Pharmaceuticals

Astellas Pharma and Aveo Drop Cancer Drug Development

Astellas Pharma and Aveo Oncology Drop Cancer Drug Development

Astellas Pharma Inc. and Aveo Oncology have ended the pact to develop experimental drug for cancer treatment. The drug development project was not successful as tivozanib Phase II trials failed to show improvement for colorectal cancer.

Due to insufficient data for the trials, US FDA had rejected tivozanib for treatment of kidney cancer in June 2013. Both the companies could not enroll enough number of patients for drug trail on breast cancer patients.

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Xarelto Rejected by FDA for Expanded Use

Xarelto Rejected by FDA for Expanded Use

Johnson & Johnson anti-clotting drug Xarelto has been rejected for expanded use in stent thrombosis and thrombotic cardiovascular events by the US Food and Drug Administration. The third-time filed request by pharmaceutical major Bayer for blood thinner has been rejected by FDA. The US regulator has issued complete response letter for the supplemental New Drug application filed by the company.

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Kadcyla, Novel Breast Cancer Drug Launch in UK

Kadcyla, Novel Breast Cancer Drug Launch in UK

UK welcomes the launch of new drug, Kadcyla, to treat terminal condition breast cancer in women who failed to respond to conventional treatment with Herceptin and chemotherapy.

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Merck Agrees to $100 million NuvaRing Settlement

Merck Agrees to $100 million NuvaRing Settlement

Merck & Co. has agreed to settle contraceptive NovaRing lawsuits by making an average payment $58,000 per case. The settlement would cost the pharmaceutical major more than $100 million. The company was facing several lawsuits in Missouri and New Jersey federal and state courts.

The company has been blamed for promoting the device even after knowing about increased risk of blood clots among women. A 2011 FDA report associated NuvaRing with higher risk of blood clots.

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Ipsen Reports Positive Results for Dysport Next Generation

Ipsen Reports Positive Results for Dysport Next Generation

French pharmaceutical major Ipsen SA has announced positive results for Dysport Next Generation experimental drug in phase III trials. The neurological movement disorder drug has been termed effective with first dose.

The company will proceed with more studies to file for regulatory approval for cervical dystonia drug. Compared to Dysport, DNG worked better on patients. The study also found DNG more effective compared to placebo in glabellar lines Phase II study.

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Furiex diarrhea-predominant IBS Drug eluxadoline Shows Encouraging Results

Furiex diarrhea-predominant IBS Drug eluxadoline Shows Encouraging Results

Furiex Pharmaceuticals has reported encouraging results for experimental irritable bowel syndrome drug in late-stage trials. The company stock doubled after the positive news on outcomes of two large studies for diarrhea-predominant irritable bowel syndrome.

Compared to previous close of $45.97, the stock touched intraday high of $121.97. The company has crossed $1 billion mark in valuations for the first time. Market experts believe that Furiex could generate good sales volume as there is only one more drug in the US market at the moment, for the condition.

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AMGEN Declares Top-Line Results of ‘Evolocumab’ in 5th-Late-Stage Study

AMGEN Declares Top-Line Results of ‘Evolocumab’ in 5th-Late-Stage Study

The fifth successful clinical study of Amgen Inc.’s experimental drug has been proved successful in treating patients with genetically high cholesterol levels. Evolocumab has successfully fulfilled all standards of a late-stage trial, RUTHERFORD-2 trial, on 329 patients suffering with heterozygous familial hypercholesterolemia.

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J&J Provides Open Access to its Drug Clinical Trials to Outside Researchers

J&J Provides Open Access to its Drug Clinical Trials to Outside Researchers

Johnson & Johnson Group has joined hands with Yale University researchers, to provide open access to company's data from clinical trials. 'Yale University's Open Data Access' Project (YODA) is an agreement signed by the Yale researchers to offer drug findings of the J&J clinical trials to outside researchers.

This campaign has been led by AllTrials group, which describes this move by the J&J Company as a 'game-Changer' for pharmaceutical industry.

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World’s First Insulin Capsule Successful in Phase IIa Trial

World’s First Insulin Capsule Successful in Phase IIa Trial

Israel's Oramed has moved a step closer towards its goal after declaring that that its insulin capsule has fulfilled all primary and secondary standards of Phase IIa clinical trial, conducted on 30 patients with Type 2 diabetes.

In tough competition with Novo Nordisk of Denmark to develop the world's first insulin pill, Oramed has cemented its position ahead of its rival.

The oral drug delivery specialist claimed that it is planning to launch larger mid-stage study in third quarter of this year. Whereas, Novo Nordisk has not even yet started the Phase II trial.

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European Regulators Approve Albiglutide

European Regulators Approve Albiglutide

A once-weekly injectable glucagonlike peptide 1 (GLP 1) diabetes drug, albiglutide, has received green signal from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), said GlaxoSmithKline. This drug has been approved for use as monotherapy in patients with Type 2 diabetes.

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