Voclosporin: New immunosuppressive
Isotechnika Inc. announced today that the International Nonproprietary Name (INN) expert committee has accepted the proposed generic name of its lead immunosuppressive drug, ISA247. ISA247 will now be referred to as voclosporin. The name will serve to identify the active pharmaceutical substance during the drugs' life-timeworldwide.Voclosporin is a next generation calcineurin inhibitor, which recently completed a Phase 2b North American trial for the prevention of kidneyrejection following transplantation. An extension to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis are ongoing. Our partner, Lux Biosciences, is currently conducting three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LX211 by Lux) for the treatment of uveitis
Novel oral anticoagulant Pradaxa® (dabigatran etexilate) approved by the European Commission
Boehringer Ingelheim announced that the European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa® (dabigatran etexilate) in all 27 EU member states. It is anticipated that Pradaxa® will be launched in Germany and the United Kingdom in the coming weeks.
Pradaxa® is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.
The standard recommended dosage of Pradaxa® is a fixed oral dose of 220 mg given once daily. A single capsule of 110 mg (half-dose) is administered orally between 1 and 4 hours following surgery, continuing with 2 capsules once daily thereafter for a total of 10 days in total knee replacement patients and 28-35 days in total hip replacement patients. A second approved dosage of 150 mg taken as two capsules of 75 mg is recommended for specific patient populations, including patients over 75 years of age and those with moderate renal impairment.
Pradaxa® prevents thrombus formation by specifically and selectively inhibiting thrombin, the central and essential enzyme that enables the conversion of fibrinogen into fibrin during the coagulation cascade, and therefore prevents the development of a thrombus
FDA Looking Into Montelukast sodium Suicide Risk
The USFDA is investigating a possible connection between the use of Merck’s Singulair and changes in behavior and mood involving suicidal thoughts and suicide. The agency said in an Early Communication Thursday that it is considering, but has not reached a decision on, possible regulatory action. Singulair (Montelukast sodium), Merck’s top-selling product, had worldwide sales of $4.3 billion last year. Singulair is a leukotriene receptor antagonist indicated for treating asthma, and the symptoms of allergic rhinitis and for preventing exercise-induced asthma.
Isotechnika Inc. announced today that the International Nonproprietary Name (INN) expert committee has accepted the proposed generic name of its lead immunosuppressive drug, ISA247. ISA247 will now be referred to as voclosporin. The name will serve to identify the active pharmaceutical substance during the drugs' life-timeworldwide.Voclosporin is a next generation calcineurin inhibitor, which recently completed a Phase 2b North American trial for the prevention of kidneyrejection following transplantation. An extension to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis are ongoing. Our partner, Lux Biosciences, is currently conducting three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LX211 by Lux) for the treatment of uveitis
Novel oral anticoagulant Pradaxa® (dabigatran etexilate) approved by the European Commission
Boehringer Ingelheim announced that the European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa® (dabigatran etexilate) in all 27 EU member states. It is anticipated that Pradaxa® will be launched in Germany and the United Kingdom in the coming weeks.
Pradaxa® is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.
The standard recommended dosage of Pradaxa® is a fixed oral dose of 220 mg given once daily. A single capsule of 110 mg (half-dose) is administered orally between 1 and 4 hours following surgery, continuing with 2 capsules once daily thereafter for a total of 10 days in total knee replacement patients and 28-35 days in total hip replacement patients. A second approved dosage of 150 mg taken as two capsules of 75 mg is recommended for specific patient populations, including patients over 75 years of age and those with moderate renal impairment.
Pradaxa® prevents thrombus formation by specifically and selectively inhibiting thrombin, the central and essential enzyme that enables the conversion of fibrinogen into fibrin during the coagulation cascade, and therefore prevents the development of a thrombus
FDA Looking Into Montelukast sodium Suicide Risk
The USFDA is investigating a possible connection between the use of Merck’s Singulair and changes in behavior and mood involving suicidal thoughts and suicide. The agency said in an Early Communication Thursday that it is considering, but has not reached a decision on, possible regulatory action. Singulair (Montelukast sodium), Merck’s top-selling product, had worldwide sales of $4.3 billion last year. Singulair is a leukotriene receptor antagonist indicated for treating asthma, and the symptoms of allergic rhinitis and for preventing exercise-induced asthma.
