Tuesday, March 10, 2026

 

 

Teva Pharmaceuticals' Dipesh Patel on Building Digital Capabilities in a Trust-First Category

(3/10, Rachel Tipograph & Sarah Hofstetter, ADWEEK) ...In this episode of Brave Commerce, Rachel Tipograph and Sarah Hofstetter sit down with Dipesh Patel, senior director of digital transformation & ecommerce for global OTC at Teva Pharmaceuticals, to discuss what it takes to drive transformation in a category where trust, accuracy, and regulation shape the pace of change... Full

 

 

Trump's Rx Plan Promises Savings, but Economists See a Hidden Trade-off

(3/9, Amanda Macias, Fox News) ..."When drug prices are capped or negotiated down, companies anticipate lower returns, reducing investment in drug research and development," said Olivia Mitchell, a professor of business economics and public policy at the Wharton School. "Economic evidence shows that lower prices depress incentives to develop new drugs," she added... Full

 

Senate Dems Ask How Trump's MFN Deals Mesh With GENEROUS Model

(3/9, Gabrielle Wanneh, Inside Health Policy) ...The latest letter was sent to AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Gilead, GSK, Johnson & Johnson, Merck, Novartis and Sanofi, and the companies have until March 23 to respond to the lawmakers' inquiry... Sub. Req’d

 

FDA Unveils 4th Revision of Draft Guidance for Looser Biosimilar Testing Requirements

(3/9, Zoey Becker, Fierce Pharma) ...In its draft guidance, the FDA offers recommendations for streamlining unnecessary PK testing when "scientifically justified," a change that could save biosimilar drugmakers up to 50% of their PK study costs, which equates to about $20 million, the agency said in a press release... Full

 

FDA's Regulatory Reforms to Unlock Competition and Lower Drug Costs

(3/9, Martin A. Makary, MD, MPH1; Sarah Yim, MD1; Mustafa Ünlü, PhD, JD1 et al, JAMA) ...In lieu of recommending a CES to support a demonstration of biosimilarity, FDA recommends that sponsors consider a streamlined approach where a CES may not be necessary. Rather, a comparative analytical assessment, pharmacokinetic similarity data, and an assessment of immunogenicity may be sufficient to demonstrate biosimilarity without a CES... Full

 

Two Leaders' Views on National PBM Reform: Biosimilar and ERISA Benefits

(3/9, Stanton Mehr, Biosimilars Review & Report) ...A summary of remarks on PBM reform and the FTC–ESI settlement by speakers at last month's Association for Accessible Medicines' Access 2026 conference... Full

 

Open the Books on PBMs

(3/9, Andrew Langer, Jerry Rogers, RealClearHealth) ...Greater disclosure does not automatically lower prices, but it does create the conditions for accountability. If employers can see how their pharmacy benefits are structured—and where the money goes—they are better positioned to negotiate contracts that prioritize value and patient access... Full

 

Nonprofit Aims to Modernize Manufacturing by Clearing Capital Hurdle

(3/10, Nick Paul Taylor, BioSpace) ...At the nonprofit API Innovation Center (APIIC), CEO Kevin Webb has a possible answer for how to tilt finances in favor of investments in continuous manufacturing... Full

 

NCPA: 22% Of Pharmacies Going 28+ Days Without MFP Drug Refunds

(3/9, Gabrielle Wanneh, Inside Health Policy) ...The pharmacy group is urging CMS to press drug companies for speedier claims processing, provide clearer instruction regarding the calculation of refund payments in manufacturers' effectuation plans for the new "maximum fair price" of select drugs, and demand more of the cash flow mitigation strategies manufacturers were required to implement... Sub. Req’d

 

Print Isn't Dead: New Bid to Keep Drug Inserts

(310, Maya Goldman, Axios) ...The National Community Pharmacists Association and the National Black Nurses Association are among six trade groups endorsing the House bill to require keeping the printed inserts, the Pharmaceutical Printed Literature Association told Axios... Full

 

FDA Official Details Top GMP Violations Cited in Inspection Reports

(3/9, Joanne S. Eglovitch, Regulatory Focus) ...Simone Pitts, a national expert pharmaceutical investigator in the Office of Human and Animal Drug Inspectorate (OHADI) at the US Food and Drug Administration (FDA), stated that inadequate oversight of manufacturing operations by the quality control unit (QCU) was the top deviation identified in Form 483 inspection reports for pharmaceutical companies during FY 2024... Full

 

What Prasad's Exit Means for the FDA Moving Forward

(3/9, Zachary Brennan, Endpoints News) ...Prasad's departure could not only change how the Center for Biologics Evaluation and Research reviews vaccines, and particularly mRNA vaccines, but also how it deals with rare disease drug applications that saw a flurry of rejections even as the agency pledged to support them... Sub. Req’d

 

 

AstraZeneca's Enhertu Gets Priority Review from FDA for HER2-Positive Breast Cancer

(3/10, Patrick Lavery, Contract Pharma) ...The FDA granted the Priority Review for treatment of adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Specifically, the indication is for such patients who have residual invasive disease following neoadjuvant HER2-targeted treatment... Full

 

Pfizer Ramps Up Plans for Trispecific After Phase 2 Eczema Win

(3/9, James Waldron, Fierce Biotech) ...The Big Pharma evaluated three once-monthly doses of tilrekimig—which targets IL-4, IL-13 and thymic stromal lymphopoietin (TSLP)—against placebo in adults with moderate to severe atopic dermatitis. The phase 2 trial hit is primary endpoint of demonstrating a statistically significant increase in the proportion of patients who saw the size and severity of their eczema reduce by over 75% at Week 16 across all three doses, Pfizer explained in a March 9 release... Full

 

 

Amphastar's Secretive Inhaler Candidate Revealed As Atrovent HFA Generic After FDA Nod

(3/9, Dean Rudge, Generics Bulletin) ...Amphastar Pharmaceuticals has secured US [FDA] approval for its once-mysterious inhaler candidate AMP-007, a generic version of Boehringer Ingelheim's Atrovent HFA (ipratropium bromide) inhalation aerosol, setting the stage for what the company believes could become one of its most meaningful growth drivers in 2026... Global Sub. Full

 

Why the 'Mad Scramble' to Fill Hormone Therapy Prescriptions for Menopause

(3/10, Allison Aubrey, NPR) ...Doctors who prescribe hormone therapy to manage menopausal symptoms report rolling shortages and delays, which are, in part, due to rising demand. It's a reversal from the early 2000s, when the treatment fell sharply out of favor... Full

 

Delhi HC Dismisses Novo Nordisk's Appeal To Block Dr Reddy's Key Ozempic Ingredient Exports

(3/9, Nupur Dogra and Prajwal Jayaraj, NDTV) ...The Delhi High Court on Monday backed Dr Reddy's Laboratories Ltd. in its legal dispute with Novo Nordisk regarding the export and manufacture of semaglutide, a key ingredient for drugs such as Ozempic and Wegovy that are used in diabetes and chronic weight management respectively... Full

 

 

Sandoz Splits Out Biosimilars And Generics With New Business Structure

(3/10, Dave Wallace, Generics Bulletin) ...Sandoz has unveiled a major reorganization of its generics and biosimilars operations into two distinct businesses, bringing in Ferring and Merck veteran Armin Metzger to lead a new global biosimilars unit while at the same time assigning existing executives to generics roles... Global Sub. Full

 

Formycon Flags Missed Guidance Ahead Of The FY2025 Results Report

(3/9, Urte Fultinaviciute, Generics Bulletin) ...Formycon announced it was €10m ($11.6m) short of meeting its forecasted revenues range of €55m to €65m. Despite "a strong increase" in Q4 performance, group revenues for FY2025 stand at approximately €45m. This was "partly due to longer negotiations to conclude further commercialization and development partnerships, for example, for the Keytruda (pembrolizumab) biosimilar candidate FYB206, in order to optimize their financial terms."... Global Sub. Full

 

Drug Shortages Persist Due to Cost, Complexity, and Fragile Supply

(3/10, Brian Nowosielski, Lani Bertrand, Drug Topics) ..."I think we could look at the main drivers of drug shortages and understand that these are difficult issues to solve, and they go outside of what might be within the control of any type of pharmacy leader in any care setting," Lani Bertrand, senior director of clinical marketing & thought leadership at Omnicell, told Drug Topics. "The main drivers are low price or low cost of the drugs that are on shortage, manufacturer complexity, geographic concentration, and lastly, quality concerns."... Full

 

JPMorgan Employees Advance Suit Over Prescription Drug Costs

(3/9, Lauren Clason, Bloomberg Law) ...The employees allege JPMorgan breached its fiduciary duties under the Employee Retirement Income Security Act by overpaying for prescription drugs through its contract with CVS Health Corp., in some cases by thousands of dollars. JPMorgan argued the employees suffered no injury because they still received all their promised benefits, and that they were simply assuming costs would be lower under another PBM... Sub. Req’d

 

Pipeline of New Drugs to Fight Superbugs Is ‘Worryingly Thin', Experts Warn

(3/10, Julia Kollewe, The Guardian) ...The number of projects from large pharma companies has shrunk by 35% over the past five years, from 92 to 60 medicines in development, according to a report from the Access to Medicine Foundation (AMF), a Netherlands-based non-profit group, and the Wellcome Trust... Sub. Req’d

 

 

EU Finalizes Pharma Reform Package, Clarifies New Rules On Modular Market Protection

(3/9, Eliza Slawther, Pink Sheet) ...The final draft version of the pharma reform package, which comprises a new directive and regulation for governing pharmaceutical products in the EU, was published on March 6, marking a significant step forward for the new legislation. The draft text explains the exact criteria that medicines must meet to benefit from the maximum amount of total market exclusivity in the EU, which will be 11 years once the new legislation enters into force... Global Sub. Full

 

Redrawing The Biopharma Map: India's Rise in The Biosimilars Era

(3/10, Dr Cyrus Karkaria, Express Pharma) ...The approval of 146 recombinant biosimilar therapeutic products, from insulins and growth factors to monoclonal antibodies, was more than a tally on a regulator's report. It is a sign that India has not only mastered scale, but is fast becoming a contender in one of the most technically demanding and highly regulated corners of global healthcare. The shift is unmistakable. Affordability and reach remain vital, but they are no longer the only measures of success... Full

 

Korea Developing AI Drug Reviews, Unveils National Biopharma AI Strategy

(3/10, Jung Won Shin, Pink Sheet) ...The Ministry of Food and Drug Safety (MFDS) has started the full-scale development of an AI-based drug review system by forming a dedicated task force, while the Ministry of Science and ICT announced a national strategy to establish an innovative AI-driven ecosystem that aims to boost the country's new drug pipeline by 10 times and achieve 300 IND approvals based on generative AI over the next five years... Global Sub. Full

 

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