Wednesday, July 23, 2025

Trump Says He May Use Trade to Force Countries, Pharma Companies to Buy into His Most Favored Nation Provision

(7/22, Alec Schemmel, Fox Business) ...President Donald Trump hinted at a new trade tactic on Tuesday evening. Speaking at a White House event, which included Republican allies from Congress and his Cabinet, Trump said that if pharmaceutical companies and other countries don't get behind his most favored nation policy to lower drug prices for Americans, then Trump would consider using trade to force their hand. During the president's roughly hour-long address at the Tuesday night event, he predicted the policies of his administration could lead to as much as a 1,000% decrease in drug prices for Americans, if his plan comes to fruition... Full

200% Tariffs in Offing? Trump Vows to Slash Drug Prices Using Import Restrictions

(7/22, The Economic Times) ...Speaking at a White House event with Republican lawmakers, Trump addressed the issue of prescription drug costs. He pledged to decrease the amount consumers pay for these medications. "Drug companies will have lot of problems if they don't agree to bring prices down," he said, making clear he plans to use trade policy as leverage. "We are going to get drug prices down." He also stated, "We will use import restrictions to force foreign suppliers to cut drug prices."... Full

Big Pharma Pioneers the TOFU Tariff Trade

(7/22, Aimee Donnellan, Reuters) ...Big Pharma is giving Donald Trump's credibility a booster shot. Buoyant stock markets generally seem to rest on the belief that the U.S. president always chickens out on provocative trade measures, known as the TACO principle. Yet drugmakers like Britain's $213 billion AstraZeneca, which on Monday revealed a surprisingly solid $50-billion American investment plan, seem to believe that sector-specific tariffs are possible or even likely. Call it the TOFU trade: Trump Occasionally Follows Up... Full

AstraZeneca Bets Big On U.S. As Researchers Warn Of Talent Exodus

(7/22, Maaisha Osman, Inside Health Policy) ...AstraZeneca CEO Pascal Soriot also used the announcement to issue a broader plea on drug pricing and R&D sustainability. "The U.S. cannot be expected to carry the global cost of innovation alone," he said in a press conference with reporters Monday, calling for "price equalization" across wealthy nations to distribute the cost of drug development...Soriot also said the company fully supports the Trump administration's push to boost domestic U.S. drug manufacturing, calling it a matter of national security. "We totally understand and support the need for the United States to ensure that medicines serving patients here are made here," Soriot said. He added that recent tariffs are "accelerating" the industry's shift toward onshore production... Sub. Req’d

Trump's Pharmaceutical Tariffs Will Dig America's Vulnerable Deeper in Medical Debt

(7/22, Lyndon Haviland, The Hill) ...President Trump recently announced his intent to impose a 200 percent tariff on pharmaceuticals to lure drug manufacturing back to the U.S. This action, if implemented, will come at great cost to millions of Americans already struggling to cover their medical bills and force them deeper into health care debt...Trump's tariff proposals will hurt those dependent on generic medications especially hard. That's because nearly 80 percent of generic capsules and tablets Americans consume come from outside the U.S. Analysis by Brookings found that, given the low margins on generic prescriptions, tariff pressure could result in the discontinuation of certain drugs that, for many, are their only affordable option... Full

Patent Reforms Take Center Stage At First FTC-DOJ Drug Pricing Panel

(7/22, Gabrielle Wanneh, Inside Health Policy) ...Academics and advocates for affordable drugs pressed for patent reforms to boost the accessibility and affordability of generic drugs and biosimilars at a recent event hosted by the Federal Trade Commission and the Justice Department's Antitrust Division, touting reforms like prohibiting payments to delay the market entry of lower-cost medications and barring multiple patent filings to extend market exclusivity. Panelists also saw a need for reform of pharmacy benefit managers (PBMs) and the 340B drug discount program... Sub. Req’d

