Heron Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved SUSTOL® (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
Coherus BioSciences, Inc. announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under the 351(k) pathway.
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Alkermes plc announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
Sun Pharmaceutical Industries Ltd announced the extension of its Imatinib Mesylate Savings Card programme beyond July 31, 2016. Sun Pharma launched this programme as part of the imatinib mesylate launch in February 2016. The programme is aimed at delivering greater access to the drug by patients who have commercial insurance, but whose out-of-pocket cost may exceed an affordable amount.
Intec Pharma Ltd, a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, announced the initiation of a new clinical development programme for its Accordion Pill platform with the two primary cannabinoids contained in Cannabis sativa.
The China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for Eisai's in-house developed anticancer agent eribulin mesylate (eribulin, product name: Halaven) for use in the treatment of patients with locally advanced or metastatic breast cancer in China.
Masimo announced the CE marking for the pediatric indication for O3 regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, helps clinicians monitor cerebral oxygenation.
Allergan plc, a leading global pharmaceutical company, and Gedeon Richter Plc. provided a clinical and regulatory update on cariprazine. For more than a decade both companies have conducted over 20 clinical trials enrolling thousands of patients worldwide to evaluate the efficacy and safety of cariprazine for patients suffering from a broad range of mental health illnesses.
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Merck , known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck with partial funding from Samsung Bioepis.
Quest Diagnostics announced CogniSense™, a digital cognitive assessment tool that aids in a physician's assessment, diagnosis and care management of individuals with cognitive dysfunction. CogniSense is designed to overcome several limitations of conventional paper-based cognitive assessment, such as lack of objective, easily trackable data over time and integration to electronic health records (EHRs).
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