Monday, April 7, 2025

Teva Announces FDA Acceptance of sBLA for AJOVY

(4/7, The Fly) ...Teva Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted its supplemental Biologics License Application for AJOVY to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms or more. If approved, AJOVY would be the only calcitonin gene-related peptide antagonist for migraine prevention in adults and episodic migraine prevention in pediatric patients... Sub. Req’d

Teva Crib Sheet Reveals Uzedy, Lenalidomide Expectations Ahead Of Q1

(4/7, Dean Rudge, Generics Bulletin) ...Teva has broken new ground by publishing an ‘aide memoire' document – a compilation of financial guidance and commentary for the firm's current financial year "to assist investors with estimating its financial performance ahead of first quarter 2025 results," which are due to be released on 7 May. The Israeli firm is sticking with its January forecast of 2025 adjusted EBITDA of $4.5bn-$5bn and a broad 2025 revenue outlook of $16.8bn-$17.4bn. Teva has reported 2024 adjusted EBITDA of $4.78bn, leaving the potential for a near $300m drop... Global Sub. Full

Viatris Reaches Nationwide Settlement to Resolve Opioid-related Claims

(4/7, The Fly) ...Viatris has reached a nationwide settlement framework to resolve opioid-related claims by states, local governments, and Tribes against the Company and certain of its subsidiaries. The company said, "While the Company's presence in the U.S. opioids market is very small, the Company has agreed to this settlement to provide closure on these matters... Sub. Req’d

Lilly Inks $1.4B Capsid Deal with Sangamo to Build CNS-Targeted Genomic Therapies

(4/3, Pavan Kamat, FirstWord PHARMA) ....STAC-BBB, which has demonstrated blood-brain barrier penetration and neuronal transduction capabilities in non-human primates, "has the potential to play an important role in the treatment landscape by addressing longstanding challenges associated with delivering therapies to the [CNS]," according to Sandy Macrae, chief executive of Sangamo. The agreement offers Lilly exclusive rights to the capsid for one initial disease target, with the option to include up to four additional targets... Sub. Req’d

Aurobindo Pharma Subsidiary Secures EU Approval for Dyrupeg, a Pegylated Filgrastim Biosimilar

(4/5, Aman Shukla, Upturn Business) ...This approval, given to CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma, marks a key step in expanding the company's biosimilar portfolio in Europe. The announcement came on April 05, 2025, reinforcing Aurobindo's growing presence in the global pharmaceutical market... Full

Meitheal Adds To US Liraglutide List As It Looks To Ease Shortage Concerns

(4/4, Dean Rudge, Generics Bulletin) ...Meitheal Pharmaceuticals is continuing to prove its credentials in the off-patent space, receiving US Food and Drug Administration for and launching a generic version of Novo Nordisk's Victoza (liraglutide) type 2 diabetes treatment. "Liraglutide injection represents Meitheal's first commercial injector pen product and its first commercial diabetes medication," the firm noted after launching the GLP-1 agonist... Global Sub. Req’d

Quallent's Questionable Ustekinumab Biosimilar Pricing, and Enbrel Price Ceiling in the Rockies

(4/4, Stanton Mehr, Biosimilars Review & Report) ...Strangely, the new Stelara biosimilar pricing, directly conflicts with a September 5, 2024 press release from Evernorth (Quallent's parent), which promised a price "more than 80% lower than Stelara's list price." This would have been in line with other ustekinumab biosimilar discounts. What makes even less sense, however, is that Samsung Bioepis and its marketing partner Sandoz told BR&R previously that it will sell the branded product, Pyzchiva, at a discount of 80%... Full

Early Success of Adalimumab Biosimilars Featured at AMCP 2025

(4/5, Skylar Jeremias, The Center for Biosimilars) ...The early adoption of adalimumab biosimilars in the US health care landscape presents key considerations for managed care stakeholders evaluating coverage decisions, patient access, and long-term cost management strategies. Two recent retrospective studies, presented as posters at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025), provide important insights into these factors, highlighting adherence, comparable outcomes, and cost savings... Full

Q&A: A Conversation with GLP-1 Co-Discoverer Jens Juul Holst on the Future of Incretin-Based Drugs

(4/5, Elizabeth Cairns, Endpoints News) ...Cairns: At least you've had a little while to get used to it. Are you proud? Holst: I'm extremely happy about these awards, not for my personal satisfaction, but because of the general appreciation of the work we've done. I'm a medical doctor and it's fantastic to see these incredible results coming up in front of my eyes. It was something we hoped for, of course, but it was completely unpredictable many years ago when we uncovered this hormone... Sub. Req’d