Advocates Want New Bipartisan PBM Reform Package To Stand Alone

(7/22, Leslie Small, Pink Sheet) ...Stakeholders are hoping a new PBM reform package can avoid the limitations of the budget reconciliation process during the next legislative push for enactment. The PBM Reform Act, which was announced July 10, contains many of the measures that were included, but later removed, from a year-end spending bill in 2024. Some provisions were included in the House of Representatives version of the "One Big Beautiful Bill Act," but left out of the legislation that cleared the Senate... Global Sub. Full

Medicare Patients Face Higher Drug Costs, Despite IRA Promises

(7/22, Elizabeth Carpenter, PhRMA) ...Insurers and PBMs are shifting costs to patients through higher deductibles and coinsurance in response to the IRA. And while the IRA caps annual out-of-pocket costs at $2,000, most beneficiaries won't hit that cap and may see their costs increase through higher deductibles and coinsurance...The IRA doesn't guarantee savings at the pharmacy. Insurers and PBMs are finding new ways to pass costs to patients. Policymakers must hold insurers and PBMs accountable if they're serious about lowering drug costs... Full

Makary's New Voucher Program Seeks ‘Most Favored Nation' Pricing

(7/22, Zachary Brennan, Endpoints News) ...The Commissioner's National Priority Voucher (CNPV) pilot program will provide up to five companies with a non-transferable voucher that must be used within two years and address one of several priorities of the commissioner, including price affordability. The "affordability" priority is a new addition from the launch of the voucher last month. The agency says meeting that priority could include reducing drug prices to match those in comparably developed nations, in line with President Donald Trump's ‘most favored nation' plan. However, it remains unclear if drug developers will be willing to discuss prices or how a price could be lowered to an ex-US comparator if it's a novel therapy... Sub. Req’d

The U.S. Drug System Strikes a Reasonable Balance Between Incentivizing Innovation and Promoting Competition

(7/23, Wayne Winegarden, Pacific Research Institute) ...There is scant evidence that drug prices are unaffordable due to widespread anticompetitive activities. Focusing on this issue is a distraction, consequently. It is problematic because the focus on these non-issues makes it more difficult to implement positive reforms that will promote greater affordability... Full

Connecticut Seeks Approval to Make Generic GLP-1 Alternative

(7/22, Mike Savino, NBC Connecticut) ...Consumers are not the only ones struggling to pay the rising prices of popular GLP-1 drugs, as states like Connecticut see skyrocketing costs. After spending a combined $103 million in fiscal year 2024, the state is estimated to dole out $150 million through Medicaid and another $60 million for state employee insurance plans for the drug. So the state is pursuing a dramatic solution – developing a generic alternative... Full

Roche Canada Announces Polivy® (Polatuzumab Vedotin for Injection) for the First-Line Treatment of Adults With Large B-Cell Lymphoma is Now Publicly Reimbursed in Québec

(7/23, Roche Canada) ...Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that Polivy® (polatuzumab vedotin for injection) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL, is now publicly funded in Québec. Roche Canada is fully committed to continuing to work with the other provincial and territorial jurisdictions to make Polivy available to patients as soon as possible through all public drug plans... Full

US Federal Circuit Clears Path for MSN to Market Entresto Generic

(7/23, Dean Rudge, Generics Bulletin) ...The US Federal Circuit has denied Novartis' request to block MSN Laboratories from launching a generic version of Entresto, while also lifting an earlier temporary injunction. The Federal Circuit's order paves the way for an ‘at-risk' launch as the dispute over US patent 11,096,918 remains under appeal. US sales of Entresto remain substantial, with the brand delivering turnover of around $400m per month for originator Novartis... Global Sub. Full

Fresenius Receives European Commission Approval for Denosumab Biosimilars

(7/23, Fresenius) ...Fresenius announced today that the European Commission has granted approval for their denosumab biosimilars Conexxence®* and Bomyntra®* in Europe. The two approvals cover all indications of the reference products including osteoporosis in postmenopausal women and at-risk men, treatment-related bone loss, prevention of skeletal complications from cancer metastasis to bone, and giant cell tumor of bone... Full

