Wednesday, April 30, 2025

TEV ‘749 Survey Shows Many Nurses Prefer Intramuscular Injections, with Andrew Cutler, MD

(4/29, Andrew Cutler, MD., HCPLive) ...HCPLive spoke with SOLARIS investigator Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University and chief medical officer at Neuroscience Education Institute, about Teva's prospective, cross-sectional, observational, online study completed by 70 patients, 11 physicians, and 24 nurses who reported their attitudes on and experiences with LAI treatment, delivery of care, and treatment satisfaction. Cutler discussed the drivers behind the high satisfaction, unexpected findings, and what are the next steps for advancing TEV- ‘749 toward regulatory approval... Full

GSK 'Well Positioned' for Potential Tariffs After Beating Forecasts

(4/30, Pushkala Aripaka, Maggie Fick, Reuters) ...GSK reaffirmed its 2025 outlook and said it was "well positioned" to absorb potential U.S. pharmaceutical tariffs, after reporting stronger-than-expected first-quarter results...GSK said it had identified options within its supply chain and productivity initiatives to mitigate any hit from pharmaceutical tariffs, but did not provide details... Full

Incyte Expects Minimal Tariff Hit, Lifts Blood Cancer Drug's 2025 Forecast

(4/29, Kamal Choudhury, Reuters) ...Incyte Corp raised the annual sales forecast for its blood cancer drug Jakafi on Tuesday, and said it expects minimal impact from U.S. tariffs due to its flexibility in sourcing supplies. CEO Hervé Hoppenot credited the drugmaker's tariff resilience to its "dual sourcing" strategy, which allows it to make key products in the U.S. or Europe, in a conference call with analysts... Full

Sandoz Reports First-Qtr 2025 Net Sales Growth of 3%

(4/20, The Pharma Letter) ...Net sales of generics for the first quarter amounted to $2,480 million, also up 3%. Volume contributed six percentage points of growth, partly offset by price erosion of three percentage points. Biosimilars net sales were $671 million, reflecting growth of 11% (+14% on a CGR basis). Biosimilars represented 27% of total net sales in the quarter...Sandoz explained that the only tariffs applicable to the company, as part of recent implementation from the US government, is a total 20% China tariff, implemented on March 4, 2025, and a tariff on any medicines coming from Canada but outside the scope of the United States-Mexico-Canada Agreement... Sub. Req’d

Sandoz Inks License Agreement with Henlius for Yervoy Biosimilar

(4/29, Sandra Levy, Drug Store News) ...Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the United States. The core sequence patent for ipilimumab expired in March 2025 in the United States and will expire no later than February 2026 in the EU... Full

Novo Moves Past GLP-1 Spat with Hims & Hers, Tapping Telehealth Company to Offer Discounted Wegovy

(4/29, Andrea Park, Fierce Pharma) ...The companies announced Tuesday that brand-name Wegovy will now be available through the Hims platform beginning this week. A $599 bundled monthly subscription will give self-pay members access to Hims & Hers' 24/7 clinical support and nutritional guidance, plus prescriptions for all doses of Wegovy for weight management via the drugmaker's NovoCare Pharmacy... Full

Regeneron's Eylea Franchise Suffers Double Whammy with Sales Decline and Surprise FDA Rejection

(4/29, Fraiser Kansteiner, Fierce Pharma) ...Over the first three months of 2025, Regeneron's sales from the Eylea franchise—approved in a range of retinal conditions like macular degeneration and diabetic retinopathy—fell 26% versus 2024's first quarter, the company said in a Tuesday press release. Overall, the franchise generated $1.04 billion during the quarter...Meanwhile, Regeneron's newer and higher-dose version of the eye med, Eylea HD, grew U.S. sales 54% over the same period in 2024 to $307 million. Still, those gains weren't enough to offset a significant sales decline for the franchise overall between January and March... Full

Gland Pharma Receives USFDA Approval for Latanoprostene Bunod Ophthalmic Solution

(4/30, Business Standard) ...The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024%, of Bausch and Lomb, Inc...Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity... Full

Strides Pharma's US Arm Acquires Four Drugs to Bolster Portfolio

(4/30, Business Standard) ...Strides Pharma Science said that its step-down wholly owned subsidiary in the US, Stride Pharma Inc, has acquired four approved ANDAs for the US Market from Nostrum Laboratories, Inc., USA. The portfolio consists of liquids and immediate release solid orals which are in the therapeutic segment to treat infections associated with UTIs (Urinary Tract Infections), Pain Management, Allergy Symptoms and Attention Deficit Disorder (ADD/ ADHD) and Narcolepsy... Full

