Monday, February 10, 2025

Sanofi, AstraZeneca Back Teva's Call to Rehear Case On Patent Listings

(2/7, Nicole DeFeudis, Endpoints News) ...Sanofi, AstraZeneca and two leading trade groups want clarity around an appellate decision that called for Teva to delist five inhaler patents from the FDA's Orange Book. The drugmakers, along with PhRMA and BIO, argued that the December opinion could sow confusion around the current patent system. They filed briefs this week supporting Teva's request for a rehearing before the full US Court of Appeals for the Federal Circuit... Full

Medincell: Completion of the Pivotal Phase 3 Trial for Olanzapine LAI in Schizophrenia Conducted by Teva Pharmaceuticals

(2/10, Medincell) ...Medincell to receive a $5 million development milestone payment from Teva with SOLARIS study completion (last patient last visit) Richard Malamut, Chief Medical Officer at Medincell comments: "Our partner is advancing the clinical development of the olanzapine LAI with plans for regulatory submission in the US. This structured approach highlights a strong commitment to addressing a critical unmet need. As a result of Medincell technology, a long-acting injectable formulation of olanzapine may be widely used by patients with schizophrenia."... Full

Axsome Therapeutics Announces Settlement Agreement Resolving AUVELITY® (Dextromethorphan HBr – Bupropion HCl) Patent Litigation

(2/10, Axsome Therapeutics, Inc.) ...Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of AUVELITY beginning on or after March 31, 2039, if pediatric exclusivity is granted for AUVELITY, or on or after September 30, 2038, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. In accordance with the agreement, the parties will terminate all ongoing litigation between Axsome and Teva regarding AUVELITY patents pending in the U.S. District Court for the District of New Jersey... Full

Sun Pharma: Don't Call Us, We'll Call You On Biosimilars

(2/7, Dean Rudge, Generics Bulletin) ...Sun Pharma appears to be growing jaded with questions about the firm's potential investment in biosimilars, stressing that allocating R&D spend correctly - currently in generics and, increasingly, specialty products - would always be at the heart of its decision-making. "Every quarter, we come back to this question," said Sun's managing director, Dilip Shanghvi, speaking during the firm's financial third quarter earnings call..."I think for us the question is where do we allocate the R&D spend?" Shanghvi noted. "Because we have a finite amount of money that we can invest in R&D - so speciality, generics, and whether we can also invest in creating a biosimilar pipeline."... Global Sub. Full

Natco Pharma Gets USFDA Nod for Tablets Used for Treating High Blood Pressure in Lungs

(2/10, CNBC TV-18) ...The tablets in the strength of 32mg are the generic version of Tracleer...Natco Pharma believes it holds the sole First-to-File status for this product, making it eligible for a 180-day exclusivity period upon launch. However, the company has kept launch details confidential... Full

US FDA Approves AbbVie-Pfizer's Treatment for Intra-Abdominal Infections

(2/7, Christy Santhosh, Reuters) ...AbbVie said on Friday that the U.S. Food and Drug Administration approved its drug for complicated intra-abdominal infections, including those caused by drug-resistant bacteria...AbbVie said Emblaveo can be used to treat IAIs, including those caused by Gram-negative bacteria that have developed a high resistance to antimicrobial medicines... Full

Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of America

(2/10, Bio-Thera Solutions) ...Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506. Intas Pharmaceuticals, through its US-specialty division Accord BioPharma, will be responsible for commercializing the product in the United States of America. Bio-Thera will receive an upfront payment of $21 million USD, as well as further development and commercial milestones of up to $143.5 million USD... Full

Generics Advocates: Tariffs Won't Bring Drug, API Production Onshore

(2/7, Jessica Karins, Inside Health Policy) ...AAM CEO John Murphy has previously warned tariffs could disrupt the global supply chain for pharmaceuticals and worsen drug shortages. But as medical product manufacturers push for exemptions to tariffs, generic drug advocates are also warning that making foreign-sourced drugs less accessible wouldn't boost production in the United States... Sub. Req’d

Trump And Tariffs Top Generic Industry Concerns

(2/7, Dave Wallace, Pink Sheet) ..."To be sure, proposed tariffs that might impact our supply chain would benefit no one and produce very little in terms of US advantage," Murphy said during his opening address to the conference. "In fact, poorly planned and executed tariffs could decimate portions of our industry in the United States and significantly harm patient care and hamper US healthcare security."... Global Sub. Full