Biocon Unit Launches Entracept Biosimilar in Australia, Expands Global Footprint

(7/23, CNBC TV-18) ...Nepexto will be marketed in Australia by Biocon Biologics' local partner, Generic Health, a leading supplier of high-quality generic prescription, injectable, and over-the-counter medicines. The partnership aims to broaden patient access to affordable treatment options in the country... Full

Daewoong Pharmaceutical Enters Biosimilar Race with Dupixent Candidate as First Pipeline

(7/22, Cheon Okhyeon, KorMedi) ...Daewoong Pharmaceutical is making a full-fledged entry into the biosimilar business as a new growth driver, bringing on board Dr. Seung-Seo Hong, a key figure in Celltrion's biosimilar development. As its first pipeline, Daewoong has selected a biosimilar referencing the blockbuster atopic dermatitis drug Dupixent (ingredient: dupilumab)...With the substance patent set to expire in 2029, biosimilar market entry is expected to begin thereafter. At the early stage, Daewoong plans to work with CDMOs (Contract Development and Manufacturing Organizations) for production... Full

Why CVS Stopped Sharing Sales Data On its Leading Humira Biosimilar

(7/22, Zachary Brennan, Endpoints News) ..."Cordavis felt it was no longer in its best interest to provide competitors data on our sales," a CVS spokesperson told Endpoints News via email. "Because of how successfully CVS Caremark was able to transition patients from branded Humira to the lower cost Hyrimoz last year, Hyrimoz has become the dominant biosimilar on the market."...Seven Humira biosimilars currently have discounted prices that are 85% or more off of AbbVie's brand-name version, and Hyrimoz is priced at an 81% discount. Andrew Bourgoin, founder of the biosimilar consultancy Bourgoin Insights Group, told Endpoints that he's concerned about being left with "uncertainty" without the data, especially as "Cordavis data showed what appeared to be strong traction for their Hyrimoz product."... Sub. Req’d

9 Drugs in Shortage

(7/22, Alexandra Murphy, Becker's Hospital Review) ...Dextroamphetamine extended-release capsules: Teva has reported a shortage of dextroamphetamine sulfate extended-release capsules, a central nervous system stimulant used to treat ADHD and narcolepsy in 5-, 10- and 15-milligram presentations. No reason was provided for the shortage and Amneal's Dexedrine Spansule capsules are available as alternatives... Full

FDA Warns Glenmark for Failure to Investigate Dissolution Failures

(7/22, Joanne S. Eglovitch, Regulatory Focus) ...The company's site in Madhya Pradesh, India, was inspected in early to mid-February. The warning letter was published on FDA's website on July 22. The company was reprimanded for failing to conduct a proper investigation into the tablets' inability to dissolve during stability testing. The firms attributed the failure to particles in the active pharmaceutical ingredient (API), but this explanation was insufficient. FDA said Glenmark has a process control in place to control the particle sizes in the API... Full

FDA Inspection Finds Leaks and Mold at Sun Pharma Halol Facility

(7/23, Dean Rudge, Generics Bulletin) ...Sun Pharma's Halol facility in Gujarat is facing severe scrutiny after a recent FDA inspection revealed multiple compliance issues and unsanitary conditions. Outlined in a 19-page Form 483 report, key findings included a leaking ceiling in a drug storage area, with mold growing in hazardous conditions. The FDA also cited violations in equipment safety, with ongoing issues of metal particulate contamination introduced by worn filling machine parts... Global Sub. Full

Generic Drugmakers Navigate Industry Turmoil With Resilience, Patient-First Focus

