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8008 News Found

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
News | December 05, 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

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
News | December 05, 2022

Merck to present data from Its hematology portfolio ASH meeting

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
Clinical Trials | December 05, 2022

Jemperli RUBY phase III trial met its primary endpoint

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
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

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
News | December 02, 2022

World’s first intra-nasal vaccine for COVID developed by India has got approval from CDSCO

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
News | December 02, 2022

Orchid Pharma launches Rs. 500 Cr QIP programme

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
Drug Approval | December 02, 2022

Alembic receives USFDA final approval for Diclofenac Sodium Topical Solution USP

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
Drug Approval | December 02, 2022

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules

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
News | December 02, 2022

Briefs: Piramal Enterprises and Shilpa Medicare

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
Medical Device | December 01, 2022

Freudenberg Medical launches HelixFlex TPE Tubing for India

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