Samsung Bioepis Wins US Lawsuit, Securing Sales for Stelara Biosimilar Fizzchiva

(4/30, Heo Ji-yoan, ChosunBiz) ...Samsung Bioepis won a lawsuit against Johnson & Johnson (J&J), the parent company of Janssen, the original developer of the autoimmune disease treatment Stelara. According to the industry on the 30th, the U.S. District Court for New Jersey dismissed J&J's motion for a preliminary injunction regarding Samsung Bioepis's sale of the Stelara biosimilar Fizzchiva on the 28^th... Full

Novartis Again Beats MSN Push to Launch Entresto Copy Early

(4/29, Christopher Yasiejko, Bloomberg Law) ...During Tuesday's hearing, Christina Schwarz of Venable LLP, representing Novartis, rejected any parallels drawn between the Entresto delisting dispute and Teva Pharmaceutical Industries Ltd.'s failed effort to preserve Orange Book listings for its ProAir HFA inhaler patents in a clash with Amneal Pharmaceuticals Inc. Teva vowed to appeal its loss to the US Supreme Court. "Our case certainly is nothing like the facts in Teva," Schwarz said. "And Teva did not claim any active ingredients at all."... Sub. Req’d

Sanofi, Novartis Face Skeptical Judge On Drug Rebate Model Plan

(4/29, Nyah Phengsitthy, Bloomberg Law) ...Sanofi SA, Novartis AG, Bristol Myers Squibb Co., Eli Lilly & Co., and health tech company Kalderos Inc., sought to convince Judge Dabney L. Friedrich of the US District Court for the District of Columbia that the US Health Resources and Services Administration acted unlawfully when it rejected proposals from drugmakers to discount medicines through a rebate model rather than up front to covered entities under the federal 340B Drug Pricing Program... Sub. Req’d

Targeted Therapies Transform CLL Care: Inside the Era of BTK and BCL-2 Inhibitors

(4/29, Alexandra Gerlach, Pharmacy Times) ...Experts at the Community Oncology Alliance 2025 Community Oncology Conference discussed the treatment of CLL with BTK and BCL-2 inhibitors, focusing on key points including the importance of patient selection based on genetic mutations; current treatment options with emphasis on their efficacy and adverse effects (AEs); and the role of pharmacists in managing these therapies... Full

Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships

(4/29, Skylar Jeremias, The Center For Biosimilars) ...Sharing insights from across the biosimilar pipeline, panelists included Michael Sarshad, managing director and biosimilar lead at Syneos Health Consulting; Haoheng (Sandy) Yen of Henlius USA; Sean McGowan, senior vice president of biosimilars and oncology at Amneal Pharmaceuticals; and Sujay Singh, CEO of Sujan Biologics... Full

GLP-1 Medications Continue to Increase Market Growth | Asembia 2025

(4/29, Ashley Gallagher, Drug Topics) ...The pharmaceutical industry is experiencing major transformation, driven by breakthrough glucagon-like peptide-1 (GLP-1) medications, the evolving biosimilar landscape, and complex regulatory changes that are challenging traditional health care delivery models, according to Doug Long, vice president of industry relations at IQVIA, in a session at Asembia's AXS25 Summit... Full

Understanding the Use of Medicines in the U.S. 2025

(4/30, IQVIA) ...Areas of focus in this year's report range from looking at how medicine usage patterns have shifted, to the impact of out-of-pocket costs and benefit designs on patients, to the complex nature of drug pricing. Dynamics that have become apparent during 2024 have driven significant revisions to the outlook, and in this report the drivers of change in medicine spending over the next five years are deconstructed to enable better understanding. This examination includes the impact of novel obesity and diabetes medicines which have been significant drivers of growth, and the uptake of other novel medicines expanding into new patient populations and becoming established as backbone therapies... Full

GLP-1s Can Help Employers Lower Medical Costs in 2 Years, New Study Finds

(4/20, Bertha Coombs, CNBC) ...Aon researchers found that within two years, improved health outcomes for patients who were taking GLP-1 drugs lowers the cost of medical care for them and their employers by as much as 13% for the most adherent patients...Since 2023, GLP-1s have driven up employer spending on drugs at a faster pace than high-priced specialty drugs used to treat cancer and autoimmune conditions, according to an Evernorth study... Full

