Monday, May 11, 2026

 

 

Revisiting Pharma's Tariff Reality

(5/8, Fraiser Kansteiner, Ayla Ellison, Fierce Pharma) ...In this episode of "The Top Line," Fierce Pharma's Fraiser Kansteiner sits down with Chris Young, a principal in KPMG's trade and customs practice, to discuss the pharma tariff landscape following President Donald Trump's announcement in early April of a potential 100% tariff on imported drugs. Young explains how the policy could affect smaller drugmakers that haven't inked high-profile pricing deals with the government and shares best practices for navigating the rapidly evolving U.S. trade environment... Full

 

Patients Should Not Have to Wait Until 2028 for Accountability

(5/8, Justin Leventhal, RealClearHealth) ...When pricing is visible PBMs that lower costs win business, and those that rely on hidden margins lose it. Fixing the problem means shedding light on this industry. Before federal requirements go into effect, state legislators can still act to require transparency from PBMs operating within their borders, including clear reporting on rebate pass-through and their prioritization of generics and name brands. Patients should not have to wait until 2028 for accountability... Full

 

A Look at the GENEROUS Model and Factors That Could Impact Medicaid Drug Costs

(5/8, Elizabeth Williams, Robin Rudowitz, and Rhiannon Euhus, KFF) ...This issue brief provides background on the GENEROUS model, examines the factors that will contribute to the model's overall impact on Medicaid drug costs, and illustrates how savings will depend on model details that are confidential or uncertain at this time... Full

 

Trump Is Planning to Fire FDA Commissioner Marty Makary

(5/8, Liz Essley and Josh Dawsey, Wall Street Journal) ...Asked late Friday about Makary's possible departure, Trump said: "I know nothing about it." Trump's plan isn't yet final and could change. "President Trump has assembled the most experienced and talented administration in history, an administration that continues to focus on delivering more historic victories for the American people," said White House spokesman Kush Desai... Sub. Req'd

 

Editorial: Marty Makary's Fatal Mistakes

(5/8, The Wall Street Journal) ...Removing Dr. Makary is a necessary step to remedy a toxic culture that has taken hold at the FDA. Whomever Mr. Trump taps to take over will have his work cut out repairing the damage. One place to start is reversing the agency's arbitrary and callous rejections of rare disease and cancer treatments. There's no time to waste for patients today and tomorrow... Sub. Req'd

 

 

Johnson & Johnson Advances Dual-Pathway Strategy in Refractory IBD

(5/8, Emily Schoenthaler, BioPharm International) ...Johnson & Johnson has reported Phase 2b results for its investigational co-antibody therapy JNJ-4804, suggesting potential clinical benefit in patients with highly refractory inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD). The data, presented at Digestive Disease Week 2026, add to growing interest in combination biologic strategies for patients who fail multiple advanced therapies... Full

 

Johnson & Johnson Launches 'Generation Fine' Depression Project

(5/8, Ben Adams, Fierce Pharma) ...The new global campaign plays on the idea that many people with depression will say they are "fine," despite struggling with the condition. J&J is also highlighting a new 850-person survey tied to the campaign that found nearly four in five patients living with major depressive disorder (MDD) "don't believe antidepressants will help them reach remission."... Full

 

 

Who's Hired? Viatris Begins Search For New CFO

(5/8, Dave Wallace, Generics Bulletin) ...Teva has appointed Marjana Senk Erminio as its global brand director for biosimilars. Erminio previously served at Santen Pharmaceutical as marketing director for ophthalmology and glaucoma in the Europe, Middle East and Africa region, before which she worked at Astellas as associate director of omnichannel strategy and capabilities for EMEA... Global Sub. Full

 

Sandoz CEO Says Size of Weight-Loss Generics Market Is Unknown

(5/8, Adria Calatayud, The Wall Street Journal) ...Switzerland's Sandoz aims to launch its own generic version of semaglutide in Canada and Brazil this year, Saynor said..."I describe our launches in Brazil and Canada as an experiment to see how the markets evolve, what are the price points, how different patient segments will want different products, how the governments react to this product," Saynor said... Sub. Req'd

 

GLP-1 Patent Expiry & the Rise of Generics: Transforming the Drug Delivery Device Landscape & Procurement Strategy

