Tuesday, March 11, 2025

Pharmalittle: We're Reading About HHS Buyout Offers, A Novo Obesity Trial, and More

(3/10, Ed Silverman, STAT+) ...Teva told the court last week it will ask the justices to review the issue. The same day, the appeals court, with exclusive jurisdiction over patent cases, denied Teva's petition to reconsider a December ruling affirming an order that the company must delist five patents covering its ProAir HFA asthma inhaler from a FDA registry of approved drugs because they do not cover the treatment's active ingredient, albuterol sulfate. Teva urged the Federal Circuit to continue pausing enforcement of a district court order in favor of Amneal Pharmaceuticals... Sub. Req’d

Judge Certifies Bellwether Classes in Generic Drug Litigation

(3/10, Katie Arcieri, Bloomberg Law) ...A federal judge certified several classes of direct and end-payer purchasers for test trials in drug price-fixing litigation against makers of two generic drugs, clomipramine and clobetasol...Defendants in the clobetasol case include Akorn Inc., Fougera Pharmaceuticals Inc., and Hi-Tech Pharmacal Co. Inc. Defendants in the clomipramine case are Mylan Inc., Sandoz Inc., and Taro Pharmaceutical USA Inc... Sub. Req’d

Sandoz Suggests Coherus' Cimerli Strategy Was ‘Unsustainable'

(3/10, Dave Wallace, Generics Bulletin) ...In the wake of Formycon's recent announcement that US marketing partner Sandoz would be pausing commercialization of the Cimerli rival to Lucentis that it recently took over from Coherus, Sandoz management has offered a few more details on its plans for the ranibizumab biosimilar. Sandoz management has set out more details of how it intends to reposition in the US market the Cimerli (ranibizumab-eqrn) biosimilar to Lucentis that it licenses from Formycon... Global Sub. Full

First Xarelto Generics Waved Through In The US: When Will They Launch?

(3/10, Dean Rudge, Generics Bulletin) ...Lupin and Sun Pharma's Taro, which have just won the first US Food and Drug Administration approvals for generics to J&J/Bayer's blockbuster Xa inhibitor Xarelto, remain locked in litigation over a patent expiring in 2039...Patent-infringement litigation over the ‘310 patent has been consolidated in the US District Court for the District of Delaware, with Lupin and Taro both named as defendants in the case. On the other hand, claims of the ‘310 patent were declared invalid by the US Patent and Trademark Office's Patent Trial and Appeal Board in inter partes review proceedings initiated by Viatris, with Teva and Invagen joining... Global Sub. Full

Data On New Novo Nordisk Obesity Drug Disappoints in Trial, Shares Drop

(3/10, Maggie Fick, Stine Jacobsen, Reuters) ...Monday's data demonstrated that CagriSema does deliver better weight-loss than Wegovy. "However, the market wants Novo to have the best weight loss agent, which is clearly not the case," Novo shareholder Markus Manns told Reuters. "Novo's main mistake was to set expectations for CagriSema too high." The market is punishing Novo because its successor to Wegovy is on par with Mounjaro, he added... Full

Eli Lilly Plans to Launch Weight-Loss Drug in Emerging Markets this Year

(3/10, Sriparna Roy and Christy Santhosh, Reuters) ...Eli Lilly plans to launch its blockbuster diabetes and weight-loss drug in major emerging markets like India, Brazil and Mexico in the second half of 2025 as production capacity increases, its finance chief said on Monday..."The size is significant. We're talking about 900 million patients that could benefit from Mounjaro," Chief Financial Officer Lucas Montarce told investors and analysts at the Leerink Partners Global Healthcare Conference... Full

Arvinas, Pfizer's PROTAC Data Fall Short of Hype in Breast Cancer

(3/11, Elizabeth Cairns, Endpoints News) ...Arvinas and Pfizer's targeted protein degrader has not managed to distinguish itself from other, similar breast cancer drugs, according to pivotal data released Tuesday. Results of the Phase 3 VERITAC-2 trial show that vepdegestrant extended progression-free survival in patients with mutated estrogen receptor genes, but not in the overall population... Full

