Friday, September 26, 2025

Teva Pharmaceuticals: Pipeline Momentum Signals New Era For Investors

(9/25, Seeking Alpha) ...I want to give credit to Kåre Schultz, the former CEO, who did a tremendous job of getting Teva back on track to prosperity...In my opinion, he was more than successful in addressing the threat known as the "opioid crisis," including creating a safety cushion, which in the Form 10-Qs and 10-Ks is referred to as "provision for legal settlements and loss contingencies," and which has grown to $5 billion by the end of June 2025. In addition, Richard Francis continues to actively develop a portfolio of experimental drugs, among which, in my view, emrusolmin [treatment of multiple system atrophy], duvakitug, and TEV-'408 [celiac disease] have the greatest commercial potential...That's why I continue to cover Teva with a Buy rating... Full

Trump Plans New Tariff Push With 100% Rate On Patented Drugs

(9/26, Lauren Dezenski, Madison Muller, and Jennifer A Dlouhy, Bloomberg) ..."Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America," Trump posted on social media Thursday, without offering specifics on which producers will be impacted. "There will, therefore, be no Tariff on these Pharmaceutical Products if construction has started."...Trump's posts offered no further details. The pharmaceuticals plan, as described by the president, may allow for wide exemptions for companies with presences in the US. The White House did not immediately respond to a request for more specifics... Sub. Req’d

U.S. to Impose 100% Tariff On Branded, Patented Drugs Unless Firms Build Plants Locally, Trump Says

(9/26, Lim Hui Jie and Annika Kim Constantino, CNBC) ...Some health policy experts also say the move could disrupt the drug supply chain at the expense of U.S. patients, driving up costs for certain treatments or even exacerbating the medication shortages plaguing the nation. Drugmakers often rely on a global network of manufacturing sites for different steps of the production process. There "is the potential for higher prescription drug prices in an environment where we're already pushing very hard to try to get those prices down," Leigh Purvis, prescription drug policy principal in AARP's Public Policy Institute, told CNBC before the tariff announcement... Full

Trump's Tariff Threat Spotlights Drugmakers' US Factory Progress

(9/26, Jason Gale, Amber Tong and Kanoko Matsuyama, Bloomberg) ...Tariffs could weigh on Chinese companies' long-term plans to expand directly in the US, Morgan Stanley analysts wrote in a note. Their "moonshot" pathway to direct US operations, with many aspiring to sell their innovative therapies to American patients, "may face another layer of uncertainties, if the tariff barriers are to stay," they said. Analysts at Leerink Partners flagged a series of unanswered questions about how the policy will work... Full

Switzerland's Roche Flags U.S. Plans After Trump Pharma Tariff Announcement

(9/26, Paul Arnold, Reuters) ...Roche and Novartis are Switzerland's two biggest pharmaceutical firms with major U.S. production operations. Novartis, which also made a large U.S. investment pledge earlier this year, did not immediately reply to a request for comment. An industry source estimated that, based on the initial U.S. indications, the tariffs as set out by Trump on Thursday would probably not apply to the two Swiss companies... Full

EU, Japan Express Confidence in Capped US Tariffs On Drugs

(9/26, Philip Blenkinsop; Makini Brice, Reuters) ..."This clear all-inclusive 15% tariff ceiling for EU exports represents an insurance policy that no higher tariffs will emerge for European economic operators. The EU is the only trade partner to achieve this outcome with the US," a Commission spokesperson said. Japan also referred to its joint statement with Washington, which said that U.S. tariff rates on Japanese semiconductors and pharmaceuticals would not exceed those applied to others such as the European Union. In a post on Truth Social on Thursday, Trump announced a fresh round of tariffs that also covered trucks at 25% and furniture at 30-50%... Full

Trump Spares Generic Drugs from Pharma Tariffs, But Are They Still at Risk? Explained

(9/26, Riya R Alex, Mint) ...Indian pharmaceutical exports, including generic drugs, are unlikely to be affected by US President Donald Trump's recent announcement of 100 per cent tariffs on "any branded or patented" drugs imported into the US from October 1. Even though generic drugs are exempt, companies remain uncertain about tariffs due to a US government investigation under Section 232 to determine if pharmaceutical imports threaten national security, according to a report by Moneycontrol. "The latest tariff announcement is for branded or patented drugs, and not applicable to generics," the news agency quoted Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA)... Full

HHS, CMS Send Trump's Drug Pricing Pilot To White House For Review

(9/25, Maaisha Osman, Inside Health Policy) ...HHS and CMS submitted details of a much-anticipated new drug pricing pilot program, the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, to the White House for official review and sources expect that President Donald Trump will be announcing the model, linked to his "most favored nation" executive order, in the coming weeks... Sub. Req’d

Exclusive: White House Weighs Broad Drug Pricing Announcement as Soon as Next Week

(9/25, Max Bayer and Drew Armstrong, Endpoints News) ...It's possible the plans for the event could change, and several companies who had been in talks with the administration said they hadn't yet received any invitation to appear at the White House. It's also possible the administration could announce a series of one-off agreements with companies. "The White House is committed to delivering on President Trump's push to end global freeriding and lower drug prices for everyday Americans to MFN rates. Unless officially announced by the White House, however, any reporting about specific policy actions should be treated as speculative," White House spokesperson Kush Desai said in a statement to Endpoints News... Sub. Req’d

Is the MFN Order a Potential Solution for High Drug Prices?

(9/26, Mike Hollan, PharmExec.com) ...Peter Rubin, executive director of No Patient Left Behind, spoke with Pharmaceutical Executive about President Trump's Most-Favored Nation (MFN) order and the widespread impact it could have on the industry...According to Rubin, the ruling is likely to impact more than just pricing. He also believes that it will be hard to even find a fair price for the drugs using the MFN order as determining a drug's true value is more difficult that it first appears... Full

PBMs Are Reportedly Aiming to Get Ahead of Regulatory Reform. Pharmacies Are Skeptical

(9/25, Paige Minemyer, Fierce Healthcare) ...Policy changes for the PBM industry have seen bipartisan support, though meaningful actions haven't made it out of Congress yet. But a new report from Bloomberg suggests the Pharmaceutical Care Management Association (PCMA), which represents PBMs, is coming directly to the Trump administration with new proposals. In the article, it says the PCMA is pitching business changes to the Centers for Medicare & Medicaid Services in a bid to avoid further regulation... Full

NACDS Expresses Outrage at the Idea of PBMs Policing Themselves

(9/25, NACDS) ..."NACDS shares the Administration's goal of improving healthcare affordability and access, and urges them to reject the ludicrous proposal from the PBMs, instead moving forward with strong, enforceable reforms that will realize that objective. Similarly, we urge Congress to expedite the passage of the bipartisan PBM reforms that were previously agreed upon and only removed from recent legislative packages for reasons unrelated to the substance of the reforms. For years, PBMs have acted with almost no oversight. NACDS stands shoulder to shoulder with patients, pharmacists, and communities calling for change."... Full

New ADHD Lobbying Coalition Launches

(9/26, Maya Goldman, Axios) ...Mindful Choices for ADHD launched Thursday with funding from a pharmaceutical company. "There are important areas where both research and public information have been lacking," said executive director Jakara Eason. "We think that our role is to bring forward the data, highlight areas where more research is needed, and to provide clear guidance so that policymakers can make those informed choices."...Tris Pharma, a specialty drugmaker that produces ADHD therapies, provided the initial funding for the group and sits on the organization's steering committee... Full

FDA Official Updates On Advancing RWE Program, Lists Common Reasons For Rejection

(9/25, Joanne S. Eglovitch, Regulatory Focus) ...FDA official updates on advancing RWE program, lists common reasons for rejectionSome of the main reasons the US Food and Drug Administration (FDA) rejects applicants from participating in its Advancing Real-World Evidence (RWE) Program include concerns that proposed real-world data (RWD) studies will use heterogeneous patient populations or that the studies will provide supportive, rather than primary evidence, to support regulatory decisions... Full

