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US Food and Drug Administration (FDA) - Articles and news items

FDA to review Mylan and Biocon’s biosimilar application

Industry news / 17 February 2017 / Niamh Marriott, Digital Editor

The US Food and Drug Administration (FDA) has accepted Mylan and Biocon’s biologics license application for MYL-1401H, a proposed biosimilar to Neulasta…

Suicidal ideation

FDA approves new psoriasis drug that induced suicide in trial

Industry news / 17 February 2017 / Niamh Marriott, Digital Editor

The US Food and Drug Administration (FDA) has approved Valeant’s Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light […]

Driving business value from pharmaceutical serialisation

Blog, Z Homepage promo / 15 February 2017 / Nicolás Giménez Stamminger, Manager IT Advisory, KPMG Switzerland

KMPG’s Nicolás Giménez Stamminger explains why serialisation is the solution to counterfeit medicines and how to implement a cost-effective serialisation strategy…

zika virus

FDA approves Abbott’s molecular Zika virus test

Industry news / 3 February 2017 / Niamh Marriott, Digital Editor

The US Food and Drug Administration (FDA) has authorised Abbott’s molecular test to detect Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample) for emergency use. This is the first molecular test made by a commercial manufacturer authorised to detect Zika in whole blood samples; this is significant since the […]

FDA extends review period for Eli Lilly’s rheumatoid arthritis drug

Industry news / 16 January 2017 / Niamh Marriott, Digital Editor

Baricitinib is also being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus, and a phase 3 trial for patients…

FDA accepts Mylan and Biocon’s biosimilar biologics license application

Industry news / 12 January 2017 / Niamh Marriott, Digital Editor

This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers…

Ovarian assay

FDA approves Roche’s assay to assess ovarian reserve

Industry news / 10 January 2017 / Niamh Marriott, Digital Editor

The blood test produces standardised results for assessing ovarian reserve as compared with the use of vaginal ultrasound…

Aridis’ human monoclonal antibody pneumonia trial a safe success

Industry news / 9 January 2017 / Niamh Marriott, Digital Editor

AR-301 (Salvecin) is a fully human monoclonal IgG1 antibody that specifically targets S. aureus alpha-toxin and protects host cells from destruction…

FDA to review 3 new diabetes drugs that reduce cardiovascular death risk

Industry news / 5 January 2017 / Niamh Marriott, Digital Editor

In the trial, empagliflozin significantly reduced the relative risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack by 14%…

FDA grants priority review for Bayer’s liver cancer treatment

Industry news / 4 January 2017 / Niamh Louise Marriott, Digital Editor

The application is based on data from the placebo-controlled Phase III trial which investigated the drug as a second line treatment…

FDA clears Glenmark’s HER2+ cancer drug for Phase I trial

Industry news / 3 January 2017 / Niamh Louise Marriott, Digital Editor

Preclinical studies suggest GBR 1302 may have activity against a range of HER2-expressing tumour types, including breast, gastric and other cancers…

NICE and FDA team up for technology collaboration

Industry news / 20 December 2016 / Niamh Louise Marriott, Digital Editor

The National Institute of Health and Care Excellence (NICE) and the United States’ Food and Drug Administration (FDA) will team up, using technology to…

 

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