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Curis, Debiopharm Start Phase 1 Study in Renal Cell Carcinoma

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Curis Inc. and Debiopharma begin a Phase 1 study of Debio 0932, a heat shock protein 90 inhibitor in combination with everolimus i...

Orphan Drug Designation for Pancreatic Cancer Therapy

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FDA grants Aduro BioTech an orphan drug designation for CRS-207 for treating pancreatic cancer.

FDA Reviewers Generally Positive on Simeprevir

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FDA medical reviewers says Janssens experimental hepatitis C drug simeprevir appears to be effective but has some side effects.

QS and MDR Violations Seen in Northern Digital Inspection

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FDA warns Northern Digital about Quality System and Medical Device Reporting violations in its manufacturing of reflective passive...

GPhA Says Biosimilars Need Same Name as Originals

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Generic drug manufacturers tell the World Health Organization that biosimilars should be given the same non-proprietary name as th...

Indian High Court Probes NCE Drug Study Process

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An Indian Supreme Court order risks delays on 162 drug studies by asking Indian regulators how they approve global clinical trials...

Bard Class 1 Recall of LifeStent Solo Vascular Stent

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FDA says Bard Peripheral Vascular has begun a Class 1 recall of its LifeStent Solo Vascular Stent due to deployment issues.

CareFusion Class 1 Recall of AVEA Ventilators

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CareFusion begins a Class 1 recall of its AVEA ventilators because they may experience an under-reporting of tidal volume if used ...

Osiris Therapeutuics Needs BLA to Market Products: CBER

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A CBER untitled letter says Osiris Therapeutics will need a BLA in order to market its amniotic/chorionic-based products.

Specialty Medicine Compounding Pharmacy Recalls Products

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Specialty Medicine Compounding Pharmacy recalls all lots of unexpired human and veterinary sterile products due to particulate mat...