Tuesday, April 1, 2025

Latest Teva Data in Schizophrenia for Long-Acting Injectable of Olanzapine

(4/1, The Pharma Letter) ..."Schizophrenia is an incredibly complex condition with profound impacts on mental health and daily life. That's why understanding the treatment perspectives of patients and healthcare providers is integral to Teva's research, and these survey results underscore the personal approach we've taken with the development of TEV-'749," said Dr Eric Hughes, executive vice president, global R&D and chief medical officer at Teva... Sub. Req’d

Medincell's Partner Teva Presented Phase 3 Survey Results Demonstrating Patient and Healthcare Professional Satisfaction with Olanzapine LAI

(3/31, Medincell) ...Teva is currently preparing for regulatory submission and launch of Olanzapine LAI, with long-term full safety data expected to be released in Q2 2025 and an NDA submission anticipated in H2 2025. UZEDY®, the other drug, was approved by the US FDA in April 2023... Full

Teva Provigil ‘Pay For Delay' Fines Should Stand, AG Says

(4/1, Dave Wallace, Generics Bulletin) ...Teva should not be able to overturn European fines imposed over a historical "pay-for-delay" arrangement covering Cephalon's Provigil (modafinil), an advocate general of the CJEU has recommended..."In support of their appeal, the appellants raise two grounds of appeal," Rantos acknowledged, including supposed errors of law by the General Court in applying the test to establish the existence of a restriction of competition by object, and in examining the anti-competitive effects of the settlement agreement... Global Sub. Full

What's Next? Five Things To Look Out For In April

(4/1, Dean Rudge, Generics Bulletin) ...Teva is set to complete this month the divestment of Teva Takeda, its joint venture with Takeda Pharmaceutical in Japan, as it seeks to focus on bringing innovative medicines to the Japanese market...Alvotech and Teva's Selarsdi (ustekinumab-aekn) US biosimilar to Stelara will be granted full interchangeable status with the reference product from April 30, following the expiry of exclusivity previously handed to Amgen's Wezlana (ustekinumab-auub)... Global Sub. Full

Accord's Denosumab Biosimilars Get Thumbs-Up From EMA

(3/31, Dave Wallace, Generics Bulletin) ...Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA's CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin... Global Sub. Full

Richter Confirms European Tocilizumab Filing

(3/31, Generics Bulletin) ..."The submission of the tocilizumab biosimilar to the EMA is yet another milestone in building Richter's affordable medicines portfolio," commented Erik Bogsch, head of the firm's biotechnology business unit. "This biosimilar - when approved - will provide access to a broad range of our patients in Europe to this important biological drug."... Global Sub. Full

First-Line Acalabrutinib Plus BR Receives CHMP Recommendation for Mantle Cell Lymphoma

(3/31, Jax DiEugenio, OncLive) ...The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of acalabrutinib (Calquence) in combination with bendamustine and rituximab (Rituxan; BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not candidates for autologous stem cell transplant... Full

European Commission Approves Pfizer's RSV Vaccine for Adults at Increased Risk of Disease

(4/1, Maggie Fick, Reuters) ...The European Commission approved Pfizer's respiratory syncytial virus vaccine for the prevention of lower respiratory tract disease caused by RSV in adults aged 18 to 59 at increased risk of the disease, the company said on Tuesday. The expanded EU approval, applicable in all 27 countries of the bloc, is for Pfizer's Abrysvo vaccine, which was backed by the European Medicines Agency's panel of experts in March... Full

Alembic Pharma Receives USFDA Final Approval for Pantoprazole Sodium Injection

(4/1, Business Standard) ...The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Protonix I.V. for Injection, of Wyeth Pharmaceuticals LLC. Pantoprazole sodium for injection is indicated for the treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. It is also indicated for the treatment of pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome in adults... Full

Axsome's Depression Treatment Fails to Meet Main Goal of Late-Stage Study

(4/1, Mariam Sunny, Reuters) ...Axsome Therapeutics said on Tuesday its experimental drug to treat major depressive disorder failed to meet the main goal of a late-stage study... Full