AstraZeneca, Novartis Execute ‘US for US' Strategy as Pharma Tariffs Near

(4/29, Anna Brown, Endpoints News) ...With the industry on tenterhooks on what the pharma-specific tariffs may look like, AstraZeneca and Novartis said Tuesday that their local production capacity will be key in sidestepping these levies. "Our goal, as I mentioned, is to have 100% of our products produced in the US for the US," Novartis CEO Vas Narasimhan said during its first-quarter earnings call with the media Tuesday. "And we do have a little bit of a lower mix at the moment, but that, again, is something we believe is manageable," he added... Sub. Req’d

Novartis CEO Brushes Off Tariffs But Says Trump Pricing Controls Would Be ‘Devastating'

(4/29, Annalee Armstrong, BioSpace) ...Vas Narasimhan said on Tuesday that if the U.S. adopts international drug pricing, all companies would have to "relook at their medium- to long-term outlook."...Speaking on Novartis' first quarter earnings call Tuesday morning, Narasimhan said the "Most Favored Nations" rule "would be devastating to the industry." Trump unsuccessfully attempted to raise the policy in his first term, but he recently revisited the idea, suggesting he may try to match U.S. drug prices to other nations where the products are cheaper... Full

Pfizer CEO Says Tariff Uncertainty is Deterring Further U.S. Investment in Manufacturing, R&D

(4/29, Annika Kim Constantino, NBC News) ...Pfizer CEO Albert Bourla on Tuesday said uncertainty around President Donald Trump's planned pharmaceutical tariffs is deterring the company from further investing in U.S. manufacturing and research and development. Bourla's remarks on the company's first-quarter earnings call came in response to a question about what Pfizer wants to see from tariff negotiations that would push the company to increase investments in the U.S. It comes as drugmakers brace for Trump's levies on pharmaceuticals imported into the country — his administration's bid to boost domestic manufacturing... Full

Pfizer CEO Bourla Suggests Pharma Tariffs Will Focus On US Adversaries, Not Allies

(4/29, Max Bayer, Endpoints News) ...Speaking during the company's quarterly earnings call, Bourla said he was "cautiously optimistic" that any findings from the White House's ongoing Section 232 investigation into pharmaceutical products would focus on imports from countries that are an actual national security risk, as opposed to allies. His read comes from conversations with the White House and associated staff, he told investors...A White House official reached for comment told Endpoints that it's too early to say what the outcome of the investigation will be... Sub. Req’d

Aragen's CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

(4/29, Vibha Ravi, Pink Sheet) ...Aragen's CEO Manni Kantipudi, who is keenly watching the Trump Administration's moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma's US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview... Global Sub. Full

US Tariffs Likely to Disrupt Drug Development Costs and Prices, Says GlobalData

(4/30, Pharmaceutical Technology) ...While the pharmaceutical industry is currently exempt from US tariffs, there is an increased risk to the stability of the pharmaceutical supply chain. With US President Donald Trump leaning towards implementing additional tariffs on the pharmaceutical sector, there is potential to disrupt drug development costs and drug prices, with any tariffs increasing the import costs of many raw materials and active pharmaceutical ingredients, according to GlobalData, a leading data and analytics company... Full

ICER To Compare Effectiveness, Value Of GLP-1s For Obesity

(4/29, Luke Zarzecki, Inside Health Policy) ...The Institute for Clinical and Economic Review (ICER) announced Tuesday (April 29) it will compare the clinical effectiveness and value of Eli Lilly's subcutaneous tirzepatide and Novo Nordisk's subcutaneous and oral semaglutide in treating obesity and examine how the treatments impact obesity-related outcomes... Sub. Req’d

Is Taking Fewer Medications the Key to Lowering Drug Costs in the U.S.?

