Clinical Intelligence

Mayo Clinic researchers identify new enzyme to fight Alzheimer's

Wednesday, September 19, 2012 12:58 PM

An enzyme that could represent a powerful new tool for combating Alzheimer's disease has been discovered by researchers at Mayo Clinic in Florida.

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Navidea Biopharma enrolls first patient in phase II Alzheimer’s trial of NAV4694

Wednesday, September 19, 2012 12:31 PM

Navidea Biopharmaceuticals, a Dublin, Ohio-based biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has commenced enrollment at two sites participating in its phase II, open-label, safety and efficacy PET imaging study of [18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with probable Alzheimer's disease (AD).

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FDA approves new multiple sclerosis treatment Aubagio

Friday, September 14, 2012 12:48 PM

The FDA has approved Sanofi Aventis’ Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

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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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