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RSS FeedPosted by Michael Wonder on 24 Jun 2020
Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...
Posted by Michael Wonder on 24 Jun 2020
Renibus Therapeutics receives FDA fast track designation for RBT-9 treatment in COVID-19
23 June 2020 - Renibus Therapeutics announced today that it has been granted fast track designation by the FDA for RBT-9 ...
Posted by Michael Wonder on 23 Jun 2020
Polynoma receives FDA fast track designation for its melanoma cancer vaccine seviprotimut-L
23 June 2020 - Polynoma announces that the U.S. FDA has granted its application for fast track designation of seviprotimut-L, ...
Posted by Michael Wonder on 23 Jun 2020
FDA maintains the pace of meeting its goals on applications for medical products during the pandemic
23 June 2020 - One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the ...
Posted by Michael Wonder on 23 Jun 2020
Academia developing medicines for rare diseases to receive free EMA scientific advice
23 June 2020 - To further encourage the development of treatments for rare diseases, EMA will waive all fees for ...
Posted by Michael Wonder on 23 Jun 2020
FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials
23 June 2020 - The U.S. FDA today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence. ...
Posted by Michael Wonder on 23 Jun 2020
Imbruvica (ibrutinib) seeks to expand U.S. label with long-term data in Waldenström's macroglobulinaemia
23 June 2020 - Submission is based on results of more than five years of follow-up data from the Phase 3 ...
Posted by Michael Wonder on 23 Jun 2020
Deciphera announces Health Canada’s authorisation of Qinlock (ripretinib) for the treatment of fourth-line gastro-intestinal stromal tumour
22 June 2020 - Qinlock significantly improved progression-free survival and showed clinically meaningful overall survival in global INVICTUS Phase 3 study. ...
Posted by Michael Wonder on 23 Jun 2020
Submissions received: fees and charges proposal 2020-21
23 June 2020 - On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, ...
Posted by Michael Wonder on 23 Jun 2020
Myovant Sciences announces priority review and FDA acceptance of new drug application for once daily, oral relugolix for advanced prostate cancer
22 June 2020 - Priority review status expected to accelerate review, with a target FDA action date of 20 December ...
Posted by Michael Wonder on 22 Jun 2020
FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma
22 June 2020 - Today the Food and Drug Administration granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) for adult ...
Posted by Michael Wonder on 22 Jun 2020
European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
22 June 2020 - Senior officials from the European Commission, EMA and the United States FDA held their 2020 bilateral ...
Posted by Michael Wonder on 22 Jun 2020
FDA accepts supplemental biologics license application for Botox (onabotulinumtoxinA) for the treatment of paediatric patients with neurogenic detrusor overactivity
22 June 2020 - Application seeks to extend use of Botox for patients 5 to 17 years old. ...
Posted by Michael Wonder on 22 Jun 2020
Anti-COVID drug may be ready in Australia by the end of the year
21 June 2020 - A global breakthrough on a new antiviral drug that scientists believe could block the coronavirus has ...
Posted by Michael Wonder on 22 Jun 2020
European Medicines Agency validates application for Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
22 June 2020 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation ...