Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 385

Results For "NDA"

4016 News Found

FDA grants Emergency Use Authorization for next-generation Covid-19 assays
Digitisation | August 19, 2021

FDA grants Emergency Use Authorization for next-generation Covid-19 assays

Thermo Fisher’s kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes Covid-19


Finding a cure for HIV
Drug Approval | August 19, 2021

Finding a cure for HIV

The group, known as the HIV Obstruction by Programmed Epigenetics (HOPE) Collaboratory, will be led by researchers at Gladstone Institutes, Scripps Research Florida, and Weill Cornell Medicine. Their approach, which aims to both silence and permanently remove HIV from the body, takes advantage of knowledge about how other viruses have become naturally inactivated over time.


Ind-Ra predicts growth in US sales for Indian pharma from H2FY22
News | August 18, 2021

Ind-Ra predicts growth in US sales for Indian pharma from H2FY22

Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume


Centre releases Rs 1,300 crores to Northeast states to fight Covid-19
Policy | August 18, 2021

Centre releases Rs 1,300 crores to Northeast states to fight Covid-19

The funds will be used to buy medicines, enhance oxygen supply and augment the bed capacity in the local and district level hospitals


Novartis announces positive results from Phase 3 trials of Beovu for diabetes
Drug Approval | August 18, 2021

Novartis announces positive results from Phase 3 trials of Beovu for diabetes

Results from year two of the pivotal Phase 3 KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one


Real world data from Paraguay shows one-shot Sputnik Light vaccine has high safety and efficacy of 93.5 %
Biotech | August 18, 2021

Real world data from Paraguay shows one-shot Sputnik Light vaccine has high safety and efficacy of 93.5 %

Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik


Apollo Children’s hospital saves new born with rare brain vascular malformation
Healthcare | August 18, 2021

Apollo Children’s hospital saves new born with rare brain vascular malformation

Seen in 1 in 3 million births, the malformation was detected at the antenatal stage during the mother's pregnancy


Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


Lupin receives tentative U.S. FDA approval for Brivaracetam tablets
Drug Approval | August 17, 2021

Lupin receives tentative U.S. FDA approval for Brivaracetam tablets

Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older


One more lab approved for batch-testing and release of Covid-19 vaccines
News | August 17, 2021

One more lab approved for batch-testing and release of Covid-19 vaccines

National Institute of Animal Biotechnology, Hyderabad can now conduct quality checks and consequent lot release of Covid-19 vaccines