Clinical Intelligence

Omeros files IND application for lead compound in schizophrenia program

Monday, September 10, 2012 11:54 AM

Omeros, a Seattle-based clinical-stage biopharmaceutical company, has filed an Investigational New Drug Application (IND) with the FDA to initiate clinical trials evaluating OMS824, the company's lead compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders.

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Orexo submits NDA for Zubsolv for opiod dependence

Friday, September 7, 2012 01:41 PM

Orexo, an emerging specialty pharmaceutical company, has submited a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans.

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FDA approves Pfizer’s new orphan drug for chronic myelogenous leukemia

Thursday, September 6, 2012 08:25 AM

The FDA has approved Pfizer’s Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults.

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Janssen R&D gains FDA priority review for TB drug

Wednesday, September 5, 2012 11:32 AM

The FDA has granted Janssen Research & Development priority review to the New Drug Application (NDA) for bedaquiline (TMC207) to treat pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults as part of combination therapy.

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Soligenix reports positive phase Ib results with Ricin toxin vaccine

Tuesday, September 4, 2012 08:43 AM

Soligenix, a development stage biopharmaceutical company based in Princeton, N.J., released results of a phase Ib trial of an aluminum hydroxide (Alum) adjuvanted formulation of RiVax, designed to improve the immunogenicity of the vaccine.

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FDA approves new treatment for severe neutropenia in cancer patients

Tuesday, September 4, 2012 08:30 AM

The FDA has approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.

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FDA approves first drug formulated for children with rare brain tumor

Monday, September 3, 2012 08:25 AM

The FDA has approved Novartis’ Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor used to treat subependymal giant cell astrocytoma (SEGA, a rare brain tumor).

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Sophiris' transrectal injection of PRX302 for enlarged prostate well tolerated

Monday, September 3, 2012 08:16 AM

Sophiris Bio, a urology company based in La Jolla, Calif., released data from its transrectal safety study, in which PRX302, the company's drug candidate for the treatment of benign prostatic hyperplasia (BPH or enlarged prostate), was well tolerated through three months following a transrectal injection.

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Bayer submits NDA for regorafenib for gastrointestinal stromal tumors

Friday, August 31, 2012 12:02 PM

Bayer HealthCare and Onyx Pharmaceuticals, a global biopharmaceutical company based in San Francisco, have submitted a New Drug Application (NDA) to the FDA for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.

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Arrowhead completes enrollment in phase 1b trial of CALAA-01 in solid tumors

Friday, August 31, 2012 09:48 AM

Through its Calando Pharmaceuticals subsidiary, Arrowhead Research, a clinical stage targeted therapeutics company based in Pasadena, Calif., has completed enrollment of a phase 1b clinical trial of CALAA-01, its RNAi therapeutic candidate targeting solid tumors.

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