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The deadline for voluntary registration of Class A and Class B medical devices with the regulator ended on September 30, 2021 and registration became compulsory from October 1, 2021. Manufacturers are required to complete mandatory registration with the CDSCO by September 30, 2022. It has come to the notice that a significant number
Clean Rooms | 16/02/2022 | By Darshana | 575
Novartis inks option, collaboration & licensing pact with BeiGene for TIGIT inhibitor ociperlimab
Novartis announced the signing of an option, collaboration and license agreement with BeiGene, Ltd. for ociperlimab (BGB-A1217), expanding the company?s research and development activities in immuno-oncology. Ociperlimab is a late-stage TIGIT inhibitor, a novel class of anti-cancer therapies that blocks the TIGIT protein receptor
Clean Rooms | 22/12/2021 | By Darshana | 488
VAV Life Sciences invests Rs.15 crore to expand capacity for lipids used in Covid-19 vaccines
Mumbai-based VAV Life Sciences, through its subsidiary VAV Lipids, has announced it has invested Rs.15 crore (US$ 2 million) to boost production capacity to meet the unprecedented overseas demand for lipidic ingredients
Clean Rooms | 24/11/2021 | By Darshana | 715
NPPA extends ceiling price regulation on orthopaedic knee implants for one more year
The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price it imposed on orthopaedic knee implants for knee replacement system in August, 2017, to one more year up to September 15, 2022. The ceiling price was applicable till September 15, 2021, according to an earlier notification
Clean Rooms | 20/09/2021 | By Darshana | 617
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 | 620
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 | 595
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 | 236
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 | 549
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 | 229
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 | 361
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