Tipping Point: Tariffs Create Uncertainty, Risk Long-Term Price Increases, Shortages

(2/7, Sue Sutter Pink Sheet) ...President Trump's 10% tariff on goods imported from China includes finished dosage forms and active pharmaceutical ingredients. Although price increases and shortages are not expected in the short term, in the long term manufacturers could drop product lines if they cannot absorb the extra costs. As with the congressional debate over the BIOSECURE Act, the tariffs should force pharmaceutical manufacturers to re-evaluate the need for a more diverse supply chain... Global Sub. Full

The US Relies On China for Key Medicines. They Won't Be Spared from Tariffs

(2/8, Joseph Choi, The Hill) ..."The Chinese market is a key supplier for key starting materials and [Active Pharmaceutical Ingredient (API)] to the generic supply chain," said John Murphy, president and CEO of the Association for Accessible Medicines (AAM)...The margins for manufacturing generic drugs are razor-thin, and any disruptions to the supply chain are apt to cause shortages or delays... Full

Here's How Trump's Tariffs On China Could Impact Drug Pricing and Other Healthcare Costs

(2/10, Alec Schemmel, FOX News) ...A survey by market research group Black Book Research found that 84% of the healthcare consumers they questioned said they expect to see higher costs due to increased pricing on medical treatments and drugs as a result of Trump's new tariffs. But health policy expert Chris Pope posited that healthcare is "not a very highly tradable sector" and that the sectors that do rely on trade relations, like pharmaceutical drugs or medical devices, will hinge on the magnitude of any Trump tariffs... Full

Trump is Unlikely to End Medicare Drug Price Talks — Here's What That Means for Patients and Pharma

(2/10, Annika Kim Constantino, CNBC) ...President Donald Trump likely won't do away with a process that allows Medicare to negotiate drug prices with manufacturers, even as he erases Joe Biden's other policy accomplishments. But Trump will likely make some changes to those price talks, and it may not require help from Congress. Trump could either weaken the negotiations in a way that bodes well for the pharmaceutical industry, or try to achieve even deeper savings for patients and the federal government to outdo his predecessor... Full

PhRMA Pegs Key Areas To Hike Transparency In Drug Price Negotiations

(2/7, Maaisha Osman, Inside Health Policy) ...The pharmaceutical lobby group tells IHP transparency could be improved in the agency's application of the bona fide marketing standard to determine when generic competition is available, selection of therapeutic alternatives, evaluation of real-world evidence, and selection of studies used to determine the maximum fair price for selected drugs... Sub. Req’d

Budzinski Introduces Legislation to Increase Competition and Lower Prescription Drug Costs

(2/7, U.S. Representative Nikki Budzinski) ...Today, Congresswoman Nikki Budzinski (IL-13) introduced the Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act, which would discourage pharmaceutical companies from parking their exclusivity on a generic drug application... Full

User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says

(2/7, Nielsen Hobbs, Pink Sheet) ...Speaking at the Association for Accessible Medicines' annual meeting in Amelia Island, FL, Gottlieb told the audience of generic industry executives that "my recommendation to industry leaders when they've asked me about this was to try to get some language inserted into the reconciliation bill that's going to pass early this year that extends out the current user agreement at the current funding levels for another year or two."... Global Sub. Full

More From Access 2025

(2/7, Bob Pollock, Lachman Consultants) ...There were a lot of great speakers at Access 2025, the Association for Accessible Medicines (AAM) annual meeting held from February 3rd to 5th. Here are a few of some of the most interesting topics that were discussed in fireside-chat formats... Full

Seizing Intellectual Property for Medicines Is Not a Path to Prosperity

(2/10, Kirsten Axelsen and Peter Pitts, RealClearHealth) ...Since healthcare is among the biggest costs to the federal government, it is reasonable to evaluate what is spent on medical care and to consider policies and regulations to root out waste. However, the re-emergence of proposals to take away intellectual property for drugs is counterproductive; they do not reduce costs, and invoking these policies would inform investors in a leading U.S. industry, that they should find a better place for their money. At the same time, China has strengthened its intellectual property and is now home to over one-quarter of new drug development worldwide. Weakening intellectual property is not on the path to health and prosperity... Full