India's Zydus Lifesciences to Buy 86% Stake in French Medical Devices Maker

(3/11, Kashish Tandon, Reuters) ...India's Zydus Lifesciences said on Tuesday it will acquire an 85.6% stake in France's Amplitude Surgical for 256.8 million euros (nearly $280 million) as part of its plans to expand further in the global medical devices market. The acquisition, which is a nearly 81% premium to Amplitude's last close, comes as India's pharmaceutical industry is bracing itself for U.S. President Donald Trump's plans to tax pharmaceutical imports... Full

Amgen, Fresenius Settle Suit Over Prolia, Xgeva Biosimilars

(3/10, Christopher Yasiejko, Bloomberg Law) ...The agreement dismissed all claims and affirmative defenses Amgen and Fresenius had asserted against each other, but without prejudice, leaving the door open to renewing the allegations, according to Judge Christine P. O'Hearn's order issued March 7 in the US District Court for the District of New Jersey. The parties' "global confidential settlement allows Fresenius to launch its biosimilar products in the US as early as June 30" and in Europe in November 2025, Amgen said in a statement, adding that "specific financial terms remain confidential."... Sub. Req’d

Popular Award-Winning Spot Treatment Recalled Over 'Cancer-Causing Chemical' Fears

(3/11, Sophie Thompson, Indy100) ...A voluntary recall issue has been served for a popular La Roche-Posay product in the US after it was found among 66 leading skincare buys containing "potentially unhealthy" levels of a cancer-causing chemical...Among those named were Clean & Clear, Clear Pore, Sandra Dee M.D., Galderma, Vie Naturelle, Ecuate, Differin, Humane, Oxy, Encube, Nixa Skincare, Dr. Song, CeraVe, Mylan, Zapzyt, Urban Skin Rx, Rugby, Perrigo, Glenmark, Oceanside, Teva, Sandoz, Replenix, Prasco, M.A.D Skincare, Aspexia and Daylogic, many of which are owned by skincare giants including Estee Lauder, and L'Oreal... Full

Expert: Leveraging AI to Improve Biosimilar Adoption and Cost Savings

(3/10, Kennedy Ferruggia and Josh Canavan, Pharmacy Times) ...In an interview with Pharmacy Times®, Josh Canavan, head of pharmacy at RazorMetrics, discusses how artificial intelligence (AI) can analyze biosimilar fill rates and identify potential issues in pharmacy claims. Canavan highlights the complexity of biosimilar prescribing, with physicians struggling to navigate different insurance formularies and multiple biosimilar options... Full

Pfizer CEO Urges Innovation Policies Over Tariffs To Compete With China

(3/10, Maaisha Osman, Inside Health Policy) ...Pfizer CEO Albert Bourla warned that U.S. tariffs on Chinese imports pose a greater threat to U.S.-China relations than to Pfizer itself. While acknowledging that China remains a key growth market for his company, Bourla emphasized that the country is swiftly becoming a biotech powerhouse and urged U.S. policymakers to foster innovation to maintain global competitiveness... Sub. Req’d

Senate Dems Demand Kennedy Disclose Details of Mar-a-Lago Meetings with Drug Execs

(3/10, Nathaniel Weixel, The Hill) ...In a letter to Kennedy sent Monday, Sens. Elizabeth Warren (D-Mass.), Bernie Sanders (I-Vt.) and Ron Wyden (D-Ore.) said he "owes the public an explanation" for what happened during the meetings, why he took part, "and whether they will affect your commitment to ensuring that Americans receive the relief they deserve from high drug prices."... Full

CSRxP: Trump Voters Want Follow-Through On Drug Pricing

(3/10, Gabrielle Wanneh, Inside Health Policy) ...A recent survey commissioned by the Campaign for Sustainable Rx Pricing (CSRxP) found that voters across the political spectrum, including a significant share of those who voted to elect President Donald Trump, want the president to hold drug companies accountable for their role in maintaining high prescription drug prices. The findings show voters support cracking down on common practices drug makers use to game the patent system and prevent more affordable drugs from entering the market sooner... Sub. Req’d

CMS Deletes Medicare Advantage Vision Statement, Signaling Another Shift from Health Equity

