Blog
RSS FeedPosted by Michael Wonder on 21 Dec 2018
Nabriva Therapeutics submits new drug applications to U.S. FDA for intravenous and oral lefamulin to treat community-acquired bacterial pneumonia in adults
20 December 2018 - Nabriva Therapeutics announced the submission of two new drug applications to the U.S. FDA for the ...
Posted by Michael Wonder on 20 Dec 2018
AbbVie submits new drug application to U.S. FDA and marketing authorisation application to EMA for upadacitinib for treatment of adults with moderate to severe rheumatoid arthritis
20 December 2018 - Regulatory applications supported by robust SELECT Phase 3 program evaluating more than 4,000 patients with moderate to ...
Posted by Michael Wonder on 20 Dec 2018
Pharmaxis announces resubmission of Bronchitol NDA in USA
18 December 2018 - Pharmaxis today announced the resubmission of the Bronchitol new drug application with the United States FDA ...
Posted by Michael Wonder on 20 Dec 2018
ADMA Biologics provides regulatory update on Bivigam PAS submissions
19 December 2018 - FDA issues complete response letter for drug substance, approves supplement for drug product. ...
Posted by Michael Wonder on 20 Dec 2018
Chugai's satralizumab receives FDA breakthrough therapy designation for neuromyelitis optica and neuromyelitis optica spectrum disorders
19 December 2018 - Designation is seventh for Chugai originated drug. ...
Posted by Michael Wonder on 20 Dec 2018
FDA approves new indication for Envarsus XR (tacrolimus extended-release tablets)
19 December 2018 - Veloxis Pharmaceuticals announced today that the U.S. FDA approved a new indication for Envarsus XR (tacrolimus ...
Posted by Michael Wonder on 20 Dec 2018
FDA approves Merck’s Keytruda (pembrolizumab) for the treatment of adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, a rare form of skin cancer
19 December 2018 - Accelerated approval based on results of CITN-09/KEYNOTE-017, where Keytruda monotherapy demonstrated an objective response rate of 56%. ...
Posted by Michael Wonder on 20 Dec 2018
DBV Technologies provides update on Viaskin Peanut for children four to 11 years of age
19 December 2018 - Application withdrawn following discussions with FDA regarding insufficient data on manufacturing procedures and quality controls. ...
Posted by Michael Wonder on 19 Dec 2018
Lynparza approved by US FDA for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer
19 December 2018 - AstraZeneca and MSD’s Lynparza reduced the risk of disease progression or death by 70% compared to placebo ...
Posted by Michael Wonder on 19 Dec 2018
More lawsuits = higher drug prices
18 December 2018 - The FDA pulls an Obama rule that was a trial-lawyer special. ...
Posted by Michael Wonder on 19 Dec 2018
Equillium granted U.S. FDA fast track designation for EQ001 for the treatment of acute graft-versus-host disease
19 December 2018 - Company plans to initiate Phase 1b/2 EQUATE clinical trial in early 2019. ...
Posted by Michael Wonder on 19 Dec 2018
FDA advances new scientific framework to promote greater predictability, efficiency in oncology drug development
19 December 2018 - Today, the U.S. FDA issued guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and ...
Posted by Michael Wonder on 19 Dec 2018
Comparative assessment of clinical benefit using the ESMO Magnitude of Clinical Benefit Scale version 1.1 and the ASCO Value Framework Net Health Benefit Score
19 December 2018 - To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) ...
Posted by Michael Wonder on 18 Dec 2018
Establishing the effectiveness of procedural interventions: the limited role of randomised trials
18 December 2018 - Procedural interventions comprise a large and growing component of medical care. Patients, physicians, health care organisations, and ...
Posted by Michael Wonder on 18 Dec 2018
Warren unveils bill to lower drug prices by letting government manufacture them
18 December 2018 - Senator Elizabeth Warren has unveiled a bill aimed at lowering drug prices by allowing the government ...