Thursday, September 25, 2025

Teva Trumpets Latest LAI Data – This Time On Olanzapine

(9/24, Dave Wallace, Generics Bulletin) ...Christine Fox, Teva's executive vice-president for US commercial, summarized the opportunity overall for Teva to have "a best-in-class LAI franchise – so not one medicine but two. And underpinning that, it's with two very well-established molecules with a wide range of patients." "We're really, really excited about this opportunity," Fox set out. "We think that this is a really unique position to be in on answering these unmet needs with a differentiated LAI franchise. We know that we can address a broad spectrum of patients. Most of the patients will either be able to benefit from Uzedy or olanzapine, and we think we have a really excellent go-to market capability and opportunity to really be a leader in the psych space and advance that as we go."... Global Sub. Full

Teva Pharma (TEVA) PT Raised to $26 at UBS, 2030 Sales Estimate Increased

(9/24, Streetinsider.com) ...UBS analyst Ashwani Verma raised the price target on Teva Pharma to $26.00 (from $23.00) while maintaining a Buy rating... Sub. Req’d

US Implements EU Trade Deal, 15% Autos Tariffs Retroactive to Aug 1

(9/25, David Lawder, Reuters) ...President Donald Trump's administration said on Wednesday it was formally implementing the U.S. trade agreement with the European Union, confirming that a 15% duty rate for EU autos and auto parts began on August 1 and listing tariff exemptions for generic pharmaceuticals, aircraft and aircraft parts...The U.S. notice also specifies hundreds of products from the EU that are exempt from Trump's new tariffs, including natural resources such as cork lacking in the United States, all aircraft and aircraft parts, and generic pharmaceuticals and their ingredients and chemical precursors... Full

Pence Group Challenges Trump On Drug Pricing Plans

(9/24, Megan R. Wilson, The Washington Post) ...A group founded by former vice president Mike Pence is trying to rally opposition around parts of the Trump administration's drug pricing agenda... Sub. Req’d

Drug Middlemen Aim to Avoid New Rules With Voluntary Changes

(9/24, John Tozzi and Rachel Cohrs Zhang, Bloomberg) ...The main lobbying group that represents so-called pharmacy benefit managers, the Pharmaceutical Care Management Association, has drafted proposals to bring to the Centers for Medicare and Medicaid Services, according to a document viewed by Bloomberg News. Among the proposals under discussion are ensuring patients don't pay more than a pharmacy would charge to someone without insurance, increasing the use of lower-cost versions of expensive biologic drugs and boosting payments to rural and independent pharmacies... Sub. Req’d

AstraZeneca Files to Try to Bring IRA Fight to Supreme Court 

(9/24, Nicole DeFeudis, Endpoints News) ...AstraZeneca asked the US Supreme Court to review its challenge to Medicare drug price negotiations, escalating the long-running legal battle between pharma and the government over the law. The company said in its petition, which was made public this week, that "with the IRA's price-controls set to take effect on January 1, review is warranted now."...Legal experts have said the fight is far from over. The Third Circuit could decide any day on a similar case brought by Novo Nordisk, while Merck and Teva await rulings in a federal district court in DC... Sub. Req’d

Bausch Pulls Xifaxan From Medicaid/340B As Medicare Negotiated Price Looms

(9/24, Cathy Kelly, Pink Sheet) ...Bausch Health will withdraw its Xifaxan antibacterial from the Medicaid and 340B programs as of Oct. 1. The move comes a little more than a year before Xifaxan will face a negotiated price in Medicare in 2027...Xifaxan's exposure to a Medicare-set price in 2027 could be the beginning of a steeper price decline because the drug is expected to lose exclusivity the following year. Teva, Sandoz and Sun Pharma have reached Xifaxan litigation settlements with Bausch that allow generic launches on Jan. 1, 2028... Global Sub. Full

People with Medicare Will Face Higher Costs for Some Orphan Drugs Due to Changes in the New Tax and Budget Law

(9/24, Juliette Cubanski and Tricia Neuman, KFF) ...The law that established the negotiation program, the Inflation Reduction Act of 2022, excluded certain types of drugs from negotiation, including orphan drugs approved to treat a single rare disease or condition. The new tax and budget reconciliation law passed by Congressional Republicans and signed by President Trump modifies the orphan drug exclusion in ways that will lead to higher Medicare spending, according to the Congressional Budget Office (CBO), and higher costs for beneficiaries who take these medications... Full

