USFDA

One of India’s largest sterile Injectables company, Claris Lifesciences Limited (Claris/Company), announced today that it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, wherein the US FDA has concluded that the inspection stands closed and the facility was found to be acceptable.

AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.

The U.S. Food and Drug Administration (FDA) approved ZINBRYTATM (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS), Biogen and Abbvie announced. Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to two or more therapies indicated for the treatment of multiple sclerosis (MS).

The U.S. Food and Drug Administration approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Axumin is marketed by Blue Earth Diagnostics, Ltd., Oxford, United Kingdom

Braeburn Pharmaceuticals announces that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine delivers buprenorphine continuously for up to six months and should be used as part of a complete treatment program to include counseling and psychosocial support.

Novavax, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax’ RSV F-Protein nanoparticle vaccine candidate (RSV F Vaccine) for the protection of older adults (60 years of age and older).

Seqirus announced that the US Food and Drug Administration (FDA) has approved FLUCELVAX QUADRIVALENT™(Influenza Vaccine),the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. The use of a four-strain influenza vaccine like FLUCELVAX QUADRIVALENT may now provide protection against both B lineages, which may lead to a decrease in the influenza burden.

Symbiomix announced positive results from the second pivotal trial of lead product candidate SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV). SYM-1219 (secnidazole) is a potent, next-generation 5-nitroimidazole antibiotic with superior pharmacokinetic properties that enable efficacy with significantly less total drug exposure than first generation nitroimidazoles, leading to excellent safety, tolerability and adherence.

DelMar Pharmaceutical Inc. announced the successful completion of an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA).

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Merck,  known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade.