Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 112

Results For "regulatory"

1531 News Found

Lupin selects HPE GreenLake edge-to-cloud platform
Digitisation | May 09, 2022

Lupin selects HPE GreenLake edge-to-cloud platform

Lupin recognized the need to digitize more applications, improve scalability, decrease risk of security breaches and eliminate critical data loss


Novavax submits variations to expand approval in Australia and New Zealand for adolescents
Biotech | May 08, 2022

Novavax submits variations to expand approval in Australia and New Zealand for adolescents

If granted, Nuvaxovid would be the first protein-based Covid-19 vaccine option for adolescents in Australia and New Zealand


ACG appoints Udit K Singh as CEO of its Inspection division
People | May 06, 2022

ACG appoints Udit K Singh as CEO of its Inspection division

He will be responsible for ensuring that every dose of medication that ACG Inspection’s pharmaceutical and nutraceutical partners provide is manufactured and delivered exactly as intended


Avantor to create a new manufacturing hub in Singapore
News | May 05, 2022

Avantor to create a new manufacturing hub in Singapore

The new hub, which brings Avantor solutions closer to regional customers and strengthens global supply chain capabilities, will be fully operational early next year


HPRA completes audit of Biocon Biologics New mAbs drug substance facility
Biotech | May 04, 2022

HPRA completes audit of Biocon Biologics New mAbs drug substance facility

The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency


India’s Drugs Controller General green lights trial of TRIA heart valve
News | May 04, 2022

India’s Drugs Controller General green lights trial of TRIA heart valve

The procedures have been performed by Dr. Kaushal Pandey at P.D. Hinduja Hospital in Mumbai, India


Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone
Biotech | May 02, 2022

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023


Global Cord Blood Corp acquires Cellenkos to advance cell therapy market
Biotech | May 01, 2022

Global Cord Blood Corp acquires Cellenkos to advance cell therapy market

CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products


Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks


Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Biotech | April 29, 2022

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children