GLP-1 and Biosimilars Trends, Impact on Payers and Costs | AMCP Annual 2025

(4/4, Pearl Steinzor, Managed Healthcare Executive) ...The GLP-1 market continues to see significant growth, now valued at $100 billion, according to Long. These drugs, primarily used for diabetes, have also gained traction in weight management, with the weight-loss sector alone reaching $20 billion. "We noticed that women are far more likely to use a weight loss drug than men," Long noted... Full

Optimizing Biosimilar Implementation: A Framework for Access, Adoption, and Sustainability | Written Recap

(4/4, Peter Wehrwein, Managed Healthcare Executive) ...Tichy said the Mayo Clinic Health System takes a very proactive approach to biosimilars, anticipating launch dates, talking to practice leaders and reaching out to manufacturers. He said the Mayo system tends to drive prescriptions to a specific "workhorse product." He said the two top priorities when implementing a biosimilar are to ensure it is clinically equivalent to the brand-name innovator product and that the biosimilar is not too disruptive for patients and providers. "Our providers are very comfortable with the use of biosimilars... Full

FDA Tells Drugmakers to Redo Studies Run by a Contract Research Firm Due to Data Integrity Issues

(4/4, Ed Silverman, STAT+) ...In a rare move, the U.S. Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by a contract research organization. The agency identified "significant" problems with data integrity and the way studies were conducted by Raptim Research, which had been hired by the drugmakers to test their medicines. The FDA expressed concern, specifically, about in-vitro studies, which are run to test biological processes... Sub. Req’d

Trump Pushes Tariff-Driven Reshoring, but Big Pharma and CDMOs Embrace Regionalization

(4/7, Pharma Manufacturing) ..."Regionalization is a stronger theme than reshoring," Leerink Partners analysts wrote in a recent note to investors. In Asia Pacific, Europe, and North America, they said "global pharma players are designing supply chains for local-for-local execution." Although Big Pharma companies such as Eli Lilly and Johnson & Johnson have grabbed headlines recently, with tens of billions of dollars of promised investments to reshore their respective manufacturing to the U.S... Full

China's Retaliatory Tariffs on US Could Mean More Headwinds for Drugmakers

(4/4, Anna Brown, Endpoints News) ...China's announcement of 34% tariffs on all US imports — a retaliation against US tariffs that were announced this week — could create more challenges for drugmakers already navigating a dampened Chinese market and increased competition there. China's Ministry of Finance said Friday that the country will put a 34% levy "on all imported goods originating from the US." The tariff starts April 10, a day after President Donald Trump's similar tariffs are supposed to go into effect... Sub. Req’d

Threat of Future Tariffs on Pharmaceutical Imports Alarms Health Care Community

(4/4, Andres Gutierrez, CBS News) ...Nearly all of the United States' generic drugs come from overseas. In a last-minute move Wednesday, the Trump administration excluded pharmaceuticals from Wednesday's retaliatory tariffs, giving consumers a break for now. "There are some people who can't even afford their little co-pay," said Bobby Benson, owner and pharmacist at Belmont Pharmacy in Las Vegas. Benson has even set up an IOU system for his customers and says some already ration their medications... Full

Generic Medications From Overseas Could Get More Expensive

(4/4, CBS News) ...So far, foreign-made medicines have been spared from President Trump's trade war. But the president has vowed they could be his next target with an import tax as high as 25%. Andres Gutierrez reports... Full

Ending Pharma's Tariff Exemption Could Cause Generic-Drug Shortage -- Market Talk

(4/4, Dow Jones) ...There could be a shortage of generic drugs if tariffs are implemented for pharmaceutical companies, which have long been exempt from trade duties, Bernstein analyst Courtney Breen tells WSJ. Generic-drug makers typically have thinner margins than brand-name companies like Eli Lilly and Merck, and are also more concentrated in countries such as China and India, Breen says... Sub. Req’d

Trump Spares Drugmakers From Tariffs; Costs Could Still Go up

(4/4, Joseph Choi, The Hill) ...According to Tom Kraus, vice president of government relations at the American Society of Health-System Pharmacists, the fact that bulk chemicals — the starting materials for drugs — have not been exempted from Trump's tariffs means generics could still be impacted. "There's still a risk here. There's still questions about what applies, and at a minimum, it looks like the key starting materials are still subject to tariffs," Kraus noted. "So, you know, from our perspective, that creates risk, particularly in the generic market."... Full

