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Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) is a leading Israeli multinational pharmaceutical company headquartered in Tel Aviv, Israel. As the world's largest generic drug manufacturer, Teva plays a pivotal role in the global healthcare industry. The company derives approximately 50% of its sales from North America, contributing significantly to the total number of generic prescriptions in the United States.
Teva's extensive portfolio includes not only generic drugs but also active pharmaceutical ingredients (APIs) and proprietary pharmaceuticals. The company's operations are categorized into three main therapeutic areas:
- Central Nervous System (CNS): Featuring notable products such as Copaxone, Ajovy, and Austedo, Teva addresses critical CNS disorders with innovative treatments.
- Respiratory: Products like Qvar and ProAir contribute to Teva's robust respiratory medicine lineup, catering to patients with various respiratory conditions.
- Oncology: Teva's oncology portfolio includes groundbreaking medicines such as Truxima, Herzuma, and Bendeka/Treanda, providing essential treatments for cancer patients.
In addition to its pharmaceutical products, Teva is a major player in active pharmaceutical ingredients, offering contract manufacturing services and owning Anda, a U.S.-based distributor of generic and specialty drugs.
Teva's global presence extends beyond North America, with significant operations in Europe, Japan, Russia, and its home country, Israel. The company's strategic partnerships and innovations keep it at the forefront of the pharmaceutical industry. Recent developments include advancements in biosimilars and innovative treatments.
Financially, Teva continues to maintain a strong position, focusing on growth and resilience amidst market challenges. The company is committed to improving patient health worldwide by providing high-quality, affordable medicines.
Teva Pharmaceuticals has reached a settlement with the Attorney General of Louisiana concerning opioid-related claims. The agreement, contingent upon state confirmation by November 2, 2021, includes a payment of $15 million over 18 years and the donation of $3 million worth of lifesaving medicines. Teva is also pursuing a national settlement and continues defending itself in ongoing litigation in states like New York and California. The company views this settlement as a significant step toward aiding those affected by opioid addiction.
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.
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.
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