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Drug activist group AIDAN raises concerns over EUA for COVAXIN expresspharma
January 05, 2021
The All India Drug Action Network (AIDAN), a drug activists group has issued a statement asking the DCGI to make public all the data and analyses on which the decisions have been made to grant EUA to the COVID-19 vaccines.
SEC recommends EUA for Covaxin from Bharat Biotech expresspharma
January 04, 2021
The expert panel deliberated on Bharat Biotech’s EUA application after it submitted additional data, facts and analysis after Friday's review meeting.
SEC meets to discuss EUA applications from Pfizer, SII and Bharat Biotech expresspharma
December 31, 2020
The Subject Expert Committee (SEC) in the Central Drugs Standard Control Organisation (CDSCO) met on December 30, 2020, in the afternoon to consider the Emergency Use Authorisation (EUA) requests of Pfizer, Serum Institute of India (SII) and ...
SEC asks Bharat Serums to revise phase I/II trial protocols for equine antiserum to treat COVID-19 expresspharma
December 29, 2020
The SEC has recommended grant of permission to conduct the clinical trial provided the company submits the revised clinical trial protocol to CDSCO.
SEC asks Biocon to submit safety, mortality data for Itolizumab expresspharma
December 03, 2020
The company claims that approximately 2000 COVID-19 patients used the drug under the emergency use authorisation.
SEC asks CDSCO to submit adverse event report of death during Umifenovir trial expresspharma
October 16, 2020
The Subject Expert Committee (SEC) has asked CDSCO to submit data of the reported serious adverse event (SAE), a single death, from the clinical trials of the drug combination of Favipiravir + Umifenovir by Glenmark Pharmaceuticals.
Harpoon and Gossamer sneak out IPOs before potential SEC shutdown pharmaphorum
February 15, 2019
Immunotherapy specialist Harpoon Therapeutics has joined a group of biotechs that have sneaked out IPOs before another potential US government shutdown this weekend that could prevent further listings.
Innovus Pharma announces $3.17 million private placement biospectrumasia
January 02, 2019
The net proceeds from the offering are anticipated to be approximately $2.765 million. The Company intends to use the net proceeds for working capital and general corporate purposes.
Navidea brings on new chief medical officer focused on imaging biomarkers fiercebiotech
December 29, 2018
Precision immunodiagnostic and immunotherapy firm Navidea Biopharmaceuticals named Michael Rosol, Ph.D., to be its new chief medical officer, effective Dec. 17.....
Irish authorities demand €1.6bn in back tax from Perrigo pharmaceutical-technology
December 24, 2018
The Irish tax authority Revenue Commissioners has issued a Notice of Amended Assessment (NoA) to Perrigo stating the company owes €1.64bn in tax from 2013 intellectual property sales by Elan Pharma, which was later acquired by Perrigo.....

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