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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 | 247
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 | 260
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 | 208
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 | 316
I Holland Present their Latest Tablet Tooling Developments at ACHEMA Pulse Next Week
I Holland, the world's best-known manufacturer of tablet punches and dies for the pharmaceutical and nutraceutical industries, has announced it will be exhibiting some of it most innovative products at ACHEMA Pulse from 15-19 June, including the new die table segment cleaning equipment
Clean Rooms | 09/06/2021 | By Darshana | 247
Lupin, Granules India recall around 9.71 lakh bottles of diabetes drug in the US
Lupin and Granules India are recalling close to 9.71 lakh bottles of generic diabetes drug in the US due to the possibility of the affected lot containing cancer-causing nitrosodimethylamine (NDMA) above the acceptable intake limit
Clean Rooms | 27/07/2020 | By Darshana | 417
Lupin's Pithampur Facilities Complete Successful UK MHRA Inspection
Pharma major Lupin Limited (Lupin) today announced the successful close out of the inspection carried out by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory agency of the United Kingdom (UK)
Clean Rooms | 08/05/2020 | By Darshana | 611
Karnataka forms expert committee to study epidemiology of COVID-19 & assess infection transmission
Karnataka has now constituted a committee of experts to look into the interventions to be taken to tackle COVID-19. The state as on Monday reported 237 cases, 8 fatalities and 60 discharges
Clean Rooms | 14/04/2020 | By Darshana | 449
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