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RSS FeedPosted 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
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 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 ...
Posted by Michael Wonder on 10 Nov 2020
Bayer submits marketing authorization applications for finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes
9 November 2020 - Regulatory submissions based on positive data from Phase 3 FIDELIO-DKD trial recently published in the New England ...
Posted by Michael Wonder on 10 Nov 2020
Lilly's neutralising antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorisation for the treatment of recently diagnosed COVID-19
9 November 2020 - Bamlanivimab is authorised for treatment of recently diagnosed, mild to moderate COVID-19 in high-risk patients. ...
Posted by Michael Wonder on 09 Nov 2020
FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers
9 November 2020 - On 6 November, the FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to ...
Posted by Michael Wonder on 09 Nov 2020
Impel Neuropharma announces FDA submission of new drug application for INP104 for the acute treatment of migraine
9 November 2020 - The INP104 new drug application is supported by results from the Phase 3 STOP 301 trial. ...
Posted by Michael Wonder on 09 Nov 2020
FDA grants rare paediatric disease designation to AMO Pharma for AMO-02 for treatment of congenital myotonic dystrophy
9 November 2020 - Designation qualifies AMO-02 for fast track review and AMO Pharma to receive a priority review voucher pending ...