New detailed data from the RELIEVE UCCD study support overall efficacy and safety of duvakitug in all pre-specified subgroups across the different dosesNew endpoints presented include findings on clinical and endoscopic outcomes and histological- endoscopic mucosal improvementFindings to form the basis for a Phase 3 program, anticipated to start in H2 2025 PARSIPPANY, N.J. and PARIS, Feb. 22, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TAS ...

In October 2024, the U.S. Food and Drug Administration (FDA) approved SELARSDI™ for all indications matching the reference product Stelara® (ustekinumab) and has granted a provisional determination of interchangeability for SELARSDISELARSDI is the second biosimilar to launch in the U.S. under the Teva and Alvotech strategic partnership, which includes nine products SELARSDI is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 ...

TEL AVIV, Israel, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will conduct a conference call and live webcast at 8 am E.T. on Monday, February 24, 2025. During the conference call, Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, and external IBD key opinion leaders (KOLs) will discuss new data presented for duvakitug (anti-TL1A) positive Phase 2b results at the 20th Annual Congress of the European ...

TEL AVIV, Israel, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will conduct a conference call and live webcast at 8 am E.T. on Monday, February 24, 2025. During the conference call, Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, and external IBD key opinion leaders (KOLs) will discuss new data presented for duvakitug (anti-TL1A) positive Phase 2b results at the 20th Annual Congress of the European ...

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibe ...

Regulatory Approvals and Partnerships - Teva and Alvotech announced FDA approval of SIMLANDI® (adalimumab-ryvk) as an interchangeable biosimilar to Humira® for multiple conditions, with availability in the U.S. starting May 21, 2024[53]. - FDA approved SELARSDITM (ustekinumab-aekn) for subcutaneous use as a biosimilar to Stelara® for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients[54]. - Teva entered a strategic partnership with Samsung Bioepis for the commercialization of EPYSQLI® (eculizumab) in the U.S. for treating PNH, aHUS, and gMG[55]. - Teva announced a collaboration with Formycon for the commercialization of FYB203, a biosimilar candidate to Eylea® in Europe and other regions[56]. Intellectual Property and Patent Protection - AUSTEDO® (deutetrabenazine) is protected by 14 Orange Book patents expiring between 2031 and 2038, with agreements allowing generic sales starting in April 2033[65]. - UZEDY® (risperidone) was launched in the U.S. in May 2023, protected by four Orange Book patents expiring between 2027 and 2040[67]. - AJOVY® (fremanezumab-vfrm) is the only anti-CGRP subcutaneous product indicated for quarterly treatment, with patents expiring in 2026 at the earliest and extensions until 2031[69]. - Teva has 18 patents for BENDEKA expiring in 2026 and 2031, with recent court affirmations of patent validity[10]. Business Strategy and Operations - Teva intends to divest its API business, aligning with its Pivot to Growth strategy, announced on January 31, 2024[80]. - In 2024, Teva produced approximately 72 billion tablets and capsules, and 547 million sterile units across 34 plants in 27 countries[96]. - Teva's R&D pipeline includes over 1,000 generic products in various stages of approval, focusing on high-value generics and complex formulations[84]. - The innovative medicines pipeline includes projects in neuroscience and immunology, with collaborations with Sanofi and Modag[91]. Employee and Workforce Management - As of December 31, 2024, the total global workforce consisted of 36,830 employees, with a full-time equivalent of 36,167[119]. - The company reported a total of 33,892 full-time employees, a decrease from 35,001 in 2023[120]. - The employee turnover rate is monitored continuously as an important indicator of retention and engagement[120]. - The company has implemented a new talent development system based on AI capabilities, rolled out to approximately 12,000 employees globally by the end of 2024[132]. Financial Performance and Market Challenges - In 2024, total revenues from sales of generic medicines were $9,461 million, representing 57.2% of total revenues[196]. - The U.S. generics market is expected to face significant adverse challenges, including limitations on pricing influence and decreased value from future launches[197]. - Pricing pressures from customers and market competition are expected to continue affecting revenues and profits from generic products[198]. - The company may face challenges in raising additional funds in the future, impacting growth strategies and potential acquisitions[226]. Compliance and Regulatory Environment - The company is subject to extensive regulation by the FDA and DEA, which governs the development, manufacture, and distribution of its products, with noncompliance potentially leading to severe penalties[141]. - The Hatch-Waxman Act provides a five-year data exclusivity for new chemical entities and a three-year market exclusivity for certain NDAs, impacting the company's product approval timelines[145]. - The company is required to rebate 13% of the average manufacturer price for generic drugs and 23.1% or the difference between the average manufacturer price and the commercial best price for products marketed under NDAs or BLAs[155]. - The company is subject to inspections and compliance reviews by the FDA, which can impact its ability to market new products[142]. Supply Chain and Operational Risks - Supply chain disruptions due to macroeconomic issues and regulatory actions have impacted the company's ability to meet demand[230]. - The company is implementing measures to ensure continuous supply amidst increasing medicine shortages globally, which may involve legal and regulatory compliance challenges[245]. - Supply chain interruptions, particularly for key raw materials, could adversely affect cash flows and operational results, especially given the reliance on single sources for some materials[244]. - The complexity of product manufacturing processes and reliance on third-party suppliers may lead to operational disruptions if not managed effectively[243]. Market Competition and Product Performance - COPAXONE faces increasing competition from generic versions and other MS treatments, impacting its market position[10]. - AJOVY faces strong competition from two recently launched products and emerging oral CGRP therapies, impacting market share[213]. - UZEDY, a late entrant in the long-acting injectables market, faces significant competition from established products, which may hinder growth[213]. - The market for biosimilars is facing intense competition, and the company aims to capitalize on late-stage biosimilar opportunities[209].

