Friday, April 25, 2025

Teva-Handok Lands Expanded Korea Nod for Austedo in Drug-Induced Movement Disorder

(4/25, Kim Ji-hye, Korea Biomedical Review) ...Teva-Handok has picked up a label expansion in Korea for Austedo (deutetrabenazine), securing regulatory clearance for the drug to treat tardive dyskinesia (TD) -- a potentially irreversible movement disorder tied to long-term use of antipsychotics... Full

Samsung Bioepis' Second Quarter 2025 Biosimilar Market Report Highlights US Debut of Ustekinumab Biosimilars with WAC Discounts Over 80% and Regulatory Streamlining

(4/24, Samsung Bioepis Co.) ..."The first quarter of 2025 has witnessed substantial developments in market competition and regulatory paradigm. Among the most significant milestones was the launch of ustekinumab biosimilars following the loss of exclusivity for Stelara. This expansion has played a pivotal role in fostering market competition and encouraging more dynamic pricing strategies," said Thomas Newcomer, Vice President, Head of US Commercial Operations at Samsung Bioepis... Full

Decade of Biosimilars Yields $36 Billion in Savings and Strengthens Supply Chain

(4/24, Cameron Santoro, The Center For Biosimilars) ...Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by improving patient access and the supply chain, but continued education and a robust pipeline are crucial for future growth... Full

Gilead Posts Profit, Says HIV Prevention Drug On Track for Mid-June

(4/24, Deena Beasley, Reuters) ...Gilead Sciences on Thursday reported a first-quarter profit, but revenue was flat, as higher sales of drugs for HIV and liver disease, along with expense tightening, offset lower cancer drug sales... Full

Bristol Myers CEO Signals Dealmaking Will Be a Top Priority in 2025

(4/24, Max Gelman, Endpoints News) ...During Thursday's first-quarter earnings call, Boerner made his strongest comments yet that Bristol Myers intends to be active at the dealmaking table this year. He referred to business development as the top "capital allocation priority" for the company in 2025, saying it will focus on "growth" opportunities from acquisitions or partnerships...The pharma giant said it already achieved one of its primary financial goals for 2025: Sales for its "growth portfolio," which includes drugs like Opdivo, Camzyos, Reblozyl and Cobenfy, made up half of total revenue in the first quarter... Sub. Req’d

Ozempic Copies Restricted After US Judge Denies Injunction

(4/24, Patrick Wingrove, Dan Levine, Reuters) ...A U.S. judge on Thursday rejected a bid by compounding pharmacies to keep making copies of Novo Nordisk's popular diabetes and weight-loss drugs Ozempic and Wegovy while a legal challenge over drug shortages unfolds, court records showed... Full

Novartis Urges Court to Break FDA Logjam Over MSN Entresto Copy

(4/24, Christopher Yasiejko, Bloomberg Law) ...The FDA told Novartis AG it won't act on a judgment delaying approval of MSN Laboratories Pvt. Ltd.'s copy of its blockbuster heart-failure drug until the court rules on MSN's request to pause enforcement of that judgment... Sub. Req’d

Halozyme Sues Merck Over Subcutaneous Keytruda as Licensing Talks Fall Through

(4/24, Angus Liu, Fierce Pharma) ...In a lawsuit filed Thursday in a New Jersey federal court, Halozyme alleges that a proposed subcutaneous formulation of Merck's popular cancer drug Keytruda infringes 15 of its patents. Those intellectual properties belong to a Halozyme patent family called Mdase, which covers a large group of modified human hyaluronidases. A hyaluronidase protein may allow for under-the-skin administration of otherwise intravenously infused drugs... Full

Lupin Recalls Nearly 3,000 Bottles of OCD Medication in the US After Subpar Stability Testing Results

(4/24, Joseph Keenan, Fraiser Kansteiner, Fierce Pharma) ...Mumbai's Lupin has issued a voluntary recall of 2,724 bottles of the tricyclic antidepressant clomiPRAMINE hydrochloride, which is used to treat obsessive-compulsive disorder (OCD) by boosting serotonin activity in the brain...According to the FDA's report, Lupin said the drug—manufactured at the company's Baltimore, Maryland, production site—failed to meet impurities and degradation specifications during an 18-month stability study... Full

Healthcare Remains Top Target for Cybercriminals with An Uptick in Hacking Attacks in 2024

(4/24, Heather Landi, Fierce Healthcare) ...Those notable breach cases affected radiology service providers, pharmaceutical firms, IT providers, medical transportation firms and pharmacies... Full

Drugmakers Brace for Trump Tariffs, While Weighing Numerous Other Worries

(4/24, Manas Mishra, Michael Erman, Patrick Wingrove, Reuters) ...Still, drugmakers are grappling with several factors that could cause upheaval, such as Trump administration efforts to shrink the federal workforce, including at the U.S. Food and Drug Administration, and probes into pharmaceutical imports that set the stage for levies on the sector...So far, there is little clarity on the rates and timings of any such tariffs. But the industry could be in for a big hit if Trump goes ahead with his plans, since the U.S. imports more than $200 billion in prescription drugs... Full

