Wednesday, April 9, 2025

AAN 2025: Fremanezumab Superior to Placebo in Reducing Monthly Migraine Days in Children and Adolescents

(4/8, Gillian McGovern, Pharmacy Times) ...When compared with placebo, fremanezumab (Ajovy; Teva Pharmaceuticals) was superior in reducing monthly migraine days, monthly headache days, and days with acute medication use in pediatric and adolescent patients with migraines, according to clinical data presented at the American Academy of Neurology Annual Conference, hosted in San Diego, California. These numerical differences, according to speaker Christina Szperka, MD, associate professor of neurology and pediatrics, Perelman School of Medicine at University of Pennsylvania, director of pediatric headache program at the Children's Hospital of Philadelphia, were observed as early as month 1, and had no new safety signals... Full

FDA Accepts Teva's Supplemental BLA for Ajovy to Prevent Pediatric Migraines

(4/8, Don Tracy, PharmExec.com) ..."Migraine is common among children and adolescents, often disrupting their education, social lives and overall well-being, yet treatment options remain limited," said Eric Hughes, MD, PhD, EVP, global R&D, chief medical officer, Teva, in a press release. "As we work to bring the benefits of Ajovy to younger patients, we build upon its proven success in adults. If approved, Ajovy could be an important step toward filling the gap in pediatric migraine care, offering a much-needed solution for this underserved population."... Full

Teva and Samsung Bioepis Announce Biosimilar EPYSQLI Injection Now Available in the U.S.

(4/8, Chain Drug Review) ...Teva Pharmaceuticals and Samsung Bioepis Co. have announced the availability of EPYSQLI (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. EPYSQLI will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris, offering one of the greatest cost-saving biosimilars to Soliris® in the U.S... Full

Bkemv and Epysqli, Two Biosimilars of Soliris, Are Now Available

(4/8, Denise Myshko, Managed Healthcare Executive) ...A Teva spokesperson said the company anticipates Epysqli will be an attractive option for payers. "Teva is committed to helping patients gain affordable access to our medicines. For decades, we've offered assistance programs to improve patient access to our medicines and to help remove barriers to treatment. Eligible patients may receive their medication at no cost or may be eligible for assistance through our programs," the spokesperson said... Full

Medication Shortage Hits

(4/9, Wairarapa Times-Age) ...Methylphenidate, prescribed under brand names Ritalin, Rubifen, Concerta and Teva, has been in short supply overseas since 2023, attributed to manufacturing difficulties and increased demand...The shortage has continued into 2025, with Pharmac reporting no New Zealand stock of six methylphenidate products (prescribed in certain dosages and release formulations). Last month, Pharmac confirmed on its website that the shortage is likely to continue throughout the year: "There may be periods in 2025 where people will not be able to get the brand of methylphenidate they normally use."... Full

Bristol Myers Wins Dismissal of Lawsuit Alleging Pomalyst Monopoly

(4/8, Jonathan Stempel, Reuters) ...In a 70-page decision made public on Tuesday, U.S. District Judge Edgardo Ramos in Manhattan said the health insurer Blue Cross Blue Shield of Louisiana and other Pomalyst purchasers failed to show that Bristol Myers and the former Celgene Corp violated the federal Sherman antitrust law. Ramos said the plaintiff purchasers failed to establish fraud in the procurement of six patents related to Pomalyst. He also said they failed to show how nine lawsuits that Celgene filed between 2017 and 2020 against generic drug producers such as Teva and Mylan were "objectively baseless" and led to fraudulent settlements... Full

Despite Multiple Headwinds, Formycon Remains Positive For Its Biosimilars Growth

(4/8, Urte Fultinaviciute, Generics Bulletin) ...2024 marked a key step towards executing its strategic plan as Formycon achieved annual group revenue of €69.7m ($76.39m), exceeding its forecast of €55m-€65m. Still, this was a 10.3% "anticipated" decrease from the previous year's revenues of €77.7m, mainly due to lower milestone payments... Global Sub. Full

Jazz Pharma to Pay $145 Million to Settle Narcolepsy Drug Antitrust Case

(4/8, Kamal Choudhury, Reuters) ...The lawsuits accused Jazz Pharma of orchestrating a scheme to delay the release of a generic version of Xyrem, made by Hikma Pharmaceuticals, leading to inflated prices for health plans. The plaintiffs, which include the city of Providence, Rhode Island, and the New York State Teamsters Council Health and Hospital Fund, lodged cases accusing Jazz of violating U.S. antitrust laws... Full

Novo Nordisk Plugs More Than $1B into Upgrade of Brazilian Manufacturing Operations for Injectable Drugs, Including GLP-1s