Brendan, a Pennsylvanian by birth:-Completed a Ph.D. at Stanford University in the field of organic synthesis (2009). -Worked for a major pharmaceutical company (Merck, 2009-2013).-Worked in biotech including start-ups (Theravance/Aspira) prior to securing employment at Caltech.-First employee and co-founder of 1200 Pharma as it spun out of Caltech garnering major investment (into the 8 figures).-Remains an avid investor, focused on market trends and especially biotechnology stocks.Analyst’s Disclosure: I/w ...

Teva Pharmaceutical Industries (TEVA) reported fourth-quarter 2024 adjusted earnings of 71 cents per share, which beat the Zacks Consensus Estimate of 70 cents. Adjusted earnings declined 29% year over year.See the Zacks Earnings Calendar to stay ahead of market-making news.Revenues for the fourth quarter were $4.23 billion, beating the Zacks Consensus Estimate of $4.10 billion. However, total revenues declined 5% from the year-ago quarter on both reported and constant currency basis. The decline is mainly ...

Stock Performance - Shares of Teva Pharmaceutical Industries lost 13.5% as of 1:15 p.m. ET, underperforming the S&P 500 and Nasdaq Composite, which lost 0.5% and 0.9%, respectively [1] Financial Results - Teva reported Q4 sales of $4.2 billion and fiscal year 2024 sales of $16.5 billion, up from 2023's revenue of $15.9 billion, slightly exceeding expectations [2] - Q4 EPS was $0.71, down significantly from Q4 2023's $1.00 but slightly exceeding the expected $0.70 [2] Guidance and Investor Sentiment - The company's 2025 EPS forecast disappointed investors, with the high end of the range ($2.65) coming in below the expected $2.76 [3] Strategic Initiatives - Teva is implementing its "Pivot to Growth strategy," focusing on cost reduction through reorganization, generics, and R&D pipeline success, though the latter has no guarantees or clear timeline [4] - The company has key drugs in later stages of trials, including treatments for ulcerative colitis and Crohn's disease, which show promise but require significant effort [5]

U.S. stocks traded lower toward the end of trading, with the Nasdaq Composite falling around 1% on Wednesday.The Dow traded down 0.16% to 44,778.55 while the NASDAQ fell 1% to 19,537.19. The S&P 500 also fell, dropping, 0.54% to 6,034.67.Check This Out: Jim Cramer: This Industrial Stock Is ‘Absolutely Terrific’, First Solar Is ‘Very Inexpensive’Leading and Lagging SectorsConsumer staples shares surged by 0.7% on Wednesday.In trading on Wednesday, information technology shares fell by 1.9%.Top HeadlineU.S. c ...