Tuesday, February 11, 2025

Axsome Secures Top Drug's Future with Teva Patent Settlement

(2/10, Ned Pagliarulo, BioPharma Dive) ...The patent settlement with Teva will ensure Auvelity remains a contributor to Axsome's business for years to come, and removes the threat of Teva entering the market earlier. The biotech has a large tranche of Auvelity patents that expire in 2034, which would have been the next line of defense if Teva had succeeded in challenging Axsome's later-dated patents... Full

Bio-Thera And Stada Nudge Closer To Limited Golimumab Biosimilar Pool

(2/10, Dean Rudge, Generics Bulletin) ...Bio-Thera Solutions has matched Alvotech with the European Medicines Agency accepting for review the Chinese manufacturer's proposed biosimilar to Johnson & Johnson's Simponi (golimumab) once-monthly subcutaneous injectable, marking another show of strength for Chinese interest in global biosimilars... Global Sub. Full

Intas' Accord Pens $165M Deal To Bring In Bio-Thera's Golimumab In The US

(2/11, Dean Rudge, Generics Bulletin) ...Intas Pharmaceuticals' Accord Biopharma unit has bolstered its US biosimilar pipeline after striking a deal to become the exclusive commercial partner for Bio-Thera Solutions' BAT2506 proposed biosimilar to Johnson & Johnson's Simponi (golimumab) subcutaneous injectable... Global Sub. Full

Biocon Moving In ‘Expedited Manner' Towards Biosimilars Approvals After Facility Clearance

(2/11, Urte Fultinaviciute, Generics Bulletin) ...Biocon Biologics' management shared updates regarding their facilities, expansion, and fast upcoming ustekinumab biosimilar launch in the US. Also, Biocon made a final acquisition payment to Viatris, while increasing its stake in the biosimilars business... Global Sub. Full

Biocon's Growth Gormula: Generics & Biosimilars

(2/11, Shilpa Phadnis and Veena Mani, Times Of India) ...Biocon is betting big on new product launches in its generics and biosimilars portfolios, which are expected to fuel its expansion in the next 2-3 years. The company is leveraging the Viatris acquisition to provide a significant boost towards an integrated biosimilars enterprise model... Full

Gland Pharma Mulls Second Site After Penning Initial Henlius Biosimilar Deal

(2/10, Dean Rudge, Generics Bulletin) ...Indian injectables specialist Gland Pharma is aiming to establish a secondary manufacturing site for some of Chinese manufacturer Shanghai Henlius Biotech's "key" biosimilar products, after signing an initial collaboration agreement with the firm that could begin to bear fruit in the coming years... Global Sub. Full

Dong-A ST Sees Profit Inch Down Amid Rising R&D Costs, Readies US Biosimilar Launch

(2/11, Kim Ji-hye, Korea Biomedical Review) ...Dong-A ST said Tuesday that its operating profit slipped 0.8 percent in 2024 to 32.5 billion won ($22.4 million) compared to a year earlier, even as revenue climbed 5.9 percent to 640.7 billion won. Net profit fell 6.3 percent to 16.2 billion won, weighed down by rising R&D and marketing expenses. The company credited its revenue growth to an expansion in prescription drug and overseas businesses, though higher spending on new product launches and pipeline development dampened profitability... Full

Boehringer Widens Fibrosis Drug's Approval Path After Boosting Lung Function in 2nd Phase 3 Trial

(2/10, James Waldron, Fierce Biotech) ...Boehringer Ingelheim has cemented the potential of its idiopathic pulmonary fibrosis (IPF) drug with a second phase 3 win in a related lung disease leading the drugmaker to expand the indications it will seek FDA approval for...Armed with the latest results, Boehringer said it will request that FDA and global regulators approve nerandomilast as a treatment for PPF, a type of interstitial lung disease... Full

Exclusive: Germany's Merck in Advanced Talks to Acquire US Biotech Firm Springworks

(2/10, Sabrina Valle, Patricia Weiss, Reuters) ...In its most recent quarterly earnings, Merck reported a 12% rise in adjusted quarterly earnings, helped by temporarily lower spending on drug development and a rebound in demand for its specialty materials. "Given Merck KGaA's existing franchise in oncology, which constitutes about 25% of its healthcare sales in 2024, we see the potential acquisition of SpringWorks as likely complementary and giving potential for synergies," analysts at JPMorgan wrote in a note... Full

