Friday, April 3, 2026

 

 

Trump Imposes Tariffs on Pharmaceuticals, Adjusts Duties on Steel, Other Metals

(4/3, Daniel Desrochers, Megan Messerly and David Lim, Politico) ...The pharmaceutical tariffs order contains a raft of exemptions, including for generic drugs and for companies that have already committed to building manufacturing plants in the U.S. by the end of Trump's term. Countries that have struck trade agreements with the administration will also receive lower rates, drastically narrowing how many drugs will ultimately be hit by the triple-digit duties... Full

 

Tariff Exemptions Shield Major Drugmakers, Leaving Mid-Sized Biotech In The Crosshairs

(4/2, Maaisha Osman, Inside Health Policy) ...Larger pharmaceutical companies will have 120 days before a 100% tariff on patented drugs takes effect, during which the administration expects firms to announce plans to build manufacturing capacity in the United States that would qualify them for a reduced 20% tariff. Smaller companies would have 180 days to make similar commitments, the official said, noting that many rely on contract manufacturers that are already expanding domestic production capacity... Sub. Req’d

 

Small Drugmakers, Facing Threat of Tariffs, Negotiate Pricing Deals with White House

(4/3, Daniel Payne, STAT+) ...The new negotiations suggest the administration is looking to replicate the strategy it used with larger drugmakers: extract voluntary, confidential agreements in pursuit of lower prices and more domestic manufacturing...The number of companies in talks with the administration remains unclear, as does the question of whether or when the sides will reach agreement... Sub. Req’d

 

How Trump's New Drug Tariffs Could Affect Prescription Prices

(4/2, Gabe Whisnant, Newsweek) ...Critics warn the tariffs could raise costs instead. Stephen J. Ubl, CEO of the pharmaceutical trade group PhRMA, said taxes "on cutting-edge medicines will increase costs and could jeopardize billions in U.S. investments," adding that many imports come from long-standing U.S. allies. Economists and consumer advocates have also cautioned that if companies do not absorb the added costs or qualify for exemptions, higher import expenses could be passed through the supply chain to insurers, hospitals and patients, affecting premiums and out-of-pocket spending... Full

 

Most Favored Nation Pricing Deals, Demos Complicate Medicare Negotiation Prospects

(4/2, Cathy Kelly, Pink Sheet) ...The challenge posed by the MFN deals is not theoretical. Three of the drugs promoted on the TrumpRx portal are undergoing the Medicare negotiation process now: GlaxoSmithKline's Anoro Ellipta, Bristol Myers Squibb's Orencia and Pfizer's Xeljanz. [CMS official and consultant Kristi Martin] pointed out that other drugs on the site could be considered therapeutic alternatives for drugs being negotiated and their pricing matters as comparators... Global Sub. Full

 

US MFN Policies Are Driving The Need For Better RWE

(4/2, Francesca Bruce, Pink Sheet) ..."People have been talking about real-world evidence being important for ages, but I think things are accelerating," said [Mark Larkin, chief executive of Vitaccess,] in an interview with the Pink Sheet. One big driver of the growing need for high-quality longitudinal evidence is the MFN policies, he said... Global Sub. Full

 

New Weight Loss Drug to Be Sold on Trump's Pharmaceutical Cost Comparison Platform

(4/2, Olivia Rinaldi, CBS News) ...A White House official says TrumpRx, the low-cost pharmaceutical comparison website launched by the administration in February, will provide coupons for Foundayo to Americans without insurance starting at $149 for the first dose. The refills will be marked at $199 and future prescriptions will be $299. The pill will also be sold at a similar price on Eli Lilly's direct to consumer platform "Lilly Direct."... Full

 

Trump's Obesity Drug Plan for Medicare Would Cost Insurers Billions

(4/2, Rachel Cohrs Zhang, Bloomberg) ...Savings of more than $900 million during the program's first year would only cover the costs for an estimated 4.4% of the patients who would become newly eligible for the drugs, according to researchers led by Vanderbilt University Professor of Health Policy Stacie Dusetzina... Full

 

HHS Updates Medicare Drug Cost-Sharing, Plan Quality Ratings

(4/2, Ganny Belloni , Bloomberg Law) ...The final rule (RIN 0938-AV63), released Thursday by the Centers for Medicare & Medicaid Services, implements changes to Part D enacted under the Inflation Reduction Act in 2022 and will update the methodology used to calculate insurers' "star ratings," which are quality scores that determine bonuses and marketing privileges. The changes would take effect in 2027... Sub. Req’d

