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PBR Staff Writer Published 24 February 2014 US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic fibrosis (CF).

Germany-based pharmaceutical firm Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Pradaxa (dabigatran etexilate) to treat venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).

Dainippon Sumitomo Pharma (DSP) has received approval from Health Canada for use of Latuda (lurasidone HCl) as monotherapy or as adjunctive therapy with lithium or valproate to treat depressive episodes associated with bipolar I disorder.

GSK has received approval from FDA for its Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adult patients with type 2 diabetes.

PBR Staff Writer Published 01 May 2014 The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Incruse Ellipta (umeclidinium) for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.

Otsuka and Lundbeck has received approval from Health Canada to use its intramuscular (IM) once-monthly injectable formulation 'Abilify Maintena' for the maintenance treatment of schizophrenia in stabilized adult patients.

Not that long ago, I was updating a key research project here at Best Practices; and as usual, I was waiting on approval from our research manager...

PBR Staff Writer Published 27 March 2014 The European Commission (EC) has granted marketing authorization for GlaxoSmithKline's (GSK's) once-weekly diabetes treatment, Eperzan (albiglutide). The drug is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control as monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance.

BioLight Life Sciences Investments announced that DiagnosTear has received all necessary approvals from Sheba Medical Center near Tel Aviv to begin a clinical study with its TeaRx, point-of-care Dry Eye Syndrome diagnostic assay.

PBR Staff Writer Published 21 March 2014 Novartis has launched the Lucentis (ranibizumab) pre-filled syringe (PFS) in Germany and plans to introduce the product in other markets throughout 2014. In October 2013, the company has received approval from the European authorities for Lucentis PFS, which is a new way of administering Lucentis that is specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.