Novartis Escalates Court Fight Against Maine 340B Law 

(9/25, Nicole DeFeudis, Endpoints News) ...A Novartis spokesperson told Endpoints News that it "continues to believe Maine's 340B contract pharmacy mandate is unconstitutional." "State 340B statutes, like Maine's, interfere with the federal 340B program as outlined by Congress and will only exacerbate widely acknowledged program integrity concerns," the spokesperson said... Sub. Req’d

US FDA Approves Eli Lilly's Therapy for Advanced Breast Cancer

(9/26, Siddhi Mahatole and Padmanabhan Ananthan, Reuters) ...The therapy, Inluriyo, was approved based on data from a late-stage trial in which patients had a 38% lower chance of their cancer progressing or death compared to those on standard treatments, the drugmaker said...The therapy is expected to be available in the United States in the next few weeks, with a list price of $22,500 per 28 days for the 400 mg dose, the company told Reuters in an email... Full

Transpire Claims First-Mover Advantage On US Breo Ellipta Rival

(9/25, Dave Wallace, Generics Bulletin) ...Transpire Bio says it has become the first firm to file a paragraph IV ANDA challenging GSK's Breo Ellipta in the US. Assuming ANDA approval by the FDA, Transpire believes it will be eligible for 180 days of market exclusivity with a first generic rival to the $2.02bn brand in the US. Other developers including Hikma and Iconovo have previously indicated that they are developing Breo Ellipta rivals... Global Sub. Full

Margins Under Pressure: Immunology's Crowded New Era

(9/26, The Pharma Letter) ...For two decades, immunology was the golden child of biopharma. Blockbusters like Humira (adalimumab), Enbrel (etanercept) and Remicade (infliximab) dominated the sales charts and funded pipelines across the industry. That era is fading fast. Biosimilars have pulled the rug from under those franchises, payers are dictating terms, and newer entrants in interleukins and JAK inhibitors are finding it hard to command premium prices. The sector is undergoing a reset — and the question is whether innovation can keep pace with commercial reality... Sub. Req’d

Pfizer's Metsera Deal Could Spark More M&A for Pharmas 'Tiptoeing into Obesity'

(9/25, Kyle LaHucik, Endpoints News) ...Analysts told Endpoints News they expect that Pfizer's decision to buy Metsera may kick-start more acquisitions of obesity drug developers. "For the right price and right deal structure, pharma would rather acquire than license," BMO research analyst Evan Seigerman said...AbbVie, AstraZeneca and Merck have all "tiptoed into obesity" with licensing deals over the past few years, according to Leerink analyst David Risinger, and Wall Street is "waiting to see if those companies step up in obesity in a bigger way in 2026 through additional transactions."... Sub. Req’d

Pharma's Direct-to-Consumer Future Runs Through GoodRx

(9/26, Adam J. Fein, Ph.D., Drug Channels) ...The next era of DTC will be defined not by who captures attention, but by who delivers affordability and access at scale. Patients expect it. Policymakers demand it. And manufacturers can't compete without it. GoodRx is uniquely positioned to bridge the gap between awareness and action, trusted by patients and healthcare professionals, integrated with pharmacies, and proven to drive results. For manufacturers, the path forward is clear: partner with platforms that transform affordability into adherence and market access into measurable performance... Full

Britain Says Pushing for Better Outcome On US Pharma Tariffs

(9/26, Alistair Smout, Reuters) ...Britain on Friday said it was pressing the United States on pharmaceutical tariffs in hope of a beneficial outcome, after President Donald Trump said a new 100% tariff would apply to firms unless they build a manufacturing presence in the country..."We know this will be concerning for industry, which is why we've been actively engaging with the U.S. and will continue to do so over the coming days," a British government spokesperson said. "Sectors such as pharmaceuticals are critical to our economy ... so we will continue to press the U.S. for outcomes that reflect the strength of our relationship and deliver real benefits for UK industry."... Full

Govt to Study New 100% US Tariff On Branded Pharma Imports

(9/26, Sean Whelan, RTE) ...Tánaiste Simon Harris has said the Government will study a new tariff of 100% on branded pharmaceutical imports from companies that are not building manufacturing plants in the US...He said: "We will be studying the impact of this announcement, which includes a number of exemptions, together with EU colleagues. "I want to stress, however, that the EU and US Joint Statement issued on August 21, last made absolutely clear that any new tariffs announced by the US on pharmaceuticals under its Section 232 investigation would be capped at 15% for pharma products being exported by the EU. "This remains the case and underlines again the value of the agreement reached last month."... Full

EU Must Keep US MFN Pricing In Mind During Pharma Package Talks, Lawyer Says

(9/25, Eliza Slawther, Pink Sheet) ...EU legislators may want to consider the risks posed by current and future US drug pricing policy changes when finalizing the new pharma reform package, Maarten Meulenbelt, head of the international law firm Sidley Austin's global life sciences practice in Europe, has suggested...Meulenbelt told the Pink Sheet that MFN pricing was "not a short-term question" for EU legislators to consider in relation to the pharma package overhaul. "The pharma package is likely to provide the basis for the EU ecosystem for the next 15 to 20 years. Therefore, we are not only discussing the risk of MFN pricing in the US in 2025 or 2026, but over the next 10 to 15 years," he said... Global Sub. Full

EU Critical Medicines Act Must Not Be ‘Watered Down', Industry Urges

(9/25, Dave Wallace, Generics Bulletin) ...Medicines for Europe has issued a stinging rebuke to those who would seek to water down the Critical Medicines Act to pursue low prices at the cost of supply security. In an open letter from the association's director general Adrian van den Hoven, Medicines for Europe also criticizes the "selfishness" of national stockpiling measures. Medicines for Europe has also signed up to a joint statement with the European Fine Chemicals Group and originator body EFPIA to show solidarity on the Critical Medicines Act... Global Sub. Full

Small Country, Big Voice: Ireland's Presidency Could Impact EU Pharma Policy

(9/25, Francesca Bruce, Pink Sheet) ...Ireland, with its "outsized pharmaceutical voice," will assume the presidency of the Council of the EU in July 2026. Ireland's collaborative approach to policy making means that the presidency will be a big opportunity to drive changes that could make the European life sciences sector more competitive. Such action points could include clarifying EU data protection rules to better support AI and strengthening intellectual property rights... Global Sub. Full

Uncertainty Looms Over Indian Pharma After US Tariff Move, Says InCred Asset Management

(9/26, Prashant Nair, Nigel D'Souza and Surabhi Upadhyay, CNBC TV-18) ...Prashant Paroda of Allspring Global Investments believes the tariff impact on Indian generic pharma will be limited, as they are key to controlling US healthcare costs. He suggests the Indian market's next trigger will be domestic, pinning hopes on a consumption revival during the Diwali festival season, especially in auto sales. Given India's recent underperformance, he feels an earnings recovery could spur market gains... Full

India & Mexico Begin Discussions to Expand Opportunities for Indian Pharma Industry

(9/26, Shardul Nautiyal, Pharmabiz.com) ...In a significant step toward strengthening bilateral healthcare ties, India and Mexico have opened discussions aimed at expanding opportunities for the Indian pharmaceuticals industry to enhance access to affordable medical products in Mexico, mutual acceptance and recognition of the Indian Pharmacopoeia (IP) and boosting investment in clinical research... Full

Trump's Tariffs On Imported Drugs ‘Not a Big Concern' for China's Pharma Firms: Jefferies

(9/26, Xinmei Shen, South China Morning News) ...The proposed tariffs are "not a big concern" for Chinese drug makers, as these firms have "minimal drug sales exposure to the US", analysts at US investment bank Jefferies wrote in a research note titled "Tariffs Barely Dent China's Healthcare Powerhouses" published on Friday. Most Chinese biotech firms, or pre-commercialisation drug developers, have expanded their market reach in the US in recent years through licensing deals with multinational pharmaceutical companies. They have US partners and are "immune" to tariffs, according to Jefferies... Full

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