(4/8, Fraiser Kansteiner, Fierce Pharma) ...Now, in a bid to boost its production capacity in Latin America's most populous country, Novo is plugging 6.4 billion Brazilian reais (roughly $1.09 billion) into an expansion of its manufacturing plant in the Brazilian city of Montes Claros. The investment, which marks one of the largest ever for pharmaceuticals in Brazil, will "significantly" bolster the facility's capacity to crank out a variety of injectables, including GLP-1 medicines like Ozempic and Wegovy, Novo said in a Portuguese-language press release... Full

Q&A: Lundbeck's Head of R&D On Letting ‘Biology Speak' in Neuroscience

(4/8, Max Gelman, Endpoints News) ...Endpoints News sat down last week over Zoom with [Lundbeck’s R&D Head Johan Luthman] as researchers descended on San Diego last weekend for the American Academy of Neurology's annual meeting to discuss the latest data and advances in the field. The conversation touched on neuroscience's evolution, the dichotomy between psychiatry and neurology, and what's next for Cobenfy, the schizophrenia drug at the center of Bristol Myers Squibb's acquisition of Karuna Therapeutics... Full

Glenmark Pharma Recalls 39 Products Sent to US; Shares Tank 7%

(4/9, Meghna Sen, CNBC TV-18) ...The recall, initiated in March, was classified as Class-II by the FDA on April 8, 2025. Most of the recalled products were manufactured at Glenmark's Pithampur plant. According to the US FDA website, the majority of these recalls were due to the drugs reaching their expiry date in March 2025. Since the products are at or near expiry, the recall was deemed likely... Full

US Pharmaceutical Pipeline Expands With Innovation and Competition

(4/8, Skylar Jeremias, AJMC) ...2025 is expected to bring a number of new traditional and specialty pharmaceuticals, including the first generic and biosimilar competitors for blockbuster brands and innovative therapies for cancer and neurological disorders, according to 2 presentations at the annual meeting of the Academy of Managed Care Pharmacy... Full

Trump Says ‘Major' Pharmaceutical Tariffs On The Way

(4/9, Gregory Svirnovskiy, Politico) ......"We're going to be announcing very shortly a major tariff on pharmaceuticals," he said at a dinner of the National Republican Congressional Committee. "And when they hear that, they will leave China. They will leave other places because they have to sell - most of their product is sold here and they're going to be opening up their plants all over the place." The president gave no details on the pharmaceutical tariffs... Full

Pharma is Next in Line As Trump Says Tariffs Are Coming 'Very Shortly'

(4/9, Anna Brown, Endpoints News) ...Pharma industry members and investors have warned against Trump's tariffs. Billionaire hedge fund manager Bill Ackman called for a delay on the levies by as much as three months, Ackman said on X on Tuesday. But later that day, Trump's Trade Representative Jamieson Greer said there would be no change in tariff tactics during his testimony at a Senate hearing..."Having all drug products from every country hit with tariffs is a major blow to everyone, and it's going to increase costs," Mollie Sitkowski, a trade compliance partner at US law firm Faegre Drinker, told Endpoints News last week... Full

Big Pharma Has Partial Immunity from Trump Tariffs

(4/9, Aimee Donnellan, Reuters) ...Last Wednesday, when U.S. President Donald Trump unveiled a raft of duties on countries and industries he held back on hitting pharmaceuticals. He followed up on Tuesday by saying he would soon announce a "major" tariff on pharmaceutical imports. But the industry's complex supply chains and the risk of deaths caused by shortages mean they may emerge less damaged than carmakers or brewers... Full

US Pharma Tariff Reprieve May Be Ending

(4/8, Jessica Merrill, Pink Sheet) ...The industry got an initial reprieve when President Donald Trump exempted pharmaceuticals in his announcement of widespread double-digit tariffs on most goods imported to the US from all trading partners on April 2. But some industry observers expect the administration could phase in tariffs for pharmaceuticals as early as May..."Any day now, potentially by the end of the week, we will hear updates on the next ones, with pharmaceuticals being the second on the list," Monet Stanford, VP of healthcare policy at the public policy research firm Washington Analysis, said in an interview... Full

Tariffs Are Just Part of Pharma's Wall Street Tumble

(4/9, Tine Reed, Axios) ...CEO David Ricks told the BBC that drug companies like his would be forced to take on the full burden of tariffs rather than pass the costs to consumers because there are so many controls on the price of medicine... Full

Medicare GLP-1 Coverage Back in Congress' Hands

(4/8, Victoria Knight, Axios Pro) ...A PhRMA spokesperson told Axios that the trade group was "disappointed by CMS' decision" since there's a strong evidence base on how the medicines "can provide meaningful value to patients and generate savings for our health care system." The group will continue to work with the Trump administration and Congress on ways to improve affordability and access for those in Medicaid and Medicare who are living with obesity, the spokesperson said... Sub. Req’d