 

Cost-Related Medication Non-Adherence Declined After the Inflation Reduction Act

(4/2, Dave Fornell, Cardiovascular Business) ...To analyze changes related to the new Medicare provisions, researchers compared survey responses from 2024 with responses from 2021-2023. The responses showed less cost-related medication non-adherence, including skipping or reducing doses, delaying prescription fills or foregoing medications due to cost after the law went into effect... Full

 

The Tide Is Starting to Turn in Pharma's Favor for the Future of 340b

(4/2, Nicole DeFeudis, Endpoints News) ...DOJ attorneys wrote in amicus briefs filed in February and March that states should not have the authority to enforce 340B... Sub. Req’d

 

GDUFA IV: Sticking Points Emerge as Negotiations Press on

(4/2, Ferdous Al-Faruque, Regulatory Focus) ...According to meeting minutes from 4 and 6 March, FDA and industy...agreed on draft commitment letter language on topics including a policy for prioritizing abbreviated new drug applications (ANDAs), maximum daily dose (MDD) enhancement, and updates to the inactive ingredient database. Additionally, industry withdrew a proposal to expand the pre-launch activities importation requests (PLAIR) process, which FDA felt was outside the scope of the GDUFA negotiations... Full

 

US FDA Approval Output Still Not Showing Impact Of Departures

(4/2, Derrick Gingery, Pink Sheet) ...NDA and BLA approval counts appears to have dropped a bit during the first two months of calendar year 2026. Only 19 were posted through February, or 9.5 per month...The monthly average is lower than in calendar year 2025, but still near the range since 2013... Global Sub. Full

 

EPA Flags Microplastics, Pharmaceuticals as Contaminants in Drinking Water

(4/2, Will Stone, NPR) ...Their inclusion on the list gives local regulators a tool to evaluate risks in their water supply, the EPA says, and it can set the stage for more research and regulatory action — but doesn't actually guarantee that will happen... Full

 

Why Do Prescription Drugs Cost So Much? A Fight Is Brewing in the Louisiana Legislature.

(4/3, Alyse Pfeil, Nola) ...Sen. Adam Bass, R-Bossier City, said even after holding meetings over the last several months on the topic, drug manufacturers and pharmacy benefits managers still haven't provided important information about how drug prices are determined. "Neither industry has been completely forthcoming," said Bass, who is spearheading the effort. Now he and other lawmakers are pushing for legislation that would force those businesses to turn over internal information they say will help determine why drug costs are rising... Full

 

David Marin Talks to POLITICO About ‘New Forcefulness' at PCMA

(4/2, PCMA Blog) ...The Pharmacy Benefit Manager (PBM) industry has too long been defined by others, and PCMA is recommitted to telling its own story, new President and CEO Dave Marin told POLITICO in an exclusive interview. The organization is pursuing a new strategy to recapture its own narrative, refocus on how policies impact patients, and attract new partners to advance shared priorities. Following the passage of PBM reform earlier this year, Marin talked about how this is an inflection point for the industry and an opportunity for policymakers to turn their focus to the real obstacles to prescription drug affordability and access... Full

 

 

Another AstraZeneca Emerald Glimmers as Imfinzi, Imjudo Delay Liver Cancer Progression

(4/2, Angus Liu, Fierce Pharma) ...Results from the phase 3 Emerald-3 trial showed that the combination, paired with transarterial chemoembolizaton (TACE) and Lenvima, significantly improved progression-free survival (PFS) versus TACE alone in patients with unresectable locoregional hepatocellular carcinoma. Lenvima is a multikinase inhibitor sold by Merck & Co. and Eisai... Full

 

 

Cipla Expands U.S. Respiratory Portfolio With Approval of Nintedanib Capsules (100mg & 150mg) for Idiopathic Pulmonary Fibrosis

(4/3, Cipla) ...Cipla...announced final approval from the U.S. [FDA] for its [ANDA] for Nintedanib Capsules, 100 mg and 150 mg, indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Cipla's Nintedanib Capsules are the generic therapeutic equivalent of Ofev®, marketed by Boehringer Ingelheim... Full

 

