reflects drug companies' set price list."...A spokesperson for the Association for Accessible Medicines, a trade group that represents generic drugmakers, said the group is still assessing the potential impact of the tariffs as well as the specifics of the trade deal... Full

GSK in Talks With Trump Administration On U.S. Drug Pricing, CEO Says

(7/30, Pushkala Aripaka and Maggie Fick, Reuters) ...British drugmaker GSK said on Wednesday it is in talks with the Trump administration about ways to lower U.S. drug costs, becoming the latest pharmaceutical company to acknowledge action under pressure from Washington to rein in prices... Full

Policymakers Urged To Thwart Unnecessary Drug Patent Filings

(7/29, Gabrielle Wanneh, Inside Health Policy) ...Maryll Toufanian, senior vice president for regulatory strategy and government affairs at Amneal Pharmaceuticals, said current regulations governing FDA's Orange Book can lead to brand drug companies filing patents that represent little to no meaningful innovation...Toufanian also highlighted court cases such as Teva v. Amneal, in which the federal circuit appellate court ruled Teva Pharmaceuticals must delist five patents from the Orange Book after the company sued Amneal for patent infringement when it sought to sell a generic version of Teva's ProAir HFA inhaler... Sub. Req’d

Telehealth Companies Strengthen DC Lobbying On Compounding, Rx Drugs, Medicare Flexibilities

(7/29, Christian Robles, Inside Health Policy) ...Individual telehealth companies have intensified their Washington lobbying efforts since the Trump administration took office amid regulatory limits on their ability to prescribe compounded GLP-1s and a looming Sept. 30 deadline for extension of Medicare telehealth flexibilities, an Inside Health Policy review of 2025 Q1 and Q2 House lobbying disclosures found. Two major telehealth providers, Hims & Hers and GoodRx, have partnered with Trump world-connected firm Continental Strategy as part of their heightened lobbying efforts... Sub. Req’d

Regulations, Not Anticompetitive Actions, Are Obstructing Drug Competition

(7/30, Wayne Winegarden, PRI) ...Promoting greater affordability while maintaining patients' access to medicines requires beneficial reforms that target the specific flaws that pervade the system. Specifically, policies need to fix the disincentives created by the third-party payer system, improve price transparency for drugs, reform the current drug rebate system, and reform the 340B program. Focusing reforms on these areas is the surest way to promote the dual goals of affordability and continued innovation... Full

Drug Innovation Should Benefit Patients. PBMs Are Preventing That From Happening.

(7/29, Kathy Chang, Healthcare Dive) ...It's possible to reform the market into one where pharmaceutical innovation benefits many more patients and far fewer intermediaries. If health plans want to transform the drug supply chain, they'll need the courage to leave behind a rebate system that actually encourages higher prices and lower access and instead push for a system that provides transparency into the true net cost of the drug for patients... Full

Clearing the Thicket: New Report Outlines Legislative Fixes to Boost Biosimilar Access

(7/29, Skylar Jeremias, The Center For Biosimilars) ...The promise of biosimilars to revolutionize patient access and affordability in health care faces a formidable adversary: patent thickets. A recent white paper from the Association for Accessible Medicines (AAM) laid bare how complex patent landscapes and protracted litigation were significantly delaying the entry of more affordable biologic alternatives, ultimately impacting patients and straining the US health care system. The report not only detailed these challenges but also outlined legislative solutions aimed at fostering a more competitive and sustainable biosimilar market... Full

US FDA's Chief Medical and Science Officer Prasad Departs Agency

(7/30, Gnaneshwar Rajan and Shivani Tanna, Reuters) ...Vinay Prasad, the U.S. Food and Drug Administration's chief medical and science officer, has left the health regulator, the U.S. Department of Health and Human Services, which oversees the FDA, said on Tuesday, confirming an earlier news report. "Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family," an HHS spokesperson said in an emailed statement to Reuters... Full

GDUFA Fee Schedule for FY 2026 Hits the Street—Big Jump In Application Fees

(7/29, Bob Pollock, Lachman Consultants) ...Every single one of the GDUFA for FY 2026 has risen, but the application fee rose more than 10% for a whopping increase of $36,327 for the submission of a new ANDA... Full

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

(7/30, Nielsen Hobbs and Derrick Gingery, Pink Sheet) ...Despite that higher volume of submissions, FDA anticipates that CDER will have fewer meetings with sponsors, including written responses only, projecting 3,843 in FY 2026 compared to the 4,028 it had in FY 2024. In contrast, the Center for Biologics Evaluation and Research, is anticipating an increase in meetings and written responses (1,001 up from 923 in FY 2024) as well as one additional application (13 instead of 12)... Global Sub. Full

Experts Offer Advice On Avoiding Common Warning Letter Citations

(7/29, Joanne S. Eglovitch, Regulatory Focus) ...Experts said that good manufacturing practice (GMP) violations, including inadequate procedures, insufficient training, and problems with data integrity, were commonly cited by US Food and Drug Administration investigators during drug and medical device facility inspections and offered advice on how to avoid enforcement actions related to these violations... Full

