Blog
RSS FeedPosted by Michael Wonder on 20 Dec 2016
Juno Therapeutics' and Celgene Corporation's investigational drug JCAR017 granted breakthrough therapy designation from FDA and priority medicines eligibility from EMA for relapsed/refractory diffuse large B cell lymphoma
20 December 2016 - Early results recently announced with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia. ...
Posted by Michael Wonder on 20 Dec 2016
Novo Nordisk receives FDA approval of Tresiba (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes
19 December 2016 - Novo Nordisk today announced that the U.S. FDA approved an expanded indication for Tresiba (insulin degludec injection ...
Posted by Michael Wonder on 20 Dec 2016
Pfizer receives approval in the European Union for Nimenrix (meningococcal group A, C, W-135 and Y conjugate vaccine) in infants six weeks of age and older
19 December 2016 - Pfizer announced today the European Commission has approved an expanded indication for Nimenrix (meningococcal group A, C, ...
Posted by Michael Wonder on 20 Dec 2016
FDA grants Conatus fast track designation for development of emricasan in NASH cirrhosis
3 February 2016 - Conatus Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the company's emricasan ...
Posted by Michael Wonder on 20 Dec 2016
Dynavax receives complete response letter from U.S. FDA for biologics license application for Heplisav-B
14 November 2016 - Dynavax Technologies today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 20 Dec 2016
TGA approves new uses for Janssen's Imbruvica
20 December 2016 - The TGA has approved the use of ibrutinib for first-line use in patients with chronic lymphocytic ...
Posted by Michael Wonder on 20 Dec 2016
Celltrion’s biosimilar granted marketing approval recommendation in Europe
19 December 2016 - South Korea’s Celltrion Inc., the world’s first developer of a biosimilar version to treat rheumatoid arthritis, ...
Posted by Michael Wonder on 20 Dec 2016
Tonix Pharmaceuticals’ PTSD Phase 3 ready drug candidate, TNX-102 SL, granted breakthrough therapy designation by the FDA
19 December 2016 - Responding to AtEase study results in military-related PTSD population, FDA agrees to work closely with Tonix ...
Posted by Michael Wonder on 19 Dec 2016
FDA grants accelerated approval to new treatment for advanced ovarian cancer
19 December 2016 - The U.S. FDA today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain ...
Posted by Michael Wonder on 18 Dec 2016
Summary of submissions and outcomes from the November 2016 PBAC meeting
19 December 2016 - 70 submissions were considered at the July 2016 PBAC meeting (this includes submissions relating to “Other ...
Posted 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 ...