Thursday, February 27, 2025

2025 Community Routes: Access to Mental Health Care Grants Awarded to Clinics in Alabama, Mississippi, and Texas, Funded by Teva Pharmaceuticals

(2/27, Kim Ofilas, Direct Relief) ...Direct Relief, Teva Pharmaceuticals, and the National Association of Free and Charitable Clinics today announced the funding of Community Routes: Access to Mental Health Care grants, awarding $75,000 to each of 11 free and charitable clinics/pharmacies across Alabama, Mississippi, and Texas..."Every day uninsured patients face barriers to accessing basic mental health services they need," said Carol Richardson, Sustainability and Health Equity Lead, Teva U.S. "This latest round of grant funding will enable clinics in more states to expand existing or develop innovative new behavioral health programs that meet the needs of their local patient populations"... Full

FDA Accepts Supplemental New Drug Application for Teva, Medincell's Uzedy for Bipolar I Disorder

(2/26, Don Tracy, PharmExec.com) ...The FDA has accepted a supplemental New Drug Application (sNDA) from Teva Pharmaceuticals and Medincell for Udezy (risperidone) extended-release injectable suspension as a maintenance treatment for adults with bipolar I disorder (BP-I). According to Teva, the application is based on existing clinical data for the treatment as well as prior FDA findings on the safety and efficacy of risperidone treating BP-I. The safety and tolerability of Udezy was evaluated in the pivotal Phase III RISE and SHINE trials... Full

Methylphenidate Shortage: Major ADHD Drugs, Concerta, Teva to Last Until 2026

(2/27, Hannah Cross, The Nightly) ...In Australia, there are three approved brands for the long-acting drug: Concerta, Methylphenidate-Teva XR and Ritalin LA...Last week, Janssen-Cilag advised the Therapeutic Goods Administration the shortage would last all year and affect all strengths — 18mg, 27mg, 36mg and 54mg. Details of manufacturing issues and whether they're related to Janssen-Cilag's Belgium-based plant remain unclear, but the shortage is affecting multiple countries. It led to Teva Pharma Australia reporting its own shortage because of an "unexpected increase in demand due to other sponsors unable to supply", also affecting all four strengths and set to last all year... Full

MedImpact Expands Access to Two Biosimilars for Stelara

(2/26, MedImpact) ...MedImpact Healthcare Systems, the nation's largest independent provider of health solutions, technology, and pharmacy benefit management services, announced that it is expanding access to two biosimilar alternatives to Stelara (ustekinumab), Selarsdi (ustekinumab-aekn) and Yesintek (ustekinumab-kfce). Consistent with its mission of delivering affordability without compromising access, MedImpact's approach to biosimilars is pharmacy- and manufacturer-neutral... Full

Glenmark Pharma Launches Epinephrine Injection In US

(2/27, Press Trust Of India) ...Glenmark Pharmaceuticals Inc, USA, an arm of the company, launched the Epinephrine Injection of strength 10 mg/10 mL (1 mg/mL) multiple-dose vial, Glenmark Pharma said in a statement. The company's Glenmark's Epinephrine injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial is bioequivalent and therapeutically equivalent to the reference-listed drug of BPI Labs, LLC, it added... Full

Henlius Secures First Overseas Approval For Bevacizumab Biosimilar

(2/26, Adam Zamecnik, Generics Bulletin) ...Shanghai Henlius Biotech and its local partner Eurofarma have managed to land the very first overseas approval of Henlius' Avastin (bevacizumab) biosimilar Hanbetai in Bolivia, amplifying the Chinese firm's presence in Latin America... Global Sub. Full

After Rejection, Regeneron Seeks Accelerated Approval of Bispecific for Only One of Two Types of Lymphoma

