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Results For "regulatory-filing"

90 News Found

Cadila Healthcare receives permission to conduct Phase III trials for two-dose ZyCoV-D
News | October 06, 2021

Cadila Healthcare receives permission to conduct Phase III trials for two-dose ZyCoV-D

The company has already received the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses on August 20


AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid
Biotech | October 05, 2021

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid

The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


Zydus agrees to sell Mifegest and Cytolog to Integrace
News | September 21, 2021

Zydus agrees to sell Mifegest and Cytolog to Integrace

The purchaser is a part of the portfolio companies of PE firm True North. The said transaction is not a related party transaction.


Lincoln Pharma plans to launch Cephalosporin product portfolio soon
Drug Approval | September 21, 2021

Lincoln Pharma plans to launch Cephalosporin product portfolio soon

Cephalosporin is a bactericidal, broad-spectrum, and P-lactam antibiotic originally derived from the fungus Acremonium, which is used to treat bacterial infections such as pneumonia, skin infections, ear infection, strep throat, staph infections, tonsillitis, bronchitis among others


U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations
News | September 20, 2021

U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations

The company said in a regulatory filing that it was confident of addressing the observations satisfactorily


Lupin to settle litigations over diabetes drug
News | September 16, 2021

Lupin to settle litigations over diabetes drug

The board has approved the settlement of US $ 248 million towards Direct Purchaser group and Retailer Opt-Out group subject to court approval


Morpen Laboratories to transfer its medical devices business to a wholly owned subsidiary
News | September 02, 2021

Morpen Laboratories to transfer its medical devices business to a wholly owned subsidiary

The revenues and profits derived from the new subsidiary will be consolidated in the parent company


Cipla forms JV with Kemwell Biopharma
News | August 25, 2021

Cipla forms JV with Kemwell Biopharma

The agreement is to develop, manufacture and commercialise biosimilars for the global market.


PI Industries acquires API business of Ind Swift Laboratories
News | August 02, 2021

PI Industries acquires API business of Ind Swift Laboratories

Turnover of API division of ISLL stood at Rs 856.58 crore