Novartis Buys Blackstone's Anthos for Up to $3.1 Billion

(2/11, Ludwig Burger, Paolo Laudani and Ariane Luthi, Reuters) ...The deal underlines the Swiss group's commitment to cardiovascular therapies, one of five medical areas that it is focusing on, as its best-selling heart failure drug Entresto loses patent protection this year. The transaction, expected to close in the first half of this year, also concludes a high-profile development partnership between a drug major and a private equity firm, an emerging funding model that has been explored by the industry... Full

Decade After $8B Deal, Roche Offloads InterMune to Mysterious Specialty Pharma

(2/10, Kyle LaHucik, Endpoints News) ...Cayman Islands-based Legacy Pharma is run by Mark Thompson, the former CEO of Concordia, another specialty pharma that had a price-hiking reputation. It put out a short press release last week saying it had completed the acquisition of InterMune and the US IP rights to its idiopathic pulmonary fibrosis medicine Esbriet (pirfenidone) from Roche's Genentech for undisclosed terms... Full

Welcome Wezlana: Using Adalimumab to Predict Ustekinumab Market Potential

(2/10, Dracey Poore, The Center For Biosimilars) ...The FDA has now approved 6 additional ustekinumab biosimilars. Launches are expected for these products as early as February 2025. The Stelara market is one of the highest-grossing biologic markets in the US. According to IQVIA, the invoiced sales of Stelara in 2024 reached $17 billion. The ustekinumab biosimilars launching in 2025 plan to launch with the same indications as the Stelara product, which could provide impactful savings to the health care system. 2025 is a pivotal and exciting year for biosimilars to enhance patient access to expensive biologics in the GI space, as well as reduce the overall burden on the health care system... Full

FDA Cites Indian Ingredients Supplier for Deleting Records

(2/10, Ed Silverman, STAT+) ...The FDA warning highlights ongoing anxiety over quality control among pharmaceutical manufacturers in India, which supplies about 40% of generic drugs to the U.S. This is a significant portion, given that roughly 90% of all prescriptions dispensed in the U.S. are generics. China, however, is the world's largest producer of active pharmaceutical ingredients and supplies many companies in India... Sub. Req’d

Pharma Companies Turn to AI to Speed Up Drug Development, But Hit Hurdles

(2/10, Helena Smolak and Adrià Calatayud, The Wall Street Journal) ...Executives and industry experts caution that AI adoption is still at an early stage and that it will take time, possibly years, before its potential is achieved. Still, some big pharmaceutical companies are ramping up the use of AI to discover and develop drugs. Their hope is that the technology will help them accelerate and optimize a long and expensive process that often fails to deliver results... Sub. Req’d

Gottlieb: Industry Should Punt User Fee Talks, Seek 1-2 Year Deferral

(2/10, Jessica Karins, Inside Health Policy) ...Speaking at the Association for Accessible Medicines (AAM) conference last week, Gottlieb said his recommendation to industry leaders is to push for legislation to be added to the upcoming reconciliation bill that will extend the current user fee agreements at the same funding levels for another year or two "and try to push this debate past the current political environment, because I see nothing good coming from having this discussion in the current political environment."... Sub. Req’d

Trump's Tariff Impact Likely ‘Minimal' for Brand-Name Drugmakers, Manufacturing Partners

(2/10, Anna Brown, Endpoints News) ...Trump's tariff plans were met with immediate concern from some pharmaceutical industry groups that drug prices in the US would rise and shortages would deepen. But companies like GSK and Novo Nordisk insisted last week they're well-positioned to absorb any increases in cost, should the tariffs be imposed... Full

Experts: Tariffs, Workforce Cuts Could Derail States' Drug Import Plans

(2/10, Maaisha Osman, Inside Health Policy) ...Several states submitted plans to FDA last year to import drugs from Canada in hopes of easing the ongoing drug shortage crisis, but industry experts tell Inside Health Policy that a possible 25% tariff on Canadian imports as well as President Donald Trump's push to shrink the federal workforce would diminish the already slim chances of the plans moving forward... Sub. Req’d