Who Will Pay for Prescription Drugs in 2033: DCI's Takeaways from the Latest Government Forecasts

(9/23, Adam J. Fein, Ph.D., Drug Channels) ...Below, we outline the four major takeaways from the latest projections, which continue to show that taxpayers—primarily via Medicare and Medicaid—will continue to dominate the employer-sponsored insurance market. And like it or not, vertically integrated insurers, PBMs, specialty pharmacies, and providers will continue to prosper... Full

PCMA Launches Lower the List Price Ad Campaign Calling On Big Drug Companies to Lower Prescription Drug List Prices

(9/23, PCMA) ..."Make no mistake, America's pharmacy benefit managers (PBMs) want lower list prices on all drugs for every patient. It is well past time for drug companies to stand up and be accountable for the fact that they and they alone set and raise the sticker prices on their products," said JC Scott, president and CEO of PCMA. "PBMs are working every day to reduce drug costs for patients and the employers and plan sponsors providing pharmacy benefits. Our campaign is a reminder that addressing affordability starts with and requires drug companies to do the right thing: Lower the List Price."... Full

Will Congress Limit the Cost to Consumers of Life-Saving EpiPens?

(9/24, David Lightman, The Sacramento Bee) ...A proposal by Reps. Doris Matsui, D-Sacramento, and Maxwell Frost, D-Florida, would limit out-of-pocket costs for EpiPens — $60 for a two-pack rather than $100 or more depending on insurance coverage — and other methods of dispensing epinephrine...AHIP, the industry trade group, sent The Bee this statement: "No one should be priced out of access to life-saving medications, yet drugmakers continue to set and raise their exorbitant prices unchecked," it said... Full

They Said It!: Lawmakers Highlight Critical Role of Competition to Lower Prescription Drug Prices in Markup to Advance Q1/Q2 Reforms

(9/24, The Campaign for Sustainable Rx Pricing) ...In case you missed it, the U.S. House Committee on Energy and Commerce advanced bipartisan legislation last week that would increase transparency in generic drug applications. This bipartisan, market-based solution would reform the Q1/Q2 sameness requirements from the U.S. Food and Drug Administration (FDA) that Big Pharma abuses to extend exclusivity, promoting a more efficient and streamlined generic drug approval process. According to the nonpartisan Congressional Budget Office (CBO), this solution would deliver more than $1 billion in savings... Full

Eli Lilly Plans to Bring Experimental Weight-Loss Pill in India

(9/25, Rishika Sadam and Kashish Tandon, Reuters) ...Eli Lilly plans to launch its experimental oral weight-loss drug orforglipron in India, a senior executive said on Thursday, offering an alternative to injectables that many patients in the world's most populous nation resist..."There is promise for products like that in India, if it gets approved," Winselow Tucker, Lilly India's president, said, speaking at an industry conference panel in Mumbai. He did not give a launch timeline. People in India would take their tablets rather than inject, Novo Nordisk India head Vikrant Shrotriya said... Full

In Potential $1.1B Deal, Glenmark Grabs Certain Rights to Hengrui's ADC Rival to Enhertu

(9/24, Angus Liu, Fierce Pharma) ...Jiangsu Hengrui Pharmaceuticals' dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo's blockbuster Enhertu being the latest addition. Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India's Glenmark Pharmaceuticals, the two parties announced Wednesday...The focus is on emerging markets; the partnership excludes the U.S., Canada, Europe, Japan, greater China, Central Asia and a few other countries... Full

Celltrion's Denosumab Biosimilars Approved By Health Canada

(9/24, Urte Fultinaviciute, Generics Bulletin) ...Celltrion's Stoboclo and Osenvelt have been approved by Health Canada for the same indications as the originator Prolia and Xgeva brands. This is the second pair of approved denosumab biosimilars in the country, with Sandoz gaining frontrunner position in early 2024. Celltrion has already launched its denosumab rivals in the US, while also gaining approval in Australia earlier this spring. Launch timing in Europe is still unclear... Global Sub. Full