(3/10, Noah Tong, Fierce Healthcare) ...The Centers for Medicare & Medicaid Services (CMS) wiped away the agency's stated intentions for the future of Medicare Advantage (MA), underlining new uncertainty for the future of health-related social needs, CMS Innovation Center models and the federal health program...The $2 Drug List Model would cap out-of-pocket drugs at $2 a month, but it's not certain the model will take effect under the Trump administration. Its exclusion from the VBID web page could further that line of thinking and highlights Republicans' prior negative feelings toward the IRA... Full

Compounders' Motion for Preliminary Injunction Denied in Case Over Tirzepatide Shortage

(3/10, Shelby Livingston, Endpoints News) ...The FDA confirmed Monday that the decision means large compounding facilities known as 503Bs have until March 19 to stop making copies of tirzepatide — sold by Eli Lilly as Zepbound and Mounjaro. Smaller compounding pharmacies known as 503As must stop immediately or risk FDA enforcement action. It's a win for Lilly, and it could have implications for a separate ongoing case over the FDA's removal of Novo Nordisk's obesity drug semaglutide from the official shortage list... Full

First Quarterly Reports for Competitive Generic Therapy Designation and Priority Review Applications Under Section 807 the Act

(3/10, Bob Pollock, Lachman Consultants) ..."Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy designation under section 506H of the FD&C Act."...The two charts below provide data on each of the competitive generic therapy (CGT) categories under Section 506 of the Act and describe, for the most part, the required reporting metrics required by the Act... Full

House Lawmakers Aim to Protect Federal Drug-Pricing Program

(3/10, Jeff Elkins, The Journal Record) ...Oklahoma House lawmakers will soon consider a bill protecting a federal drug discount program on the chamber's floor amid what they describe as a misinformation campaign by pharmaceutical companies. House Bill 2048 would establish the 340B Nondiscrimination Act, requiring a health insurance issuer, pharmacy benefits manager, other third-party payor, or its agent, must reimburse a 340B entity for drugs at a rate lower paid to non-340B entities for the same drug or give a lower reimbursement on the basis that it's a 340B drug... Full

Rep. Karls Pushing for Bill to Lower Prescription Drug Prices

(3/10, Joel Porter, KXNET) ...Karen Karls is asking for a ‘yes' vote on House Bill 1216, which she hopes would save families money who are paying for medication for rare diseases. Her bill seeks to cap the amount patients must pay if there is no generic form of the medication available. Karls argues that some health insurance companies now have policies called ‘copay accumulators,' which means they won't allow people to use coupons to save money on their deductible and out of pocket limits... Full

Michigan Senate Votes to Stop Drugmakers from Limiting Discounts for Hospitals

(3/10, Mark Sanchez, Crain's Grand Rapids Business) ...Senate Bill 94, which has divided health care advocacy groups, would bar pharmaceutical companies and wholesalers from limiting drug sales covered under the federal program known as 340B. The bill also would require drug companies participating in 340B to submit an annual report to the Michigan Department of Licensing and Regulatory Affairs beginning July 1, 2026 on their compliance with the law... Sub. Req’d

In Discussion With Medicines For Europe: Bracing For US Tariffs And Embracing Ukraine

(3/10, Urte Fultinaviciute, Generics Bulletin) ...Tariffs, international cooperation, and war: the off-patent industry is not immune to the political issues raging across the globe. Medicines for Europe's Adrian van den Hoven and Beata Stepniewska spoke with Generics Bulletin about what these developments mean for the sector... Global Sub. Full

EXCLUSIVE: The Critical Medicines Act that Aims to Bring Control of Pharma Back to Europe

(3/10, Sarantis Michalopoulos, Euractiv) ...The much-anticipated Critical Medicines Act wants to scale up investments in manufacturing capacity for critical medicinal products within the EU and provide the necessary financial incentives, according to a document seen by Euractiv. The Act is due to be presented by EU Health Commissioner Olivér Várhelyi in the European Parliament on Tuesday. Its main objectives are to reduce the EU's foreign dependencies, focus on domestic production of critical medicines and provide the necessary financial framework to accelerate the implementation of relevant projects... Sub. Req’d

