Tuesday, April 29, 2025

Glenmark's UK Dapagliflozin Blocked On Appeal After Teva Readied Launch

(4/29, Dean Rudge, Generics Bulletin) ...Glenmark's advantage for its UK generic version of AstraZeneca's Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief...Ultimately, in reversing the initial refusal of an injunction, the Court of Appeals found that damages would not be an adequate remedy, having considered new evidence revealing Teva was gearing up for an ‘at-risk' launch of its own generic dapagliflozin product. A letter from Teva's solicitors dated March 30, "made the point that, since Teva did not have sight of whether Glenmark was in fact ready to launch its product, Teva contended that it had ‘first mover advantage'," the court noted... Global Sub. Full

Sandoz CEO Slams EU Wide Drug Price Proposal, Warns US Tariffs Will Hurt Patient Access

(4/28, Maggie Fick, Reuters) ...Richard Saynor told Reuters that the proposal - outlined in a letter to the Financial Times last week - ignores structural drivers of high drug prices in the United States. "It made me smile, made me laugh," Saynor said of the proposal, adding that he thinks the Trump administration will succeed in driving down prices for brand-name medicines. But he said big pharmaceutical companies should not respond by hiking prices in Europe, which would hurt patient access... Full

Hikma Doubles Down On 2025 Guidance Despite Tariff Anxiety And Injectables Competition

(4/28, Adam Zamecnik, Generics Bulletin) ...Hikma Pharmaceuticals has doubled down on its previous financial guidance for 2025 despite ongoing questions surrounding the impact of tariffs imposed by the Trump administration on global trade and increased competition in the injectables sector. Overall, the pharmaceutical player continues to expect the group's revenue to rise by between 4% to 6% – up from $3.127bn in 2024 – with core operating profit forecasted to range between $730m and $770m... Global Sub. Full

Iconovo Slims Down As It Focuses On Commercialization

(4/29, Dave Wallace, Generics Bulletin) ...As Iconovo moves from the development stage to commercialization of its generic inhaled products, the Swedish firm has set out plans to cut costs by reducing its headcount, citing a reduced need for product development resources. Iconovo – which develops inhaled generic medicines based on proprietary inhalers and dry powder formulations – said it was "planning an organizational change that is expected to reduce the cost base by approximately SEK14m-SEK16m ($1.45m-$1.66m) on an annual basis from the third quarter of 2025."... Global Sub. Full

Novartis Posts Better-Than-Expected First-Quarter Sales, Raises Full-Year Guidance

(4/29, Karen Gilchrist, CNBC) ..."Even in this I think complex geopolitical environment, we feel confident we can deliver now this upgraded guidance," CEO Vas Narasimhan told CNBC's "Squawk Box Europe" on Tuesday. Sales continued to be driven primarily by the company's blockbuster heart-failure drug Entresto and arthritis medication Cosentyx. However, Narasimhan highlighted growing demand for its Kisqali breast cancer treatment, Kesimpta multiple schlerosis medication and Leqvio cholesterol drug... Full

WuXi AppTec Sees Growth After 2024 Dip, Plans ‘Lean' Operations to Temper ‘External Opportunities'

(4/28, Anna Brown, Endpoints News) ...WuXi AppTec's revenue rose for the first few months of 2025, signaling that pressures from the proposed Biosecure Act may be subsiding even as the threat of pharma tariffs remains. The CDMO pulled in 21% more revenue for the first three months of 2025, reporting a revenue of 9.65 billion yuan ($1.32 billion), compared to the 7.63 billion yuan ($1 billion) reported for the same period last year... Sub. Req’d

Pfizer Beats Profit Estimates On Cost Cuts, Heart Drug Sales

(4/29, Bhanvi Satija, Christy Santhosh and Michael Erman, Reuters) ...U.S. drugmaker Pfizer reported first-quarter profit above Wall Street estimates on Tuesday, helped by cots cuts and better-than-expected sales of its heart disease drug, Vyndaqel...Investors are closely watching for any potential impact on Pfizer's vaccine business and any changes to recommendations for receiving flu, COVID and other shots under the new health secretary Robert F Kennedy Jr., a longtime vaccine skeptic. Pfizer and other drugmakers are also at risk of proposed hefty duties on trade partners such as China, which is a key source of raw ingredients and supplies for the pharmaceutical and medical device industries... Full