Drugmakers See a Substantial, But Manageable, Hit to Business from Tariffs. But the Worst May Lie Ahead

(4/24, Andrew Dunn, Endpoints News) ...On Thursday, several of the world's largest pharma companies — Merck, Bristol Myers Squibb, Sanofi and Roche — reported quarterly earnings and shared their financial forecasts for the year. The message from the industry is that the impact of the tariffs is real, but manageable. And the drugmakers were eager to position themselves as fully prepared for whatever may come next...But the biggest risk is yet to come. On calls with investors and reporters, pharma leaders were tight-lipped about the threat of industry-specific tariffs on drugs. Trump has taken aim at pharma with a desire to see more manufacturing in the US. He said on April 8 that "we're going to be announcing very shortly a major tariff on pharmaceuticals." The timing, scope and severity of these tariffs, though, remain unknown... Sub. Req’d

Trump's Plans to Assess Tariffs On Imported Drugs Could Raise Prices, Cause Drug Shortages

(4/25, Ken Alltucker, USA Today) ...Tariffs are more likely to disrupt prices and production of generic drugs because these medications rely on lower-cost materials, ingredients and manufacturing in China and India, said Mariana Socal, associate professor of health policy and management at Johns Hopkins Bloomberg School of Public Health...Socal said said global competition keeps generic prices lower for consumers. If generic drugmakers and distributors must pay tariff-related costs, they might need to further cut production costs. That could mean generic manufacturers ship a "lower quality product that has a lower cost," Socal said. With a tariff on generic imports, "it's likely millions and millions of people will be affected by this," Socal said... Full

Once All-Powerful, Pharma's Allies in Washington Are Fleeting

(4/24, Lauren Gardner, David Lim, Politico) ...Industry groups have criticized the agency downsizing — but only in moderate tones. At the time of the firings, earlier this month, a spokesperson for PhRMA, the brand name drug lobby, said they "raise questions" about the FDA's ability to support innovation. But in a statement to POLITICO on Wednesday, PhRMA spokesperson Alex Schriver stressed areas of agreement with Trump, around the need to revitalize American manufacturing and rein in insurers, the pharmacy benefit companies that insurers hire to negotiate drug prices, and hospitals, arguing those three industries are most responsible for high health care costs... Full

Sen. Cassidy Calls for 340B Reform, Increased Oversight of Hospitals, Contract Pharmacies

(4/24, Dave Muoio, Fierce Healthcare) ...A new report on the 340B Drug Pricing Program released Thursday by the chairman of the Senate Health, Education, Labor and Pensions Committee calls for "much-needed" legislative reforms around transparency and oversight of the contentious discount program...PhRMA, the lobbying group representing drugmakers, applauded the senator's report and calls for reformative legislation. In a statement, PhRMA Senior Vice President of Public Affairs Alex Schriver said the finding adds "to the mounting evidence on how big, tax-exempt hospitals, as well as for-profit contract pharmacies and drug middlemen, exploit the system," which it said raises costs for patients, payers and taxpayers alike... Full

If CMS Takes Over 340B, Will Government Allow Rebate Model Changes?

(4/24, Cathy Kelly, Pink Sheet) ...Signs the Trump Administration will shift regulatory oversight of the 340B outpatient drug discount to the US Centers for Medicare and Medicaid Services may be good news for manufacturers. The Trump Administration outlined plans for moving control of the program from the Health Resources and Services Administration's Office of Pharmacy Affairs in a preliminary federal budget proposal for fiscal year 2026 that would shutter the agency... Global Sub. Full

Only Two-Thirds of FDA-Approved Biosimilars Have Launched, Report Finds

(4/24, Zachary Brennan, Endpoints News) ...As President Donald Trump has sought to speed the development and approval of new biosimilar competition to expensive biologics, only 66% of FDA-approved biosimilars have actually been commercialized, more than a decade since the agency began approving them, a new Samsung Bioepis quarterly report found. The launch tally includes 10 new FDA biosimilar approvals in the first quarter of 2025 and five new launches, for 48 commercializations out of 73 approvals. Even still, blockbusters like AbbVie's Humira and Amgen's Enbrel have continued to thwart any major competition, as biosimilars to their cash cows first won FDA approval starting in 2016... Sub. Req’d

With the FDA in Turmoil, The ‘Revolving Door' With Industry is Spinning Faster

(4/25, Allison DeAngelis, Jason Mast, and Elaine Chen, STAT+) ...Scores of FDA employees are searching for an exit from an agency in turmoil, particularly staff members tasked with reviewing drug applications, according to interviews with former employees and industry recruiters. Many of those joining the exodus were protected from the layoffs that hit the agency earlier this month, but their work environment has become morose, and cuts to other departments are making it more difficult to do their jobs... Sub. Req’d

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

(4/24, Sue Sutter and Derrick Gingery, Pink Sheet) ...Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior drug quality inspection officials are retiring. The loss of institutional knowledge will make agency inspections tougher to conduct and complicate industry's ability to respond to inspections, experts said...John Claud, counsel at Hyman, Phelps and McNamara in Washington, DC, said the OII leadership retirements are also a loss for the pharmaceutical industry. "Drug facility inspections and drug quality issues are really complex scientific, evidentiary, circumstantial regulatory issues. There's almost no end to the degree of knowledge that one needs to have to sort of help navigate those types of potentially complex" situations, Claud said in an interview... Global Sub. Full