(4/30, Berkeley Lovelace Jr., NBC News) ...In recent weeks, top health officials have floated an idea for bringing down prescription drug costs in the United States: getting Americans to take fewer medications. Health policy experts say that while the goal is reasonable, the approach places too much blame on patients and overlooks key issues with drug pricing... Full

USTR 2025 Special 301 Report Corrects Course

(4/29, Ernest Kawka, PhRMA) ...This year's Special 301 Report is significant given the Administration's focus on eliminating unfair and non-reciprocal trade practices abroad. The report returns to its statutory purpose to address the significant IP and market access challenges faced by biopharmaceutical innovators abroad that had been abandoned by the previous Administration... Full

US FDA Chief Says Firings Won't Hinder Agency's Target Dates for Drug Reviews

(4/29, Manas Mishra, Reuters) ...The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the agency under the Trump administration, its chief said. In an interview posted on a prominent industry blog, FDA commissioner Martin Makary also said there were no plans for major reorganization at the agency, unlike those planned by Health and Human Services Secretary Robert F. Kennedy Jr. at its other health counterparts... Full

Makary: No Major Reorg Plans For FDA, No Interference From RFK Jr.

(4/29, Jessica Karins, Inside Health Policy) ...There will be no significant reorganization of FDA along the lines of those being eyed for other major HHS agencies, FDA Commissioner Marty Makary said in a recent interview, also asserting that he makes final decisions on FDA approvals and regulations without interference by HHS Secretary Robert F. Kennedy Jr. Makary said he rejected a sweeping proposal that Inside Health Policy recently reported would have merged the agency's review centers into one... Sub. Req’d

Exclusive: In Conversation with FDA Commissioner Dr. Marty Makary.

(4/29, Jeremy Faust, MD., Inside Medicine) ...Dr. Makary—who preceded me as editor-in-chief of MedPage Today—kindly agreed to an exclusive conversation (which took place via two phone calls and follow-up emails) to address the issues raised and related topics, to provide his impressions of the early days of his tenure, and to share his vision for the agency...Among other things, Dr. Makary breaks some news here by stating, for the first time, that there will be no significant reorganization at the FDA, like those proposed for other HHS agencies... Full

Nessel Sues 2 of Nation's Largest Prescription Drug Middlemen for Price Fixing

(4/29, Dustin Walsh, Crain's Detroit Business) ...In a lawsuit against St. Louis-based Express Scripts and Eagan, Minn,-based Prime Therapeutics in U.S. District Court in Michigan, Michigan Attorney General Dana Nessel alleges the PBMs fixed prices for medications and structured low reimbursement rates for independent pharmacies, leading to mass pharmacy closures across the state... Sub. Req’d

States Act On PBM Laws While Congress Idles

(4/30, Lauren Berryman, Modern Healthcare) ...For the first time, pharmacy benefit manager parent companies including CVS Health, Cigna and UnitedHealth Group must decide between running moneymaking PBMs or patient-facing pharmacies in a state. The law is already serving as a blueprint for future policy in other states, and industry responses could foreshadow what's to come...If these policies proliferate or are imposed nationally, it would trigger a major reorganization of the healthcare sector... Sub. Req’d

NGOs Warn of Big Pharma's Influence On EU Drug Reform

(4/29, Gerardo Fortuna, Euronews) ...Three large NGOs signalled concern on Monday that Big Pharma is seeking to impact reforms of the EU drug framework by persuading the European Commission to introduce new incentives to support innovation amid growing global trade tensions...According to meeting minutes obtained by Euronews, discussions among EU diplomats on Monday touched on security of supply, parallel trade, and innovation, but the thorny issue of regulatory protection was not explored in detail. Following a meeting with Commission President Ursula von der Leyen, pharmaceutical industry CEOs reiterated calls for stronger intellectual property protections... Full

Australia's CSL Evaluates China Tariff Exemptions for its US-Made Drugs

(4/30, Andrew Silver, Reuters) ...Australia's CSL Ltd said it's evaluating whether its drugs used in surgery would be exempted from 125% tariffs China imposed on U.S.-made goods, as it seeks to minimise impact of a trade war between Beijing and Washington... Full

China Still Go-To Source for New Drugs Despite Tariff Minefield

(4/30, Annalee Armstrong, BioSpace) ..."You should go where the best assets are and if equally good assets are available at a lower price, you go where the science is," Sam Fazeli, director of research for Global Industries and senior pharmaceuticals analyst at Bloomberg Intelligence, told BioSpace. According to GlobalData, large pharma in-licensed 28% of innovative drugs from Chinese biopharma companies in 2024, hitting a record high. Values for these transactions rose 66% from $16.6 billion in 2023 to $41.5 billion a year later. Looking at just the U.S. licensing deals with Chinese firms, GlobalData found that total deal value rose from $15.7 billion in 2023 to $21.3 billion in 2024... Full

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