Welcome to our dedicated page for Teva Pharm news (Ticker: TEVA), a resource for investors and traders seeking the latest updates and insights on Teva Pharm stock.
Teva Pharmaceutical Industries Limited reports developments across its global pharmaceutical business, including complex generic medicines, biosimilars, pharmacy brands, and innovative medicines in neuroscience and immunology. News commonly covers financial results, investor conference presentations, R&D updates, regulatory milestones, and product or patient-support launches tied to brands and candidates such as UZEDY, PONLIMSI, and proposed biosimilars.
As an Israel-based issuer with ADSs traded under TEVA, company updates also address ADR-relevant investor communications, operating outlook materials, partnerships, and strategy around a generics platform supporting a broader biopharmaceutical portfolio.
Alvotech announced the FDA has deferred action on the application for AVT02, a proposed biosimilar to Humira, pending necessary facility assessments. The FDA can defer without identifying deficiencies when inspections cannot be completed due to factors such as travel restrictions. Alvotech collaborates with the FDA for safe coordination of inspections. They are the only company that has conducted a switching study supporting interchangeability for Humira's high-concentration biosimilar. Teva Pharmaceuticals is the exclusive partner for AVT02's commercialization in the U.S.
Alvotech announced positive top-line results from a randomized study evaluating the bioequivalence of its biosimilar AVT02 (adalimumab) and Humira, demonstrating no significant differences in efficacy, safety, or immunogenicity. This study, aimed at supporting FDA approval as an interchangeable product, involved 568 patients across Europe. Alvotech is the first to submit a high-concentration biosimilar for Humira and has partnered with Teva Pharmaceuticals for U.S. commercialization. These results mark a significant milestone towards providing affordable treatment options for chronic conditions.
Teva Pharmaceuticals announced positive results from a network meta-analysis evaluating the effectiveness of AJOVY (fremanezumab), atogepant, and rimegepant in preventing episodic migraine. This analysis showed AJOVY's superiority in reducing monthly migraine days compared to both atogepant and rimegepant. The findings were shared during the International Headache Society Congress on September 8-12, 2021. AJOVY stands out as the only long-acting anti-CGRP subcutaneous injection approved for migraine prevention. The study reinforces the value of AJOVY in improving patient outcomes with significant migraine burdens.
Teva Pharmaceutical Industries announced that the New Drug Application (NDA) for TV-46000/mdc-IRM, an extended-release injectable suspension for schizophrenia treatment, has been accepted by the U.S. FDA. This acceptance is based on Phase 3 data from two pivotal studies, RISE and SHINE, which assessed the drug's efficacy, safety, and tolerability.
Teva remains responsible for clinical development and commercialization, while MedinCell will receive milestones and royalties. This marks a significant milestone for both companies in the mental health space.
Teva Pharmaceutical Industries Ltd. announces the presentation of 18 abstracts on AJOVY and other migraine treatments at the International Headache Society and European Headache Federation Congress from September 8-12, 2021. The late-breaking data includes a network meta-analysis showing the efficacy of AJOVY (fremanezumab-vfrm) and compared it to Atogepant and Rimegepant for episodic migraine prevention. This highlights Teva's commitment to improving migraine management, aiming for more migraine-free days for patients.
Teva Pharmaceuticals has announced results from a post hoc analysis of a 3-year open-label extension study for AUSTEDO (deutetrabenazine) tablets in treating tardive dyskinesia (TD). Published in The American Journal of Geriatric Psychiatry, this study evaluated efficacy and safety in patients under and over 55 years. TD affects approximately 500,000 individuals in the U.S., with higher rates in older patients. The analysis may guide treatment decisions, particularly for older adults, although the findings highlight the need for cautious interpretation due to the uncontrolled data.
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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) reported Q2 2021 revenues of $3,910 million, a slight increase of 1% year-over-year. Despite a 5% revenue decline in North America primarily from COPAXONE and Anda, overall profitability improved, reflected by GAAP net income of $207 million, or $0.19 per share. Free cash flow reached $625 million, and net debt reduced by $500 million to $22.7 billion. Teva lowered its revenue outlook for 2021 due to pandemic impacts but reaffirmed earnings and cash flow guidance. Notably, AUSTEDO sales rose, and AJOVY achieved $70 million in net sales worldwide.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced significant leadership changes aimed at enhancing its North America Commercial operations. Brendan O’Grady will depart the company, with Sven Dethlefs appointed as the new head of North America Commercial. Other changes include Mark Sabag transitioning to Executive Vice President, International Markets Commercial, Galia Inbar promoted to Chief Human Resources Officer, and Eli Shani elevated to Executive Vice President, Global Marketing and Portfolio. These changes are effective August 15, 2021.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) will announce its financial results for Q2 2021 on July 28, 2021, at 7:00 a.m. ET. A conference call will follow at 8:00 a.m. ET, accessible via dial-in or live webcast. This event is part of Teva's ongoing commitment to transparency and stakeholder engagement. Teva has a diverse portfolio of over 3,500 products, serving around 200 million patients daily. The company remains focused on its generics and specialty medicines sector, though it faces forward-looking risks related to competition and regulatory issues.