Pharma News

Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications.

Eli Lilly and Company and Incyte Corporation  announced that new data from RA-BEACON - a pivotal phase 3 study of baricitinib in the treatment of moderate-to-severe rheumatoid arthritis (RA) - showed baricitinib demonstrated significant improvement in patient-reported outcomes and health-related quality of life (HRQOL) measures, fatigue and pain compared with placebo. The results of the study were published in Annals of the Rheumatic Diseases. The global trial is part of the ongoing study of baricitinib, a once-daily oral medication currently under regulatory review for the treatment of moderate-to-severe RA.

Biocon and Mylan have announced that the European Medicines Agency (EMA) has accepted for review marketing authorization application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.

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Pfizer China announced that it has received approval from the Chinese Food and Drug Administration (CFDA) to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13®, in China for active immunization for the prevention of invasive diseases (including bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused by Streptococcus pneumoniae (S. Pneumoniae) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children aged 6 weeks to 15 months. S. pneumoniae is the most common cause of invasive disease as well as pneumonia and upper respiratory tract infections

Pfizer Inc. announced the discontinuation of the global clinical development programmeme for bococizumab, its investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide value to patients, physicians, or shareholders. As a result, Pfizer has decided to discontinue the development programme, including the two ongoing cardiovascular outcome studies.

Allergan plc, a leading global pharmaceutical company, announced that it has successfully completed the acquisition of Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases.

Ajanta Pharma Limited, announced US FDA approval and launch of amlodipine + olmesartan medoxomil tablets in the US market through its wholly owned subsidiary Ajanta Pharma USA Inc.

PharmaCyte Biotech, Inc. , a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®,  announced that it has submitted a request for a pre-IND meeting with the U. S. Food and Drug Administration (FDA) for its planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC)

Novartis announced  that the US Food and Drug Administration (FDA) accepted the company's New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib) as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole.