Johnson & Johnson (JNJ) Responds to Reuters Talc Article; Hancock Jaffe (HJLI) Sees Significant Milestones Coming Up; Celltrion, Teva Pharma (TEVA) FDA OKs HERZUMA
Shares of Johnson & Johnson (NYSE:JNJ) plunged $14.84 (or -10.04%) to $133.00 on Friday following a special report by Reuters indicating that the company knew for decades that asbestos lurked in its Baby Powder.
According to a Reuters' investigation, pharmacy giant Johnson & Johnson has for decades known its raw talc and finished powders at times tested positive for small quantities of asbestos – in one case at levels reported as “rather high” -, with the company's doctors and lawyers vexed by the findings but failing to alert the U.S. Food and Drug Administration (FDA) or consumers.
After the closing bell, Johnson & Johnson said that thousands of tests by the company, regulators, leading independent labs, and academic institutions have repeatedly shown that its talc does not contain asbestos, adding that the Reuters article is one-sided, false, and inflammatory.
Johnson & Johnson, together with its subsidiaries, researches and develops, manufactures, and sells various products in the health care field worldwide.
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Hancock Jaffe Laboratories Inc. (Nasdaq:HJLI) said recently that it expects to achieve some significant milestones during the first quarter of 2019 in the development of two of its key products. The CoreoGraft is one of those products.
The company will begin a feasibility study for its CoreoGraft bioprosthetic graft on January 29th at the Texas Heart Institute. The pre-clinical study will involve a series of CoreoGraft implantations. HJLI expects to have preliminary results from the study immediately after the first implantations and final results from the study at the end of March, 2019.
Approximately 180,000 coronary artery bypass surgeries are performed each year in the U.S., necessitating between 300,000 and 450,00 bypass grafts to revascularize the heart. Studies have shown that up to 40 percent of saphenous vein grafts become occluded or clogged as early as one year after bypass surgery. The CoreoGraft is a potential alternative to saphenous vein grafting.
HJLI specializes in developing and manufacturing bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases.
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Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said Friday that the FDA has approved HERZUMA (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Genentech's HERCEPTIN (trastuzumab) for certain indications.
The FDA approval is based on a review of a comprehensive data package inclusive of foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data. The results of the clinical development program for HERZUMA demonstrated that there were no clinically meaningful differences in purity, potency and safety between HERZUMA and HERCEPTIN for the treatment of HER2-overexpressing breast cancer for the approved indications.
Celltrion and Teva Pharmaceutical entered into an exclusive partnership in October 2016 to commercialize HERZUMA in the U.S. and Canada.
Teva Pharmaceutical Industries develops, manufactures, markets, and distributes generic medicines and a portfolio of specialty medicines worldwide.
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