Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2016
Janssen submits application seeking FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate to severe plaque psoriasis
16 December 2016 - Janssen Biotech announced today the submission of a supplemental biologics license application to the U.S. FDA seeking ...
Posted by Michael Wonder on 17 Dec 2016
Novartis drug Votubia recommended by CHMP for EU approval to treat refractory partial-onset seizures in patients with TSC
16 December 2016 - CHMP positive opinion based on pivotal study showing adjunctive treatment with everolimus achieved clinically significant seizure ...
Posted by Michael Wonder on 17 Dec 2016
ViiV Healthcare announces CHMP positive opinion to lower the age and weight limit for Tivicay (dolutegravir) in children and adolescents living with HIV in Europe
16 December 2016 - ViiV Healthcare today announced that the CHMP has adopted a positive opinion on the Type II variation ...
Posted by Michael Wonder on 17 Dec 2016
European Medicines Agency’s CHMP recommends Merck’s Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumours have high PD-L1 expression with no EGFR or ALK positive tumour mutations
16 December 2016 - First anti-PD-1 therapy to receive a CHMP positive opinion for previously untreated patients with metastatic non-small-cell ...
Posted by Michael Wonder on 17 Dec 2016
Novartis receives positive CHMP recommendation for Ilaris to treat rare diseases in adults and children called Periodic Fever Syndromes
16 December 2016 - Periodic Fever Syndromes are rare diseases mostly affecting children and cause recurrent and disabling fevers with ...
Posted by Michael Wonder on 17 Dec 2016
CHMP recommends approval of Lilly's baricitinib for the treatment of adults with moderate to severe active rheumatoid arthritis
16 December 2016 - Eli Lilly and Company and Incyte Corporation announced today that the EMA's CHMP has issued a ...
Posted by Michael Wonder on 17 Dec 2016
CHMP recommends EU conditional approval of Roche’s Alecensa (alectinib) for people with previously treated ALK-positive NSCLC
16 December 2016 - Roche announced today that the EMA CHMP has adopted a positive opinion for the use of Alecensa ...
Posted by Michael Wonder on 16 Dec 2016
Why did new drug approvals in the U.S. plunge this year?
15 December 2016 - New drug approvals dropped more than 50% this year. ...
Posted by Michael Wonder on 16 Dec 2016
Advanced Accelerator Applications announces European Commission approval of SomaKit TOC
15 December 2016 - AAA today announced that following a positive opinion issued by the EMA in October 2016, the European ...
Posted by Michael Wonder on 15 Dec 2016
Health Canada approves Stelara for the treatment of adults with moderately to severely active Crohn's disease
14 December 2016 - Stelara offers a new approach to treating Crohn's disease in Canada, which has one of the ...
Posted by Michael Wonder on 15 Dec 2016
Health Canada approves CSL Behring’s Afstyla for the treatment of haemophilia A
14 December 2016 - Afstyla is the first and only single-chain recombinant factor VIII for haemophilia A, specifically designed for ...
Posted by Michael Wonder on 15 Dec 2016
European Commission grants Intercept's Ocaliva (obeticholic acid) marketing authorisation for the treatment of primary biliary cholangitis
14 December 2016 - Intercept Pharmaceuticals today announced that the European Commission has granted conditional approval for Ocaliva (obeticholic acid) ...
Posted by Michael Wonder on 14 Dec 2016
Ferring receives EU approval for Rekovelle (follitropin delta)
13 December 2016 - A novel human recombinant follicle stimulating hormone administered using an individualised dosing regimen. ...
Posted by Michael Wonder on 14 Dec 2016
FDA approves Eucrisa for eczema
14 December 2016 - The U.S. FDA today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in ...
Posted by Michael Wonder on 14 Dec 2016
New formulation of Rituxan now available to Canadians living with non-Hodgkin's lymphoma
13 December 2016 - Canadians living with non-Hodgkin's lymphoma, one of the most commonly diagnosed blood cancers in Canada, now have ...