Eli Lilly Threatens Obesity Drug Copycat Makers After Shortage

(4/1, Nyah Phengsitthy, Bloomberg Law) ...Eli Lilly & Co. is targeting additional drug compounders and telehealth companies that make copycat versions of its weight loss drug, with plans Tuesday to file two lawsuits and send about fifty cease-and-desist letters. The company is demanding that the compounders and telehealth companies stop mass producing its blockbuster drug tirzepatide—a diabetes and obesity treatment branded as Mounjaro and Zepbound... Full

Pharma's Reputation Would Improve if Drugmakers Offered Digital Health Services, Patients Say

(4/1, Andrea Park, Fierce Pharma) ...Nearly three-quarters of the more than 400 adults surveyed in January by ixlayer and Ipsos said they'd value help from drugmakers to eliminate the obstacles they face in accessing needed healthcare. Going even further, more than 80% agreed that pharmas should offer resources that make it easier to access care and treatments... Full

Exclusive: Pharma Industry Lobbies Trump for Phased Tariffs, Sources Say

(4/1, Maggie Fick and Michael Erman, Reuters) ...The four sources, who asked not to be named because discussions between the administration and industry have been confidential, said it is their understanding that Trump will not announce specifics on any pharma tariffs on Wednesday. Still, the largest multinational drug companies now expect U.S. tariffs targeting medical products are inevitable and hope to secure an incremental ramp-up to the 25% tariff the president has threatened, rather than 25% from day one, the four sources said. "The idea of incremental ramp up of tariffs, a sort of gradation if you will, is definitely out there from the pharma industry side," according to one of the sources... Full

Trump's Pharma Threats Take Tariffs Into Uncharted Territory

(4/1, Jennifer Duggan, Madison Muller and Naomi Kresge, Bloomberg) ...Protectionist policies will raise the prices of active ingredients for these producers, many of whom may have little recourse to return manufacturing to the US in the short term. Consumers are likely to feel the hit too, in the form of higher prices, potential shortages and financial strain on health care providers...One possibility is that tariffs will be determined by where a medicine's active pharmaceutical ingredient is made, rather than where the final product is assembled... Sub. Req’d

Mark Cuban Says Cost Plus Drugs Would Pass On Tariff Costs

(4/1, Jordan Hart, Business Insider) ...Although the pharmaceutical company is safe from President Donald Trump's tariffs on China, cofounder Mark Cuban said any potential tariff on goods imported from India would force Cost Plus Drugs to raise the price of its medications. "We won't have a choice," Cuban said during an appearance on the "Somebody's Gotta Win with Tara Palmeri" podcast...If India tariffs were implemented, he said, his company would be transparent with consumers about the cost of tariffs and broker fees and pass them "directly" on to customers. There would be no way for Cost Plus Drugs to "eat" the costs... Full

Reduce Drug Spending by Drastically Simplifying Monopolies On Drugs

(4/1, Alfred Engelberg, STAT) ...If Congress wants free and fair markets, it must use the tools available to create and maintain them. Otherwise, government-sponsored health insurance programs will lack sufficient financial resources to provide access to new lifesaving medicines. Senator Cassidy is right. If patients can't afford a new medicine, it may as well not exist... Full

Drivers Of Prescription Drug Costs And What Healthcare Leaders Can Do

(3/31, Danny Sanchez, Forbes) ...With a change of leadership in Washington, D.C., now is the time to address the nation's most serious challenges, particularly within the U.S. healthcare system. About eight in 10 American adults believe prescription drug prices are unreasonable, and the pressure is on for policymakers to address the problem...Given the PBM reform legislation introduced in Congress, I believe we may be rapidly approaching a point at which these recommendations will no longer be optional. It's time for the legacy PBM players to get on the reform bus now before they are forced to make these changes... Sub. Req’d

PBMs Must Prepare For Revival Of Drug Price Transparency Requirements

(3/31, Jill Drachenberg, Pink Sheet) ...PBM price transparency rules are not expected to fall away with President Trump wanting to ensure they are enforced. More legal wrangling over the rules may occur, but may be impacted by the broader PBM reform landscape. Experts said PBMs should become familiar with the transparency standards to prepare for data to be released... Global Sub. Full

The Preserve Access to Affordable Generics and Biosimilars Act: It's Back! And Bigger and Bolder Than Before!