Kashiv BioSciences & JAMP Pharma Launch Biosimilars in Canada

(9/24, Rachel Klemovitch, Contract Pharma) ...Pexegra and Filra biosimilars will be marketed in Canada through an exclusive agreement with JAMP Pharma Corporation. Exegra (6 mg/0.6 mL pre-filled syringe) and Filra (300 mcg/0.5 mL and 480 mcg/0.8 mL pre-filled syringe) are used to treat neutropenia, low neutrophils, which are a type of white blood cell that fight infection, which is commonly experienced by patients undergoing chemotherapy... Full

Alkem Launches Pertuzumab Biosimilar In India

(9/24, Dave Wallace, Generics Bulletin) ...Alkem has launched a pertuzumab biosimilar rival to Perjeta in India. The firm emphasized that the biosimilar "meets global standards and is backed by trusted science." Alkem's Enzene subsidiary, which developed the product, has a broad pipeline of further biosimilars in the works... Global Sub. Full

Alembic Pharma Gets USFDA Nod for Generic Drug to Treat Depression, Anxiety

(9/25, Press Trust Of India) ...Alembic Pharmaceuticals Ltd on Thursday said it has received a final approval from the US health regulator for its generic version of Paroxetine extended-release tablets indicated for treatment of depression and anxiety. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Paroxetine extended-release tablets of strengths 25 mg and 37.5 mg, Alembic Pharmaceuticals said in a regulatory filing... Full

Lupin Receives FDA Tentative Approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets

(9/25, Indian Pharma Post) ...Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. This product would be manufactured at Lupin's Nagpur facility in India... Full

Generics Makers to Sell Gilead's Yeztugo at $40 a Year Under Deals with Gates Foundation, Others

(9/24, Zoey Becker, Fierce Pharma) ...Unitaid, the Clinton Health Access Initiative (CHAI) and Wits RHI—a South African HIV research institute—are teaming up with Dr. Reddy's to provide the PrEP drug for $40 per year in 120 low- and middle-income countries starting in 2027. The $40 price point puts the long-acting injectable on par with daily oral PrEP meds, according to CHAI. "It's a new model for how innovation reaches those who need it the most," CHAI's CEO Buddy Shah said in a press release... Full

Ipca Labs to License Cancer, Autoimmune Disorder Drug to US Firm BSS

(9/24, Jomy Jos Pullokaran, CNBC TV-18) ...Drug firm Ipca Laboratories Ltd on Wednesday (September 24) announced that it has signed a definitive technology transfer and joint development agreement with BioSimilar Sciences PR LLC (BSS), USA, for a next-generation monoclonal antibody biosimilar targeting cancer and autoimmune diseases...Under the terms, BSS will hold exclusive rights for the US and Canada and non-exclusive rights in certain Latin American countries. The first biosimilar launch is planned for 2027, with another molecule expected to seek FDA approval by 2028/29... Full

Direct-to-Patient Programs Are in the Works at 94% of Pharmas, Set to Become 'Standard Practice': Survey

(9/25, Andrea Park, Fierce Pharma) ...The vast majority of drugmakers are either considering or have already established direct-to-patient (DTP) programs, cutting out middlemen to offer services like virtual care consultations, payment support, at-home diagnostics and digital pharmacies. That's according to a new report from ixlayer, based on a recent survey of about three dozen respondents from pharmas of all sizes. Ixlayer is slated to formally unveil the survey's findings during a virtual panel discussion Thursday afternoon alongside speakers from AstraZeneca and Klick... Full

Industry Unites for a Bold Critical Medicines Act that Prioritises Secure Supply of Medicines for Patients

(9/24, Medicines for Europe) ...Speaking today in the European Parliament, at a dedicated event hosted by MEP Tomislav Sokol, (EPP) and MEP Vlad Vasile-Voiculescu (RE), health leaders shared their vision for a bold critical medicines act, as the legislative process continues. The Act should enable Europe to achieve open strategic autonomy in healthcare and boost stable supply of API's and medicines for patients... Full

UK Wants to End Pricing Feud With Drugs Companies, Says Science Minister

(9/24, Hannah Kuchler and Svenja Nierwetberg, Financial Times) ...Lord Patrick Vallance told the Financial Times that "all options" were on the table in terms of UK drugs pricing, after big pharma companies slammed the UK as uncompetitive in recent weeks and shelved investments. "We need to fix the commercial environment so that it's good enough to get those companies back again and benefits patients in the NHS," he said on Wednesday. He added that this "means probably for medicines, we need to pay a bit more for some of them"... Sub. Req’d

