Friday, August 22, 2025

1 Big Thing: Pharma Firms Walk a Tightrope With Trump

(8/22, Peter Sullivan, Axios) ...The manufacturers aren't likely to agree to Trump's full demands. But they aren't publicly rebuffing him, and at least some are open to talks. Pfizer CEO Albert Bourla, for example, said on an earnings call this month that he had spoken with Trump since receiving one of the letters. He referred to the demands as a "base of what the president wants," indicating they are just a starting point for negotiations... Full

Ireland Will Be Relieved at Trump's Tariff Cap On Vital Pharma Sector

(8/21, Cliff Taylor, The Irish Times) ...A 15 per cent tariff is still high enough, if that is what emerge. IPHA, the body which represents the sector in Ireland, points out that it will be a burden on the sector and a drag on investment and job. It is a higher margin sector, so may be able to work through the new imposition, but at a cost. It will cause problems but not chaos. There is also another hopeful mention in the statement that generic drugs and their inputs and some chemicals may stay at a zero tariff – which would be a boost for parts of the industry here... Sub. Req’d

US-EU Trade Deal Impacts on Pharma Industry More ‘Manageable' Than Expected

(8/21, Anjalee Khemlani, Yahoo Finance) ...There is also another hopeful mention in the statement that generic drugs and their inputs and some chemicals may stay at a zero tariff – which would be a boost for parts of the industry here. The details of what exactly this applies to have not been laid out in full and will be important if we are to judge what will be covered by this exemption. IPHA says this leaves open the option of tariffs on branded medicines and will not support investment - which will be a key argument of the sector in the weeks to come... Full

1 Big Thing: Pharma Firms Walk a Tightrope With Trump

(8/22, Peter Sullivan, Axios) ...The manufacturers aren't likely to agree to Trump's full demands. But they aren't publicly rebuffing him, and at least some are open to talks. Pfizer CEO Albert Bourla, for example, said on an earnings call this month that he had spoken with Trump since receiving one of the letters. He referred to the demands as a "base of what the president wants," indicating they are just a starting point for negotiations... Full

A New Pharma Factory Shows How Hard it Could Be for Drugmakers to Outrun Trump's Tariffs

(8/21, Angelica Peebles, CNBC) ...Fujifilm's timing couldn't be better, as President Donald Trump threatens to impose tariffs on pharmaceuticals to encourage companies to make more medicines in the U.S. But the plans for this complex were underway well before Trump proposed higher duties. It's taken five years and more than $3 billion to turn the idea into reality. And it shows how difficult it would be for drugmakers to quickly increase production in the U.S., even with a possible grace period that Trump has floated... Full

Biopharma Has Promised $290B+ in US Manufacturing in the Past Six Months

(8/21, Anna Brown, Endpoints News) ...Pharma companies have pledged at least $292 billion to expand their US production footprints since early this year, as Johnson & Johnson added detail on how it will spend part of its multibillion-dollar promise it made in March. Companies have been making an effort to reshore their manufacturing to the US since President Donald Trump threatened tariffs on pharma goods. These expansion budgets are spread out over several years by as much as a decade. Some of it may not come to fruition, and others' pledges include ones from previously announced plans that predate Trump's return to office... Sub. Req’d

Pharma's Move Into Direct-To-Patient Sales Facing Legal, Practical and Political Hurdles

(8/21, Cathy Kelly, Pink Sheet) ...Pharma companies are actively exploring direct purchasing programs as a way to increase price transparency, cut out supply chain middlemen and respond to pricing pressure from the Trump Administration. For Eli Lilly and Novo Nordisk, DTC programs are also part of a counteroffensive against direct-sales programs involving compounded GLP-1 drugs for obesity...Existing DTC programs come in different flavors but for those involving telehealth prescribing, anti-kickback laws pose a major concern. A recent Texas lawsuit against Lilly accuses the company of violating anti-kickback laws by offering to underwrite support services for prescribers and also cites the LillyDirect DTC program as potentially problematic... Global Sub. Full

In the War Against PBMs, Patient Interests Are Secondary

(8/21, Claudia Nunes, RealClearMarkets) ...Contrary to the narrative their enemies push, PBMs do not set prices. Instead, they negotiate them down. They do so with slim profit margins, averaging around 2%, far below the margins of pharmaceutical companies or large S&P 500 companies, which hover around 12%. From an economic perspective, PBMs operate with a vertically integrated model, meaning they are present at different stages of the value chain, from negotiating with manufacturers to distribution through their own pharmacies. Some anti-PBM policies – such as Act 624 in Arkansas, which is due to take effect in January 2026 – originate from concerns about this structure, such as PBMs owning pharmacies. Those concerns are misplaced. PBMs owning pharmacies does not undermine competition. In fact, it can increase efficiency, ensure stable supply, and reduce costs for patients... Full