(3/31, Kurt R. Karst, FDA Law Blog) ...While the focus of this post is S. 1096, we note that S. 1095 would authorize the Federal Trade Commission to initiate a civil action against any person or entity that submits a baseless petition to FDA with the intent that the Agency's review of the petition would delay the approval of a generic drug, a biosimilar biological product, or certain other new drugs... Full

What's Next After Marks? At FDA, Questions Over More Top Exits and Future Vision for Drug Agency

(3/31, Zachary Brennan, Endpoints News) ...There may be more exits coming soon. Scott Gottlieb, who served as FDA commissioner during the first Trump administration and is now a Pfizer board member, on Monday predicted on CNBC that more senior FDA officials would leave the agency within days...There could also be bigger changes to the structure at the FDA. In a note to investors on Monday, analysts at Cantor Fitzgerald hinted at a possible reorganization of the agency to combine the drugs and biologics centers, which operate separately... Full

Former FDA Officials, Experts Decry HHS Staff Cuts

(3/31, Joanne S. Eglovitch, Regulatory Focus) ...Robert Pollock, a senior advisor at Lachman Consultants, mentioned that project managers and consumer safety officers may be affected by the budget cuts, although the details are still unclear. These individuals serve as the primary point of contact for applicants regarding their applications. Pollock stated that for sponsors submitting new drug applications or new generic drug applications, these individuals are their first and only point of contact regarding their applications. He also noted that if this occurs, the review process could be significantly impacted... Full

Michigan Lawmakers Want to Lower Prescription Drug Prices with New Board

(3/31, Molly Birch, WLUC) ...Michigan Democratic senators are raising awareness of three bills aimed to create a Prescription Drug Affordability Board. Board members would be tasked with exploring the costs of certain medications. They would use their findings to set pricing caps for how much a pharmaceutical company can charge for the medications. Sen. Hertel says this is the best solution to lower drug costs for Michiganders... Full

U.S. Tariffs On Canadian Drugs Could Impact Supply of Antibiotics, HIV Medication: Study

(4/1, Daniel Otis, CTV News) ...Published Monday in The Journal of the American Medical Association, the effort was led by University of Toronto drug policy researcher Mina Tadrous. "Tariffs could disrupt access to essential drugs in the U.S., especially drugs where the Canadian is the only or the most commonly used product," said Tadrous, who is also a licensed pharmacist. "This is across the board for treatments for infections and chronic diseases." Some medications that are sole sourced from Canada include clinically important drugs like Ibalizumab, which is used to treat HIV infections, and Oxcarbazepine, which is used to prevent seizures... Full

Trump's Proposed Tariffs Likely to Cause Shortages of Canadian-Made Drugs in U.S., Study Says

(3/31, Chris Hannay, The Globe and Mail) ...The tariff study specifically looked at the U.S. market, but Prof. Tadrous said supply chain disruptions could spread to Canada, too. Prof. Tadrous was lead author on the paper and worked with Shanzeh Chaudhry of U of T, Jan Panhuysen of the Hertie School in Berlin, and Ioannis Konstantinidis and Katie Suda of the University of Pittsburgh... Full

Pharmaceutical Exports to US Could Halve if Tariffs Applied, Cabinet to Hear

(4/1, Mícheál Lehane, RTE) ...Exports of pharmaceuticals and chemicals from Ireland to the US could decline by about half if the Trump administration applies a 20% tariff on the sector and the EU does the same, the Cabinet will be told today. Tánaiste Simon Harris will bring a memo to Cabinet detailing the potential economic impact for Ireland ahead of the expected decision by the US to introduce tariffs on EU countries from as early as tomorrow... Full

