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Jemperli RUBY phase III trial met its primary endpoint
Diagnostic Center | 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


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)


Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21
News | December 01, 2022

Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21

QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.


Sai Life Sciences appoints Stephen Hermitage as VP, CMC
People | November 28, 2022

Sai Life Sciences appoints Stephen Hermitage as VP, CMC

Steve joins Sai Life Sciences from GlaxoSmithKline (GSK) where he was a department head and member of the global chemical development leadership team.


Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer
Drug Approval | November 27, 2022

Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer

Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial


CPHI Frankfurt 2022: Global pharma confidence hits record high in CPHI Pharma Index
News | November 26, 2022

CPHI Frankfurt 2022: Global pharma confidence hits record high in CPHI Pharma Index

In fact, the overall CPHI Pharma Index – a collateralised metric of all major ranking categories – has risen by more than 8%, the largest year-on-year gain in the survey’s six year history


USFDA inspects Lupin's Mandideep Unit-1 facility
News | November 25, 2022

USFDA inspects Lupin's Mandideep Unit-1 facility

The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site


Biocon enters commercialization agreement with Zentiva
News | November 24, 2022

Biocon enters commercialization agreement with Zentiva

Under the terms of this agreement Biocon will be responsible for the manufacturing and supply of Liraglutide to Zentiva, for its commercialization across 30 countries in Europe


Dr. Bharti Pawar to participate in Global Conference on Antimicrobial Resistance
News | November 24, 2022

Dr. Bharti Pawar to participate in Global Conference on Antimicrobial Resistance

The conference is also expected to pave the way for nations to come out with bold and specific political commitments in the 2024 UN General Assembly High-Level Meeting on AMR