FL Judge Cites FDA Role As He Dismisses Novo Compounding Lawsuit

(2/7, Jessica Karins, Inside Health Policy) ...A federal district court said it is FDA's role, not the states, to regulate compounding as it dismissed a lawsuit filed by Novo Nordisk against compounders of its semaglutide GLP-1 drugs, boosting compounders' stance that only FDA has the authority to enforce federal drug law. The court said the company didn't have grounds for the claim compounders violated the state's unfair trade practices law... Sub. Req’d

Trump's 10-for-1 Order Puts Pressure On FDA to Find Regulations to Nix

(2/7, Feredous Al-Faruque, Regulatory Focus) ...President Donald Trump's order requiring the removal of 10 regulations, rules, or guidances for each new one issued will put administrative pressure the US Food and Drug Administration (FDA) and other federal health agencies. Experts who spoke to Focus said this could lead to a more frugal stance from regulators when it comes to promulgating new regulations and guidance... Full

Major FDA Staff Cuts Would Slow Drug Reviews, Experts Say

(2/7, Zachary Brennan, Endpoints News) ...While staff cuts or other significant workforce disruptions via an executive order could ensnare thousands of FDA employees, according to a report by the Wall Street Journal, experts told Endpoints News they don't expect cuts to hit those who are paid by industry user fees. But even a reduction in other FDA staff could still create problems with drug reviews... Full

Switching to Biosimilars Could Save £1Bn Over Five Years, Says NHS England

(2/7, Sophie Willis, The Pharmaceutical Journal) ...Commenting on the guidance, a spokesperson for NHS England told The Pharmaceutical Journal on February 6, 2025 that "there is an opportunity with biologic medicines to save £1bn over five years by rapidly taking up new biosimilar drugs that have, or will shortly be available, on the UK market"... Full

India's Pharma Exports Set to Reach $350 Billion by 2047, Report Finds

(2/10, Express Pharma) ...This growth is expected to position India as the healthcare custodian of the world, contributing to the vision of a Viksit Bharat. While India is the largest supplier of generic drugs globally, accounting for one in five generic drugs sold worldwide, the country currently ranks 11th in terms of export value. The report suggests that by innovating and diversifying its export basket, India can secure a position among the top five nations in export value by 2047... Full

India Needs to Develop Strategies to Mitigate the Impact of USAID Funding Freeze

(2/8, Nandita Vijayasimha, Pharmabiz.com) ...Sachin Marihal, co-founder and chairman, SaSPinjara Life Sciences, a technical and business consultation provider, told Pharmabiz that there is a need to devise strategies to mitigate the impact of USAID funding freeze on Indian pharma companies. Here companies should look to diversify their funding sources beyond US government aid. Exploring partnerships with other governments, international organisations, and private donors is important... Full

China Deepens Comprehensive Reform to Strengthen Drug, Medical Device Regulation

(2/7, The Pharma Letter) ...China has issued a guideline on comprehensively deepening the reform of regulation of drugs and medical devices to promote the high-quality development of the pharmaceutical industry, the National Medical Products Administration (NMPA) noted on its website...It specifies that by 2035, China expects to fully ensure the safety, efficacy and accessibility of drugs and medical devices, and for its pharmaceutical industry to have stronger innovation, creativity and global competitiveness, with its regulatory system modernized... Sub. Req’d

China's Health Regulator Defends Quality of Local Generic Drugs

(2/9, Brenda Goh, Reuters) ...China's healthcare regulator on Sunday (Feb 9) defended the efficacy of off-patent medicines it had approved to be distributed through the country's public hospitals, saying an investigation into quality concerns had found them to be unsubstantiated. In an interview with the state-backed People's Daily newspaper, the National Healthcare Security Administration (NHSA) said it performed evaluations to ensure that so-called generic drugs were consistent with the quality and efficacy of original research drugs and strictly supervised them after approval... Full

Study Says Generic Drugs are as Effective as Branded Ones

(2/10, Li Yan, China Daily) ...A recent investigation by Chinese healthcare and drug regulators has found that generic drugs purchased through the country's bulk procurement programs are as effective as their original versions, and concerns about quality issues primarily stem from isolated cases or subjective experiences... Full

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