Generics Must Compete On Price, Not Safety

(8/21, Sally Pipes, Forbes) ...Patients and doctors trust generics because they are required to be clinically equivalent to their branded counterparts—matching on active ingredient, dosage, route of administration, therapeutic effect, and safety. The Hatch-Waxman Act of 1984 enshrined that principle, striking a balance that has made the U.S. generic market the strongest in the world—and the most affordable. Now, the FDA is putting that trust at risk... Full

Major U.S. Drug Manufacturing Plant Did Not Properly Investigate Cat Hair, Pests, and Other Problems, FDA Finds

(8/21, Ed Silverman and Elaine Chen, STAT+) ...Cat hair, pests, bacteria, and equipment failures. These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company's acquisition of Catalent, one of the largest contract manufacturers serving the pharmaceutical industry. A copy of a Food and Drug Administration inspection report was obtained by STAT... Sub. Req’d

Vanda Asks FDA's Makary to Review Approval of Hetlioz Generics

(8/21, Jonathan Block, Seeking Alpha) ...Vanda Pharmaceuticals has formally asked U.S. FDA Commissioner Marty Makary to review the recently retired director of the Center for Drug Evaluation and Research's decision to uphold the approval of two generics of Hetlioz (tasimelteon). Generic tasimelteon is available from Teva Pharmaceutical and Apotex... Full

Biocon Alludes To Double-Digit Generic Growth Despite Limited Revlimid Rival Sales Drying Up Growth

(8/22, Urtė Fultinavičiūtė, Generics Bulletin) ...Biocon's generics business saw a 34% quarter-on-quarter decline, as the volume-limited lenalidomide sales reached their ceiling. Now, it looks at liraglutide launches across the globe to bring the business back to growth... Global Sub. Full

Carac Authorized Generic Returns In US Under Dr. Reddy's Banner

(8/22, Dean Rudge, Generics Bulletin) ...Dr. Reddy's Laboratories has strengthened its dermatology and US generics portfolio by launching an authorized generic version of Switzerland-based B2B firm Extrovis' Carac (fluorouracil) 0.5% cream – eight years after an earlier authorized generic launched by Spear Pharmaceuticals was discontinued... Global Sub. Full

OneSource CEO On Next-Gen GLP-1 Innovator Talks, Xbrane And Viatris Partnering

(8/22, Vibha Ravi, Scrip) ...OneSource Specialty CEO Neeraj Sharma discusses with Scrip exploratory talks with next-gen GLP-1 innovators, prospects for semaglutide generics and investment in Swedish firm Xbrane, among other topics... Global Sub. Full

Government Ends Talks With Pharma Groups On NHS Drug Pricing

(8/22, Anna Gross and Hannah Kuchler, Financial Times) ...The UK's health secretary issued a private ultimatum to the Association of the British Pharmaceutical Industry on Wednesday saying that if they did not vote to accept the government's latest "generous" offer on drug pricing the existing mechanism would remain in place... Sub. Req’d

Wes Streeting Issues Private Ultimatum to Pharma Groups in NHS Pricing Talks

(8/21, Anna Gross and Hannah Kuchler, Financial Times) ...The UK's health secretary has issued a private ultimatum to pharmaceutical companies to accept the government's latest offer on drug pricing by Friday or he will publicly end the talks, raising the stakes in negotiations over how much the NHS should pay for treatments. Wes Streeting said in a letter to the Association of the British Pharmaceutical Industry that they had been given ample time to consider the "generous" offer put to them on drug pricing in recent weeks, but had "repeatedly delayed" making a decision... Sub. Req’d

Stricter Shelf Life Rule a Bitter Pill to Swallow for Pharma Companies

(8/21, Teena Thacker, The Economic Times) ...A new regulation by the CDSCO mandates that exported drugs must have at least 60% shelf life remaining, causing significant losses to the Indian pharma industry. Manufacturers are now forced to destroy stocks to comply with this rule. The industry is urging for a revision, citing unnecessary losses and questioning the need when importing countries permit shorter shelf lives... Sub. Req’d

Poor Countries Pay More for Essential Drugs, Have Less Availability, Data Suggest

(8/21, Mary Van Beusekom, MS, CIDRAP) ...The availability and affordability of essential medicines vary widely around the world, with wealthier countries seeing lower real prices than poorer ones after adjusting for purchasing power, according to a 2022 analysis of 87 high-, middle-, and low-income countries...Countries' gross domestic product per capita was linked to nominal drug prices, indicating that wealthier countries generally had higher drug prices. But adjusting for the purchasing power of different currencies revealed an inverse association, suggesting that richer countries had lower real prices... Full

US Policy Shift Sparks German Contingency Plans For Accessing ClinicalTrials.gov, PubMed

(8/21, Pink Sheet) ...IQWiG, Germany's health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable... Global Sub. Full

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