Partnership Agreement - Samsung Bioepis and Teva Pharmaceutical Industries have entered into a license, development, and commercialization agreement for EPYSQLI®, a biosimilar to Soliris®, in the US [1] - Samsung Bioepis will handle development, regulatory registration, manufacturing, and supply, while Teva will manage commercialization in the US [2] - EPYSQLI is indicated for treating rare diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) [3] Strategic Importance - The partnership aims to increase access to treatment for rare disease patients, addressing high costs and limited availability [4] - The collaboration aligns with Teva's Pivot to Growth strategy, expanding its biosimilar portfolio to 18 assets [5] - Samsung Bioepis' biosimilars portfolio now includes nine biosimilars available in over 40 countries, covering therapeutic areas such as immunology, oncology, and hematology [5] Regulatory Approvals - EPYSQLI was approved by the US FDA in July 2024 for PNH and aHUS, with an expanded indication for gMG in November 2024 [4] - The product received approval from the European Commission in May 2023 and Korea's Ministry of Food and Drug Safety in January 2024 [4] - EPYSQLI has been commercially available in Europe since July 2023 and in Korea since April 2024 [4] Product Details - EPYSQLI is a complement inhibitor used to treat PNH, aHUS, and gMG in adult patients who are anti-acetylcholine receptor (AchR) antibody positive [3][6] - The product is not indicated for Shiga toxin E coli-related hemolytic uremic syndrome (STEC-HUS) [8] - EPYSQLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of serious meningococcal infections [10][17] Safety Information - EPYSQLI increases the risk of serious infections caused by Neisseria meningitidis, which can be life-threatening or fatal [9][12] - Patients must complete or update meningococcal vaccination at least two weeks prior to the first dose of EPYSQLI [13][15] - Monitoring for early signs of meningococcal infection is critical, and treatment should be interrupted if serious infection occurs [16] Adverse Reactions - Common adverse reactions in PNH trials include headache, nasopharyngitis, back pain, and nausea [27] - In aHUS trials, frequent adverse reactions include headache, diarrhea, hypertension, and upper respiratory infection [27] - In gMG trials, musculoskeletal pain was the most frequently reported adverse reaction [28]

Since the publication of my last article , "Teva's Transformation: From Generics Leader To Branded Drug Innovator," Teva Pharmaceutical Industries Limited's (NYSE: TEVA ) stock price has risen by more than 25%. Despite the continued caution and even pessimism ofWith over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realm ...

TEL AVIV, Israel, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that Richard Francis, Teva's President and CEO, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025. The presentation will begin at 8:15 A.M. Pacific Time (11:15 A.M. Eastern Time). To access a live webcast of the presentation, visit Teva’s Investor Relations website at https://ir.tevapharm.com/Events-and-Presentations. An archived version of ...

TEL AVIV, Israel, Dec. 20, 2024 (GLOBE NEWSWIRE) --  Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will issue a press release on its fourth quarter and full year 2024 financial results, as well as on its financial guidance for 2025, on Wednesday, January 29, 2025, at 7:00 a.m. ET. Following the release, Teva will conduct a conference call and live webcast on the same day, at 8:00 a.m. ET. In order to participate, please register in advance here to obtain a local or toll-f ...

Teva Pharmaceutical Industries Ltd. TEVA and Sanofi SA’s SNY Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD).In the RELIEVE UCCD study, 36.2% (low-dose) and 47.8% (high-dose) of patients with ulcerative colitis treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14.BofA Securities raised the price target for Teva to $25 from $23 wit ...

Teva Pharmaceutical Industries Ltd. (TEVA) shares rallied 26.5% in the last trading session to close at $20.88. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 0.1% gain over the past four weeks.This jump in share price came after management reported positive results from a mid-stage study on its experimental anti-TL1A therapy, duvakitug, in Ulcerative Colitis and Crohn's disease, which are the two main types ...

Primary endpoints met in ulcerative colitis (UC) and Crohn's disease (CD), the most common forms of inflammatory bowel disease (IBD)Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibodySanofi and Teva plan to initiate Phase 3 development in IBD, pending regulatory discussions PARSIPPANY, N.J. and PARIS, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Sanof ...

Teva hosting investor call today at 8:00 a.m. ET (U.S.)Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD)Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibodySanofi and Teva plan to initiate Phase 3 development in IBD, pending regulatory discussions PARSIPPANY, N.J. and PARIS, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmace ...

Teva entered into an agreement with JKI Co., Ltd. (“JKI”) established by the fund managed and operated by private equity firm J-Will Partners Co., Ltd. ("J-Will”), through which JKI will acquire Teva-TakedaThe agreement is aligned with Teva's Pivot to Growth strategy to focus its businessThe expected divestment of Teva-Takeda, Teva's business venture in Japan, which includes generics products and legacy products, will allow Teva to focus on bringing its innovative medicines to the Japanese market TEL AVIV, ...

AJOVY® (fremanezumab) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period in pediatric patients aged 6-17 years1Efficacy consistent with fremanezumab pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed Full data presented as a late breaker at European Headache Congress (EHC) 4-7 December in Rotterdam, Netherlands TEL AVIV, Israel, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industr ...