(2/26, Lei Lei Wu, Endpoints News) ...Regeneron said Wednesday that the FDA set a decision deadline of July 30 for odronextamab in follicular lymphoma that has returned or is not responding to treatment. The drug would be for patients who have tried at least two previous lines of systemic therapy. However, Regeneron is no longer asking for accelerated approval in DLBCL. "Due to competitor developments, we no longer believe odronextamab in R/R DLBCL has an accelerated approval path and therefore, we plan to seek full approval pending data from ongoing Phase 3 studies," a Regeneron spokesperson told Endpoints News via email... Full

Jazz 'Active and Looking' at M&A Deals of 'Various Sizes' as it Wraps Up Epidiolex Patent Fights: Execs

(2/25, Angus Liu, Fierce Pharma) ..."We plan to further diversify our commercial and pipeline portfolios through strategic corporate development, which remains a key focus for Jazz," Cozadd said on the call Tuesday. "As part of our ongoing search, we're evaluating neuroscience and oncology assets while also contemplating other rare and orphan diseases," he continued. "In addition, durability of revenue, efficiency of commercial call points and alignment with our expanded R&D capabilities are part of our considerations."... Full

Merck, Glenmark Lose Bid to Toss Claims in Zetia Antitrust Case

(2/26, Katie Arcieri, Bloomberg Law) ...Judge David S. Doty of the US District Court for the District of Minnesota in a Tuesday order denied Merck and Glenmark's motion to dismiss claims that the agreement caused insurer plaintiff United HealthCare Services Inc., a unit of UnitedHealth Group Inc., to pay more for Zetia and a related drug Vytorin, both manufactured by Merck... Sub. Req’d

Drug May Offer New Hope for Preventing Migraines in Kids and Teens

(2/26, News Medical Life Sciences) ...For children and teens living with migraine, there may be a new preventive treatment, according to a preliminary study released today, February 26, 2025, that will be presented at the American Academy of Neurology's 77th Annual Meeting taking place April 5–9, 2025, in San Diego and online. Researchers found the drug zonisamide, which has been used to treat seizures, may reduce migraine days in this age group. This study does not prove that zonisamide reduces migraine days; it only shows an association... Full

Lilly Plans to Invest $27 Billion in New US Plants as Trump Threatens Pharmaceutical Tariffs

(2/26, Patrick Wingrove, Ahmed Aboulenein, Reuters) ...Eli Lilly plans to spend at least $27 billion to build four new manufacturing plants in the U.S., the drugmaker said at a Washington press conference on Wednesday, as it grapples with the threat of drug import duties from the Trump administration...The CEO said in a statement earlier on Wednesday that tax-cutting legislation introduced in Trump's first term had been foundational to the drugmaker's domestic manufacturing investments... Full

A New Era of Made in America Drug Manufacturing

(2/27, Tina Reed, Axios) ...The Trump administration's pressure on the pharma industry to bring production to the U.S. may represent a shift from Trump's first term, when lowering drug prices and increasing price transparency were the stated priorities, Anna Chorniy, a health economist at Icahn School of Medicine at Mount Sinai, told Axios in an email. Bringing production to the U.S. could ultimately result in higher production costs, which could be passed on to consumers, she said... Full

Time is Enemy for Lawmakers Pushing PBM Changes

(2/26, Nathaniel Weixel, The Hill) ...House lawmakers held a hearing Wednesday on "reining in" PBM business practices, a sign that Republicans remain interested in the issue. But with much of the attention in Congress focused on reconciliation, it isn't clear whether there will be enough political will among GOP leadership to do anything but a "clean" funding bill, without PBM changes or other health extenders... Full

PBM Reform Legislation Do-Over Will Need Bipartisan Help Amid Partisan Budget Battle

(2/27, Cathy Kelly, Pink Sheet) ...The hearing was mainly a retread of the need for reforms. But members also tried to outline their plans to move the package. Since the bill likely will not fit into the must-pass budget reconciliation package under negotiation, Guthrie said the committee must reach a bipartisan agreement... Global Sub. Full

Why Your Pharmacy May Be Disappearing

(2/26, Justin Leventhal, DC Journal) ...Increased transparency would enable insurers, pharmacies and manufacturers to negotiate, ultimately reducing drug prices and protecting independent pharmacies from predatory PBM practices. Now is the time to shine a light on PBMs and demand reform before even more local pharmacies disappear for good... Full