Pharma Carveout Raises Questions

(4/5, Robert Weisman, The Boston Globe) ..."Pharmaceutical executives are expecting there are sector tariffs coming behind these,'' said Bill George, executive fellow at Harvard Business School and former CEO at medical device giant Medtronic, who has been meeting with drug company leaders and other top executives in recent weeks. "They're not off the hook. That's their view.'' The exemption raised as many questions as it answered for drug makers clustered in Cambridge's Kendall Square and other biopharma hubs in the Boston area... Full

Trump HHS Continues Some Biden Medicare Policies, Revises Others

(4/4, Tony Pugh, Bloomberg Law ) ...The Trump administration offered a mix of old and new provisions in its revised 2026 Medicare Advantage and Part D Contract Year 2026 final rule. Much of the rule (RIN 0938-AV40) released Friday by the Centers for Medicare & Medicaid Services continues or modifies provisions first implemented by the Biden administration through the Inflation Reduction Act in 2024 and 2025. But the rule scrapped a proposal by the Biden administration for Medicare and Medicaid to cover anti-obesity drugs for weight loss... Sub. Req’d

HHS Floats Major FDA Reorganization That Would Merge All Product Centers

(4/4, Jessica Karins, Jalen Brown, Inside Health Policy) ...The reorganization plan, which was shared with Inside Health Policy by a source who received it from HHS, includes combining FDA's review divisions into a new "Office of Product Evaluation and Regulation" that would serve as a "central hub for product review and regulatory decision-making across drugs, biologics, devices, tobacco, and foods." The office would be formed from the offices that review drugs, biologics, medical devices, tobacco products, human foods and veterinary products... Sub. Req’d

US FDA's Review Performance Held Steady Despite Stormy First Quarter

(4/4, Bridget Silverman, Pink Sheet) ...The full impact of cuts to FDA staff, from senior leadership to review operations and inspections, will take some time to emerge. Products with reviews that were already close to completion before staff cuts presumably would be easier to finish on time than the applications that are currently in earlier assessment stages. The FDA approved 10 novel agents in the first quarter of calendar year 2025, seven from the Center for Drug Evaluation and Research and three from the Center for Biologics Evaluation and Research... Global Sub. Full

Source: E&C To Hold Bipartisan Briefing With RFK Jr.'s Staff

(4/4, Sigi Ris, Inside Health Policy ) ...An HHS memo obtained by IHP outlines the department's likely talking points for the upcoming House E&C briefing. It says the 10,000 workers that were cut were either redundant or held unnecessary administrative positions. "All personnel decisions were made in direct consultation with HHS's 13 operating divisions (OpDiv) leaders as they are the innovative and policy experts best suited to address the consolidation needs of their respective agencies," the memo says... Sub. Req’d

FDA Staff Cuts Could Disrupt Drug Reviews, Putting Agency's Critical Funding Programs at Risk: Reports

(4/4, Fraiser Kansteiner, Fierce Pharma) ...As reports surface detailing the extent of Robert F. Kennedy Jr.'s layoffs at the Department of Health and Human Services, FDA officials are sounding the alarm about their ability to review applications for new drugs moving forward. The 3,500 job cuts recently announced at the FDA, some of which went into effect Tuesday, have already claimed staff essential to the drug review process, Reuters reported Friday, citing both current and former sources at the regulator... Full

The Skyrocketing Cost of Weight-Loss Drugs Has State Medicaid Programs Looking for a Solution

(4/6, Susan Haigh and Marc Levy, Associated Press) ..."It is a medication that's gotten a lot of hype and a lot of press, and has become very popular in its use and it is wildly expensive," Dr. Val Arkoosh, Pennsylvania's human services secretary, told a state House hearing in March. At least 14 states already cover the cost of GLP-1 medications for obesity treatment for patients on Medicaid, the federal health care program for people with low incomes. Democrats and Republicans in at least a half-dozen other states floated bills this year to require the same coverage... Full

Trump Pulls Back Biden's Plan to Cover Weight Loss Drugs

(4/4, Jessie Hellmann, Roll Call) ...The Trump administration will not finalize a Biden-era plan to require coverage of anti-obesity medications in Medicare and Medicaid. In a rule finalized Friday afternoon, the Centers for Medicare and Medicaid Services stated it does not intend to continue with the Biden proposal, which was released in November. CMS did not provide a reason for dropping the proposal, but a spokesperson said finalizing the coverage is "not appropriate at this time."... Full

