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RSS FeedPosted by Michael Wonder on 12 Nov 2020
Cystic Fibrosis Canada says 'life-changing' drug coming to Canada, but approval months away
11 November 2020 - The drug's manufacturer says it's moving forward with its cystic fibrosis medicines in Canada. ...
Posted by Michael Wonder on 12 Nov 2020
The challenges ahead with monoclonal antibodies: from authorisation to access
11 November 2020 - When President Trump received an infusion of a monoclonal antibody cocktail (REGN-COV2, Regeneron) on October 2, ...
Posted by Michael Wonder on 11 Nov 2020
Angiocrine Bioscience announces FDA regenerative medicine advanced therapy designation granted to AB-205 (universal E-CEL cell therapy) to treat organ vascular niche injuries for the prevention of severe toxicities in lymphoma patients undergoing curative high-dose therapy with autologous stem cell transplantation
11 November 2020 - Angiocrine Bioscience today announced that the U.S. FDA granted the regenerative medicine advanced therapy designation for AB-205, ...
Posted by Michael Wonder on 11 Nov 2020
Surface Oncology announces FDA fast track designation granted by U.S. Food and Drug Administration for SRF388 to treat liver cancer
11 November 2020 - Surface Oncology today announced that the U.S. FDA has granted fast track designation to SRF388 for ...
Posted by Michael Wonder on 11 Nov 2020
Pfizer vaccine will be shipped in 'Eskies' as vaccines get preliminary approval
11 November 2020 - The Pfizer COVID-19 vaccine will be moved around Australia in specialised Eskies as part of a ...
Posted by Michael Wonder on 11 Nov 2020
Clinigen's Totect (dexrazoxane) receives FDA approval for new indication to treat incidence and severity of cardiomyopathy associated with doxorubicin in women with metastatic breast cancer
10 November 2020 - Clinigen announced today that the FDA has granted approval to broaden the indication for Totect to now ...
Posted by Michael Wonder on 11 Nov 2020
FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development
9 November 2020 - To further promote and protect public health, it is important that people who are in clinical trials ...
Posted by Michael Wonder on 11 Nov 2020
Sebela Pharmaceuticals receives FDA approval for Sutab tablets for colonoscopy preparation
10 November 2020 - Sebela Pharmaceuticals today announces that the U.S. FDA approved Sutab (sodium sulphate, magnesium sulphate and potassium chloride) ...
Posted by Michael Wonder on 11 Nov 2020
Therapeutic Goods Administration gives green light for early Pfizer vaccine
11 November 2020 - The nation’s medicines regulator has paved the way for an early release of Pfizer’s breakthrough COVID-19 ...
Posted by Michael Wonder on 10 Nov 2020
Manufacturer moves to bring 'life-changing' cystic fibrosis drugs to Canada
10 November 2020 - A pharmaceutical company says it's taking steps to bring cystic fibrosis drugs to Canada in a ...
Posted by Michael Wonder on 10 Nov 2020
Health Canada approves Maviret 8 week treatment duration for treatment naïve patients with genotype 3 compensated cirrhosis
10 November 2020 - Maviret (glecaprevir/pibrentasvir) is the only 8 week oral treatment approved for all hepatitis C virus genotypes. ...
Posted by Michael Wonder on 10 Nov 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of pancreatic cancer
10 November 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 10 Nov 2020
Supernus provides regulatory updates for SPN-812 and SPN-830
9 November 2020 - The U.S. FDA has issued a complete response letter regarding the new drug application for SPN-812 ...
Posted by Michael Wonder on 10 Nov 2020
The next big challenge after a COVID-19 vaccine is giving it to enough people
10 November 2020 - With Pfizer’s COVID-19 vaccine on track to be authorised as early as next month, Western governments ...
Posted by Michael Wonder on 10 Nov 2020
Pfizer’s and BioNTech’s vaccine is the start of the end of the pandemic
9 November 2020 - Its 90% effectiveness is as good as it gets, and bodes well for other vaccines. But getting ...