UK Drug Price Rises Necessary, Says Patrick Vallance

(9/25, Simon Jack, BBC News) ...The price the NHS pays for medicines will need to rise to stop a wave of pharmaceutical investment leaving the UK, science minister Patrick Vallance has said...Streeting previously insisted that he would not allow pharma companies to "rip off" taxpayers and described drug companies' approach as "short-sighted". However, he struck a more conciliatory tone on Wednesday saying "it's a live conversation – not just domestically with the industry but internationally with the US as well"... Full

Moderna Opens UK Facility as Drug Pricing Spat Rumbles On

(9/25, Phil Taylor, Pharmaphorum) ...The Moderna Innovation and Technology Centre (MITC) in Harwell is the flagship part of a 10-year, £1 billion investment in the UK by the US pharma company, with the potential to produce up to 250 million doses of mRNA vaccines per year if there is a pandemic...Streeting said at the opening that the opening of the MITC is "the next pivotal moment in boosting our nation's health, innovation and economy," adding: "Pioneering centres like these will help ensure this country remains a powerhouse in this growing industry."... Full

Pharma Is Pushing $200,000 Cancer Drugs When Cheaper Doses May Work

(9/24, Robert Langreth, Bloomberg) ...In a basement treatment room one day in May, several of those who've made it inside sit in beds getting an intravenous drip of a Bristol Myers Squibb Co. drug called Opdivo or a competing Merck & Co. drug, Keytruda. A single infusion might cost at least $7,000 at the standard dose in the US, and a year's treatment more than $200,000. Here, by financial necessity, most of the patients are getting as little as one-sixth of that. The remarkable thing is that the radically low doses may also be effective at keeping cancer sufferers alive, doctors here and in other hospitals across India say. The science isn't settled, but hospitals in Israel, France, the Netherlands, Canada and the UK are all testing or implementing more modest dose reductions... Full

Denmark's Central Bank Cuts Growth Outlook Citing US Tariffs, Pharmaceuticals Slowdown

(9/24, Anna Ringstrom, Reuters) ...Denmark's central bank on Wednesday cut its GDP forecasts for 2025-2027, citing a negative impact from U.S. trade tariffs and weaker growth in the pharmaceuticals industry, where weight-loss drug maker Novo Nordisk has seen rising competition... Full

Trump's Pharma Clampdown Threatens ‘Dramatic' Fall in Irish Corporation Tax Receipts - ESRI

(9/25, Dominic Coyle, The Irish Times) ...The paper by Prof John FitzGerald examined the prospects for Ireland's significant pharmaceuticals sector in the wake of the US decision to impose a 15 per cent tariff on all medicines imported into that country. It also considered how any further US policy changes might impact the industry in Ireland and the broader Irish economy. Published alongside the Economic and Social Research Institute's (ESRI) quarterly economic commentary, it noted that the imposition of tariffs has serious implications for the Irish economy. But it warns that worse could be yet to come... Full

QULIPTA® (atogepant) Now Publicly Reimbursed in Quebec for Chronic Migraine and CGRP Class Review Published

(9/25, AbbVie) ...AbbVie announced today that the RAMQ has listed QULIPTA® in their formulary for the prevention of chronic migraine and episodic migraine. This will be followed by reimbursement by private plans, mimicking the public formulary... Full

Czechia's Generic-Heavy Pharma Sector Downplays US Tariff Risks

(9/24, Aneta Zachová, Euractiv) ...Under the current EU–US arrangement, most European products will be subject to a 15% duty, including brand-name drugs, active pharmaceutical ingredients (APIs), and related chemical precursors; however, generics are likely to remain largely duty-free. Despite residual uncertainty, Czechia remains calm. "The United States is not among the main export markets for the Czech pharmaceutical industry; this trend applies more to other EU countries," Czech Industry and Trade Ministry spokesperson Marek Vošahlík told Euractiv... Full

Deals, Drugs, And Disruption: Glenmark, Lupin, IPCA Labs And Others Lead India's Pharma Opportunity Boom

(9/25, Varsha Chandnani and Anas Ali, NDTV Profit) ...All things considered, it is apparent that the Indian pharma market is on the move and it is not relying solely on generics anymore. Although there is still a long way to go, global partnerships, high-margin therapies and and innovation-driven growth may serve as the next big themes in the pharma space... Full

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