AstraZeneca, AbbVie Lose Minnesota Contract Pharmacy Law Suit

(4/4, Ganny Belloni, Bloomberg Law) ...A federal court denied pharmaceutical companies' challenges of a Minnesota law requiring drugmakers to offer discounted medications to a potentially unlimited number of pharmacies that partner with safety net facilities in the state. Judge David S. Doty from the US District Court for the District of Minnesota on Thursday granted the state's motion to dismiss complaints from AstraZeneca Pharmaceuticals LP and Abbvie Inc. alleging that Minnesota's statute 62J.96 expanded the scope of the federal 340B law and is unconstitutional... Sub. Req’d

Assembly Democrats to Host Hearings Examining Impact of PBMs on Drug Prices

(4/7, John Harrington, ROI-NJ.com) ...These hearings come as concern increases about the impact PBMs have on the health care system. PBMs were originally established to control drug costs and improve efficiency, however, recent federal investigations suggest that some of these businesses may in actuality be contributing to higher prescription prices and reduced medication access... Full

PDAB Expansion Nears, FAMLI Implementation Gets Farther Off

(4/6, Danielle J. Brown, Maryland Matters) ...A bill that would expand the authority of a state board that is working to lower certain prescription drug costs is ready for the governor's consideration, after the Senate passed House Bill 424 on party lines Friday evening. The Prescription Drug Affordability Board is currently tasked with finding ways to reduce the cost of prescription drugs on the state's health plan, saving some taxpayer dollars in the process... Full

EU Commission Head Discusses U.S. Tariff Response with Auto, Steel and Pharma Executives

(4/7, Julia Payne and Maggie Fick, Reuters) ...European Commission President Ursula von der Leyen held a call with metals industry representatives on Monday and was speaking to the automobile sector later to discuss how to respond to U.S. tariffs, sources and a letter showed. The calls aimed to collect more data to strategise further trade counter-measures beyond Brussels' upcoming response to Washington's previously announced steel duties, which will be voted on later this week. A third call with the European pharmaceuticals industry is planned for Tuesday... Full

Trump's Tariffs Will Lead To ‘Instability' And ‘Less Investment' In UK

(4/4, Eliza Slawther, Pink Sheet) ...The US president Donald Trump announced a sweeping tariff plan on 2 April, targeting almost all goods and US trading partners across the globe. However, it appears that pharmaceuticals are one of the few products exempt from these tariffs. Richard Harrington, a former member of the UK parliament and current member of the House of Lords, said during a 3 April industry conference that "the truth is, nobody knows the details whatsoever" of how the tariffs will affect the pharma industry... Global Sub. Full

Biosimilars Industry Buoyed By EMA Paper On Reducing Clinical Trials

(4/7, Dave Wallace, Generics Bulletin) ...Medicines for Europe could hardly have chosen a better date to hold its 2025 annual biosimilars conference. Less than 48 hours before the event kicked off in Amsterdam midway through last week, the European Medicines Agency published a landmark draft reflection paper on streamlining the development and assessment of biosimilar medicines, a long-awaited move that marks a significant step towards reducing the need for comparative efficacy trials to support biosimilar filings... Global Sub. Full

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

(4/7, Jung Won Shin, Pink Sheet) ...On top of the recent major tariff announcement from US President Donald Trump, a ruling by South Korea's Constitutional Court last week to go ahead with the removal of impeached former president Yoon Suk-yeol for his short-lived declaration of martial law may have hit them even harder. The northeast Asian country seems to be gearing up quickly for a planned presidential election in early June, while the government is preparing support measures for industry sectors with urgent needs ahead of the general 25% US tariff due to come into force on Korean exports to the US this week... Global Sub. Full

The Landscape of Drug Development and the Pharmaceutical Industry in Italy: Challenges, Trends, and the Role of Generics

(4/7, Anzela Minosi, Pharmacy Times) ...The drug development process in Italy is more or less the same as in the US.4 In Italy, there are 2 organizations that deal with drug development. While the Italian Department of Health approves animal studies, it is the Italian counterpart of the FDA, the Agenzia Italiana del Farmaco (AIFA), which oversees human studies. Additionally, the Italian National Institute of Health (Istituto Superiore di Sanità) supports these agencies by creating technical-scientific reports during both the preclinical and clinical stages of development... Full

Sun Pharma Launches Fexuprazan Tablets 40 Mg in India

(4/7, Business Standard) ...Sun Pharmaceutical Industries has announced the launch of FEXUCLUE, a novel potassium-competitive acid blocker (P-CAB), in India. The drug, available in 40 mg tablets, is approved as a new treatment for adults with erosive esophagitis of all grades. FEXUCLUE, containing Fexuprazan, is primarily used to treat acid-related disorders, including gastroesophageal reflux disease (GERD) and erosive esophagitis. It is also being studied for the prevention of NSAID-induced peptic ulcers and gastritis... Full

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