AstraZeneca Sales, Earnings Rise; Warns of Mounting Legal Challenges in China

(4/29, Helena Smolak, The Wall Street Journal) ...The British pharmaceutical giant said Tuesday that its core earnings per share--the company's preferred metric, which strips out exceptional and other one-off items-- increased to $2.49 from $2.06 the prior-year period. Total revenue rose 10% at constant currency to $13.59 billion. In its oncology segment--the drugmaker's top business--revenue grew 13% to $5.64 billion, accelerated by demand for lung cancer drug Tagrisso and its treatment Imfinzi. Revenue in China rose 3% to $1.805 billion... Sub. Req’d

AstraZeneca Posts Another Truqap Study Fail, Says China Import Tax Could Triple

(4/29, Elizabeth Cairns, Endpoints News) ...AstraZeneca CEO Pascal Soriot said on a media call that the company still believes Truqap's potential sales could be in the $1 billion to $3 billion range. "We still believe Truqap has potential, but of course, having missed on this prostate study, the potential will be smaller," he said...Elsewhere, AstraZeneca said the unpaid tax bill it is facing in China would be larger than it had previously thought — meaning the fine authorities can impose could be bigger still...And Soriot said there were no concerns so far that cuts to the US regulator would affect the approval timelines of AstraZeneca's products, as has happened to Stealth BioTherapeutics' rare disease drug... Sub. Req’d

Celltrion and Samsung Bioepis Intensify Korean Biosimilar Race for Keytruda

(4/29, Lee Han-soo, Korea Biomedical Review) ...Keytruda (ingredient: pembrolizumab), developed by U.S. pharmaceutical company Merck, known as MSD outside North America, is a third-generation immune checkpoint inhibitor used to treat a wide range of cancers, including non-small cell lung cancer (NSCLC), melanoma, and head and neck cancers...Among Korean contenders, Celltrion gave the most recent update, stressing that it has received approval from the Ministry of Food and Drug Safety to initiate a phase 3 clinical trial of its Keytruda biosimilar candidate CT-P51 on Monday. The trial will enroll 606 patients with metastatic non-squamous NSCLC who have not received prior systemic therapy... Full

Roche Suggests Perjeta Biosimilars May Not Hit Until 2027 ‘Or Later'

(4/29, Dean Rudge, Generics Bulletin) ...Roche says the potential for biosimilar competition to its Perjeta (pertuzumab) blockbuster HER2 inhibitor for breast cancer is "not a threat that we're super worried about right now," considering the lack of proposed rivals in late-stage development or filing. Meanwhile, the Swiss originator is not expecting biosimilars to launch until "the end of 2027 or later," after would-be biosimilar sponsor Organon earlier revealed plans to begin launching as early as 2026... Global Sub. Full

AACR: Boehringer Ingelheim Proves Durability of 'Unparalleled' HER2-Mutant Lung Cancer Candidate

(4/28, Zoey Becker, Fierce Biotech) ...Boehringer Ingelheim unveiled new data from its top oncology prospect zongertinib, further backing the drug's prowess in previously treated patients with advanced non-small cell lung cancer (NSCLC) who have the relatively rare human epidermal growth factor receptor 2 (HER2)- mutations within the tyrosine kinase domain (TKD)... Full

Merck to Invest $1 Billion in New Delaware Plant to Boost US Manufacturing

(4/29, Mariam Sunny, Reuters) ...U.S. drugmaker Merck said on Tuesday it is investing $1 billion in a new Delaware plant to expand domestic production as it prepares to deal with President Donald Trump's tariffs. The new facility will produce biologic drugs and Keytruda, becoming Merck's first in-house U.S. site to make the blockbuster cancer treatment, the company said...The company expects labs at the new facility to be fully operational by 2028 and produce experimental drugs by 2030... Full

Neurocrine Sues Zydus to Guard Ingrezza's New Sprinkle Form

(4/28, Christopher Yasiejko, Bloomberg Law) ...Neurocrine filed suits on April 25 in both the District of Delaware and District of New Jersey accusing Zydus of infringing the patents with its generic versions of the sprinkled-granules formulation of valbenazine, Ingrezza Sprinkle's active ingredient. The suit belongs in Delaware, Neurocrine said, adding that it also filed the New Jersey complaint "out of an abundance of caution."... Sub. Req’d

