Tuesday, June 3, 2025

'Why Wouldn't You Use This?': Teva Plots $2Bn LAI Schizophrenia Franchise

(6/2, Dean Rudge, Generics Bulletin) ...Teva is aiming to build a long-acting injectable schizophrenia franchise worth between $1.5bn and $2bn in annual sales at its peak, bolstered by a high unmet need and poor adherence for oral medications, which is set open up a meaningful market opportunity in the coming years for the technology platform it is commercializing via MedinCell...Eric Hughes, Teva's head of global R&D and chief medical officer, said at the time that, based on the company's clinical findings, the company's TV-44749 olanzapine candidate was "night and day" compared to its main competitor. "We think we have a really unique opportunity to have a best-in-class LAI franchise, anchored to these well-established molecules," commented Christine Fox, Teva's US commercial head, speaking during the firm's 29 May Innovation & Strategy Day presentation... Global Sub. Full 

Bristol Myers to Pay $1.5 Billion Upfront for BioNTech Cancer Drug Partnership

(6/2, Reuters) ...Bristol Myers Squibb has agreed to pay up to $11.1 billion to partner with Germany's BioNTech and develop the latter's next-generation cancer immunotherapy, which could take on rival Merck & Co's best-selling drug Keytruda. The deal, which includes $3.5 billion in unconditional payments, underpins BioNTech's ambition to continue a costly long-term focus on experimental cancer treatments and show that its success as Pfizer's COVID-19 vaccine partner was not a one-off achievement... Sub. Req’d

Merck Held Talks to Buy Biotech MoonLake for over $3 Billion, FT Reports

(6/2, Reuters) ...Merck has held talks to buy Swiss biotech MoonLake Immunotherapeutics for more than $3 billion, the Financial Times reported on Monday, citing three people familiar with the matter. MoonLake's shares rose 19% in extended trading. Merck submitted a nonbinding offer for MoonLake earlier this year, according to the, which added that the initial approach was rejected but talks could be revived... Sub. Req’d

Q&A: Sandoz CEO Richard Saynor on Generic GLP-1s, Trump's Industry Impact, and Mark Cuban's Company

(6/3, Andrew Dunn, Endpoints News) ...In a wide-ranging interview with Endpoints News, Saynor shared his views on President Donald Trump's impact on the industry, preparing for the launch of generic GLP-1s, and whether Mark Cuban Cost Plus Drug Company actually competes with generic drugmakers... Sub. Req’d

Parents Sue Over Son's Asthma Death Days After Inhaler Price Soared Without Warning

(6/3, Jason Kane, Anne Thompson and Linda Carroll, NBC News) ...The Schmidtknechts are pushing for legislation that would require a 90-day warning when an insurance company's formulary is changed. They are also suing Optum Rx, the PBM that took Cole's Advair Diskus off his insurance company's formulary, and Walgreens, his pharmacy, which, the Schmidtknechts say, didn't offer Cole a way to control his asthma while another solution could be found... Full

Interchangeable Denosumab Biosimilars Jubbonti, Wyost Now Available

(6/2, Diana Ernst, Rph, MPR) ...Jubbonti® (denosumab-bbdz) and Wyost® (denosumab-bbdz), interchangeable biosimilars to Prolia® (denosumab) and Xgeva® (denosumab), respectively, are now available from Sandoz... Full

Teva's Layoffs Signal Deeper Fault Lines In The Pharmaceutical Business Model

(6/2, Rita Numerof, Forbes) ...It reveals a deep challenge facing generics manufacturers in the U.S. and globally: the current market structure does not reward the cost-saving potential of generic or biosimilar drugs. Instead, it privileges the profit margins of expensive branded medications... Full

 

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

(6/2, Anju Ghangurde, Generics Bulletin) ...Sun's CEO (North America) Abhay Gandhi indicated that Leqselvi is slated for launch in the second quarter of the current fiscal year and the company still believes the product is "competitive," though the "time to expected peak will move a little."..."The attempt of the team will be to try and make up for this lost time by increasing the focus and investment on the product to try and mitigate it to the extent that we can," Gandhi said on the earnings call for the fourth quarter of fiscal year 2025... Global Sub. Full

Indoco Remedies Subsidiary Launches Generic Drug in UK

(6/3, Press Trust of India) ...Indoco Remedies UK Ltd has launched Ticagrelor film-coated tablets 90mg in the UK, the Mumbai-based drug maker said in a regulatory filing... Full

Amid Rough Waters, Regeneron Puts Nearly $2B on the Line For Chinese Obesity Drug

