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Dr. Reddy’s Laboratories gets FDA acceptance for DRL_RI BLA
The filing of the company’s dossier in April this year was based on the data package including pre-clinical and head-to-head clinical studies that show similarity in pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity with the EU and US reference products
China’s NMPA approves Enhertu as monotherapy for HER2-low breast cancer patients
The approval was based on the findings from the DESTINY-Breast04 Phase 3 trial in which AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease progression or death by 50%
Establishment of Asahi Kasei Healthcare Headquarters in the US
The Primary Executive Officer for Healthcare and staff will be located in existing Asahi Kasei offices in Chelmsford, Massachusetts, a suburb of Boston
Ocean Biomedical’s vaccine candidate shows promising results against malaria
The US-based biopharma company is now focusing its multi-pronged malaria programme to address the chronic malaria crisis in sub-Saharan Africa
Incyte’s ruxolitinib cream meets primary endpoint in Phase 3 AD trial
In the study, the positive topline results showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved IGA-TS in comparison to patients administered with vehicle control
Establishment of Asahi Kasei Healthcare Headquarters in the United States
Asahi Kasei announced that it is moving the global headquarters for its Healthcare Business to the United States. The Primary Executive Officer for Healthcare and staff will be located in existing Asahi Kasei offices in Chelmsford, Massachusetts, a suburb of Boston.
Astellas Completes Acquisition of Iveric Bio
The Acquisition was completed on July 11, 2023, US Eastern Time, as follows, and Iveric Bio has become Astellas’ wholly-owned subsidiary
Thermo Fisher Scientific to Acquire CorEvitas
Advances World-Class Clinical Research Capabilities with Leading Regulatory-Grade Registries Platform.
Expected to Be Immediately Accretive to Adjusted Earnings Per Share 1
Synlogic Granted Fast Track Designation from FDA for labafenogene marselecobac (SYNB1934) for Treatment of Phenylketonuria
Labafenogene marselecobac (previously known as SYNB1934) is an orally administered, non-systemically absorbed, potential treatment for phenylketonuria (PKU), a rare metabolic disease
UK’s MHRA clears GSK’s Arexvy to prevent lower respiratory tract disease
The approval was based on the finding from the Phase 3 trial in which Arexvy showed high overall vaccination effectiveness against RSV-LRTD, even in persons with specific underlying medical problems