UZEDY® Accelerates: 2025 Revenue Outlook Raised to $190–$200M (from ~$160M); Olanzapine LAI On Track for Submission in 2025

(7/30, Medincell) ...Updated 2025 Revenue Outlook by Teva from ~$160 to $190 - $200 million. Q2 2025 sales $54 million, 2.2x increase compared to Q2 2024. H1 2025 sales $93 million, 2.3x increase compared to H1 2024... Full

Eli Lilly Eyes SoC Status as Jaypirca Proves Superior to Imbruvica in CLL/SLL

(7/30, Annabel Kartal Allen, Clinical Trials Arena) ...Eli Lilly's Jaypirca (pirtobrutinib) has been shown to be superior to Johnson & Johnson (J&J) and AbbVie's star Bruton's tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) in chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL)...This builds on the positive results of the Phase III BRUIN CLL-321 trial (NCT04666038), which found that Jaypirca can reduce the risk of disease progression or death by 46% compared with Gilead's Zydelig (idelalisib) plus Biogen and Genentech's Rituxan (rituximab), and Teva Pharmaceuticals' Treanda (bendamustine) plus Rituxan... Full

Evotec Accelerates Asset-Light Strategy With $300 Mln Biosimilars Deal To Sandoz

(7/30, RTTNews) ...Evotec SE has announced the signing of a non-binding term sheet with Sandoz AG regarding the potential sale of Just - Evotec Biologics EU, which includes the J.POD biologics manufacturing facility in Toulouse, France. The proposed transaction is designed to transfer biosimilar manufacturing capabilities to Sandoz, enabling it to produce biosimilar medicines using Evotec's advanced continuous manufacturing technology... Full

AZ Proposes US Price Cut Options as CEO Pascal Soriot Sides with Global 'Rebalancing of Pricing'

(7/29, Zoey Becker, Fierce Pharma) ...With a presence in "every country around the world," AstraZeneca is a global company and remains "committed to the U.K.," [CEO Pascal] Soriot affirmed. However, a U.S.-focused mindset is not out of the question. "We want to behave in the U.S. as a U.S. company," the CEO said...AZ has had "many discussions" with the Trump administration on price qualms and has made "proposals that would lead to price reductions of our products," Soriot revealed. The CEO overall sides with the ideals of the pricing policy. "I do believe a rebalancing of pricing around the world is necessary," the CEO said. "The U.S. can no longer pay for the R&D of the world."... Full

GSK Boosts Annual Growth Outlook as Second-Quarter Profit Beats Forecasts

(7/30, Pushkala Aripaka and Maggie Fick, Reuters) ...British drugmaker GSK (GSK.L) expects annual sales and profit to be towards the top of its forecast range, after second-quarter sales and earnings beat expectations on Wednesday, bolstering its bid to reignite growth amid U.S. political challenges. The development is a positive step towards GSK's long-term ambition to meet annual sales of more than 40 billion pounds ($53.44 billion) by 2031 amidst multiple headwinds, including potential pharmaceutical tariffs... Full

Lilly Set for Strong Quarter After Novo Profit Warning

(7/29, Patrick Wingrove and Bhanvi Satija, Reuters) ...Lilly's weight-loss drug Zepbound leads the U.S. market and has faced less competition from cheaper copies made by compounding pharmacies, giving it an edge, they said, after investors wiped $70 billion from Novo's market value. Novo, which sells the obesity drug Wegovy and related diabetes medicine Ozempic, on Tuesday issued a profit warning, citing lower U.S. growth expectations and competition including from compounded versions. "I think that this is a pretty positive report for Lilly just because it shows the competitive note it has against their largest competitor," said Dave Wagner, portfolio manager at Aptus Capital Advisors... Full

Wegovy Maker Novo's Profit Warning Triggers $70 Billion Share Rout

(7/29, Jacob Gronholt-Pedersen, Stine Jacobsen, and Maggie Fick, Reuters) ...Investors wiped $70 billion off Novo Nordisk's market value on Tuesday after the maker of weight-loss drug Wegovy issued a profit warning and named a new CEO, as it battles rising competition in the obesity drug market..."The magnitude of the guidance cut is a shocker," Markus Manns, a portfolio manager at mutual fund firm Union Investment, a Novo shareholder, told Reuters, adding that Novo's issues went deeper than "compounded" copycats to Wegovy... Full

How Novo Nordisk Lost Its Lead in the Weight Loss Race

(7/30, Hannah Kuchler, Financial Times) ...Some in the industry think Novo's core problem is quite simple: US rival Eli Lilly came up with a better product. Trials found more weight loss from Lilly's Mounjaro and Zepbound than Ozempic and another Novo drug Wegovy, and anecdotally doctors report fewer side effects. "You can't magically change the product profile," said Gareth Powell, a healthcare fund manager at Polar Capital, an investor in both groups. Ultimately, many shareholders and analysts now see this as Lilly's market to lose. Tim Opler, a managing director in Stifel's global healthcare group, said Lilly had worked at "double speed" to commercialise their drugs. "Lilly just outgunned Novo," he said... Sub. Req’d

