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RSS FeedPosted by Michael Wonder on 06 Jan 2021
KYE Pharmaceuticals announces approval of Corzyna in Canada (ranolazine extended release tablets)
5 January 2020 - KYE Pharmaceuticals today announced an important milestone, Corzyna (ranolazine extended release tablets) has now been approved by ...
Posted by Michael Wonder on 06 Jan 2021
Marius Pharmaceuticals submits new drug application to U.S. FDA for next generation oral testosterone replacement therapy in male patients with hypogonadism
5 January 2021 - Kyzatrex new drug application includes data demonstrating less than 2 mm Hg mean SBP increase as measured ...
Posted by Michael Wonder on 05 Jan 2021
Genentech’s novel anti-TIGIT tiragolumab granted FDA breakthrough therapy designation in combination with Tecentriq for PD-L1 high non-small cell lung cancer
4 January 2021 - Tiragolumab is the first anti-TIGIT therapy to be granted breakthrough therapy designation and marks the 37th ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its Type II Variation marketing authorisation application ...
Posted by Michael Wonder on 05 Jan 2021
Daiichi Sankyo submits application for oncolytic virus teserpaturev (G47∆) for treatment of patients with malignant glioma in Japan
5 January 2020 - Daiichi Sankyo and the University of Tokyo are collaboratively developing teserpaturev, which has received SAKIGAKE designation and ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for resected oesophageal or gastro-oesophageal junction cancer following chemoradiotherapy
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its marketing authorisation application for Opdivo (nivolumab) ...
Posted by Michael Wonder on 04 Jan 2021
Ibrutinib with rituximab in previously untreated chronic lymphocytic leukaemia: indication of added benefit over FCR
4 January 2020 - The new drug combination prolongs overall survival in patients in good general health. No study data are ...
Posted by Michael Wonder on 04 Jan 2021
FDA grants ARX788 fast track designation for HER2 positive metastatic breast cancer
4 January 2021 - Ambrx announced that the U.S. FDA granted ARX788 fast track designation as monotherapy for the treatment of ...
Posted by Michael Wonder on 04 Jan 2021
Provention Bio announces U.S. FDA filing of a biologics license application and priority review for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk Individuals
4 January 2020 - FDA sets PDUFA goal date of 2 July 2021. ...
Posted by Michael Wonder on 04 Jan 2021
US FDA accepts regulatory submission from Pfizer and OPKO for review of somatrogon to treat pediatric patients with growth hormone deficiency
4 January 2020 - If approved, somatrogon will serve as a once-weekly treatment option. ...
Posted by Michael Wonder on 04 Jan 2021
NICE collaboration on streamlined licensing and patient access process for new medicines opened on January 1st
4 January 2020 - Companies can now submit medicines for the new Innovative Licensing and Access Pathway following close collaboration between ...
Posted by Michael Wonder on 04 Jan 2021
ALS patients and advocates say Canada needs better access to new treatments
3 January 2020 - 'The clock is ticking for us,' says a Niagara man who has ALS, and has joined the ...
Posted by Michael Wonder on 01 Jan 2021
New Zealand Pharmaceutical Schedule - 1 January 2021
1 January 2021 - The January 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 01 Jan 2021
Schedule of Pharmaceutical Benefits - 1 January 2021 update
1 January 2021 - The January 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 01 Jan 2021
CytRx issues statement regarding U.S. regulatory review of arimoclomol for Niemann-Pick disease type C
31 December 2020 - CytRx today provided an update on the U.S. FDA review of Orphazyme new drug application for arimoclomol ...