Clinical Trials - April 15, 2014
Vivolux gets green light on cancer study
The Swedish drug discovery company has announced that the FDA has granted clearance to proceed with VLX600 into the clinical phase I/II. VLX600 is one of the company’s drug projects, recently published in the journal Nature Communications. The drug candidate kills sleeping cell populations in regions of solid tumors that are metabolically compromised due to poor vascularization – areas that cannot […]
Drug Development Pharma - March 3, 2014
Green light for AstraZeneca’s Bydureon Pen
The FDA has approved the Bydureon Pen as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The pen is a pre-filled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process. It contains the same formulation and […]
Drug Development Pharma - February 28, 2014
Oasmia gets FDA approval for veterinary drug
The U.S. Food and Drug Administration (FDA) has conditionally approved the Swedish pharmaceutical company’s product Paccal. Paccal Vet-CA1 is the first veterinary drug to utilize paclitaxel, a frequently used chemotherapeutics for the treatment of a wide range of cancers in humans. Paccal Vet-CA1 is specifically formulated for use in dogs for the treatment of canine skin and mammary cancers. […]
Drug Development Pharma - February 25, 2014
FDA approves Myalept to treat rare metabolic disease
The U.S. Food and Drug Administration has approved AstraZeneca’s and Bristol-Myers Squibb’s Myalept as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. The safety and effectiveness of Myalept, an analog of leptin made through recombinant DNA technology, were evaluated in an open-label, […]
Drug Development Pharma - February 12, 2014
AstraZeneca’s Onglyza on review
The diabetes drug Onglyza is under the FDA’s microscope as the agency said it would review possible heart risks associated with the medication. The decision comes after a study published in the New England Journal of Medicine. The study flagged an increase in heart failure hospitalizations among patients who used Onglyza (saxagliptin). The active ingredient is […]
Drug Development Pharma - January 14, 2014
US FDA approves FARXIGA tablets for the treatment of adult patients with type 2 diabetes
AstraZeneca and Bristol-Myers Squibb Company announced the US Food and Drug Administration (FDA) approved FARXIGA™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. FARXIGA should not be used for the treatment of patients with type 1 diabetes or […]
