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Sarepta Therapeutics Comments on Erroneous Submission to US FDA Adverse Event Reporting System (FAERS)
Sarepta Therapeutics, Inc, the leader in precision genetic medicine for rare diseases, was informed earlier that an adverse event report was erroneously submitted to the FDA’s adverse event reporting system (FAERs), a post-marketing surveillance database for approved therapies. Our...
Drug Research
Vesselon Acquires FDA-Approved Lipid Microsphere Drug Imagent For Therapeutic Platform
Vesselon, an oncology therapeutics company, announced the acquisition of an FDA-approved drug Imagent®. Vesselon will use Imagent to create novel therapeutic complexes in four classes of cancer drugs: cytokines, oncolytic viruses, monoclonal antibodies, and nucleic acid constructs.
Vesselon incorporates Imagent...
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Zenith Epigenetics and China-Based Newsoara Biopharma Announce Licensing Agreement for ZEN-3694
Zenith Capital Corp. announced that Zenith Epigenetics Ltd. , a wholly-owned subsidiary of Zenith Capital, has entered into a licensing agreement with Newsoara BioPharma Co., Ltd. for the Company’s lead compound, ZEN-3694, in China, Hong Kong, Taiwan, and Macau...
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Aucta Pharmaceuticals Announces Licensing of Vigabatrin for Oral Solution in China
Aucta Pharmaceuticals, Inc. ,a technology based company focusing on the development and commercialization of Branded Specialty Products, announced that the Company has entered into an exclusive license agreement with Jiangsu Wanbang Biopharmaceuticals Group Co., Ltd., a subsidiary of Shanghai...
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Sempre health partners with Blue cross blue shield of Arizona to help members save on Medications
Sempre Health, the leading solution for behavior-based healthcare pricing, announced a partnership with Blue Cross Blue Shield of Arizona (BCBSAZ) that features a new way for BCBSAZ members to save on medications. Starting this month, many BCBSAZ members will...
Drug Research
FDA Approves Daiichi Sankyos TURALIO pexidartinib for the Treatment of Select Patients with TGCT a Rare and Debilitating Tumor
Daiichi Sankyo Company, Limited announced that the U.S. FDA approved TURALIO™ (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
TGCT is...
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Amicus Therapeutics Receives Marketing Authorization for Galafold for Fabry Disease in Argentina
Amicus Therapeutics announced that the Agency of Medicines, Food and Medical Devices (ANMAT) in Argentina has granted approval for the first-in-class, oral small molecule pharmacological chaperone Galafold® (migalastat), as a monotherapy for the treatment of people aged 16 years...
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