Clinical Intelligence

FDA approves long-acting recombinant coagulation Factor IX concentrate for hemophilia B

Monday, March 31, 2014 01:10 PM

The FDA has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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Kite Pharma granted FDA Orphan Drug Designation for Anti-CD19

Monday, March 31, 2014 01:06 PM

Kite Pharma, a clinical-stage biotechnology company focused on developing engineered autologous T cell therapy (eACT) products for cancer, has announced that the FDA Office of Orphan Products Development (OOPD) granted Orphan Drug Designation for the company's lead investigational therapy, an autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL).

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Janssen expands global cardiovascular research program with three new studies

Monday, March 31, 2014 12:56 PM

Janssen R&D is adding three new clinical trials to its EXPLORER global cardiovascular research program for XARELTO (rivaroxaban), a broadly indicated oral Factor Xa inhibitor. The additional trials will evaluate rivaroxaban for the treatment or prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in pediatric and other patient populations, including those at risk for DVT or PE due to a concurrent medical illness. The new studies will include more than 11,000 patients in over 30 countries.

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FDA approves Topamax for migraine prevention in adolescents

Monday, March 31, 2014 12:55 PM

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a dailybasis to reduce the frequency of migraine headaches.

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FDA approves Otezla to treat psoriatic arthritis

Friday, March 28, 2014 12:50 PM

The FDA has approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

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Mast Therapeutics initiates phase II study of MST-188 for acute limb ischemia

Friday, March 28, 2014 12:48 PM

Mast Therapeutics has initiated a phase II, clinical proof-of-concept study of MST-188 in combination with recombinant tissue plasminogen activator (rt-PA) in patients with acute lower limb ischemia.

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Avanir Pharmaceuticals receives NDA acceptance for AVP-825 for migraines

Friday, March 28, 2014 12:42 PM

Avanir Pharmaceuticals, a biopharmaceutical company focused on central nervous system disorders, has announced that the FDA has accepted the company's New Drug Application (NDA) of AVP-825, its innovative Breath Powered investigational drug-device combination product for the acute treatment of migraine.

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Agios enrolls first patient in phase I study of AG-120

Friday, March 21, 2014 09:49 AM

Agios Pharmaceuticals, a company focused on discovering and developing novel drugs to treat cancer and inborn errors of metabolism (IEMs), has announced that the first patient has been dosed in a phase I study of AG-120 in patients with advanced hematologic malignancies with an isocitrate dehydrogenase-1 (IDH1) mutation. AG-120 is an orally available, selective, potent inhibitor of the mutated IDH1 protein, making it the first targeted therapeutic candidate to treat patients with cancers that harbor the IDH1 mutation.

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Novo Nordisk releases positive results in N8-GP trial

Thursday, March 20, 2014 03:22 PM

Novo Nordisk has completed pathfinder2, the first phase III trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for hemophilia A patients. Pathfinder2 is a multi-national trial evaluating safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment  in patients with hemophilia A, who are 12 years or older. 

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FDA approves Impavido to treat tropical disease leishmaniasis

Thursday, March 20, 2014 11:40 AM

The FDA has approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites. The disease occurs primarily in people who live in the tropics and subtropics. Most U.S. patients acquire leishmaniasis overseas.

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December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

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Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
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