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

expanded-novartis

Expanded use for Novartis’ Periodic Fever Syndrome drug after 3 new FDA approvals

Industry news / 27 September 2016 / Niamh Louise Marriott, Digital Content Producer

The expanded use is for Ilaris, a selective, high-affinity, human monoclonal antibody that inhibits Interleukin-1 (IL-1) beta, part of the immune system…

epr-logo

FDA extends PDUFA date for telotristat etiprate for the treatment of carcinoid syndrome

Industry news / 20 September 2016 / Niamh Louise Marriott, Digital Content Producer

In a notice from the FDA, the Prescription Drug User Fee Act date for its Priority Review of telotristat etiprate has been extended by three months…

epr-logo

FDA approves Shire’s CUVITRU for the treatment of primary immunodeficiency

Industry news / 20 September 2016 / Niamh Louise Marriott, Digital Content Producer

CUVITRU is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly…

epr-logo

Amplyx initiates dosing in antifungal Phase I trial for the treatment of life-threatening infections

Industry news / 20 September 2016 / Niamh Louise Marriott, Digital Content Producer

APX001 is a small molecule drug candidate that targets and inhibits the conserved fungal enzyme Gwt1, compromising fungal growth of major fungal pathogens…

antibiotics resistance

Antibiotics: resist the resistance

Blog, Z Homepage promo / 15 September 2016 / Niamh Louise Marriott, Digital Content Producer

European Pharmaceutical Review caught up with Destiny Pharma’s CEO, Dr Love, for an exclusive interview to discuss why the pharmaceutical industry needs to radically change its approach to antibiotics in order to combat the threat of bacterial resistance…

designation-orphan-drug

Orphan drug designation granted to Boehringer Ingelheim’s systemic sclerosis drug

Industry news / 13 September 2016 / Niamh Louise Marriott, Digital Content Producer

Senscis is specifically evaluating nintedanib to understand the disease process and potential benefit of the compound to treat SSc-ILD…

study-roche

Roche’s cancer immunotherapy drug has longer OS vs. chemotherapy

Industry news / 1 September 2016 / Niamh Louise Marriott, Digital Content Producer

Roche’s study for tecentriq (atezolizumab) met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events were consistent with what has […]

biosimilar-disease-drug

FDA approves Novartis’ biosimilar to treat multiple inflammatory diseases

Industry news / 1 September 2016 / Niamh Louise Marriott, Digital Content Producer

The FDA approval is based on analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis…

ofatumumab-genmab

FDA approves Genmab’s ofatumumab for relapsed CLL

Industry news / 31 August 2016 / Niamh Louise Marriott, Digital Content Producer

Approval is supported by the Phase III complement study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL…

dystrophy-fda-grant

FDA grants Santhera $246,000 for muscular dystrophy trial

Industry news / 30 August 2016 / Niamh Louise Marriott, Digital Content Producer

The FDA have granted Santhera an award of $246,000 in support of its ongoing Phase I trial with omigapil (callisto) incongenital muscular dystrophy (CMD)…

muscular-dystrophy

Mallinckrodt’s muscular dystrophy drug receives FDA fast track designation

Industry news / 26 August 2016 / Niamh Louise Marriott, Digital Content Producer

For the treatment of Duchenne muscular dystrophy (DMD), Synacthen Depot is a synthetic 24 amino acid melanocortin receptor agonist. Outside the US, it…

esketamine depression drug

FDA grants breakthrough therapy designation for depression drug

Industry news / 16 August 2016 / Janssen

Following succesful phase II trials, the FDA have granted a Breakthrough Therapy Designation for esketamine, an investigational antidepressant medication…

 

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