AstraZeneca asserts the availability of FLUMIST QUADRIVALENT Vaccine in U.S

AstraZeneca asserted that the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) has voted in favor of a renewed recommendation for the use of FLUMIST QUADRIVALENT in the U.S for the 2018-2019 season. Study results demonstrated that the new 2017-2018 H1N1 LAIV post-pandemic strain (A/Slovenia) performed significantly better than the 2015-2016 H1N1 LAIV post-pandemic strain (A/Bolivia), which was previously associated with reduced effectiveness. The antibody response…

NaviGate Cardiac Structures declares GATE bioprosthesis to treat tricuspid regurgitation

NaviGate Cardiac Structures asserted that its catheter-guided GATE valved-stent bioprosthesis became the first Canadian orthotopic valve replacement to treat severe tricuspid regurgitation. The patient, a 79-year old male, was deemed at high-risk for standard cardiac surgery and unable to withstand cardiopulmonary external circulation. A compassionate plea on his behalf was made by the Heart Team of the Institute. Dr. Rodés-Cabau, who has performed multiple procedures for atrioventricular valve dysfunction using…

Clovis Oncology sought positive vote from CHMP for Rucaparib tablets

Clovis Oncology claimed an update to the ongoing regulatory review for the Marketing Authorization Application (MAA) for Rucaparib tablets as monotherapy for the treatment of advanced ovarian cancer patients with deleterious BRCA mutation (germline and/or somatic). Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental…

Merck forays into acquiring Viralytics augmenting Immuno-Oncology Pipeline

Merck and Viralytics claimed that the companies have ventured into a definitive agreement that enumerates Merck's acquisition of Viralytics emphasizing on oncolytic immunotherapy treatments for a range of cancers. The proposed acquisition values the total issued shares in Viralytics at approximately AUD 502 million (USD 394 million). The cash consideration of AUD 1.75 per share represents a premium of 160% to the one month volume weighted average price (VWAP) of Viralytics shares. Viralytics will become a wholly-owned…

Celgene affirmed Antitrust Clearance for obtaining Juno

Celgene Corporation asserted that the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ("HSR") with respect to the previously announced tender offer by Celgene’s wholly owned subsidiary, Blue Magpie Corporation, for all issued and outstanding shares of common stock of Juno Therapeutics, Inc. for $87.00 per share, net to the seller in cash, without interest and less required withholding taxes, and subsequent merger of Blue Magpie with Juno, expired at 11:59 p.m. ET on February 20, 2018.…

Biologics assures availability of ERLEADA treatment for Non-Metastatic, Castration-Resistant Prostate Cancer

McKesson Specialty Health oncology and complex care pharmacy services company has been finalized by the Janssen Pharmaceutical Companies of Johnson & Johnson which is considered the  first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer (NM-CRPC). ERLEADA is a next-generation androgen receptor inhibitor for the treatment of patients with NM-CRPC with the goal of delaying metastases. Approval is based on an FDA Priority Review of Phase 3 SPARTAN clinical trial data,which showed that…

Vertex commences Phase 3 Study of VX-659 for CF

Vertex Pharmaceuticals affirmed initiating the first Phase 3 study of VX-659,  tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF) who have one F508delmutation and one minimal function mutation. The study set to enlist 360 patients, and the primary endpoint of the study is the mean absolute change from baseline in percent predicted forced expiratory volume in one second at week four of treatment. The study  further advocates the submission of New Drug Application…

FDA monitors destruction and recall of kratom products

U.S FDA had asserted the destruction and recall of large volume of kratom-containing dietary supplements that is ideally manufactured and distributed nationwide under the Brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. FDA, the company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies…

Chiron Recovery executed a MAT program for opioid addiction

Evidenced-based dual diagnosis treatment facility, Chiron Recovery executed a MAT program for the treatment of opioid addiction. Addiction is a chronic disease and just like other chronic diseases, we are confident that successful treatment exists in a combination of medication merged with the current psycho-social services including therapy and 12 step programs. Chiron Recovery advocates "We strongly believe based on numerous evidence-based studies that Medically Assisted Treatment (MAT) is a necessary component of…

Glenmark collaborates with SCD for Ophthalmic products in U.S and Canada

Global pharmaceutical company, Glenmark Pharmaceuticals ventured into an exclusive agreement with Sam Chun Dang Pharma. Co. Ltd. (SCD) to develop, manufacture and market a portfolio of ophthalmic products in the U.S and Canada. As per the terms of the agreement, these products will be developed and manufactured by SCD in South Korea. Glenmark will seek all market authorizations and commercialize products in North America. Robert Matsuk, President, North America & Global API at Glenmark Pharmaceuticals said  "Our…

Dr. Warren Krackov appointed Medical Director and UFE Specialist for Vascular Interventions

Dr. Warren Krackov, interventional radiologist specializing in minimally invasive treatment for dialysis access management and other vascular conditions has been named medical director of Vascular Interventions of Tampa. Dr. Krackov is board certified in diagnostic radiology with a subspecialty certificate in vascular and interventional radiology. Dr. Krackov spearheads the expansion of Vascular Interventions of Tampa's established medical services of dialysis access management and vascular access and procedures…

Alabama Fertility offers INVOcell in Alabama

Medical device company, INVO Bioscience sought FDA clearance for Intravaginal Culture System, INVOcell asserted that Alabama Fertility has augmented its scope of reproductive treatments with the addition of INVOcell. INVOcell has the ability to remarkably transform the way in which doctors assist infertility patients to become pregnant in a simpler, more natural and cost-effective manner. INVOcell is a patented medical device utilized in thee treatment of infertility enabling egg fertilization and early embryo development…

Evofem Biosciences sought FDA’s Fast Track designation for Amphora vagina gel

Biotechnology company developing innovative products to fill women's unmet healthcare needs, Evofem Biosciences asserted that the U.S FDA has extended Fast Track designation for Amphora (L-lactic acid, citric acid, and potassium bitartrate) vagina gel to forbid urogenital chlamydia in women. Amphora is primarily an investigational drug being evaluated for the prevention of certain sexually transmitted infections (STIs) and as an on-demand, non-hormonal vaginal contraceptive. The fast track designation is designed to…

GSK’s FLUARIX QUADRIVALENT exemplifies 63.2% efficacy

GSK presented at the Center for Disease Control and Prevention Advisory Committee on Immunization Practices meeting that FLUARIX QUADRIVALENT exhibited 63.2% efficacy against moderate to severe influenza of any severity in children 6 months through 35 months of age. Results were based on a randomized, observer-blind, non-influenza vaccine-controlled trial that enlisted 12,018 children in 5 independent cohorts in 13 countries in Asia, Europe and Central America from 2011 through the end of 2014. Dr. Leonard…

Dr. Farideh Bischoff appointed VP of Clinical Research for Imagion Biosystems

Company dedicated to enhancing healthcare through earlier detection of cancer, Imagion Biosystems, asserted the appointment of Farideh Bischoff, PhD as the Vice President of Clinical Research. Dr. Bischofff will spearhead the clinical program for the company's Magsense cancer detection technology that aims to achieve regulatory approval as a diagnostic device for the early detection of malignant tumor cells. Dr Bischoffs brings on board several years of experience in oncology product commercialization.Some of her key…