Monday, August 25, 2025

Teva Pharmaceutical: Tariff Relief Clears The Way For Reinvention

(8/22, Julia Ostain, Seeking Alpha) ...Teva Pharmaceutical Industries Limited's turnaround is gaining traction: branded drugs are driving margin improvement, while generics stabilize and biosimilars offer future growth potential. The recent U.S. tariff relief removes an existential threat, allowing investors to refocus on Teva's operational execution and strategic progress. Debt remains a significant overhang, but improving cash flow, margin expansion, and a visible deleveraging path support a cautiously optimistic outlook. At 7x forward earnings and with strong Israeli political backing, TEVA stock offers an appealing risk-reward profile for patient investors willing to wait for sustained growth... Full

Medicare Part D Plans Turn to Coinsurance, Higher Deductibles Amid IRA Changes

(8/22, Tim Casey, Pink Sheet) ...IRA provisions going into effect this year increased the use of coinsurance and raised deductibles among Medicare Part D plans, according to a white paper from the USC Schaeffer Center for Health Policy and Economics. With more coinsurance, Medicare beneficiaries are increasingly exposed to drug list prices. Congress could try to lower out-of-pocket costs, but the trade-off would be an increase in the cost of the program... Global Sub. Full

Why Ireland's Generic Drug Makers are the Big Winners in the Tariff War

(8/23, John Whelan, The Irish Examiner) ...As most drugs prescribed by doctors in Ireland are branded, the US tariff exemption should help progress in Ireland in the use of generics, which is well behind countries such as the UK, who have almost 90% generics usage. Israeli multinational pharmaceutical company TEVA, the world's leading provider of generic medicines, stated that it manufactures one in eight prescription packs supplied to Irish pharmacies. TEVA's main facility in Waterford is focused on respiratory medicines, and with its commercial and support office in Swords, employs 650 staff. They also have extensive manufacturing facilities in the US... Full

Where Your Medicines Are Made

(8/23, Rebecca Robbins and Jonathan Corum, The New York Times) ...U.S. Pharmacopeia, a nonprofit that sets quality standards and tracks the prescription drug supply, shared data with The New York Times that offers a window into the geography of all those shipments. The organization's data zeros in on supply for Americans and measures it by volume. A key geographic divide lies in how old medicines are, the data shows. Newer, more expensive patent-protected drugs, like those for cancer and obesity, tend to have their active ingredients made in Europe or the United States. India and China focus on lower-cost generics, such as statins and antibiotics, which account for a vast majority of prescriptions... Sub. Req’d

Cheap Drugs, High Stakes: America's Risky Bet On China

(8/22, Jianli Yang, The Hill) ...Many of the chemical building blocks that make modern medicine possible — reagents, solvents and key starting materials — are now overwhelmingly produced in China. These raw materials are essential for synthesizing active pharmaceutical ingredients, and in many cases, they have no viable substitute outside China. India, for example, supplies the majority of generic drugs to the United States, but India itself imports nearly 70 percent of its active pharmaceutical ingredients from China... Full

What Impact will Direct-to-Consumer Sales Have On Drug Prices

(8/25, Mike Hollan, PharmExec.com) ...One of the biggest issues Americans face is the high cost of healthcare in general. Drug prices are a particular pain point, with many medications costing Americans more than they can afford. Multiple administrations have attempted to address this issue, but it remains a major problem. The current administration is attempting multiple ways of reducing drug costs, with the promotion of direct-to-consumer drug sales being one of the proposed solutions. Michael Grosberg, vice president of product management, spoke with Pharmaceutical Executive about direct-to-consumer sales and what impact they'll likely have on drug prices... Full

Joshua Fredell, Pharm.D., On Rebates and Driving Down Drug Costs | PBMI Innovators

(8/22, Peter Wehrwein and Briana Contreras, Managed Healthcare Executive) ...In this final video of a three-part video series, Joshua Fredell, Pharm.D., senior vice president at CVS Caremark and a winner of Managed Healthcare Executive's PBMI Innovator Award, said most health plans prioritize achieving the lowest net drug costs, whether through rebates, lower list prices or biosimilars. As drug prices continue to climb, health plans are looking for every available tool to keep costs down. According to Joshua Fredell, Pharm.D., senior vice president at CVS Caremark, rebates remain a key part of the equation... Full

Patent Extensions Cost US $3.5 Billion in Delayed Generic Savings

(8/22, Pearl Steinzor, AJMC) ...A new study finds that drugmakers' use of overlapping patents delayed generic entry for 4 top-selling drugs, driving billions in excess spending. Brand-name drugmakers in the US often extend market exclusivity through overlapping patent thickets, delaying generic competition and keeping prices high.1 A new study analyzing commercial and Medicare drug spending from 2011 to 2021 found that such delays for 4 top-selling drugs—imatinib (Gleevec; Novartis), glatiramer (Copaxone; Teva Pharmaceuticals), celecoxib (Celebrex; Pfizer), and bimatoprost (Lumigan; AbbVie)—led to an estimated $3.5 billion in excess spending over 2 years... Full