Third Circuit Mulls Excessive Takings, Drug Selection Arguments In IRA Suit

(4/8, Gabrielle Wanneh, Inside Health Policy) ...Novo Nordisk focused primarily on its allegation that CMS broke the law by identifying six of the company's similar but distinct insulin products and qualifying them all as one product that was selected for the inaugural negotiation round...An allegation specific to the case filed by Novo Nordisk, as well as a newer case filed in January by Teva Pharmaceuticals, is that CMS violated the IRA by imposing price negotiation on more drugs than Congress intended for the first negotiation cycle by grouping six Novo Nordisk insulin products together and subjecting them all to price negotiation as the agency's "tenth" single selected drug for the program... Sub. Req’d

Novo Nordisk, HHS Clash Over ‘Negotiation-Eligible' Drugs in IRA Appeals Fight

(4/8, Nicole DeFeudis, Endpoints News) ...The drugmaker is one of several companies to sue the federal government over price negotiations under the Inflation Reduction Act. But unlike other cases, Novo is challenging CMS' decision to group together its NovoLog and Fiasp insulin products as one drug. Novo argued before the US Court of Appeals for the Third Circuit that the agency picked more "negotiation-eligible" drugs than prescribed under the statute... Full

How the IRA is Impacting the Generic Drug Market

(4/8, Matthew Norawong, PhRMA) ...Unfortunately, the Inflation Reduction Act's (IRA) price-setting provisions are a step backwards from the progress ushered in by the Hatch-Waxman framework and will disrupt the delicate balance that's made the generic drug market so robust in the U.S. By forcing generics to compete with a government-set price, the IRA undercuts their incentive to enter the market in the first place... Full

Biosimilars Forum, Biosimilars Council Urge Congressional Action On Biosimilars

(4/8, Sandra Levy, Drug Store News) ...The Biosimilars Council released Congressional testimony provided by Craig Burton, executive director of the Biosimilars Council before the House Ways & Means Health Subcommittee hearing. "Unfortunately, the long-term sustainability of the biosimilar market is in doubt-a result of the combination of ill-considered government policies as well as abuses by both brand manufacturers and pharmacy benefit managers…," Burton said... Full

PBMs Innovating to Increase Biosimilar Use, Lower Rx Costs

(4/8, PCMA) ...As the House Ways and Means Subcommittee on Health today holds a hearing on biosimilars, it's important to highlight how pharmacy benefit companies are responding to changes in the market. PBMs are working with employers and other health plan sponsors to break down the barriers surrounding biosimilars and make them more accessible and affordable for patients...Unfortunately, while PBMs work to increase access to biosimilars, Big Pharma continues to set and increase the price of drugs by exploiting loopholes and manipulating the system to delay lower-cost affordable options from being able to come to market... Full

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

(4/8, Derrick Gingery, Pink Sheet) ...An FDA official, who soon will depart as part of the reduction-in-force, told the Pink Sheet that the agency may not be able to spend the necessary amount of non-user fee dollars on the BsUFA program. As a result, the agency could lose the ability to collect biosimilar user fees...The official said the FDA calculates "effort" on a user fee program based on internal time reporting by staff. If enough people leave either through layoffs or natural attrition, program "effort" will shrink relative to non-BsUFA activities... Global Sub. Full

Could Kennedy's FDA Cuts Trigger An Obscure Clawback Provision for Industry User Fees?

(4/8, Zachary Brennan, Endpoints News) ...The industry provides more than $3 billion a year on user fees, about half of the FDA's budget. Because of last week's sweeping firings, however, a corresponding decline in spending could, at least hypothetically, trigger the provision, industry experts told Endpoints News. While it's highly unlikely and would be catastrophic for the agency and the industry, the fresh attention on the provision is yet another concern about the upheaval at the regulator under the Trump administration. For now, it's likely a theoretical risk. Reached by Endpoints, an HHS spokesperson said there was "near zero likelihood" of the trigger being activated... Full

The Great RIF(T): One FDA Division's Destruction and What it Could Mean for Generic Drugs

(4/9, Kurt R. Karst, FDA Law Blog) ...As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what that might mean for the immediate future of generic drugs in America: the Division of Policy Development in the Office of Generic Drug Policy (OGDP), which was created in late 2013/early 2014 in part to implement the first iteration of GDUFA... Full