A U.K. Trade Group is Due to Lift its Suspension of Novo Nordisk, But Critics Cite a Lack of Transparency

(3/10, Ed Silverman, STAT+) ...A U.K. industry trade group is due to lift a rare two-year suspension of Novo Nordisk over "serious breaches" promoting an obesity drug, but some academics are raising questions about the extent to which the public will know if the company has substantively changed its business practices...An ABPI spokesman did not say whether the suspension will be lifted on March 16, but maintained the ABPI board "will consider all aspects of Novo Nordisk's compliance procedure and case history in its decision, including when these cases took place and what Novo Nordisk has done as a result."... Sub. Req’d

Spain Boosts Transparency On Reimbursement Decisions And Sheds Light On Agreements With Companies

(3/10, Francesca Bruce, Pink Sheet) ...Three reports have so far been published and shed more light on the agreements between authorities and manufacturers to secure financing. A report on CSL Behring's one-time gene therapy Hemgenix (etranacogene dezaparvovec) for Hemophilia B reveals that the company signed a payment for results deal. The other reports provide more information on the decisions to reimburse BMS' cardiomyopathy drug Camzyos (mavacamtent) and Pfizer's Velsipity (etrasimod) for ulcerative colitis. The reports are available on a dedicated webpage... Global Sub. Full

Cheaper, Generic Versions of Ozempic Could Come to Canada As Early As Next Year

(3/11, Kelly Grant, The Globe and Mail) ...Generic versions of Ozempic could be available in Canada as early as next year, making Canadians among the first in the world to get cheaper copies of the type 2 diabetes drug that has become a sales and cultural juggernaut because of its weight-loss benefits. At least four companies have applied to Health Canada to sell copies of Ozempic after its market exclusivity expires on Jan. 4, 2026. Health Canada accepted submissions from the Canadian company Apotex in January and from Switzerland-based Sandoz in November, according to the regulator's website... Sub. Req’d

Czechia's Centralised Medicines Purchasing Plan Sparks Concern

(3/10, Aneta Zachová, Euractiv) ...A controversial proposal by Czech Finance Minister Zbynek Stanjura (ODS, ECR) to introduce centralised purchasing of certain medicines by health insurance companies has drawn criticism from healthcare professionals, patient organisations, and pharmaceutical industry representatives. Critics warn that the plan could restrict treatment options, limit doctors' autonomy, and increase the risk of drug shortages and corruption... Full

Bulgarian Trade Group Calls On Members of Parliament to Allocate Additional Funds

(3/10, The Pharma Letter) ...In 2025, the NHIF will pay for medicines worth nearly 3.3 billion leva ($1.8 billion) including value added tax (VAT), but the budget allocated for this is only 2.3 billion leva. The difference of 1 billion leva will be claimed back by the NHIF from the pharmaceutical companies. This "hole" in the budget is getting bigger every year. Forecasts show that in 2025, the NHIF's money for medicines will run out on September 12 and the treatment of patients for the remaining months will be paid for by the companies. In other words, the industry subsidizes the treatment of every third patient in Bulgaria... Sub. Req’d

NPPA to Consider Other Sources Also to Fix Ceiling Prices of Some Formulations

(3/10, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority (NPPA) will be exploring sources other than the Pharmatrac database, which it relies on price fixation, while fixing the ceiling prices for some of the scheduled formulations for which further data would be helpful. The decision is following an observation that there is data outside the purview of Pharmatrac, including other manufacturers whose supply chain differs from the typical retail distribution channels for pharmaceuticals... Full

Boehringer Ingelheim's Blockbuster Diabetes Drug Goes Off Patent Today—Will it Lower Treatment Costs in India?

(3/11, Sushmita Panda, Financial Express) ...Boehringer Ingelheim's blockbuster diabetes drug, Empagliflozin, is now off-patent in India, paving the way for domestic drugmakers to launch generic versions. The generic versions are likely to be become available at 20 per cent to 30 per cent of current prices...Leading domestic pharmaceutical companies like Mankind Pharma, Torrent, Alkem, Dr Reddy's, and Lupin are expected to introduce generics in the coming days... Full

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