CMS Rehires Drug Negotiation Lawyers, Indicating Trump IRA Support

(2/26, Gabrielle Wanneh, Inside Health Policy) ...At least two litigation attorneys involved with defending Medicare's drug price negotiations in court during the Biden administration have been reinstated by the Trump administration after both were laid off along with other probationary staff across federal health agencies this month, indicating an intent to continue pushing back against drug industry allegations that the law is unconstitutional and that program guidance contradicts the law, a source told Inside Health Policy Wednesday (Feb. 26)... Sub. Req’d

Medicare Spending On Common Diabetes Drugs Skyrocketed, HHS Inspector General Finds

(2/26, Max Bayer, Endpoints News) ...The use of a subset of common diabetes drugs skyrocketed in the US Medicare program over a five-year period ending in 2023, according to a new report from the HHS inspector general. The report looked at two widely used classes of diabetes drugs: GLP-1s like Novo Nordisk's Ozempic, and SGLT-2 drugs including Johnson & Johnson's Invokana. It found huge growth in the GLP-1 class, with the number of Medicare patients on Ozempic and Rybelsus, another GLP-1 from Novo, rising more than 900% each over that period... Full

Merck Expects Oncology King Keytruda to Face IRA 'Price Setting' Process Starting in 2026

(2/26, Zoey Becker, Fierce Pharma) ...Along with a key U.S. patent expiring at the end of that year, the company expects the U.S. government to select the drug for Inflation Reduction Act "government price setting" process in 2026. The negotiated prices would then take effect in January of 2028, Merck said in a recent annual SEC filing. "As a result, U.S. sales of Keytruda will decline after that time," the company explained in the filing... Full

‘I'm Focused On The Opportunities Rather Than The Challenges' – AAM Chair Haruvi Examines The New US Landscape

(2/26, Dave Wallace, Generics Bulletin) ..."I would say generally with the new administration, I'm focused on the opportunities rather than the challenges," set out Haruvi, who is also president of Sandoz North America. Acknowledging that the industry had not necessarily always done a great job at being creative in how it presented its viewpoints to policymakers, she suggested that "I think now, with this administration, we probably don't have a choice. So I think it'll push us to be much more creative, thinking out of the box how we can fix the issues."... Global Sub. Full

At Conference, Drugmakers Tout AI Efforts as US Tariffs Cast Shadow

(2/26, Kashish Tandon, Bhanvi Satija, Rishika Sadam, Reuters) ...The rising adoption of artificial intelligence in the pharmaceutical industry dominated discussions at a conference in India this week, while executives largely preferred to wait for more clarity on U.S. President Donald Trump's tariff threats. Drugmakers such as Amgen and contract manufacturers including Parexel highlighted AI's role in reducing the time taken to conduct certain parts of the trials... Full

FDA Signals Shift In Thinking On Biosimilar Trials

(2/26, Dave Wallace, Generics Bulletin) ...The US Food and Drug Administration is increasingly open to approving biosimilar filings without full Phase III clinical trial data. That is the message conveyed by two recent company disclosures that reveal scientific advice from the FDA over biosimilar applications that the agency says can be approved without the usual suite of supporting trials... Global Sub. Full

Trump Memo Directs Federal Agencies, HHS to Fire More Employees and Submit Agency Reorg Plans

(2/26, Noah Tong, Fierce Healthcare) ...Departments are still under a strict hiring freeze. Once hiring is allowed again, only one employee may be hired for every four employees fired after a new "data-driven" process is implemented... Full

Both Sides Apply Pressure to Youngkin On Prescription Drug Affordability Bill

(2/26, Brandon Jarvis, Virginia Scope) ...Freedom Virginia, the group that has been pushing for this legislation to be enacted, launched a new interactive tool on its website Wednesday to display data on pharmaceutical companies' lobbying spending between 2023 and 2024... Full

