GlaxoSmithKline has booked a 2 percent dip in revenues for the first quarter to £7.2 billion, after results were hit by a “significant currency impact” and lower sales of prescription drugs. Profit after tax fell 38 percent to £759 million, while earnings per share dropped to 11.2p from 21.4p a year ago.
NHS England chief executive Simon Stevens has indicated that chimeric antigen receptor T-cell therapy (CAR-T) could be available on the NHS this year, offering eligible patients a ‘ground-breaking’ approach to treating cancer.
Developing specialty vaccines for emerging and overlooked infectious diseases is a challenging and rewarding enterprise with specific opportunities and problems. Large companies have not historically prioritized this area and instead have focused on the development and commercialization of routine vaccines and vaccines for diseases with more significant global markets.
Video directly observed therapy (VDOT), an mHealth platform in which patients use an app to record themselves taking medications, can improve adherence and reduce costs, according to a new study.
Doctors in Germany successfully treated twins in utero using a biotech drug, pointing to a new way to eliminate disease.
The Food and Drug Administration plans to launch a full-scale version of its digital health precertification program by the end of the year.
Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for its new liquid biopsy assay, which is an expanded version of its FoundationACT® assay. The new assay will include more than 70 genes and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB). If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which means this medicine can now be used by US physicians to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
In clinical studies, more than half of patients receiving risankizumab achieved complete skin clearance (PASI 100) at one year (52 weeks) (1) The Biologics License Application is supported by four Phase 3 studies of more than 2,000 patients with moderate to severe plaque psoriasis (1-3) Risankizumab is an investigational compound designed to selectively inhibit IL-23 by binding to its p19 subunit and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing (4)
Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced that Celgene Corporation has exercised its right to expand its collaboration agreement for the research, development, and commercialization of bispecific antibody therapeutics using Zymeworks’ Azymetric™ platform.
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