Clinical Intelligence

FDA grants Biodel orphan drug designation for rare insulin disease

Friday, December 7, 2012 02:34 PM

The FDA has given special designation to glucagon, developed by specialty pharmaceutical company Biodel,for patients with congenital hyperinsulinism (CHI), or abnormally low blood sugar—a rare disorder that affects children.

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Emmaus Medical completes enrollment for phase III sickle cell disease trial

Wednesday, December 5, 2012 10:11 AM

Emmaus Medical, a specialty pharmaceutical and regenerative medicine company, has completed patient enrollment for its phase III clinical trial to study L-glutamine as a treatment for sickle cell disease.

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AVEO, Astellas initiate phase II trial in triple negative breast cancer

Monday, December 3, 2012 02:11 PM

AVEO Oncology, a Cambridge, Mass.-based cancer therapeutics company, and Astellas Pharma, A Tokyo-based a pharmaceutical company, have initiated patient enrollment in a phase II trial evaluating the efficacy of tivozanib, an investigational drug, in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer.

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The CenterWatch Monthly, December 2012

Monday, December 3, 2012 09:00 AM

Publicity, regulation tightening reins on use of KOLs

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Boston Scientific enrolls first patient in coronary stent study featuring bioabsorbable polymer coating

Friday, November 30, 2012 12:13 PM

The first patient has been enrolled in Boston Scientific’s EVOLVE II clinical trial, designed to further assess the safety and effectiveness of the SYNERGY Stent System and support FDA and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.  

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Common canine virus may lead to new vaccines for deadly human diseases

Friday, November 30, 2012 11:21 AM

Researchers at the University of Georgia have discovered that a virus commonly found in dogs may serve as the foundation for the next great breakthrough in human vaccine development.

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FDA approves Cometriq to treat rare type of thyroid cancer

Thursday, November 29, 2012 08:00 AM

The FDA has approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has spread to other parts of the body.

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Almirall’s Constella approved in Europe for IBS-C

Wednesday, November 28, 2012 12:20 PM

The European Commission has granted marketing authorization to Almirall’s Constella (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults . This approval follows the positive recommendation received from the European Committee for Medicinal Products for Human Use (CHMP) in September.

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Savara's AeroVanc granted Orphan Drug status for MRSA lung infection in CF

Tuesday, November 20, 2012 11:23 AM

The FDA has granted orphan drug status to Savara Pharmaceuticals’ AeroVanc (vancomycin hydrochloride inhalation powder) for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF).

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Abbott announces phase III Hep C program details

Friday, November 16, 2012 02:25 PM

Abbott Laboratories, a global healthcare company, has released details on its phase III hepatitis C registration program following promising results from its phase IIb clinical trial, known as Aviator.

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