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Results For "regulators"

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Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research


Govt. to organise Innovation Week to encourage startup ecosystem
Startup | December 13, 2021

Govt. to organise Innovation Week to encourage startup ecosystem

The proposed week-long event will comprise specific themes - International engagements, market access and incubation support, funding support to startups etc. and will cover the different areas of the innovation lifecycle


Medical devices industry needs reforms:  Mehernosh Daruwalla, Founder & MD, Lotus Surgicals
interviews | November 24, 2021

Medical devices industry needs reforms: Mehernosh Daruwalla, Founder & MD, Lotus Surgicals

The Indian medical devices industry has been in focus since the pandemic. From US $ 11 billion in 2020 it is expected to touch US $ 50 billion by 2025. Mehernosh Daruwalla, Founder and MD, Lotus Surgicals shares a perspective with Thomas C Thottathil on the opportunities in this sector


Indian pharma CEOs bet big on innovation to achieve US $130 bn
News | November 23, 2021

Indian pharma CEOs bet big on innovation to achieve US $130 bn

While industry steps out of its comfort zone to innovate, the government has to support by allocating funds across research lifecycle and offer incentives for innovation


Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease
Biotech | November 23, 2021

Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease

The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis


Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study
Biotech | September 21, 2021

Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study

In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year


Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV
Biotech | September 18, 2021

Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV

Initiation of EBT-101 Phase 1/2 clinical trial expected later this year


New law to regulate drugs  and medical devices soon
Policy | September 09, 2021

New law to regulate drugs and medical devices soon

The panel is headed by DCGI Dr VG Somani with representatives from various state drug regulators and health ministry


Study shows Moderna vaccine maintains antibodies against Variants of Concern and Interest
Biotech | August 13, 2021

Study shows Moderna vaccine maintains antibodies against Variants of Concern and Interest

Studies include Alpha, Beta, Gamma, Delta, Epsilon and Iota and it maintains antibodies for six months after the second dose


Pear Therapeutics’ three FDA authorised prescriptions available at OptumRx
Digitisation | August 11, 2021

Pear Therapeutics’ three FDA authorised prescriptions available at OptumRx

OptumRx to make Pear’s three commercial Prescription Digital Therapeutics accessible to patients with Optum formulary access.