Friday, June 19, 2026

 

 

Teva Submits NDA for Ecopipam in Pediatric Tourette Syndrome

(6/19, Jon Napitupulu, The Clinical Trial Vanguard) ...Teva's NDA submission for ecopipam, filed June 18, changes that calculus by bringing a selective dopamine D1 receptor antagonist into formal review, a mechanism entirely distinct from the haloperidol, pimozide, and aripiprazole that have defined the treatment landscape for decades... Full

 

Teva Submits NDA for Ecopipam to Treat Pediatric Tourette Syndrome

(6/18, StreetInsider.com) ...The NDA is supported by Phase 3 data published in JAMA Neurology, which showed ecopipam significantly delayed time to relapse compared with placebo in pediatric patients who had achieved a clinical response during an open-label treatment period. The study met its primary efficacy endpoint with statistical significance (p = 0.008)... Sub. Req'd

 

Teva Submits NDA for Ecopipam, Potential First New Tourette Syndrome Treatment in Over a Decade

(6/18, Marco Meglio, NeurologyLive) ..."The NDA submission for ecopipam is a significant milestone for a potential first-in-class treatment option in pediatric Tourette syndrome," Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer of Teva, said in a statement.1 "This reflects the momentum in our innovative pipeline through our recent acquisition of this important asset, and advances our Pivot to Growth strategy and commitment to bringing differentiated medicines for patients."... Full

 

Jefferies Continues to like Teva after Recent Pullback

(6/18, The Fly) ...[A]fter having caught up with the investor relations team, who noted there's no change to internal confidence on vitiligo and reiterated the data will be right after July 4 weekend, the firm continues to like shares after the pullback and keeps a Buy rating and $40 price target on Teva... Sub. Req'd

 

Supporting Cancer Care in Ghana, Midwifery in Haiti, and More

(6/19, Tori Gordon, Direct Relief) ...The donation includes Teva-donated chemotherapy and adjunctive therapies for women receiving treatment at BCI's Peace and Love Hospitals, as well as consumables and other supplies distributed through BCI's broader network of partner health facilities across the country... Full

 

 

US Launches Trade Investigation Into Germany's Spending on New Medicines

(6/18, Patrick Temple-West, Financial Times) ...The US Trade Representative said on Thursday it would open a so-called Section 301 investigation into Germany for allegedly "suppressing the prices of pharmaceuticals in its market below fair market value"..."This investigation will seek to determine whether persistent underpayment for innovative pharmaceutical products by Germany is unreasonable or discriminatory and burdens or restricts US commerce," the Trade Representative said... Sub. Req'd

 

U.S. Opens Tariff Probe Targeting Germany's Drug Pricing Policies

(6/19, Elsa Ohlen, CNBC) ..."President Trump has made clear that American patients should not be shouldering a disproportionate share of global pharmaceutical research and development," said U.S. Trade Representative Jamieson Greer in a statement late Thursday. "I am particularly concerned with news that Germany is fast-tracking legislation that would further reduce its spending on innovative pharmaceuticals," he said, calling it "a serious step backwards."... Full

 

US Launches Tariff Probe Into Germany Over Pharma Pricing

(6/18, Derek Wallbank, Rachel Cohrs Zhang, Bloomberg) ...Stephen Ubl, the president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his organization "appreciates the administration's commitment to challenging unfair practices abroad" and supports using Section 301 to achieve the goal. "For too long," Ubl added, "foreign governments have undervalued innovative medicines, forcing US patients and taxpayers to shoulder a disproportionate share of the costs of global innovation."... Full

 

Senate Republicans Call For Section 301 Probe Into Pharma Pricing

(6/18, Margaret Spiegelman, Inside Health Policy) ..."We are concerned that Germany, Japan, and other high-income countries continue to maintain policies inconsistent with the Administration's objective that U.S. trading partners pay their fair share for pharmaceutical innovation," the senators wrote, adding that USTR's latest Special 301 report "confirmed that these governments continue to use unfair policies to suppress pharmaceutical prices below fair market value and arbitrarily limit access to these lifesaving products."... Sub. Req'd

 

Senate Democrats Seek Input On Slew Of Drug Pricing Proposals

(6/18, Lauren Brensel, Inside Health Policy) ...The proposals, Wyden wrote in a "Dear Colleague" letter sent Tuesday (June 16), build on the Inflation Reduction Act and are intended to reduce drug prices by reducing drug costs through negotiations, enhancing affordability measures and investing in biopharmaceutical research. He said the potential policies focus on three priorities: lowering the prices manufacturers charge for prescription drugs, lowering patients' out-of-pocket costs and encouraging biopharmaceutical development in areas of unmet need... Sub. Req'd

 

MFN Could Disrupt The Affordable Medicines Patients Depend on

(6/18, Brianna Allen, PhRMA Blog) ...A new Leerink Center for Pharmacoeconomics analysis explains how MFN undermines the incentives that drive generic competition, making it harder for companies to invest in lower-cost alternatives millions of Americans rely on... Full

 

Eli Lilly Ends 340B Drug Discounts to Some Hospitals for Failing to Provide Claims Data

(6/18, Ed Silverman, Tara Bannow, STAT+) ...Eli Lilly has begun eliminating mandated price breaks to a few dozen hospitals that participate in a federal drug discount program after failing to receive comprehensive claims data... Sub. Req'd

 

