Clinical Intelligence

Edmond Pharma’s Erdosteine receives Orphan Drug Status from FDA

Wednesday, April 30, 2014 03:29 PM

The FDA has granted Orphan Drug Status to Erdosteine, a molecule discovered and developed by Italian pharmaceutical company Edmond Pharma. The Orphan Drug Status refers to the new indication for the treatment of bronchiectasis, a rare disease for which no drug therapies currently are approved in the U.S.

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FDA approves Zykadia for late-stage lung cancer

Wednesday, April 30, 2014 03:01 PM

The FDA has granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

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FDA approves Sylvant for rare Castleman’s disease

Thursday, April 24, 2014 11:39 AM

The FDA has approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).

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FDA approves Cyramza for stomach cancer

Wednesday, April 23, 2014 02:23 PM

The FDA has approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

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GSK, Genmab receive FDA approval for Arzerra (ofatumumab) for CLL

Monday, April 21, 2014 09:27 AM

GlaxoSmithKline and Genmab have announced that the FDA has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

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First patient enrolled in Boston Scientific’s new clinical registry

Friday, April 18, 2014 10:43 AM

Boston Scientific has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise Deep Brain Stimulation (DBS) System in patients with Parkinson's disease (PD).

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inVentiv Health Clinical hired by IntelliCell Biosciences for Osteoarthritis IND

Wednesday, April 16, 2014 01:39 PM

CRO inVentiv Health Clinical has been selected for an osteoarthritis Investigational New Drug application (IND) by regenerative medicine biotechnology company IntelliCell BioSciences. IntelliCell will be studying the use of adult autologous vascular cells from blood vessels in adipose tissue to treat osteoarthritis of the knee.

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New therapy for advanced prostate cancer approved in Trinidad & Tobago

Monday, April 14, 2014 10:40 AM

The Chemistry, Food and Drugs Division of the Trinidad & Tobago Ministry of Health approved the introduction of Janssen's Abiraterone Acetate, the first orally administered androgen synthesis inhibitor (testosterone) medication for the treatment of patients with metastatic castration-resistant prostate cancer.

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FDA approves expanded indication for certain pacemakers and defibrillators

Friday, April 11, 2014 01:38 PM

The FDA has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

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Pharmacyclics files sNDa for IMBRUVICA

Friday, April 11, 2014 01:16 PM

Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the FDA, based on data from the randomized, multi-center, open-label phase III RESONATE study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.

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