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Zydus gets DCGI approval to commence Phase III clinical trials with Pegylated Interferon alpha-2b expresspharma
December 07, 2020
In Phase II clinical trials, Pegylated Interferon alpha – 2b increased viral reduction and reduced the need for supplemental oxygen in moderate COVID-19 patients.
DCGI probe finds no adverse event linked to SII’s Covid-19 vaccine pharmaceutical-technology
December 04, 2020
The Drugs Controller General of India’s (DCGI) probe found that an alleged serious adverse event (SAE) suffered by a volunteer in Covid-19 vaccine trial of Serum Institute of India (SII) in Chennai was unrelated to the shot he received.
DCGI finds no linkage between Covishield shot and volunteer’s adverse event during trial expresspharma
December 03, 2020
An expert committee recommended that compensation should not be paid to the subject or legal heir/nominee of the subject.
Experts question continuation of Covishield vaccine trials in India despite adverse event report expresspharma
December 01, 2020
Censure SII’s move to file a defamation suit on the participant who reported the adverse event, stating that it will discourage honest feedback from participants and dissuade people from participating in clinical trials.
DCGI asks state drug controllers to recall ulipristal acetate tablets from market expresspharma
November 19, 2020
The decision is based on the PRAC recommendations and reported cases of liver injury in the EU.
Industry experts disagree with NPPA’s remark on FDCs expresspharma
November 10, 2020
The National Pharmaceutical Pricing Authority’s (NPPA) recently raised concerns over the approval of FDCs.
Experts seek data on remdesivir and COVID-19 treatment-related products expresspharma
November 04, 2020
Recently, Dr Reddy’s Laboratories’ plea to change the regulatory approval status of remdesivir injection, COVID-19 treatment drug, from restricted emergency use to full marketing authorisation was rejected by COVID-19 subject expert committee (SEC) of ...
COVAXIN from Bharat Biotech gets DCGI nod for Phase III clinical trials expresspharma
October 26, 2020
Covaxin, the COVID-19 vaccine candidate from Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR), has received approval from DCGI for phase III clinical trials.
Experts laud DCGI ruling to conduct phase II/III clinical trials of Sputnik-V in India expresspharma
October 09, 2020
The Indian regulator has instructed Dr Reddy’s Laboratories carry out the trials of the vaccine with proper monitoring of immune response and also submit stability data as per usage conditions.
Bayer gets DCGI nod for intravitreal aflibercept injection, Eylea to treat diabetic macular edema expresspharma
September 23, 2020
Intravitreal Aflibercept is administered via injection directly in the area of swelling in the eye.

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