Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2019
The stepped wedge cluster randomised trial: what it is and when it should be used
1 April 2019 - The basic premise of a stepped wedge cluster randomised trial is that all clusters start in the ...
Posted by Michael Wonder on 01 Apr 2019
U.S. FDA acknowledges receipt of Intellipharmaceutics' resubmission of oxycodone ER new drug application, deems it a complete response, and designates 28 August 2019 as goal date for review
29 March 2019 - Intellipharmaceutics announced today that the U.S. FDA has acknowledged receipt of its resubmission of the Oxycodone ER ...
Posted by Michael Wonder on 30 Mar 2019
Statement by FDA Commissioner, Director of FDA’s Center for Drug Evaluation and Research and Director of FDA’s Center for Biologics Evaluation and Research on expanded access–looking forward
29 March 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for ...
Posted by Michael Wonder on 30 Mar 2019
Spero Therapeutics receives FDA fast track designation for SPR994 for the treatment of complicated urinary tract infections and acute pyelonephritis
29 March 2019 - Spero Therapeutics today announced that the U.S. FDA granted fast track designation for SPR994, Spero’s lead product ...
Posted by Michael Wonder on 30 Mar 2019
bluebird bio receives positive opinion from CHMP for Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia who do not have β0/β0 Genotype
29 March 2019 - First gene therapy recommended for approval in the EU for transfusion-dependent β-thalassemia. ...
Posted by Michael Wonder on 29 Mar 2019
FDA approves new oral treatment for multiple sclerosis
29 March 2019 - The U.S. FDA today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) ...
Posted by Michael Wonder on 29 Mar 2019
Highlights from CHMP 25-28 March 2019 meeting
29 March 2019 - EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions ...
Posted by Michael Wonder on 29 Mar 2019
Janssen submits supplemental new drug application to U.S. FDA for Invokana (canagliflozin) for the treatment of chronic kidney disease in patients with type 2 diabetes mellitus
28 March 2019 - Submission is based on data from the landmark Phase 3 CREDENCE renal outcomes study, which stopped early ...
Posted by Michael Wonder on 29 Mar 2019
Amarin submits supplemental new drug application to U.S. FDA seeking new indication for Vascepa (icosapent ethyl) to reduce the risk of major adverse cardiovascular events based on landmark REDUCE-IT cardiovascular outcomes study
28 March 2019 - Amarin Corporation today announced that, as planned, it submitted a supplemental new drug application to the U.S. ...
Posted by Michael Wonder on 29 Mar 2019
Dynavax announces European Medicines Agency accepts marketing authorisation application for Heplisav-B for prevention of hepatitis B in adults
28 March 2019 - Dynavax Technologies today announced that the EMA has accepted the Company’s marketing authorisation application for review ...
Posted by Michael Wonder on 28 Mar 2019
Hospital pharmacists face dozens of drug shortages yearly
28 March 2019 - More than two-thirds of pharmacists in U.S. hospitals deal with at least 50 drug shortages every year, ...
Posted by Michael Wonder on 28 Mar 2019
Why J&J raced to put drug prices in some TV ads
28 March 2019 - One notion proposed by the Trump administration to blunt the rising cost of medicines is to ...
Posted by Michael Wonder on 28 Mar 2019
Drug makers continue to clamour for FDA approval of orphan drugs
28 March 2019 - Orphan drugs may serve small groups of patients, but they generate big numbers at the Food ...
Posted by Michael Wonder on 28 Mar 2019
FDA approves treatment for patients with a type of inflammatory arthritis
28 March 2019 - The U.S. FDA today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type ...
Posted by Michael Wonder on 28 Mar 2019
20 years of sampling and testing programme for medicines authorised for the EU
28 March 2019 - EMA and the European Directorate for the Quality of Medicines & Healthcare have reviewed EMA’s sampling ...