Monday, March 23, 2026

 

 

White House Expands TrumpRx With Three New Drugs

(3/20, Berkeley Lovelace Jr., NBC News) ...The White House said Friday it's adding three drugs for diabetes and lung disease to the self-pay platform TrumpRx, as the administration works to expand the site as part of its push to lower drug prices. The drugs, from German drugmaker Boehringer Ingelheim, are Jentadueto and Jentadueto XR, for Type 2 diabetes, as well as the COPD drug Striverdi Respimat... Full

 

Medicare Chief Says TrumpRx Is Meant to Be Narrow in Scope

(3/20, Meghana Keshavan, STAT+) ...Chris Klomp, a senior HHS official, offered a notably restrained view of TrumpRx while speaking at the STAT Breakthrough Summit East yesterday. Although President Trump described the prescription drug platform "as transformative," Klomp framed it instead as a limited, cash-pay tool rather than a systemwide fix for drug pricing. "The goal was not actually some massive reach," Klomp said... Sub. Req'd

 

Signs Of 'Most Favored Nation' Impact: What Experts Are Looking For

(3/20, Laura Tollen, Health Affairs) ...Notably, it will be difficult to disentangle stakeholders' responses to the threat of MFN from their responses to threatened tariffs-although tariffs have recently become less threatening due a Supreme Court ruling that they exceed the powers given to the president by Congress. In fact, some Observatory members believe that if the administration cannot credibly threaten tariffs that are significant in both duration and magnitude, drug manufacturers may become less interested in cooperating on MFN policies... Full

 

Economist: 'Friendshoring' Key To Reducing Chinese Drug Dependence

(3/20, Gabrielle Wanneh, Inside Health Policy) ...To fight Chinese dominance in the pharmaceutical section, the U.S. government should shift to purchasing most of the essential medicines it needs to pad its drug supply from friendly countries like India and Europe that are already taking action to reduce their own use of Chinese-manufactured materials, Brookings Institution Senior Fellow Marta Wosinska suggested to lawmakers on the House Select Committee on the Chinese Communist Party Wednesday (March 18)... Sub. Req'd

 

BsUFA IV Talks Scheduled For Early April, Is 'America First' Coming?

(3/20, Derrick Gingery, Pink Sheet) ...BsUFA IV negotiations are tentatively scheduled to begin the week of April 6, multiple sources confirmed to the Pink Sheet. The date is significant because the US [FDA] and industry negotiators like to have prescription drug and generic drug user fee reauthorization discussions largely completed before beginning BsUFA talks. Because the biosimilar program is smaller, the talks do not last as long... Global Sub. Full

 

US FDA Flags Seizure Risk With Certain Parkinson's Drugs, Seeks Label Warnings

(3/20, Reuters) ...The drugs containing the ingredients carbidopa or levodopa should state that they can cause vitamin B6 deficiency and seizures associated with it, the health regulator said... Sub. Req’d

 

FDA Seeks Input on Makary's Pilot Drug Approval Accelerator

(3/20, Zachary Brennan, Endpoints News) ...On Friday, the FDA announced a public hearing on the pilot for June 12. The agency said in a Federal Register notice that it wants input on eligibility criteria, the voucher selection process, sponsor responsibilities, FDA review procedures and program implementation... Sub. Req’d

 

National Priority Vouchers: Amid Scrutiny, US FDA Sets Meeting On Makary's Signature Program

(3/20, Bridget Silverman, Pink Sheet) ...The US [FDA's] Commissioner's National Priority Voucher will celebrate its first birthday with a public meeting on June 12, seeking feedback on the pilot program that has generated many stakeholder questions on selection criteria and other issues... Global Sub. Full

 

New Report: Generic Drug Market is Working, Taking Market Share From Brand-Name Drugs and Significantly Lowering Costs

(3/20, PCMA) ...A new report confirms that pharmacy benefit managers (PBMs) quickly promote patient access to new, affordable generic drugs over high-priced brand-name drugs. The study, conducted by Wakely Consulting Group, finds that in the first six months after a brand name drug's patent expires, generic drugs can cover as much as 80% of the market as patients quickly transition to the lower-cost alternative. Further, after two years, generic drugs dominate with up to a 97% market share against brand-name counterparts... Full

 

Key Context Is Often Missing From The Debate Over The Patent Trial and Appeal Board

(3/20, Andrew Powaleny, PhRMA Blog) ...The bottom line: Ensuring timely access to generics and biosimilars requires recognizing that PTAB is not a silver bullet for lowering costs or speeding market entry. A balanced system that protects intellectual property while enabling fair competition best supports both innovation and patient access... Full

 

 

Earendil Raises $787m as Lead TL1A Antibody Starts Phase 2

(3/23, Phil Taylor, PharmaPhorum) ...The Wilmington, Delaware-based biotech said the new financial muscle will be used to develop its AI capabilities, add to its headcount, and push its pipeline of antibody and biologic-based therapies. Its platform has generated more than 40 candidates to date, led by HXN-1001, a long-acting anti-TL1A antibody that is being prepared for phase 2 testing... Full

 

US FDA Approves Bristol Myers Squibb's Cancer Drug for Hodgkin's Lymphoma

(3/20, Reuters) ...The U.S. Food and Drug Administration said on Friday it approved Bristol Myers Squibb's combination treatment for adults and adolescents aged 12 and older with previously untreated stage III or IV classical Hodgkin's lymphoma... Sub. Req’d

 

