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Pfizer, FDA in talks on prescription details for key breast cancer drug

2015-01-08 18:21:28| Biotech - Topix.net

Pfizer Inc said Thursday it has begun talks with the U.S. Food and Drug Administration to finalize the prescription label of its breast cancer drug palbociclib, in an indication the drug was likely closer to regulatory approval. The largest U.S. drugmaker also said there was no plan for the agency to hold an advisory committee meeting to discuss the medicine prior to an approval decision.

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RPT-INTERVIEW-Halozyme CEO sees blockbuster potential in its cancer drug

2015-01-08 16:16:25| Biotech - Topix.net

The drug, PEGPH20, being tested against pancreatic cancer, has the potential to help treat several other types of solid tumor cancers, its chief executive said in an interview. Halozyme discussed interim data from a Phase II study of PEGPH20 with analysts and investors in New York on Wednesday, demonstrating its likelihood of delaying a worsening of the deadly cancer.

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Biogen reports good news with potential neuron-healing drug for MS

2015-01-08 16:16:24| Biotech - Topix.net

The first-ever drug with potential to repair past damage in the brain due to multiple sclerosis scored a win this morning when Biogen Idec reported positive news from a related trial. Based in Cambridge, Massachusetts, Biogen Idec operates a major manufacturing facility in Research Triangle Park.

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Small Biotech Gets Rights to Rare Disease Drug

2015-01-07 06:44:39| Biotech - Topix.net

The National Institutes of Health licensed rights to cyclodextrin to a biotechnology company that will take on development of the drug for the treatment of Niemann-Pick Type C disease.

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J&J buys bowel drug license option from Isis Pharma for $835 million

2015-01-06 03:00:04| Food - Topix.net

Johnson & Johnson will pay Isis Pharmaceuticals Inc up to $835 million for the option to license three drugs targeting autoimmune diseases in the bowel. Isis Pharmaceuticals said it will receive $35 million in an upfront payment and will be eligible to receive royalties on sales of the drugs.

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