(6/2, Dan Samorodnitsky, BioSpace) ...Regeneron's shares have declined nearly 17% following the failure of the company's Dupixent follow-up itepekimab. Regeneron is throwing itself into the obesity market, licensing a dual GLP-1/GIP receptor agonist from the Chinese biopharma Hansoh Pharmaceuticals Group. The deal comes after Regeneron's pipeline suffered a body blow last week on mixed results for its Sanofi-partnered Dupixent follow-up. The deal will see Regeneron work with Hansoh on the late-stage GLP1/GIP agonist HS-20094... Full

Trump's MFN Push Sparks Concerns For Generics, Biosimilars Makers

(6/2, Maaisha Osman, Inside Health Policy) ...The Trump administration's push to revive the controversial "most favored nation" (MFN) pricing policy -- alongside ongoing uncertainty around tariffs and Medicare drug price negotiations -- is creating deep uncertainty for the future of generic and biosimilar drug development in the United States, Association for Accessible Medicines (AAM) President and CEO John Murphy told Inside Health Policy in a Monday (June 2) interview... Global Sub. Full 

Trump's Tariff Threat Exposes China's Tight Grip on the Global Pharmaceuticals Industry

(6/3, John Liu, Yong Xiong, CNN) ...So far, China has made no official public threat about weaponizing its dominant position in this segment of the pharmaceutical industry. But Trump's tariffs on the sector, if imposed, could worsen existing drug shortages and drive up prices for Americans, undermining his promise to lower health care costs... Sub. Req’d

Trump's Pharmaceutical Tariffs Are Not the Right Solution for a Big Problem

(6/2, Amal Naj, Rolling Stone) ...Manufacturing innovations no doubt will help slash costs, but they will be slow and incremental. What is needed is a leapfrog to get to the goal faster. One obvious way is to strongly persuade some of the companies that export to America to move their production to the U.S. and set up modern, cost-efficient plants... Full

PBMs Fight Back Against State Restrictions

(6/3, Maya Goldman, Axios) ...The PBMs are only fighting Arkansas in the courts because they're worried other states will follow the lead of Gov. Sarah Huckabee Sanders (R) in trying to secure patient access and affordable prescriptions, Sanders' spokesman Sam Dubke wrote in an email... Full

Amid Staff Cuts, FDA Looks to AI to 'Optimise' Reviews

(6/3, Phil Taylor, pharmaphorum) ...Jeremy Walsh, who recently joined the FDA as its first chief AI officer, said Elsa would continue to be refined with new capabilities as the regulator learns how its staffers are using the tool. "AI is no longer a distant promise but a dynamic force enhancing and optimising the performance and potential of every employee," he asserted... Full

FDA's FY 2026 Budget Request Lacks New Policy Proposals

(6/2, Sue Sutter, Pink Sheet) ...Unlike previous years, the FY 2026 budget request does not propose any legislative changes. The FDA often used the annual budget process to suggest statutory fixes when it believes more authority could be useful, such as to increase drug competition and mitigate shortages... Global Sub. Full 

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

(6/2, Derrick Gingery, Pink Sheet) ...The agency's full-time equivalent employee count would drop from 20,593 in FY 2025 to 16,875 in FY 2026, if the agency's proposed budget is enacted as outlined...While the proposed cuts are significant, presidential budget requests are never enacted as submitted. Congress likely will make changes during the appropriations process... Global Sub. Full

DOGE Set Today as Their Last Day at FDA. Instead, They're Continuing to Get Full Pay and Don't Work

(6/2, Zachary Brennan, Endpoints News) ...In some cases, the employees might be costing the government more money than they were when they were working. Another to-be-fired employee who spoke to Endpoints on condition of anonymity said that while they were working for the agency, their position was funded with user-fee dollars from drugmakers. Now that they're on administrative leave, those costs are being borne by taxpayers, the person claimed... Sub. Req’d

Trump Drug Pricing Order to Have Limited Credit Impact on Indian Pharma: CRISIL

(6/2, Viswanath Pilla, Moneycontrol) ...Formulation companies with niche exposure to branded innovator drugs—currently a small slice of their revenue—may also face pricing headwinds. On the other hand, API exports, which form 15% of India's pharma exports, are expected to remain largely unaffected... Full

UK-EU Deal ‘Must Include Medicines, Not Just Sausages,' Urges Medicines UK

(6/3, Urte Fultinaviciute, Generics Bulletin) ...While resetting the EU relationship is critical as global uncertainty increases, "the ongoing negotiations must include medicines, not just sausages," wrote Medicines UK's CEO Mark Samuels on LinkedIn..."Protecting medicine supplies needs to be on a similar footing to defense," Samuels said, highlighting the UK's supply chain dependence on ingredients sourced from Europe, India, and China. "More strategic focus is required to keep supply chains running in the face of supply problems, and potentially, hybrid warfare. A partnership with the EU should support the UK's medicine supply," he added... Global Sub. Full

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