Hospitals Demand Congress Intervene After Lilly Terminates DSHs' 340B Discounts

(6/18, Gabrielle Wanneh, Inside Health Policy) ...The American Hospital Association wants Congress to immediately use its oversight authority to demand HHS take a position on what hospitals consider an attempt by Lilly to hijack the 340B program through burdensome claims-data demands. The hospital group, one of many that had been pressing the government to intervene before the company terminated 340B pricing for the affected hospitals, warns the policy will drain scarce resources from 340B hospitals and threaten patients' access to lifesaving drugs... Sub. Req'd

 

Biosimilars Deserve A Fair Chance

(6/16, Alliance of Community Health Plans) ...Even after biosimilars are accessible, adoption is not guaranteed. Nearly every stakeholder in the supply chain has a financial incentive to prefer the most expensive drug available... Full

 

PCMA Cites ERISA In Second Challenge This Week To State PBM Laws

(6/18, Lauren Brensel, Inside Health Policy) ...PCMA says the Employee Retirement Income Security Act (ERISA), a federal law, prevents states from imposing requirements on employee-sponsored plans by regulating how the plans administer benefits and manage pharmacy networks... Sub. Req'd

 

 

4 Years after Snub, GSK Partnership Helps Spero Get Utebzi Across FDA Finish Line

(6/17, Kevin Dunleavy, Fierce Pharma) ...GSK and Spero Therapeutics have scored an FDA approval for Utebzi as the first oral carbapenem antibiotic for complicated urinary tract infections (cUTI). With the nod, patients in the United States will soon have an at-home option for the infection, which is otherwise treated with infused carbapenem antibiotics... Full

 

UK Will Be First Market for Sanofi's Subcutaneous Sarclisa

(6/19, Phil Taylor, pharmaphorum) ...The company is hoping that the new Sarclisa (isatuximab) product, which uses the CirCLIQ OBI device, could go some way toward narrowing the massive market share gap between the anti-CD38 antibody and its main rival, Johnson & Johnson and Genmab's Darzalex (daratumumab), which made $14.35 billion in sales last year to Sarclisa's $690 million... Full

 

Sanofi's Sarclisa Subcutaneous Formulation Approved in Japan for Patients with Multiple Myeloma

(6/19, Sanofi) ...The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM)... Full

 

 

The Generics Bulletin Podcast: Probing The Patent Monopoly With I-MAK's Tahir Amin

(6/18, Urte Fultinaviciute, Generics Bulletin) ...Generics Bulletin senior reporter Urte Fultinaviciute talks to Tahir Amin, co-founder and CEO of I-MAK, about the current intellectual property system that curtails off-patent drug competition and global health equity... Global Sub. Full

 

FTC Orders Aurobindo to Divest 4 Drugs to Complete $250M Lannett Acquisition

(6/18, Kevin Dunleavy, Fierce Pharma) ...The products Aurobindo will have to surrender are mycophenolate mofetil, an immunosuppressant which helps prevent organ transplant rejection; pilocarpine, which treats dry mouth in patients that undergo radiation therapy for Sjogren's syndrome; rabeprazole, a proton pump inhibitor which reduces stomach acid; and niacin extended release tablets, which manage cholesterol levels and B-complex vitamin deficiency... Full

 

Dr Reddy's Challenges Bosulif With 180-Day Lead

(6/18, Dave Wallace, Generics Bulletin) ...The launch is in partnership with MSN Laboratories, with Dr Reddy's having exclusive US commercialization rights and MSN retaining responsibility for development and manufacturing... Global Sub. Full

 

FDA Approves First Generic of Roche's Flu Drug Xofluza

(6/18, Phil Taylor, pharmaphorum) ...The Xofluza (baloxavir marboxil) generic, manufactured by Norwich Pharmaceuticals, has been given the go-ahead by the FDA as a single-dose treatment for acute uncomplicated influenza and prophylaxis in patients five years of age and older... Full

 

FDA Gives Alembic Nod for 2 Generics, Tentative OK for Generic Vitrakvi

(6/18, Sandra Levy, Drug Store News) ...Tretinoin cream, 0.05%, has a market value of roughly $76 million for the 12 months ending March 2026, per IQVIA. Alembic also received the FDA's permission for haloperidol tablets, 1 mg, 2 mg, 5 mg, 10 mg and 20 mg, which is the generic of Ortho McNeil's Haldol tablets... Full

 

FDA Duloxetine Recall Highlights Generic Manufacturing Quality Gaps

(6/17, Zachary Zubulake, PharmTech) ...Thousands of bottles of duloxetine, a widely prescribed antidepressant, have been voluntarily recalled after testing showed elevated levels of N-nitroso-duloxetine, a nitrosamine impurity, according to a notice posted by the FDA...The affected lots were manufactured by Towa Pharmaceutical and distributed in the US by Breckenridge Pharmaceutical... Full

 

 

UWWTD: European Parliament Stands With Patients and Security of Medicine Supplies

(6/18, Medicines for Europe) ...Medicines for Europe urges the European Commission to act on these calls and urgently pause the EPR scheme, undertake a comprehensive independent reassessment of the implementation framework, including its methodology, economic assumptions and potential impact on medicine supply. The support of health authorities and relevant stakeholders would be key in this process. The support of European and National health authorities, as well as the relevant stakeholders, would be key in this process... Full

 

Brazil Builds Biosimilar Momentum With Eylea, Stelara Rivals

(6/19, Dean Rudge, Generics Bulletin) ...Anvisa said Eydenzelt (aflibercept), developed by Celltrion Healthcare, and Uztok (ustekinumab) from SteinCares, were approved under Brazil's biosimilar comparability pathway, which requires evidence of quality, efficacy and safety against a reference biological product... Global Sub. Full

 

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