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DCGI classifies 247 medical devices including PPEs, OT equipment and others
The Drug Controller General (India) has classified medical devices including personal protective equipment, devices in general hospitals and those pertaining to nephrology and renal care, pain management, operation theatre and certain softwares
Clean Rooms | 20/09/2021 | By Darshana | 689
ABB drives play a key role in the cleanroom infrastructure of Bharat Biotech, India's first indigenous Covid-19 vaccine manufacturer. The inbuilt application functions of ABB's ACS560 drives help in maintaining the right environmental condition
Clean Rooms | 08/09/2021 | By Darshana | 661
US FDA updates its March 2020 norms to conduct human studies
The global regulator which noted the Covid-19 as a public health emergency now insists that the clinical trial industry, investigators, and institutional Review Boards need to maintain compliance with good clinical practice (GCP), minimize risks to trial during the ongoing pandemic
Clean Rooms | 06/09/2021 | By Darshana | 267
Recipharm launches new laboratory to expand analytical services offering
Global contract development and manufacturing organisation (CDMO), Recipharm, has announced the completion of a new analytical laboratory at its facility in Bengaluru. The new lab has been in full operation since August 1, 2021
Clean Rooms | 26/08/2021 | By Darshana | 630
Covid 19 treatment: Vir Biotechnology receives AustralianTGA marketing approval for sotrovimab
Vir Biotechnology announced the first marketing authorization, granted in Australia, for its first commercial product, sotrovimab, developed in partnership with GlaxoSmithKline (GSK). This announcement follows news shared by GSK Australia that the Australian Therapeutic Goods Administration (TGA) has granted provisional marketing authorization
Clean Rooms | 25/08/2021 | By Darshana | 269
Astellas Venture Management LLC, a wholly-owned venture capital subsidiary of Astellas Pharma Inc., and LabCentral, a launchpad for early-stage life-sciences startups, announced their collaboration on the "Future Innovator Prize" formerly known as the Astellas Golden Ticket Competition
Clean Rooms | 20/08/2021 | By Darshana | 430
The Drugs Controller General (India) has said that certain changes in the active substance of an approved drug may lead to change in drug specification and require validation of the manufacturing process
Clean Rooms | 27/07/2021 | By Darshana | 348
US FDA grants breakthrough therapy status to Roche's Venclexta
Roche announced that Venclexta (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International Prognostic
Clean Rooms | 22/07/2021 | By Darshana | 313
Ipsen and IRLAB announced the signing of a licensing agreement, providing Ipsen exclusive worldwide development and commercial rights to mesdopetam, a novel dopamine D3-receptor antagonist. Mesdopetam is being assessed in phase IIb clinical trials as a potential treatment option
Clean Rooms | 17/07/2021 | By Darshana | 239
Orchard Therapeutics, a global gene therapy leader, and Pharming Group NV, a global and commercial stage biopharmaceutical company, have jointly announced a strategic collaboration to research, develop, manufacture and commercialize OTL-105
Clean Rooms | 02/07/2021 | By Darshana | 433
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