Pharma News

People living with HIV who naturally produce broadly neutralizing antibodies (bNAbs) that may help suppress the virus have different immunological profiles than people who do not, researchers report. While bNAbs cannot completely clear HIV infections in people who have already acquired the virus, many scientists believe a successful preventive HIV vaccine must induce bNAbs. The new findings indicate that bNAb production may be associated with specific variations in individual immune functions that may be triggered by unchecked HIV infection. Defining how to safely replicate these attributes in HIV-uninfected vaccine recipients may lead to better designed experimental vaccines to protect against HIV. The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. 

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Shire plc  announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. Shire is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter (ASBT), a protein which is primarily responsible for recycling bile acids from the intestine to the liver. NASH is a serious, chronic liver disease for which there are currently no approved drugs. 

Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider, PCT, with a select therapeutic development pipeline, announces that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of type 1 diabetes mellitus (TID), making it the first known therapeutic candidate for treatment of T1D to receive the designation. 

ADMA Biologics, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for RI-002, an Intravenous Immune Globulin (IVIG), for the treatment of patients with Primary Humoral Immunodeficiency Disease (PIDD). 

Zealand Pharma (Zealand), a biotechnology company, announces that the U.S. Food and Drug Administration (FDA) has granted approval of lixisenatide for the treatment of adults with type 2 diabetes. Lixisenatide, a once-daily prandial GLP-1 receptor agonist, was invented by Zealand and global development and commercial rights are licensed to Sanofi. 

CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the Taiwan Food and Drug Administration (TFDA) has approved the Investigational New Drug (IND) application for a Phase I/II clinical study of CAN-008, plus temozolomide (TMZ), during and after radiation therapy, in patients with newly-diagnosed glioblastoma multiforme (GBM). The study design  consists of an open-label, dose-escalation Phase I trial, and a multi-center, double-blind, randomized, placebo-controlled Phase II trial. The Phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The Phase II trial will evaluate efficacy and safety. The combined Phase I/II trial will enroll a total of approximately 55 patients.  The Phase I portion of the trial will commence in August 2016. 

GlaxoSmithKline Pharmaceuticals Limited  declared its financial results for the quarter ended 30th June 2016. Net sales for the quarter ended 30th June 2016 came in at Rs. 685 crores, recording a growth of 8% as compared to the same prior year period. The sales growth was adversely impacted by the Drug Pricing Control Order (DPCO) revisions in the quarter. Consequently, Profit Before Tax (PBT) at Rs. 111 crores and Profit After Tax (PAT) at Rs 72 crores decline by 23% against the same prior year period.