Cell Therapy Startup Oryon Bets on Patient-Derived Neurons for Parkinson's

(3/23, Anna Bratulic, FirstWord PHARMA) ...Oryon Cell Therapies emerged from stealth Monday with $42 million in funding — including a newly closed $21-million series A tranche — and early clinical data suggesting its autologous neuron replacement approach may improve motor function in patients with Parkinson's disease... Full

 

 

Alvotech Pivots To Dual Sourcing Amid Regulatory Reset

(3/20, Dean Rudge, Generics Bulletin) ...Alvotech expects product revenues to represent a larger share of the business as launches scale. "Teva continues to expand formulary coverage for Selarsdi (ustekinumab-aekn), forming a strong and growing market position. In Europe, Uzpruvo (ustekinumab) has established a leading position with more than 20% share of the biosimilar segment," noted Graver... Global Sub. Full

 

Formycon Unlocks Global Markets For Its Eylea Biosimilar

(3/20, Urte Fultinaviciute, Generics Bulletin) ...The deal has resolved all patent disputes related to the EU-approved biosimilars Ahzantive and Baiama, with market launches expected to start in the region in May 2026. The latest agreement also unlocked additional territories, including key markets in Latin America and the Asia Pacific regions, allowing marketing from the same month... Global Sub. Full

 

India Is Launching Cheap, Weight-Loss Drugs and Novo Nordisk Is Betting on Its Brands to Stay on Top

(3/23, Priyanka Salve and Else Ohlen, CNBC) ..."This is something that Indian generic players have been preparing for a very long time," Salil Kallianpur, an independent pharma consultant based in India, told CNBC. More than 50 brands are expected to launch generic versions of semaglutide in the coming months. That's a small number by Indian standards, because of the relative complexity of making such drugs with their more stringent quality controls, Kallianpur said... Full

 

Alkem Eyes Leadership in Weight-Loss Drugs With Aggressive Generic Pricing

(3/22, Jessica Jani, Mint) ...Alkem's injectable pen is priced at Rs1,800 per month for a starting dose. While some of its competitors have launched injectable vials at lower prices, Alkem's generic pen undercuts other pen devices launched on Saturday, which are in the range of Rs3,000-4,000 a month... Sub. Req'd

 

Editorial: What Makes GLP-1 Drugs Transformative Also Make Them Susceptible to Misuse

(3/21, The Indian Express) ...There is also a deeper scientific concern: Global prescribing thresholds, such as BMI cut-offs, are based largely on Western populations and may sit uneasily in the Indian context, where metabolic risks develop at lower body weights. Monitoring of outcomes, adverse effects and long-term use in a population that differs significantly from those in which these drugs were first studied is crucial. An unregulated rollout could widen inequities... Full

 

 

Sanofi Launches Innovation and Operation Centre in China

(3/20, Reuters) ...Sanofi launched an innovation and operation centre in the southwestern Chinese city of Chengdu on Thursday, the company said in a statement released on its Chinese social media account on Friday. The centre will support the company's R&D efforts, clinical operations, and manufacturing and supply chain services, the statement read... Sub. Req'd

 

STADA Strengthens Market Position with Growth in 2025

(3/20, UzDaily.com) ...The specialty medicines segment saw revenue grow 17%, surpassing €1 billion and accounting for nearly a quarter of total revenue. Growth was driven by biosimilars and innovative treatments. Sales of Uzpruvo (ustekinumab) continued double-digit growth across more than 20 markets, expanding coverage in bone, immunology, and oncology therapies. New biosimilars, including golimumab and tocilizumab, are planned for launch in 2026... Full

 

 

Iran War Could Threaten Long-Term Industry Sustainability

(3/20, Dave Wallace, Generics Bulletin) ...[S]peaking to Generics Bulletin directly, the IGBA said that while "no shortages have been reported by our members at this stage," the ongoing conflict was "creating significant uncertainty - driven by shipping risks, rising energy costs, handling challenges at logistics hubs, and emerging solvent supply concerns."... Global Sub. Full

 

European Regulators Expect Pharma To Track US FDA Warning Letters – Not Wait For Alerts

(3/20, Eliza Slawther, Pink Sheet) ...While these letters can impact operations in the UK and EU, the regulators for both regions expect industry to monitor warning letters and take appropriate action where necessary. Until August 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) would notify marketing authorization holders about FDA warning letters involving their suppliers, but it has since changes its approach and now expects industry to monitor and risk assess these letters... Global Sub. Full

 

Pharmexcil Seeks Urgent Industry Data as West Asia Crisis Hits Pharma Exports

(3/23, Shardul Nautiyal, Pharmabiz.com) ...Indian pharma companies, especially those with significant exposure to West Asian markets such as the UAE, Saudi Arabia, Iraq, and Iran, are reporting early signs of strain across exports, production costs, and raw material sourcing... Full

 

Korea Generic Drug Price Reform Looms; Industry Warns of Ecosystem Damage

(3/22, Lee Yeon-su, Seoul Economic Daily) ...Tensions are rising in Korea's pharmaceutical and biotech industry ahead of the government's finalization of its generic drug pricing reform plan. The industry recalls the 2012 blanket drug price reduction policy and warns that a uniform regulatory approach ignoring the industry's current standing and capabilities could damage the industrial ecosystem... Full

 

Black Canadians Hit by Cost of Prescribed Medicines

(3/23, Daysha Loppie, The Toronto Star) ...For Black Canadians, who already face higher rates of certain conditions like cardiovascular disease and diabetes,inconsistent access to prescribed treatment can mean a greater likelihood of hospitalization, said Dr. Bukola Salami, a senior author on the study. The findings also highlight a reality where a lack of adequate income and drug coverage can affect the health of Black people across the country, the researchers noted... Full

 

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