Solid 1st-Half Growth for Boehringer

(7/29, The Pharma Letter) ...In the first half of 2025, Boehringer's Human Pharma business grew 5.7% reaching 11.3 billion euros ($11.8 billion) in net sales. Growth was driven by solid global demand for key products, including 4.3 billion euros ($4.5 billion) in sales from Jardiance (empagliflozin), the treatment of chronic kidney diseases, type 2 diabetes and heart failure, and 2.0 billion euros ($2.1 billion) in sales from Ofev (nintedanib), which is used to treat idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases... Sub. Req’d

Piramal Pharma Retains FY26 Targets, Stays On Track to Reach $2 Billion Revenue by 2030

(7/30, Vinnii Motiwala, CNBC TV-18) ...Nandini Piramal, Chairperson of Piramal Pharma, said growth in complex hospital generics should pick up in the second half as new sites come online and institutional orders ramp up. She added that power brands and e-commerce continue to drive steady growth in the consumer health segment. Piramal Pharma is holding firm on its full-year guidance for the financial year ending March 2026, expecting mid-single-digit revenue growth and mid-teen earnings before interest, tax, depreciation and amortisation (EBITDA) margins... Full

Celltrion Nears Deal For US Biologics Plant To Quell Tariff Concerns

(7/30, Dean Rudge, Generics Bulletin) ...Celltrion has emerged as the preferred bidder for a large-scale cGMP biologics manufacturing plant in the US, aimed at bolstering its position amid rising tariff concerns. Once the acquisition is finalized, projected for early October 2025, Celltrion plans to further expand the facility's production capacity by 1.5 times that of its existing Plant 2 in Songdo. This strategic move is part of a broader plan to mitigate risks associated with evolving US pharmaceutical tariffs, which includes stockpiling inventory and increasing contracts with local manufacturers... Global Sub. Full

The Generics Bulletin Top 50, Part Three: New Firms Enter Global Grouping

(7/30, Dave Wallace, Generics Bulletin) ...In the third instalment of this year's Generics Bulletin Top 50, we reveal which firms have entered the ranking for the first time... Global Sub. Full

EFPIA Response to the EU-US Trade Deal

(7/28, EFPIA) ...If the intent is to secure pharmaceutical investment in research, development and manufacturing, rebalance trade and ensure a fairer distribution of how global pharmaceutical innovation is financed, then there are more effective means than tariffs that would help, rather than hinder, global advances in patient care and economic growth. From a European perspective, it means rethinking how we value innovation, significantly increasing what the region spends on innovative medicines and creating an operating environment that can accelerate turning Europe's great science into new treatments... Full

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

(7/29, Neena Brizmohun, Pink Sheet) ...A total of 26 medicines containing new active substances were approved in 1H 2025, marking a 30% increase over the 20 products approved during the same period in 2024. Six of the products received a conditional marketing authorization (CMA), a figure that already matches the total CMA count for all of 2024 and comes close to the seven and eight CMAs granted throughout 2023 and 2022, respectively. Two more CMAs have already been granted in the second half of 2025 and more are expected soon... Global Sub. Full

Trump Tariff Threat of ‘20-25%': Is Modi Government Ready to Acquiesce or Will it Fight its Corner?

(7/30, Ravi Kanth Devarakonda, The Wire) ...The chances of the Narendra Modi government acquiescing to President Donald Trump's colonial-pattern of imperial preferences is very high. This is close to what the British Raj practiced in its colonies like India. Such preferences would demand substantial tariff reduction commitments of India, including on the most sensitive agricultural products, for American products, removal of alleged non-trade barriers, as well as hundreds of billions of dollars worth of defence and energy purchases... Full

India's Draft Guidelines On Biosimilar Drugs Can Make Treatments More Accessible, Affordable

(7/30, Chetali Rao, ThePrint) ...The 2025 Draft Guidelines on Similar Biologics offer a historic opportunity to advance India's healthcare system. By removing persisting ambiguities in animal studies, clarifying conditions for clinical trials, and prioritising affordability, it will not only provide the much needed impetus to India's biosimilar industry but can also make biosimilars more accessible and reinforce India's leadership in affordable medicine... Full

Pfizer Plans to Continue Work in Russia in Years to Come

(7/30, The Pharma Letter) ...US pharma giant Pfizer has criticized the recent inclusion of the company in the list of enterprises that should be denied access to the Russian market due to "unfriendly" actions, The Pharma Letter's local correspondent reports...An official spokesman of Pfizer said in an interview with the Russian RBC business paper, that the company did not suspend its activities in Russia and continues the supplies of drugs to local patients. "Pfizer has been providing uninterrupted supplies of drugs to patients in Russia for all these years," the company said... Sub. Req’d

Russia Experiencing Sharp Growth in Sales of Drugs Against Alcoholism

(7/29, The Pharma Letter) ...Russia is currently experiencing a strong increase in the sales of drugs against alcoholism, as the number of citizens, who suffer from alcohol addiction has significantly increased since 2022, reports The Pharma Letter's local correspondent...Russian analysts believe the growth of sales of drugs against alcoholism is mainly explained by a high level of inflation in Russia these days and a shift in demand to more expensive analogues... Sub. Req’d

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