Rep. Emerson Levy of Bend Introduces Legislation to Lower Prescription Drug Prices, Boost Price Transparency

(2/26, Barney Lerten, KTVZ21) ...Rep. Emerson Levy, D-Bend, introduced a legislative package on Tuesday before the House Committee on Health and Health Care that she said is designed to lower prescription drug costs and increase transparency in drug pricing. Building on her previous work, Levy said she introduced the bipartisan legislation to lower everyday costs for Oregonians and address health care affordability... Full

Maryland Considering Bill To Expand UPL To All Purchases

(2/26, Luke Zarzecki, Inside Health Policy) ...The bill would amend current law under which the upper payment limits (UPLs) reached by the board only apply to drugs purchased by public insurance plans. That approach contrasted with other state boards; in Colorado, for example, the UPL applies to all purchases of and payer reimbursements for the drug... Sub. Req’d

Virginia Legislature Again Sends Governor Bill To Create PDAB

(2/26, Luke Zarzecki, Inside Health Policy) ...If the PDAB established an upper payment limit (UPL) on a medication, the price ceiling would apply to all purchases and payer reimbursements of the drugs in the state, the bill says. Some state PDABs' UPLs only apply to public insurance plans, including in Maryland, where a bill is in play to expand that authority. The Virginia PDAB would also be able to use Medicare maximum fair prices in setting a UPL... Sub. Req’d

Harmonising Bioequivalence: Advancing Global Access to Generic Medicines

(2/26, Medicines for Europe and IGBA) ...The discussions and insights shared during the conference reaffirmed the commitment of IGBA and Medicines for Europe to fostering dialogue and global collaboration to address critical challenges and advance harmonisation so that regulatory progress translates into real-world solutions for patients and healthcare systems... Full

India's Contract Drug Makers Seek Government Support in China Fight

(2/27, Rishika Sadam, Kashish Tandon, Bhanvi Satija, Reuters) ...India's contract drug makers have urged the government to remove regulatory hurdles and grant faster clearance to vital raw material imports at a time when many global pharmaceutical firms are counting on the nation to reduce their reliance on China... Full

Healthcare Experts Urge India to Rewrite Clinical Trial Rules to Boost Global Market Share

(2/27, Bhanvi Satija, Kashish Tandon, Rishika Sadam, Reuters) ...India should take a page from the playbook of countries such as China and Australia if it wants a larger share of the global clinical trials market, healthcare experts said at an industry conference. As of 2022, India held an 8% share in global clinical trials - which evaluate the safety and effectiveness of new treatments - compared to China's 29%, the U.S.'s 25%, and 38% for the rest of the world, data from consultancy PwC showed... Full

Indian Pharma Rises to Global Prominence Led by Export Boom and Better Compliance Rates, McKinsey Report Reveals

(2/27, Sushmita Panda, Financial Express) ...A new report has revealed that India's pharmaceutical sector that has risen in prominence as the largest supplier of generic medicines. According to McKinsey & Company's latest report, this growth is driven by pharma exports growing faster than the global average, is at a tipping point: emerging trends in Indian and global landscapes could disrupt the current environment but could also lead to the next horizon of opportunities for the industry... Full

Health Canada Looks At Easing Burden Involved With Running Expanded Access Trials

(2/26, Vibha Sharma, Pink Sheet) ...As part of efforts to modernize its clinical trials framework, the Canadian regulator is looking to better facilitate expanded access clinical trials, which allow investigational drugs to reach patients with serious conditions before they are approved... Global Sub. Full

Opposition Tempers Cuts To Japan's High-Cost Healthcare Benefits

(2/27, Lisa Takagi, Pink Sheet) ...Recent debate In Japan about changes to a high-cost healthcare benefit scheme have cast light on the cost concerns of patients with chronic serious diseases. The country is struggling to balance increasing healthcare costs from a rapidly aging society with the need to provide a safety net for the use of more expensive therapies. Data from a major health insurance union show how increased use of antibody drugs for rare diseases has driven up its costs... Global Sub. Full

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