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Results For "regulatory"

1134 News Found

Serum seeks DCGI approval for booster dose in India
News | December 02, 2021

Serum seeks DCGI approval for booster dose in India

The UK’s Medicine and Healthcare products Regulatory Agency has already approved the booster dose of AstraZenenca’s Covid-19 vaccine, which is administered in India


Sai Life Sciences receive Certificate of Inspection from Japan PMDA
Biotech | December 02, 2021

Sai Life Sciences receive Certificate of Inspection from Japan PMDA

The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product


Premas Biotech and Oravax to test their vaccine candidate against Omicron
News | December 02, 2021

Premas Biotech and Oravax to test their vaccine candidate against Omicron

Oravax's vaccine technology is highly scalable for manufacturing and is easily transferable for wide scale logistical distribution, as there is no need for freezer storage


Lupin partners with TTP for soft-mist inhalation tech platform
Biotech | December 02, 2021

Lupin partners with TTP for soft-mist inhalation tech platform

Soft-mist inhalation (SMI) technology allows for delivery of inhalation drugs from a small, portable hand-held inhaler device without the use of propellants


GSK's antibody drug sotrovimab works against Omicron mutations
Biotech | December 02, 2021

GSK's antibody drug sotrovimab works against Omicron mutations

Preclinical data demonstrate sotrovimab, authorised in multiple countries around the world, retains activity against all tested variants of concern, including key mutations of Omicron


ZyCoV-D to be initially administered in seven states
News | December 02, 2021

ZyCoV-D to be initially administered in seven states

The three doses of ZyCoV-D are to be administered 28 days apart. The vaccine was given emergency use authorisation (EUA) by the Indian drug regulator on August 20


U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib
Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)


Galderma acquires ALASTIN Skincare to enhance its dermatology platform
Biotech | November 30, 2021

Galderma acquires ALASTIN Skincare to enhance its dermatology platform

ALASTIN’s patented, differentiated technology and products are highly synergistic with Galderma’s premium portfolio


UAE authorises Sputnik Light vaccine as universal booster
News | November 30, 2021

UAE authorises Sputnik Light vaccine as universal booster

Booster dose is available to all residents aged 18+ and can be applied six months after the second dose of any other vaccine administered in UAE


Pharma firms switch to advanced pharma manufacturing
Supply Chain | November 27, 2021

Pharma firms switch to advanced pharma manufacturing

Market demand for significant volumes and quality of biopharma products would drive continuous manufacturing technologies