Health Service Plans to Save €630M: More Weekend Work, ‘Virtual Wards', Cutting Medical Supply and Travel Costs

(3/31, Martin Wall, The Irish Times) ...The plan, to be brought to Cabinet on Tuesday by Minister for Health Jennifer Carroll MacNeill, calls for full implementation of the new public-only contract for hospital consultants that would see more medical specialists delivering services in the evenings and weekends and the winding down of private healthcare on public sites. The plan proposes maximising workforce efficiency by rostering personnel across five out of any seven days and providing services to the public over the full week... Full

Will US Tariffs Succeed in Lifting the Veil On India's Drug Safety Problem?

(3/31, Mihir Sharma, Bloomberg) ...India's exporters are bracing for President Donald Trump's tariffs. Some are confident that whatever is announced on Wednesday will not hurt them; others are genuinely uncertain how to manage if they can't export to the US. The pharmaceutical industry — which is well known globally for churning out generic drugs that are the backbone of many countries' health systems — should be particularly worried. Over 30% of Indian pharma exports go to the US, and it provides an even larger proportion of earnings... Full

US Tariff Imposition: Need Government-Level Initiatives to Overcome Tariff Barrier, Say Experts

(4/1, Pharmabiz.com) ...The United States Trade Representative, just before the initiation of the reciprocal tariffs for sectors including Pharmaceuticals from April 2, 2025, has listed various trade barriers it identified in India, including the imposition of non tariff barriers on refurbished medical devices that has impacted the import of such devices to India from April, 2024. PwC, in a report on the way forward for India in the backdrop of US reciprocal tariffs, said that the key strategies to address this include promptly voicing the industry's concerns to the government and suggesting solutions that the government can take up... Full

India Needs to Update its Rules for Biosimilars to Ensure Safe, Effective, and Affordable Medicines

(3/31, Chetali Rao,K.M. Gopakumar, The Hindu) ...Reforming the biosimilar marketing approval guidelines to do away with animal toxicology studies and make the clinical efficacy studies as an exception rather than a rule in line with UK and WHO biosimilar guidelines could result in the considerable reduction of costs and time for the biosimilar development without compromising the safety and efficacy. This savings in the cost of development is expected to reduce the prices of biosimilars substantially, a near replication of generic price reduction in India... Sub. Req’d

India's Generic Pharma Players May Be Spared from Major Tariff Blow: Jefferies

(4/1, Nandita Khemka, Money Control) ...Jefferies pointed out that India currently imposes up to 10% import duties on US drugs, with some having lower duties or exemptions. If the US enforces reciprocal tariffs, it would be, at best, 10% on imported Indian medicines to the US. Should this happen, American companies may pass on the cost increases to consumers, but if the costs are not passed on, the entire supply chain of retailers, distributors and formulation manufacturers may be forced to absorb the hit.... Full

US Tariffs On Pharma: Zydus, Dr Reddy's at Highest Risk, Says Jefferies; Check Impact On Other Indian Pharma Stocks

(4/1, Ankit Gohel, Mint) ..."Given Zydus Lifesciences and Dr Reddy's Laboratories have high US sales exposure with ~45% and 43% sales contribution, we believe they are at highest risk among generics in our coverage," Jefferies said in a report...Companies with mixed revenue streams, such as specialty pharma, biosimilars, and inhalers, may face some impact but are better positioned due to limited competition in their segments, according to Jefferies... Full

Korea To Revise ‘Innovative Company' Criteria Amid Calls From Foreign Industry

(4/1, Jung Won Shin, Pink Sheet) ...The South Korea government plans to improve the transparency and objectivity of standards for pharma firms to officially qualify as "innovative" and eligible for special policy treatment, amid foreign industry calls for improvement to the scheme. There are also plans to ease the financial requirements for participation in state R&D projects to help ventures facing temporary financial difficulties... Global Sub. Full

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