Clinical Intelligence

FDA approves Bayer’s Xofigo for advanced prostate cancer

Thursday, May 23, 2013 08:00 AM

The FDA has approved Bayer Pharmaceuticals’ Xofigo (radium Ra 223 dichloride) to treat males with symptomatic late-stage metastatic castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

More... »

Janssen Biotech’s Simponi receives FDA approval for ulcerative colitis

Monday, May 20, 2013 08:00 AM

The FDA has approved Janssen Biotech’s Simponi (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.

More... »

FDA approves GSK’s Breo Ellipta to treat COPD

Friday, May 17, 2013 01:25 PM

The FDA has approved GlaxoSmithKline and Theravance’s Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. 

More... »

Soligenix initiates phase 1 study of SGX203 for pediatric Crohn's disease

Thursday, May 16, 2013 08:00 AM

Soligenix, a clinical stage biopharmaceutical company focused on inflammatory diseases and biodefense countermeasures, has initiated the first clinical study for development of SGX203 (oral beclomethasone 17, 21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease. The program has previously received Fast Track and Orphan Drug designations from the FDA for oral BDP as a treatment for pediatric Crohn's disease.

More... »

FDA grants Breakthrough Therapy Scioderm's SD-101 for epidermolysis bullosa

Monday, May 6, 2013 12:29 PM

Scioderm’s investigational product SD-101 has received Breakthrough Therapy designation from the FDA for the treatment of inherited epidermolysis bullosa (EB). 

More... »

Raptor Pharma's Procysbi receives FDA approval for nephropathic cystinosis

Friday, May 3, 2013 02:02 PM

The FDA has approved Raptor Pharmaceutical’s Procysbi(cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children six years and older.

More... »

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. 

More... »

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.

More... »

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.

More... »

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.

More... »