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FDA approves Glaxo's injectable Tanzeum to control diabetes in adults

WASHINGTON - The Food and Drug Administration said Tuesday it approved a new injectable drug from GlaxoSmithKline plc for adults with Type 2 diabetes. The agency cleared the company's drug, Tanzeum, to help patients control their blood sugar levels, in combination with diet and exercise. Glaxo's new drug is part of the GLP-1 agonist class of drugs, which includes two other popular injected diabetes drugs, Byetta and Bydureon. GLP-1 is a hormone that helps regulate blood sugar levels.

FDA approves GSK's Tanzeum to treat type 2 diabetes

(Reuters) - The U.S. Food and Drug Administration approved GlaxoSmithKline Plc's Tanzeum injection for treating adults with type 2 diabetes, in combination with diet and exercise. Tanzeum will carry a warning on its label that tumors of the thyroid gland were observed in rodent studies with some drugs belonging to the same class. However, it is unknown whether Tanzeum causes thyroid C-cell tumors, the FDA said on its website. (http://link.reuters.com/jyp58v)

EU approves GSK's once-weekly diabetes drug

(Reuters) - GlaxoSmithKline Plc said on Wednesday that it had received European marketing approval for its once-weekly diabetes drug albiglutide, which it is marketing as Eperzan. The drug received a positive recommendation from the European Medicines Agency (EMA) in January. GSK said it expects to launch albiglutide in several countries in Europe in the third to fourth quarter this year.

Lilly weekly diabetes drug succeeds vs market leader Victoza -study

By Bill Berkrot (Reuters) - An experimental once-weekly medicine for type 2 diabetes developed by Eli Lilly and Co proved as effective in lowering blood sugar as Victoza from Danish drugmaker Novo Nordisk in an eagerly anticipated late stage study. The Lilly drug, dulaglutide, achieved the primary goal of the 599-patient study by demonstrating so-called non-inferiority to the highest approved dose of Victoza after 26 weeks, according to initial results released by the company on Tuesday.

EU regulator backs Bayer, GSK drugs, knocks back Novartis, Teva

By Kate Kelland LONDON (Reuters) - Europe's drugs regulator gave its backing on Friday for marketing approval to be granted for Bayer's pulmonary hypertension drug Adempas and for GlaxoSmithKline's diabetes medicine Eperzan. The European Medicine Agency (EMA) also backed a new drug from Dainippon Sumitomo Pharma called Latuda, for the treatment of schizophrenia, and Bemfola, a new biosimilar medicine for the treatment of infertility.

GSK diabetes drug set for European approval

LONDON (Reuters) - GlaxoSmithKline said on Friday European regulators had given the green light to its once-weekly diabetes drug albiglutide, which it is marketing as Eperzan. Albiglutide belongs to the same class of injectable GLP-1 drugs as Victoza from Novo Nordisk, as well as Byetta and Bydureon from Bristol-Myers Squibb and AstraZeneca.

FDA approves AstraZeneca type 2 diabetes drug

(Reuters) - U.S. health regulators on Wednesday approved an AstraZeneca drug from a new class of medicines to treat type 2 diabetes after previously rejecting it over safety concerns. The Food and Drug Administration nod had been expected this time around after an outside advisory panel of medical experts in December voted by a wide margin to recommend its approval, saying the benefits of the drug, dapagliflozin, outweighed its safety risks. It will be sold in the United States under the brand name Farxiga.

Bristol close to selling diabetes stake to Astra for $3 billion: WSJ

(Reuters) - Bristol-Myers Squibb Co is close to selling its stake in a diabetes partnership with AstraZeneca Plc to the British drugmaker in a deal valued at more than $3 billion, the Wall Street Journal reported on Wednesday. Bristol had announced last month that it would no longer conduct research to discover new drugs for diabetes, hepatitis C and neurological conditions, but would increase spending on medicines that harness the immune system to fight cancer.

FDA panel backs Bristol, AstraZeneca diabetes drug after earlier rebuff

By Ransdell Pierson and Ben Hirschler (Reuters) - A new type of diabetes drug from Bristol-Myers Squibb and AstraZeneca has been endorsed by U.S. medical experts, two years after it was rejected by regulators because of safety concerns. By a lopsided vote of 13 to 1, the advisory panel to the U.S. Food and Drug Administration voted on Thursday to recommend approval of dapagliflozin and said the benefits of the medicine appeared to outweigh its risks.

FDA panel backs previously rejected diabetes pill from Bristol-Myers and AstraZeneca

WASHINGTON - A panel of federal health advisers has overwhelmingly backed the benefits of an experimental diabetes drug that uses a new method to reduce blood sugar, setting aside previous concerns about the pill's safety. The Food and Drug Administration panel voted 13-1 on Thursday in favour of the drug from Bristol-Myers Squibb and AstraZeneca, downplaying possible links to bladder cancer and liver toxicity. Concerns over those risks led the same group of experts to vote against the drug in 2011, followed by a formal rejection by the FDA in early 2012.
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