Switching Between Ustekinumab Biosimilars Twice Shows No Loss of Psoriasis Control

(4/2, Giuliana Grossi, The Center for Biosimilars) ...Patients with moderate-to-severe plaque psoriasis who were switched from reference ustekinumab to a first biosimilar and then to a second maintained durable disease control with no serious adverse events, according to real-world data presented at the American Academy of Dermatology (AAD) 2026 Annual Meeting... Full

 

 

How Trump's War in Iran Is Scrambling Pharma's Shipping Options

(4/2, Michael Gibney, PharmaVoice) ...[P]harma giants with millions of tons of inventory in the Gulf need to explore new routes to mitigate risk. But with tight regulations around the pharmaceutical industry, those options are limited, [Alex Guillen, global SME life science and pharma director at Tive,] said. And the ramifications of delays and disruptions in shipping don't apply equally to all regions, he said. Developing countries often bear the burden... Full

 

For Sharvil Patel of Zydus Lifesciences It's All About Investing in Scientific Innovation

(4/3, Neetu Chandra Sharma, Business Today) ..."On the biotech front, we have one of the largest biosimilar portfolios in India with 16 biosimilars approved and 13 launches in India," [Sharvil Patel] says. The company has also secured marketing authorisations for biosimilars in multiple emerging markets...While innovation programmes attract attention, Patel often highlights the generics business as the backbone of the company's operations. "The US is our largest market," he says... Full

 

 

UK Signs Off on US Pharma Deal, Ensuring Tariff Reprieve as Britain Aims to Reattract Investments

(4/2, Zoey Becker, Fierce Pharma) ...In exchange for the tariff reprieve, the U.K. will boost the net price its National Health Service (NHS) pays for novel treatments by 25%. The arrangement lasts at least three years and makes the U.K. the first in the world to secure 0% tariffs on U.S. pharma exports, U.K. officials said in a Thursday press release... Full

 

UK Urges Pharma Companies to Invest After Reaching Drug Pricing Deal With US

(4/2, Chris Smyth, Aanu Adeoye and George Parker, Financial Times) ...Lord Patrick Vallance, UK science minister, told the FT he was optimistic that pharma groups would resume investment and "we expect them now to respond, because this has got to be a two-way thing". Britain would return to being "at the front" of life sciences globally as a result of the deal and increasing medicines spending was "what we need to do anyway" to boost the life sciences industry, he added... Sub. Req'd

 

EMA Explains How To Assess Quality Of RWD Used In Regulatory Submissions

(4/2, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency has published guidance on how to assess the quality of real-world data (RWD), and thereby enable regulators to evaluate the quality of data underpinning real-world evidence (RWE) used in regulatory assessments... Global Sub. Full

 

Euro Roundup: EMA Finalizes Reflection Paper on Biosimilar Comparative Efficacy Studies

(4/2, Nick Paul Taylor, Regulatory Focus) ...The European Medicines Agency (EMA) has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy studies (CES)... Full

 

Ottawa, Drug Companies Launch Task Force to Prepare for USMCA Talks

(4/2, Chris Hannay, The Globe and Mail) ...Canada's patented drug industry has established a task force with the federal government to prepare for coming trade talks with the United States and Mexico and respond to American pressure to raise international drug prices, including in Canada...The group is planning to meet every two weeks and prepare a report in 90 days with options for Canada's response, from changing how public insurance plans evaluate drug prices to how to boost domestic research and development... Sub. Req'd

 

Australia Says It Won't Raise Drug Prices After Trump's 100% Tariff on Pharmaceuticals Imported Into US

(4/2, Tom Mcilroy and Benita Kolovos, The Guardian) ...[Health Minister Mark] Butler said on Friday that the federal government would not succumb to pressure to lift prices in Australia. "We keep sending this clearest of possible messages to the US because we know they get the big drug companies in their ear trying to unpick the PBS here in Australia and equivalent schemes in other countries around the world," he said... Full

 

Trump's Pharmaceutical Tariff Order Gives Korean Biosimilar Makers Breathing Room -- for Now

(4/3, Kim Ji-hye, Korea Biomedical Review) ...For Korean drugmakers, the immediate effect appears limited. The one-year carve-out for biosimilars spares some of the country's biggest U.S. sellers, including Celltrion and Samsung Bioepis, from the most immediate disruption... Full

 

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