Blog
RSS FeedPosted by Michael Wonder on 06 Aug 2018
EpiPen shortage is critical – and not easy to fix
2 August 2018 - An estimated 2.6 million Canadians suffer from serious allergies and about 630,000 of them carry an ...
Posted by Michael Wonder on 06 Aug 2018
Complete response letter issued for Remoxy
6 August 2018 - Pain Therapeutics today announced it had received a complete response letter from the U.S. FDA for its ...
Posted by Michael Wonder on 06 Aug 2018
U.S. FDA grants fast track designation for BioCryst’s BCX7353
6 August 2018 - BioCryst Pharmaceuticals today announced that the Company has been granted fast track designation by the U.S. ...
Posted by Michael Wonder on 06 Aug 2018
Janssen receives positive CHMP opinion to expand Invokana and Vokanamet labelling to include positive data on cardiovascular morbidity and mortality
2 August 2018 - Update based on positive cardiovascular outcomes from CANVAS Program. ...
Posted by Michael Wonder on 04 Aug 2018
Statement from FDA Commissioner Scott Gottlieb on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes
3 August 2018 - As a public health agency, there is no greater impact we can have to improve the ...
Posted by Michael Wonder on 04 Aug 2018
EMA grants PRIME status for Roche Huntington's drug
3 August 2018 - The EMA has granted PRIME designation to Roche's RG6042 for treatment of Huntington’s disease. ...
Posted by Michael Wonder on 03 Aug 2018
Celltrion’s biosimilar Herzuma approved in Australia
2 August 2018 - Korean biopharmaceutical firm Celltrion said on 2 August that its breast cancer biosimilar has been approved ...
Posted by Michael Wonder on 03 Aug 2018
European Commission approves extension of indication for Otsuka’s Jinarc (tolvaptan) to include treatment of ADPKD patients with advanced chronic kidney disease (CKD stage 4)
2 August 2018 - Treatment that slows disease progression will now be available for CKD stage 4 patients, where no pharmacological ...
Posted by Michael Wonder on 02 Aug 2018
Aimovig (erenumab), a novel treatment developed specifically for migraine prevention receives Health Canada approval
2 August 2018 - Aimovig consistently shown to reduce monthly migraine days, with many patients achieving a 50% reduction or more. ...
Posted by Michael Wonder on 02 Aug 2018
Evolus announces early resubmission to the FDA of its biologics licence application for DWP-450
2 August 2018 - Commercial launch planned for spring 2019. ...
Posted by Michael Wonder on 02 Aug 2018
Acrux submits first-to-file application for generic version of Jublia making it eligible for 180 days of generic exclusivity
2 August 2018 - Acrux is pleased to announce that the US FDA has accepted for review the Paragraph IV Abbreviated ...
Posted by Michael Wonder on 02 Aug 2018
Amid EpiPen shortage, a Canadian-based company has approval for an alternative
1 August 2018 - Bausch Health says it is 'actively seeking' to bring anaphylaxis injector to Canadian patients. ...
Posted by Michael Wonder on 02 Aug 2018
FDA and EMA to hold workshop on breakthrough therapy and PRIME designations
2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...
Posted by Michael Wonder on 01 Aug 2018
FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development
1 August 2018 - We know that novel manufacturing technologies for both small-molecule drugs and biological products have great potential to ...
Posted by Michael Wonder on 01 Aug 2018
Brexit preparedness: EMA to further temporarily scale back and suspend activities
1 August 2018 - Next phase of business continuity plan aimed at securing essential public and animal health activities ...