Sandoz, Aurobindo Get Another Mixed Ruling in Price-Fixing Case

(4/28, Katie Arcieri, Bloomberg Law) ...Aurobindo Pharma Ltd., Sandoz Inc. and other pharma companies will confront some state antitrust and consumer-protection allegations that they conspired to fix generic drug prices after a federal judge allowed certain claims to move forward while dismissing others. Judge Michael P. Shea of the US District Court for the District of Connecticut in an April 25 order denied the pharma companies' motion to dismiss state-law claims brought by states including Arkansas, Florida, Colorado, Connecticut, Kentucky, and Virginia. However, he dismissed some claims brought by other states, including Rhode Island, Wisconsin and Alaska... Sub. Req’d

Asembia 2025: The Specialty Pharma Pipeline

(4/28, Nicholas Saraceno, PharmExec.com) ...Being led by Brad McElya, PharmD, Walgreens' senior director of clinical pharmacy strategy, the goal of the session was to investigate the top trends pertaining to specialty drug and therapy development, with a closer look at drug development landscape. "At the core of this discussion is patient care and innovation, and I believe the pipeline offers hope for patients with rare and common, debilitating diseases, signaling progress or we still have opportunities to make difference in patients' lives," he said... Full

Aurobindo Pharma Reports Fire in Andhra Unit; Operations Paused for 20-25 Days

(4/28, Jomy Jos Pullokaran, CNBC TV-18) ...Drug firm Aurobindo Pharma Limited on Monday (April 28) said it has reported a fire incident on April 27, 2025, at its penicillin-G manufacturing facility in Kakinada SEZ, Andhra Pradesh...The company clarified that the incident is not expected to have a material impact on its operations or financials. A thorough assessment of the damage is currently underway. As a precautionary measure, operations at the plant will be temporarily paused for an estimated period of 20-25 days to facilitate equipment replacements... Full

The End of Compounded GLP-1 Copies Leaves Many Patients in a ‘Lose-Lose' Position

(4/29, Katie Palmer and Elaine Chen, STAT+) ...Blockbuster obesity and diabetes drugs — such as Wegovy, Ozempic, and Mounjaro — are no longer deemed by regulators to be in shortage, so compounding pharmacies and the telehealth companies they work with must stop offering copies of the treatments. Now, hundreds of thousands of patients are stuck navigating uncharted waters as companies they entrusted with their health pursue strategies that may disrupt their care or present risks. Businesses are changing prescriptions, mixing in additives, or encouraging stockpiling of existing compounded products. Some have disappeared altogether... Sub. Req’d

Citing Health Costs, Democratic States Sue Trump Over Tariffs

(4/28, David LaRoss, Jessica Karins, Inside Health Policy) ...A dozen states with Democratic attorneys general have filed suit over President Donald Trump's use of the International Economic Emergency Powers Act (IEEPA) to enact new tariffs on U.S. trading partners as health care stakeholders worry the tariffs could significantly increase costs for hospitals, manufacturers and other stakeholders. The AGs are charging that even if IEEPA authorizes tariffs, the White House is breaking the law by using that power "arbitrarily."... Sub. Req’d

Nvidia, Eli Lilly Among CEOs to Tout US Investments With Trump

(4/28, Stephanie Lai, Bloomberg) ...Chief executive officers from Nvidia Corp., Johnson & Johnson, Eli Lilly & Co., General Electric Co. and SoftBank Group Corp. are among corporate leaders slated to visit the White House on Wednesday as President Donald Trump highlights the US investments they've announced in the first 100 days of his second term in office... Sub. Req’d

AstraZeneca 'Firmly Committed' To US Amid Tariff Threat

(4/29, AFP) ...British pharmaceutical giant AstraZeneca on Tuesday vowed to keep investing and growing its business in the United States, ahead of President Donald Trump's possible tariffs on the sector. "Our company is firmly committed to investing and growing in the US," chief executive Pascal Soriot said in an earnings statement, which also announced that first quarter profit had risen by over 30 percent to $2.92 billion... Full

Daiichi Sankyo Says Production Boost in US Will Help Cushion Tariff Impact

(4/28, Anna Brown, Endpoints News) ...Daiichi Sankyo has reiterated that its earlier plans to expand ADC manufacturing in the US, including for its blockbuster drug Enhertu, will help alleviate some pressure from President Donald Trump's looming pharma-specific tariffs...Once the pharma tariffs are announced, Daiichi will conduct a "full review and study" of its supply chains, Okuzawa said, according to an AlphaSense transcript. If it needs to, instead of moving operations over to the US for Enhertu, it has the option to expand local capacity as demand picks up, he added... Sub. Req’d

Tariff War Draws Investment Warning From $160 Billion Novo Fund

(4/28, Frances Schwartzkopff, Bloomberg Law) ...The $160 billion fund behind Ozempic-maker Novo Nordisk A/S says President Donald Trump's tariff war has created so much economic uncertainty that it now sees little likelihood it will move ahead with any big investments. "Until there is more clarity on the prospects for economic growth, we will slow down our investment activities," Kasim Kutay, chief executive officer of Novo Holdings, said in an interview. "We're in the midst of uncharted waters."... Sub. Req’d

Editorial: Trump's Good-Bad Pharma Agenda

(4/28, The Wall Street Journal) ...If the President wants to reduce drug prices while boosting U.S. investment and innovation, he could follow his successful first-term playbook: Ease regulation, cut taxes and accelerate approvals. And drop the tariffs... Sub. Req’d

New House Bill Would Cut Tax Deductions Pharma Companies Receive for Ads

(4/28, Zachary Brennan, Endpoints News) ...A bipartisan piece of legislation proposed this week would prohibit pharma companies from receiving tax deductions for direct-to-consumer drug advertising, a bill that could generate savings to offset the cost of a separate measure to change the IRA's "pill penalty."..."This legislation ensures that resources are directed towards lowering drug costs and investing in the research and development of new, life-saving treatments," Murphy said... Sub. Req’d

FDA Delays PDUFA Date for Small Biotech, Raising Questions About Impact of Agency Cuts

(4/29, Max Gelman, Endpoints News) ...A person familiar with the situation said the company hadn't been asked to run more trials or provide more data, that the FDA hadn't identified any safety concerns, and that the agency hadn't raised manufacturing issues - typical reasons for why it might reject a drug... Sub. Req’d

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie's Big ADC Bet

(4/28, Bridget Silverman, Pink Sheet) ...The US Food and Drug Administration's prescription drug user fee goal date calendar for May may be overshadowed by the May 31, goal date for Moderna's next-generation COVID-19 vaccine, given a resurgent atmosphere of mistrust of vaccines. But the agency also will act on diverse products including AbbVie's antibody-drug conjugate, Alcon's novel dry eye disease drug, a major new indication for GlaxoSmithKline's anti-interleukin-5 antibody, and Spyre/Immedica's recombinant enzyme therapy for a rare urea cycle disorder... Global Sub. Full

Bill Regulating Pharmacy Benefit Managers Passes Iowa Senate

(4/28, Robin Opsahl, Iowa Capital Dispatch) ...The legislation would set new regulations for PBMs, including requiring pharmacies to be reimbursed for the national or state average acquisition cost of a drug — a higher reimbursement rate than many pharmacies are currently receiving, according to several workers and owners of current rural pharmacies... Full

High US Tariffs On China to Propel India's Domestic API Ecosystem & Speed Up Generic Drug Global Contracts

(4/29, Nandita Vijayasimha, Pharmabiz.com) ...If the US tariffs primarily target Chinese pharmaceutical products especially APIs and generics, Indian companies could gain short-term advantages. Indian exporters like Sun Pharma, Dr. Reddy's, Cipla, and Lupin could see a boost in orders as US buyers diversify away from China. The US heavily depends on low-cost generics, a segment where Indian companies are strong. Tariffs could accelerate generic drug contracts for Indian firms, Shashank Silhare told Pharmabiz in an email... Full

China Asks Drugmakers, Hospitals to Find US Import Substitutes

(4/29, John Liu, Bloomberg) ...China has asked some of its state-owned drugmakers to study how they can reduce reliance on the US for pharmaceutical products and raw materials, people familiar with the matter said, as Beijing prepares for a potential decoupling that threatens its medical supply... Sub. Req’d

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