IPP Bureau
Lonza’s API manufacturing facility expansion in Nansha starts commercial operation
By IPP Bureau - December 06, 2022
Expanded capacity in Nansha, China will support mid-scale manufacturing to ensure a smooth transition between early-phase and large-scale commercial production
Agilent opens customer experience center for genomics and diagnostics solutions
By IPP Bureau - December 06, 2022
New Lexington, Massachusetts facility to provide customer education and collaboration opportunities
Zydus receives final approval from USFDA for Estradiol Transdermal System
By IPP Bureau - December 05, 2022
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Mirati Therapeutics announces update for the Phase 3 SAPPHIRE study
By IPP Bureau - December 05, 2022
Evaluating Investigational Sitravatinib in combination with Nivolumab for patients with non-squamous non-small cell lung cancer
Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
By IPP Bureau - December 05, 2022
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
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