(5/8, S. Akila, PharmExec.com) ...From a MedTech perspective, the implications are profound. Drug delivery devices, which were previously optimized for premium, low-volume markets, must now adapt to a high-volume, cost-sensitive environment. This shift is particularly relevant for procurement functions, which must balance cost efficiency with supply reliability in the face of increasing demand and constrained manufacturing capacity... Full

 

Sandoz on the Future of Generics and Biosimilars in Europe

(5/11, Eloise McLennan, PharmaPhorum) ...Last month, at Reuters Pharma Europe in Barcelona, Deep Dive editor Eloise McLennan sat down with Claire D'Abreu-Hayling, president of generics development and chief scientific officer at Sandoz, to explore the promise of this so-called "golden decade" of patent expiry for the sector, as well as the structural factors that can keep medicines costly for longer, and what this means for patients across Europe... Full

 

Biocon Eyes In-Licensing to Boost Biosimilars Portfolio, Targets Margin Expansion

(5/9, Anjali Singh and Sohini Das, Business Standard) ...Biocon is actively scouting for in-licensing opportunities in biosimilars as the company looks to leverage its expanding global commercial footprint to strengthen its therapy franchises, managing director and chief executive oficer (MD & CEO) Shreehas Tambe said on Thursday. "We have built capabilities across several markets and are actively looking for synergistic opportunities. "We continue to scout for such opportunities to strengthen our presence in our franchise," Tambe told journalists... Full

 

Lupin Is Betting on Complex Generics and Biosimilars for Growth. Here's Why

(5/8, Neetu Chandra Sharma, Business Today) ..."America continued to do very well because of the products that we introduced in recent times, which include Tolvaptan and Mirabegron, and before that Spiriva and Albuterol," Ramesh Swaminathan, Executive Director, CFO, Lupin told Business Today. Lupin's India business also reported growth across cardiovascular, diabetes and respiratory therapies. "In the last quarter, we grew by 14.5%, much above the industry growth rates," Swaminathan said... Full

 

Biosimilar Streamlining Means All Should 'Reach The Fruits'

(5/11, Dean Rudge, Generics Bulletin) ..."I introduced this topic in the agenda of the 2016 conference," recalled moderator Mina Grguri, senior officer of regulatory and science for biosimilars at Medicines for Europe. "Here we are a decade later, and since then there has been a growing body of scientific evidence and publications that have been accumulated by industry, the healthcare community and the global regulatory community."..."Now we can say that development without a comparative efficacy study - or the streamlined approach - has emerged as the most prominent regulatory evolution," Grguri underlined... Global Sub. Full

 

Bristol Myers Squibb Accused of Buying Off Competitors to Delay Development of Generic Cancer Drugs

(5/8, Josh Russell, Courthouse News Service) ..."Having made a laughingstock out of the distribution of lenalidomide in the United States, Celgene and Bristol Meyers Squibb are simply reaping the rewards from their successful market allocation," Centene Corporation wrote in its 235-page complaint... Full

 

 

Angelini to Buy Catalyst in $4B Play for Rare Neuro Drugs

(5/7, Gwendolyn Wu, BioPharma DIVE) ...As part of the deal, Angelini plans to "integrate Catalyst's portfolio and exceptional commercial infrastructure with its own expertise and products in brain health to develop a next-generation therapeutic platform in rare diseases." Angelini is currently studying a potential epilepsy medicine in three clinical trials... Full

 

How AstraZeneca Plans to Hit $80 Billion in Revenue and Expand in the U.S.

(5/11, Mark Maurer, The Wall Street Journal) ...The pharmaceutical giant has made progress on a pipeline of more than 25 medicines, each expected to generate more than $1 billion in revenue by the close of the decade, Chief Financial Officer Aradhana Sarin said. AstraZeneca hopes those drugs, along with new U.S. manufacturing investments and a direct listing of its shares in New York, will fuel growth... Sub. Req'd

 

Odyssey's CEO Sees $304M IPO as Chance to Create a 'Little Large Pharma'

(5/8, James Waldron, Will Maddox, Fierce Biotech) ...Odyssey's second venture has proved more successful, with the biotech today offering 15.5 million shares-above the 13.2 million shares it had predicted earlier this week. With the shares priced at $18-the top end of its anticipated range-the company expects to bring in gross proceeds of $304 million from the IPO. However, this figure also includes an adjacent private placement of 1.4 million shares to an affiliate of TPG Life Sciences Innovations... Full

 

Kiran Mazumdar-Shaw Says She Rejected 'Too Good to Refuse' Offers for Biocon, Syngene

