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Results For "PLI"

2768 News Found

Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


Caplin Point Labs posts  Q2FY22 PAT at Rs 74.98 Cr
News | November 02, 2021

Caplin Point Labs posts Q2FY22 PAT at Rs 74.98 Cr

The Board of Directors of Caplin Point Laboratories at its meeting have approved the unaudited consolidated financial results of the company for the period ended September 30, 2021


Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial
Biotech | October 28, 2021

Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population


PLI scheme has the potential to make India a pharma hub: Dr Mandaviya
Policy | October 27, 2021

PLI scheme has the potential to make India a pharma hub: Dr Mandaviya

FDI increased 98% year on year in 2020 and pharma exports grew by 18% in the last financial year


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


AstraZeneca to collaborate with VaxEquity for self-amplifying RNA therapy
Biotech | September 24, 2021

AstraZeneca to collaborate with VaxEquity for self-amplifying RNA therapy

saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level


Trialbee and Castor partner to simplify enrolment to clinical trials globally
Healthcare | September 22, 2021

Trialbee and Castor partner to simplify enrolment to clinical trials globally

Industry leaders to increase patient access to clinical research and scale remote enrollment of participants for trial sponsors to promote increased health equity


Caplin Steriles gets US FDA approval for blood pressure injection
News | September 08, 2021

Caplin Steriles gets US FDA approval for blood pressure injection

Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.


Panacea Biotech supplies 1st shipment of the second component of Sputnik V vaccine
News | September 07, 2021

Panacea Biotech supplies 1st shipment of the second component of Sputnik V vaccine

The batch will be distributed in India through a partner of RDIF and Panacea Biotec - Dr. Reddy's Laboratories