Mississippi Court Blocks GoodRx, CVS Discount Plan at Pharmacies

(4/24, Nyah Phengsitthy, Bloomberg Law) ...GoodRx Inc., CVS Pharmacy LLC, and Inside Rx LLC are temporarily blocked from forcing independent pharmacies in Mississippi to accept discount card programs, a state court ruled. GoodRx and the two pharmacy benefit managers violated a Mississippi law when it compelled independent pharmacies to accept discount cards without their permission, Mississippi's Chancery Court of Harrison County ruled in an order filed Thursday... Sub. Req’d

Senate OKs Board to Review, Limit Prices of High-Cost Medicines, But House May Block

(4/24, David Eggert, Crain's Detroit Business) ...A split Michigan Senate voted Thursday to create a state board that would review the affordability of some prescription drugs and be empowered to cap what patients and health care systems pay for them..."Prescription drug affordability boards are a disaster for patients," Stami Turk, PhRMA's public affairs director, said. "These bills put the government between patients and their doctors. They give unelected bureaucrats a veto pen over the medicine or the treatments doctors prescribe and patients need. Worse yet, they force taxpayers to foot the bill."... Sub. Req’d

Belgium Warned Not to Let ‘Pharma Valley' Become a ‘Pharma Desert'

(4/25, Nicole Verbeeck, Euractiv) ...The spectre of President Donald Trump's pharma tariffs is stalking Belgium, which is facing a strategic reckoning over the future of its pharmaceutical sector. During a parliamentary debate on April 22,, Belgian MP Irina De Knop (Open Vld) pressed Health Minister Frank Vandenbroucke on the government's long-term vision for the industry, warning that international headwinds and domestic policies threaten a pillar of Belgium's economy... Full

Health Committee Gears Up to Approve a Packed Agenda for the Legislative Term

(4/25, Thomas Mangin, Euractiv) ...The European Parliament's Health Committee (SANT) plans to work on more than 15 topics during its mandate in addition to major files such as the pharma package or the Critical Medicines Act, the draft work programme obtained by Euractiv shows...The programme also foresees transforming the implementation study on the EU Beating Cancer Plan into a full report. Another report will focus on cardiovascular diseases, supported by a newly launched working group of 16 MEPs set up on Wednesday... Full

Pfizer Warned Taoiseach Against EU Pharma Reform Plans

(4/24, Jack Power, The Irish Times) ...Pharmaceutical companies have stepped up pressure on the Government to push back against proposed new regulations of the sector, which pharma giant Pfizer privately warned could damage the Irish economy...EU states are due to vote on the contested aspects of the new pharma regulations, potentially in June. A compromise being negotiated in Brussels is understood to scale back the changes, to make them more acceptable to industry. Pharma giant MSD also pressed the Government to argue against the reforms, correspondence shows... Sub. Req’d

Trump's Tariffs Threaten Ireland's Pharma Fortune

(4/14, John Gapper, Financial Times) ...While tariffs are not the usual method for achieving corporate tax reform, they might work. Having transferred licences and intellectual property rights into Ireland to minimise US profits, pharma companies cannot simply bring them back to reduce tariffs on their Irish exports...It will be easier to divert fiscal flows than to close Irish factories and build US ones. Not only would the latter take longer and require faith that Trump will not change his mind but Ireland is a production hub for the EU... Sub. Req’d

China Exempts Some Goods from US Tariffs to Limit Trade War Pain

(4/25, Andrew Silver, Trixie Sher Li Yap and Brenda Goh, Reuters) ...Pharmaceutical companies in China are reporting that they have been able to import some drugs over the past week with tariff exemptions, the Beijing-based American Chamber of Commerce said on Friday. The move, if confirmed, could be a sign that Chinese authorities are prepared to be flexible to try to mitigate the impact of an ongoing U.S.-Chinese trade war. China's commerce ministry did not immediately respond to a request for comment... Full

MSMEs Poised to Capture Global Generics & Biosimilars Markets Through Collaborative Efforts: FPME

(4/25, Shardul Nautiyal, Pharmabiz.com) ...Amid evolving global trade dynamics and geopolitical shifts, the Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) underscores the increasing significance of Indian pharmaceutical companies and MSMEs in shaping the future of global healthcare. Dharmesh Kharwar, joint secretary of FPME and director of NGB Laboratories Pvt Ltd, highlighted the industry's collaborative push to register generics and biosimilars in key international export markets... Full

Brazil's ANVISA Clarifies Registration Procedures For Biologicals

(4/24, Francesca Bruce, Pink Sheet) ...Brazil's drug regulator, ANVISA, wants to make it easy for drug companies to register their biologics in the country and make post-registration changes. It has updated guidelines on existing registration and post-registration procedures. The new technical note incudes new drug registration subject codes... Global Sub. Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.