(7/22, Sandra Levy, Drug Store News) ...While the savings to the healthcare system are good news, David Gaugh, former interim president and CEO of Association for Accessible Medicines (AAM), cautioned "that the long-term sustainability and success of these industries and the very health of our nation's patients—hang in the balance." Gaugh added that the rate of drug shortages has increased as manufacturers face challenges, including rapid price deflation, supply chain challenges, Medicaid rebate policies that harm generic competition, slower adoption of new products due to abusive pharmacy benefit manager financial engineering and brand drug patent thickets... Full

2024 Gross-to-Net Realities at 9 Top Drugmakers: A New Era of Market Access

(7/22, Adam J. Fein, Ph.D., Drug Channels) ...This year's review includes the following nine companies: Bristol Myers Squibb, Eli Lilly and Company, Genentech, GlaxoSmithKline, Johnson & Johnson, Sanofi, Takeda, Teva, and UCB...So, journey with me to Bikini Bottom as we again delve into the murky waters of gross-to-net drug pricing...So, what did we learn on our underwater adventure through 2024's gross-to-net currents? Net prices sank for half the crew, discounts deepened, and a few brave manufacturers hoisted the "Lower List Prices" flag. As always, the sea of U.S. drug pricing remains murky, unpredictable, and full of jellyfish stings... Full

Israeli Institutional Investors Bet On Teva

(7/22, Shiri Habib-Valdhorn, Globes) ...Menora Mivtachim and Phoenix have become parties in interest in the Israeli pharmaceutical company. The share price of Teva Pharmaceutical Industries Ltd. has been treading water recently as two Israeli institutional investors have become parties in interest in the company. Last week Teva reported that Menora Mivtachim holds a 5% stake in the company and today it reported that Phoenix Financial Ltd. has a similar stake...The company will publish its financial report for the second quarter next week on July 30. Analysts expect a slight increase in revenue and earnings per share (EPS) (on a non-GAAP basis) compared with the corresponding quarter, and the average forecast is for revenue of $4.28 billion and EPS of $0.62... Full

‘Europe Has To Make Up Its Mind' – Medicines For Europe's Sieger On The Path Ahead

(7/23, Dave Wallace, Generics Bulletin) ...Medicines for Europe's interim president and Polpharma CEO Markus Sieger talks to Generics Bulletin about the European off-patent industry's priorities. Key issues include the European pharma legislation review, the Critical Medicines Act and the Urban Wastewater Treatment Directive. Sieger also discusses recent evolutions in biosimilar regulation and potential incentives for value added medicines... Global Sub. Full

How Will US Tariffs Affect the Swiss Pharma Industry?

(7/22, Aylin Elçi, Swissinfo.ch) ...Pharmaceuticals account for 40% of total Swiss exports by value, making it the largest exporting industry. Over half (60%) of those pharma exports are to the US. In what some analysts said were attempts to woo the Trump administration, Swiss and international manufacturers have pledged to invest billions of dollars in the US since the beginning of the year. But beyond the headlines, experts Swissinfo spoke to say that whether Swiss pharma is included or not in the final tariff deal, will make little difference to the industry. They say large pharma companies, which have important profit margins on drugs, can swallow higher tariffs. They add tariffs are a better option than lowering drug prices, which is another of Trump's goals and an argument he is using to negotiate... Full

Donald Trump Threatens to Use Import Restrictions On Foreign Drugmakers to Reduce Prices — Does it Affect India?

(7/23, Swastika Das Sharma, Mint) ...US President Donald Trump on Tuesday threatened to use import restrictions to pressure foreign suppliers into reducing drug prices...According to a report by The Times of India, New Delhi supplies around 35 per cent of all generic drugs prescribed in the US. Therefore, Trump's order to force foreign drugmakers to cut drug prices using import restrictions could significantly affect them, given that India and the US have not signed a trade deal yet. However, in June, Crisil Ratings had said Donald Trump's executive order on reducing prescription drug prices will have a limited impact on Indian pharma companies... Full

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