(5/8, Ekta Batra, CNBC-TV18) ..."Many offers have been made to me personally for both companies, and many would have considered them offers too good to refuse. But I have refused them because, to me, these are businesses that need to be built as long-term global businesses that are hugely profitable and sustainable. That's the legacy I want to leave," [Kiran] Mazumdar-Shaw said."Many offers have been made to me personally for both companies, and many would have considered them offers too good to refuse. But I have refused them because, to me, these are businesses that need to be built as long-term global businesses that are hugely profitable and sustainable. That's the legacy I want to leave," Mazumdar-Shaw said... Full

 

Fortune India Exclusive: The Next 10 Years Will Be About High-Value Innovation, Says Kiran Mazumdar-Shaw

(5/10, Joe Mathew, P B Jayakumar, Fortune India) ...My whole mantra is affordable innovation and access, so I am very proud that we have actually achieved a lot of our objectives. The future is of course even bigger, because I really want to make sure that even in biosimilars we innovate to differentiate... Full

 

Lupin's US Business to Stay Above $1 Billion; Biosimilars and Specialty Portfolio to Drive Growth

(5/8, Ektra Batra, CNBC TV-18) ...Ramesh Swaminathan, ED & Global CFO at Lupin, said the company expects margins to remain around 25% for the full year, supported by strong performance from products such as Tolvaptan and Mirabegron. However, he noted that rising freight costs and the possibility of future competition in key US products could create some pressure on margins... Full

 

FDA Claims There's No Estrogen Patch Shortage as Women Struggle to Get Prescriptions Filled

(5/10, Kaitlin Sullivan, NBC News) ...The FDA chief, Dr. Marty Makary, said Tuesday that the agency's move to remove the black box warning label for hormone therapy in November prompted a tremendous increase in demand for estrogen patches, but not enough to cause a shortage. "The industry has been able to keep up but barely," Makary said in an interview. "They are recalibrating their distribution and manufacturing to have more robust supply. In the interim, the estrogen patches have not risen to the criteria of being on the shortage list, but it is something to manage."... Full

 

Synthon Invests In R&D Expansion

(5/8, Dave Wallace, Generics Bulletin) ..."Synthon is expanding its R&D capabilities through a new project at its 'Pilot Plant 3' facility," the firm revealed. As part of this initiative, Synthon said, the company "is acquiring a synthesiser for oligonucleotide synthesis." Synthon said the project "supports the development of generic active pharmaceutical ingredients and strengthens Synthon's development infrastructure."... Global Sub. Full

 

Alteogen Posts Strong Q1 Earnings on GSK, Biogen Licensing Deals

(5/8, Hong Sook, Korean Biomedical Review) ...In a preliminary earnings announcement on Friday, Alteogen reported consolidated first-quarter revenue of 71.6 billion won ($48.7 million), operating profit of 39.3 billion won and net profit of 71.3 billion won... Full

 

Alvotech Announces Completion of FDA Surveillance Inspection at Reykjavik Facility

(5/11, Alvotech) ...At the conclusion of the inspection on May 8, 2026, the FDA issued a Form 483. The company believes the observations can be addressed quickly and do not raise any substantial issues with the site or its operations... Full

 

'Pharma, Not Really': Why AI's Top Young Talent Isn't Interested in a Career at Big Drugmakers

(5/8, Andrew Dunn, Endpoints News) ...The biopharma industry's absence at these major events is in sharp contrast to how C-suite leaders at big drugmakers pontificate about AI, with a giddy enthusiasm for how it will reinvent every part of their businesses. Pharma may talk up AI to investors and the public, but it's largely absent from the recruiting groundwork to lure in top talent... Sub. Req'd

 

 

Germany's Healthcare Reforms Herald More Pain for Big Pharma

(5/9, Sonja Wind, Bloomberg) ...The backlash has been swift. In a heated Bundestag debate in Berlin on Thursday, opposition lawmakers blasted Merz's government for placing too much of the burden on workers, while others argued the measures don't go far enough in reducing costs, including cutting spending on medicines... Full

 

CDSCO Asks Firms to File Safety Reports From Launch Date of New Drugs

(5/10, PTI) ...India's drug regulator has directed manufacturers and importers to submit Periodic Safety Update Reports (PSURs) for new drugs from the date of actual marketing of the product rather than from the date of regulatory approval, in a move aimed at strengthening post-marketing safety surveillance... 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.