Impax, Dr. Reddy's Settle Generic Parkinsons Drug Patent Dispute

(2/10, Lauren Castle, Bloomberg Law) ...The pharmaceutical companies agreed to voluntarily dismiss all allegations and counterclaims, according to a stipulation filed Feb. 7 in the US District Court for the District of New Jersey. The parties have "agreed to terms and conditions for a settlement of this action," according to the filing... Sub. Req’d

Fresenius Kabi Sues HHS Over Classification of Blood Thinner

(2/10, Ganny Belloni, Bloomberg Law) ...The lawsuit filed Feb. 7 in the US District Court for the District of Columbia claims that in September 2024, the Centers for Medicare & Medicaid Services decided to classify premixed bags of Fresenius Kabi's generic version of the intravenous blood thinner heparin as a novel or "innovator" drug, even though the agency labels the same drug in vial form as generic... Sub. Req’d

The IRA Hurts Generic and Biosimilar Medication Competition

(2/10, AAM) ...Supporters of the "price negotiation" process established in the Inflation Reduction Act (IRA) claimed that it would not harm generic or biosimilar competition. They explained that the IRA's price negotiations would take effect only when a generic or biosimilar version of a drug is not available. However, they neglected to share, or failed to realize, that the law set up a process under which a drug would have price controls applied before a generic or biosimilar even had the chance to come to market. Two recent events drive this home and reveal that IRA price controls serve only to undermine lower-priced generics and biosimilars... Full

US FDA Advisory Committee Freeze Raises Concerns Of Delayed, More Controversial Approvals

(2/10, Sarah Karlin-Smith and Sue Sutter, Pink Sheet) ...The US Food and Drug Administration is not scheduling new advisory committee meetings due to ongoing limits on agency communications, four sources told the Pink Sheet. Cancelling or postponing meetings could delay approval actions and make settling review team disagreements more challenging, and potentially lead to lower-quality decisions... Global Sub. Full

Balancing Competitiveness and Sustainability In EU Regulations, What's Next For Pharma

(2/10, Francesca Bruce, Pink Sheet) ...Pharmaceutical companies are preparing for a wave of EU regulations designed to minimize industrial harm to the climate and the environment, many of which will restrict the chemicals and technologies that industry uses. Furthermore, many new rules will come into effect around the same time, including some with conflicting objectives. This will not only negatively affect business operations and the supply of medicines, but will also increase financial and administrative pressures for pharma companies... Global Sub. Full

Swiss Pharma Industry Particularly Vulnerable to Trump Tariffs

(2/10, Swissinfo.ch) ...Pharmaceuticals account for 60% of all goods exported from Switzerland to the US. This means that significantly more medicines go to the US than are imported from there to Switzerland. It is well known that such trade surpluses are a thorn in Trump's side. The industry is therefore susceptible to tariffs, according to economists at UBS in a study published on Monday. In their opinion, such tariffs would be a problem. In the longer term, trade barriers could push pharmaceutical companies to move their production and research departments to the US. "Such a relocation would have a significant impact on Switzerland in terms of value creation and tax revenues."... Full

More Healthcare Bang for the Belgian Buck Needed, Says Vandenbroucke

(2/11, Nicole Verbeeck, Euractiv) ...Belgium's new government agreement has set an ambitious health agenda for the next legislative term while reaffirming Frank Vandenbroucke as Deputy Prime Minister and Minister of Social Affairs and Public Health... Full

New Danish Bill On Confidential Prices for Pharmacy Meds

(2/10, The Pharma Letter) ...A new bill has been presented for a pilot scheme that will allow pharmaceutical companies in Denmark to negotiate confidential prices for subsidized medicines in. Such an agreement could allow the public sector and pharmaceutical companies to negotiate discounts that ensure Danes receive subsidies for the purchase of the newest and best medicines... Sub. Req’d

NPPA Sets Prices for 42 Drugs, Revises Ceiling for 2 Formulations

(2/10, Business Standard) ...Prices have been fixed for drugs and formulations meant for diabetes, hypertension, heart issues, bacterial infections, allergies, and multivitamins, according to a notification from the Department of Pharmaceuticals and the NPPA. The body has also revised the ceiling price for two formulations: a 250 mg tablet of azithromycin and a fixed drug combination (FDC) of amoxicillin and clavulanic acid... Full

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