Clinical Intelligence

FDA grants Genmab’s daratumumab Breakthrough Therapy Designation

Friday, May 3, 2013 11:55 AM

The FDA has granted Breakthrough Therapy Designation for Genmab’s daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and IMiD. 

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FDA fast tracks Sanofi and KaloBios' novel biologic for Pseudomonas aeruginosa

Friday, April 26, 2013 02:31 PM

The FDA has granted Fast Track designation to Sanofi Pasteur and KaloBios Pharmaceuticals’ investigational drug KB001A, an antibody fragment intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa (Pa) in mechanically-ventilated patients.

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Halozyme initiates randomized phase II trial of PEGPH20 in pancreatic cancer

Thursday, April 25, 2013 08:00 AM

Halozyme Therapeutics, a San Diego-based biopharmaceutical company, initiated a phase II multicenter, randomized clinical trial evaluating PEGPH20, a proprietary, investigational drug as a first-line therapy for patients with stage IV metastatic pancreatic cancer.

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Rhythm initiates phase II trial of RM-131 for chronic constipation

Friday, April 19, 2013 08:00 AM

Rhythm, a biotechnology company developing peptide therapeutics that address unmet needs in metabolic diseases, initiated an additional phase II trial of RM-131, the company's novel ghrelin agonist, for the treatment of chronic constipation. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal motility.

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Elorac receives FDA Fast Track designation for naloxone for pruritus

Wednesday, April 17, 2013 12:43 PM

Elorac, a specialty pharmaceutical company focused on the treatment of dermatological disorders, has been granted Fast Track designation by the FDA for its naloxone topical lotion for the relief of pruritus in patients with cutaneous T-cell lymphoma (CTCL). There are currently no approved therapeutic treatment options available to patients and their physicians for pruritus in CTCL.

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Pfizer’s palbociclib gets FDA breakthrough label

Friday, April 12, 2013 02:37 PM

Pfizer’s investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has received Breakthrough Therapy designation by the FDA for the potential treatment of patients with breast cancer.

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OncoGenex to initiate phase II trial of OGX-427 in non-squamous NSCLC

Friday, April 12, 2013 12:17 PM

OncoGenex Pharmaceuticals, a biopharmaceutical company, plans to initiate an investigator-sponsored, randomized, double-blind, placebo-controlled phase II study, Spruce, evaluating OGX-427 in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC). The trial will investigate whether adding OGX-427 to carboplatin and pemetrexed therapy can extend progression-free survival (PFS) outcomes.

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AstraZeneca touts top-line results from OSKIRA-1 phase III study of fostamatinib in RA

Friday, April 5, 2013 12:33 PM

AstraZeneca released top-line results of OSKIRA-1, a phase III study to assess the efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for rheumatoid arthritis (RA). OSKIRA-1 had two primary endpoints: assessing signs and symptoms of RA as measured by ACR20 response rates, and an X-ray endpoint known as mTSS (modified Total Sharp Score).

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FDA approves Janssen’s Invokana for type 2 diabetes

Monday, April 1, 2013 02:15 PM

The FDA has approved Janssen Pharmaceuticals’ Invokana (canagliflozin) for the treatment of adults with type 2 diabetes.

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The CenterWatch Monthly, April 2013

Monday, April 1, 2013 10:19 AM

20 Innovators Changing the Face of the Clinical Trials Industry

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