Drug Discount Legislation Pits Pharma Against Providers in Illinois

(4/9, Jon Asplund, Crain's Chicago Business) ...In Illinois, two bills before the General Assembly, HB 3350 and SB 3727, aim to keep big pharma from cutting hospitals, clinics and pharmacies out of the federal discount program. The proposals are nearly identical to bills in other states that have either passed or are in the middle of debate...PhRMA states that federal congressional changes are needed to rein in 340b and complains that hospitals and clinics are able to charge "huge markups on medicine" by exploiting the program... Sub. Req’d

State Owes Citizens Action to Rein in Prescription Costs

(4/8, Andy Zay, The Journal Gazette) ...It is time for Hoosiers to benefit from PBM contracts, not to be taken advantage of by the monopolistic PBMs stealing millions of dollars from hardworking Hoosier taxpayers. Millions of dollars are at stake with our current drug benefit plans. We need to regain control over these bad actors causing huge increases in the cost of prescription drugs, and I believe we can do so by taking ownership of our own coverage plans to ensure Hoosier taxpayer dollars are protected... Full

Pharma CEOs Alert President Von Der Leyen to Risk of Exodus to the US

(4/8, European Federation of Pharmaceutical Industries and Associations) ...Today, CEOs of the research-based pharmaceutical industry issued a stark warning to President von der Leyen that unless Europe delivers rapid, radical policy change then pharmaceutical research, development and manufacturing is increasingly likely to be directed towards the US... Full

Press Statement Following Meeting with Commission President Ursula Von Der Leyen On Tariffs

(4/8, Medicines for Europe) ...Medicines for Europe and its delegation thanks President Von der Leyen for a strategic dialogue on how the European Commission can best support the pharmaceutical sector. The President and the Health Commissioner are committed to helping the industry and patients in Europe who rely on medicines for better health...To support the Commission and protect the unique value of the pharmaceutical industry, Medicines for Europe has developed a 5-step action plan for pharmaceuticals... Full

As Trump Threatens Tariffs On Drugs, Industry Warns EU of $100B-Plus Pharma Exodus to US

(4/8, Angus Liu, Fierce Pharma) ...Unless Europe delivers "rapid, radical policy change," pharmaceutical R&D and manufacturing is "increasingly likely to be directed towards the U.S.," pharma CEOs in the European Federation of Pharmaceutical Industries and Associations (EFPIA) warned European Commission President Ursula von der Leyen Tuesday...To help Europe keep the pharma industry, the CEOs called for several actions, including strengthening the region's competitive commercial market, intellectual property protections, regulatory framework and policy coherence... Full

Ireland Seeks to Protect Pharma Role As EU and Industry Mull Trump Tariff Response

(4/8, The Pharma Letter) ...Irish Prime Minister Micheál Martin said he had recently spoken with several pharmaceutical company chief executives and emphasized that while the situation is "challenging," he believes Ireland can still help influence decisions being made in Washington. Speaking to The Irish Independent, Mr Martin said the country would work to "reduce the impacts" of any potential US actions targeting the sector... Sub. Req’d

Trump to Tariff Pharmaceuticals Next. Will This Hurt India, A Big Medicine Exporter?

(4/9, Firstpost) ...Leading companies like Sun Pharma, Dr Reddy's, Aurobindo Pharma, Zydus Lifesciences and Glad Pharma reportedly earn 30 to 40 per cent of their revenue from the US market. The upcoming tariffs will impact. However, tariffs on pharma will not only impact Indian manufacturers but also US consumers. "In case the US starts imposing tariffs on the pharma sector, it will impact both countries," HDFC Securities analysts were quoted as saying by Mint. If tariffs are raised significantly, some Indian generic drug manufacturers might struggle to absorb costs. In such a case, they are likely to pass it on to insurers and consumers, the report says... Full

UK Promises To ‘Turbocharge' Clinical Trials As US Tariff Threat Remains

(4/8, Andrew McConaghie, Pink Sheet) ...British prime minister Sir Keir Starmer announced new measures to bolster the UK's pharma sector on April 7,, as the country moves fast to minimize the potential damage to its homegrown industries, including pharma, from US President Donald Trump's tariffs. Starmer unveiled plans for a single National Health Service database for medical research and an ambitious goal to slash clinical trial start-up times in the UK by 100 days within a year... Global Sub. Full

Spanish Authorities Investigate Sandoz Over Information-Sharing

(4/8, Dave Wallace, Generics Bulletin) ...Spain's competition authority, the CNMC, has announced that it is investigating Sandoz and its Bexal subsidiary – as well as other companies Alliance Healthcare España and Bluetab Solutions – over the exchange of sensitive commercial information relating to orders placed by pharmacies for Sandoz/Bexal generics. The CNMC said that the alleged exchange of "sensitive, unjustified and disaggregated commercial information" took place from April 2018 to April 2023... Global Sub. Full

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