IPP Bureau
Merck to present data from Its hematology portfolio ASH meeting
By IPP Bureau - December 05, 2022
Presentations include new data on investigational medicines – favezelimab (MK-4280), zilovertamab vedotin (MK-2140) and nemtabrutinib – as well as KEYTRUDA (pembrolizumab) in multiple blood cancers
Jemperli RUBY phase III trial met its primary endpoint
By IPP Bureau - December 05, 2022
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
By IPP Bureau - December 05, 2022
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
World’s first intra-nasal vaccine for COVID developed by India has got approval from CDSCO
By IPP Bureau - December 02, 2022
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
Orchid Pharma launches Rs. 500 Cr QIP programme
By IPP Bureau - December 02, 2022
With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023
Alembic receives USFDA final approval for Diclofenac Sodium Topical Solution USP
By IPP Bureau - December 02, 2022
Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA
Zydus receives final approval from USFDA for Topiramate Extended-Release capsules
By IPP Bureau - December 02, 2022
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
Briefs: Piramal Enterprises and Shilpa Medicare
By IPP Bureau - December 02, 2022
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
Freudenberg Medical launches HelixFlex TPE Tubing for India
By IPP Bureau - December 01, 2022
TPE tubing is ideal for pharmaceutical bioprocessing applications because it can be welded to existing tubing lines, and heat-sealed to allow for easy, fast, and safe fluid transport in biopharma processes
SRL Diagnostics launches laboratory in Shimla
By IPP Bureau - December 01, 2022
The laboratory has the capacity to conduct 30,000+ tests in a month ranging from simple routine tests to semi-specialized and specialized tests
WuXi STA launches parenteral formulation manufacturing line at Wuxi
By IPP Bureau - December 01, 2022
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets
By IPP Bureau - December 01, 2022
This product is based on Osmotic Controlled Release Oral Delivery System technology
Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21
By IPP Bureau - December 01, 2022
QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.
Akums partners with Leiutis and Biophore for developing products for multiple therapies
By IPP Bureau - December 01, 2022
The focus of the companies in this partnership is to synergise capabilities, leverage research and bring innovative products in specific therapeutic areas
Lonza collaborates with AbTis to extend Bioconjugation capabilities
By IPP Bureau - November 30, 2022
Collaboration to implement AbTis’ AbClick platform into Lonza’s bioconjugation toolbox