EPA Finalizes Rule Ensuring Military, Asthma Inhalers, Semiconductor Manufacturers Have Priority Access to Needed Ingredients

(8/22, United States Environmental Protection Agency) ...Priority access is being provided for the following five applications: propellants in metered dose inhalers (MDIs); certain foams for marine and trailer uses; etching of semiconductor material or wafers and the cleaning of chemical vapor deposition chambers within the semiconductor manufacturing sector; mission-critical military end uses; and onboard aerospace fire suppression... Full

FDA Says it Will Publish Reports of Adverse Events Tied to Drugs On Daily Basis

(8/22, Lizzy Lawrence, STAT+) ...The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting System, was updated quarterly... Sub. Req’d

Colorado Board Proposes Enbrel's Medicare Price for Payment Cap

(8/22, Celine Castronuovo, Bloomberg Law) ...The Colorado Prescription Drug Affordability Board voted Friday to seek public comment on a proposal to set a health plan payment cap at $583.59 per unit, or the current maximum fair price for Amgen Inc.‘s autoimmune treatment that's set to go into effect in the Medicare program in January 2026. The Colorado proposal, if finalized, would apply to all health plans in Colorado and would make the board the first panel of its kind to set a statewide cap on a high-spend drug... Sub. Req’d

Copaxone Reduces Pediatric MS Relapses by Threefold Versus Avonex

(8/22, Margarida Maia, PhD, Multiple Sclerosis News Today) ...For children and adolescents with multiple sclerosis (MS), receiving treatment with Copaxone (glatiramer acetate) or its generic formulations may reduce relapses by nearly threefold compared with Avonex (interferon beta-1a), according to data from a clinical trial...To learn more, a group of researchers in Italy conducted a Phase 3b study (EudraCT 2017–005129-18) where they randomly assigned 30 children and adolescents to receive either daily subcutaneous (under-the-skin) injections of Teva Pharmaceuticals' Copaxone or weekly intramuscular (into-the-muscle) injections of Biogen's Avonex. While more DMTs have been approved for children and adolescents with MS in recent years, these were the only two drugs approved for this indication in 2018, when the trial was launched. Nearly half of MS patients on Copaxone switched to high-efficacy treatment... Full

Vanda Slams FDA ‘Generic Bias' As It Again Seeks To Undo Hetlioz ANDA Approvals

(8/22, Dave Wallace, Generics Bulletin) ...Vanda Pharmaceuticals has made its latest bid to thwart generic competition to Hetlioz (tasimelteon) by asking FDA commissioner Marty Makary to reverse a previous agency decision upholding two ANDA approvals. Claiming an "unacceptable culture of bias toward approving generic drugs" at the FDA, Vanda criticizes former CDER Jacqueline Corrigan-Curay in connection with the earlier decision relating to Teva and MSN's generics. As it announced its latest action, Vanda slammed "FDA bureaucrats" for suggesting that the Office of the Commissioner would take two months to decide whether it would review the decision, insisting that "it is time that the rule of law return to the FDA under Dr. Makary's leadership."... Global Sub. Full

Bio-Thera & STADA Agree to Extend Biosimilars Alliance to Cover Tocilizumab to Treat Multiple Inflammatory and Autoimmune Disorders

(8/25, Pharmabiz.com) ...Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG have agreed to extend their biosimilars alliance to cover tocilizumab, an immunosuppressant monoclonal antibody indicated for certain inflammatory conditions. The effectiveness of the agreement covering tocilizumab is subject to shareholder approval... Full

Royalty Pharma to Buy Royalty Interest in Amgen's Lung Cancer Drug for Up to $950 Million

(8/25, Siddhi Mahatole, Reuters) ...Royalty Pharma said on Monday it has signed a deal with BeOne Medicines to acquire a royalty interest in Amgen's drug for small cell lung cancer for up to $950 million. The deal gives Royalty Pharma access to roughly 7% of global net sales of the therapy, which won U.S. approval last year for patients with extensive-stage small cell lung cancer who have failed chemotherapy... Full

Eli Lilly's Obesity Pill Remains a Viable Rival to Novo's Oral Wegovy Despite Data That Underwhelmed Investors

(8/24, Annika Kim Constantino, CNBC) ...Some analysts say Eli Lilly's daily obesity pill, if approved, could still be a viable competitor in the weight loss drug market despite late-stage trial data that disappointed investors. In the trial, orforglipron caused weight loss that missed Wall Street's expectations and came below what Novo Nordisk reported for its oral drug in a separate study. But Eli Lilly's drug could have a few advantages over Novo Nordisk's pill, including a lack of dietary restrictions, easier manufacturing and a potentially lower price, according to some analysts... Full

Obesity Drug Market Hits Turning Point After Lackluster Results and Lull in Startups

(8/22, Kyle LaHucik, Endpoints News) ...The initial success of GLP-1s made Novo the most valuable European company at one point and catapulted Eli Lilly's market cap close to becoming the first $1 trillion pharmaceutical company. The GLP-1 mechanism has taken the industry by storm, with some projecting the market could be as big as $150 billion by 2035, and follow-on competitors have appeared in droves. Stifel is tracking 157 obesity assets currently in clinical development..."We are not optimistic about the prospects for many pipeline projects in today's emerging obesity market," Stifel bankers wrote in a July report. "This is because (1) Lilly has a dominant portfolio and (2) semaglutide, a very good drug, will be generic in roughly five years. But the good news is that many opportunities remain to upend the market with new approaches."... Full

Stanley Druckenmiller Builds Teva Position.

(8/24, Boaz Bin-Nun, Globes) ...Famed US billionaire investor Stanley Druckenmiller's Duquesne Family Office has been buying shares of Teva Pharmaceutical Industries Ltd. for the past four consecutive quarters. Since the third quarter of 2024, Druckenmiller has purchased 16 million shares in Teva including one million shares in the second quarter of 2025, making it Duquesne's second biggest holding... Full

Wes Streeting Criticises ‘Shortsighted' Drug Firms for Rejecting Pricing Offer

(8/25, Kiran Stacey, The Guardian) ...Wes Streeting has intensified his battle with drug companies over the price of their products, saying he will not let the industry rip off British patients or taxpayers by signing up to their demands. The health secretary on Sunday accused pharmaceutical companies of being "shortsighted" and undermining their relationships with the government after the two sides failed to come to an agreement last week...Johan Kahlström, the president of Novartis UK, said it was "very difficult for global boardrooms to justify investments in the UK" as a result of the rebates... Full

VPAG Deal Failure Prompts Dire UK Industry Warnings

(8/22, The Pharma Letter) ...According to the ABPI, the consequences of this will be to hamper the government's ambition for the life science sector and wider economic growth, hurt industry's ambition to ensure the latest medical breakthroughs and treatments can reach all the NHS patients who can benefit from them, and fail to deliver on commitments set out in the UK-US Economic Prosperity Deal. Specifically, industry and government have not been able to reach agreement on the changes needed to rapidly return the UK to single-digit, internationally competitive payment rates on medicines sales to the NHS... Sub. Req’d

Big Pharma Set to Pull Investment Unless NHS Spends More On Drugs

(8/24, Eleano Hayward, The Times) ...Tom Keith-Roach, UK president of AstraZeneca, said that the UK was in a "long-term race to the bottom" in terms of the value it places on innovative medicines. "As a life science investor, it is hard for me to champion the UK as a destination for new R&D or manufacturing or clinical trials if it is impossible for me to bring that innovation to patients," he added... Full

Irish Pharma Cautious On Tariff Deal, Seeks Carve-Outs in Ongoing Negotiations

(8/22, Brain Maguire, Euractiv) ...Ireland's pharmaceutical industry sees this week's EU-US deal as avoiding potentially catastrophic tariffs, but they warn that innovation and investment risks remain. The industry has urged Ireland's government to continue pushing for better terms as the details of the deal are worked out. The EU-US deal, published in a Joint Statement yesterday, outlines a ‘Framework Agreement on Reciprocal, Fair and Balanced Trade', it gives interim stability to Europe's pharma exporters. Pharmaceuticals, a crucial Irish export sector, will be subject to a capped tariff rate of 15%, extending protections previously under threat from ongoing US Section 232 investigations... Full

Canada to Drop Many Counter-Tariffs in Olive Branch to Trump

(8/22, Brian Platt and Josh Wingrove, Bloomberg) ...Prime Minister Mark Carney announced the decision Friday after a meeting with his cabinet, confirming an earlier report from Bloomberg News. The government is changing its tariff policy to align more closely with US measures. That means a broad range of US-made consumer products will no longer face a 25% tariff when imported into Canada, as of Sept. 1, as long as they're shipped in compliance with the provisions of the US-Mexico-Canada Agreement... Full

Health Insurance Union Demands Generic Prescriptions to Combat Illegal Drug Rebates

(8/24, Hong Da-yeong, Chosunbiz) ...The National Health Insurance Workers' Union said, "Illegal rebates for drugs deteriorate the health insurance finances," adding, "We need to promote generic drug prescriptions." This means that doctors prescribe medications using the generic name instead of the brand name. When a doctor prescribes acetaminophen (the ingredient) instead of Tylenol, the pharmacist selects one of the medications with that ingredient to provide to the patient... Full

Reduction in Number of Drugs On Russian Market Expected Due to Second Extra Rule

(8/22, The Pharma Letter) ...The range of drugs available in the Russian market may significantly decrease in the short term due to protectionist measures imposed by the government in regard of domestic drugs, which are purchased at state tenders. Such a position was recently expressed by the All-Russian Union of Patients (AUP) in a letter to the national government, reports The Pharma Letter's local correspondent... Sub. Req’d

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