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 Ltd. (TEVA) is a global leader in generic medicines and biosimilars, delivering cost-effective healthcare solutions across 60+ countries. This dedicated news hub provides investors and professionals with verified updates on Teva’s strategic initiatives, regulatory milestones, and market developments.
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Teva Pharmaceuticals announced four data presentations regarding AUSTEDO (deutetrabenazine) and TV-46000, presented at the American Psychiatric Association Annual Meeting from May 21-25, 2022. Key studies include long-term safety and efficacy of AUSTEDO for tardive dyskinesia, and a new copolymer technology for TV-46000 targeting schizophrenia. Teva will also host educational sessions on mental health's social determinants and the clinical benefits of long-acting injectables in schizophrenia treatment. The data reflects Teva's commitment to addressing mental health needs.
Teva Pharmaceuticals announced findings from a clinical study on SABA use among asthma patients, presented at the ATS 2022 Annual Meeting. The study revealed significant SABA overuse, with nearly one-third of patients making over 138 inhalations in 12 weeks. Key findings indicated that 89% of patients exceeded the consensus threshold for SABA use, suggesting a potential risk for asthma exacerbation. The ProAir Digihaler digital inhaler was highlighted as a tool to help healthcare providers make informed treatment decisions based on real-time patient data.
Teva Canada Limited has announced the public formulary coverage for AJOVY® (fremanezumab) in several provinces including Ontario, British Columbia, Nova Scotia, New Brunswick, and Newfoundland, enhancing accessibility for migraine patients across Canada. AJOVY® is indicated for adults with at least four migraine days monthly. This development follows similar coverage announcements in Alberta, Saskatchewan, and Québec. The increased availability of AJOVY® is expected to improve the quality of life for many Canadians suffering from migraines.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) will present findings at the ATS 2022 Annual Meeting held from May 13-18, 2022, in San Francisco. These findings focus on the use of short-acting beta agonists (SABA) in asthma patients, utilizing data from the ProAir Digihaler. This analysis applies clinical usage thresholds from independent experts to objective patient data, marking the first such study of its kind. The research highlights the potential for digital inhalers to enhance asthma management and patient outcomes.
Teva Pharmaceutical Industries reported Q1 2022 revenues of $3.7 billion, a decrease of 8% year-over-year, primarily due to lower sales in North America. GAAP diluted loss per share was $0.86, while non-GAAP diluted EPS was $0.55. The revenue outlook for 2022 has been revised lower to $15.4 - $16.0 billion amidst foreign exchange challenges and increased competition for COPAXONE, now expected at ~$750 million. Despite these challenges, Teva reaffirmed its adjusted EBITDA guidance of $4.7 - $5.0 billion and free cash flow of $1.9 - $2.2 billion.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Auspex Pharmaceuticals have settled litigation with Lupin concerning Lupin’s ANDA for a generic version of Teva's AUSTEDO (deutetrabenazine). Under the agreement, Lupin is granted a license to sell the generic product beginning in April 2033. AUSTEDO is the only FDA-approved treatment for tardive dyskinesia and chorea associated with Huntington’s disease. Teva's intellectual property related to AUSTEDO remains intact as they continue to litigate against Aurobindo over its ANDA for a similar product.
Teva Pharmaceuticals and MedinCell announced the U.S. FDA has issued a Complete Response Letter for their New Drug Application for TV-46000 (risperidone extended-release injectable). This application aimed to treat schizophrenia but has been halted pending further review. Teva plans to collaborate with the FDA to address the feedback and continue product development. The application was based on two pivotal studies demonstrating the drug's safety and efficacy in managing schizophrenia symptoms.
Teva Pharmaceuticals, in collaboration with MedinCell, received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application for TV-46000/mdc-IRM, an injectable treatment for schizophrenia. This letter indicates that the application cannot be approved in its current form. Teva aims to work with the FDA to address feedback and remains dedicated to developing this treatment. The application was based on Phase 3 data from two pivotal studies assessing the drug's efficacy and safety.
On April 5, 2022, National Caregiver Day in Canada, Teva Canada announced a partnership with People Before Patients to enhance healthcare delivery. They launched a series of five podcasts featuring healthcare leaders and initiated a national online survey to gather insights on improving Canadian healthcare. A live virtual event is scheduled for May 10, 2022, with keynote speaker Michael Landsberg. Teva Canada has also expanded its Caregiver-Friendly Pharmacy program, aimed at supporting the 8.1 million caregivers in Canada, amidst challenges from the pandemic.