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BioPharma Drug Approval

Japan Becomes First in the World to Approve Dupixent® for Chronic Spontaneous Urticaria (CSU)

Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth appr...

February 17, 2024 | News

AstraZeneca's TAGRISSO® (osimertinib) with Chemotherapy Approved in the US for EGFR-Mutated Advanced Lung Cancer

AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with...

February 17, 2024 | News

FDA Prioritizes Review of Bristol Myers Squibb's Augtyro™ for NTRK-Positive Solid Tumors

Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for A...

February 15, 2024 | News

Innovent Biologics Advances Novel Weight Management Drug Mazdutide with NDA Acceptance in China

This groundbreaking achievement marks mazdutide as the first GLP-1R/GCGR dual agonist to successfully complete Phase 3 trials in support of an NDA ...

February 08, 2024 | Regulatory

Luye Pharma Licenses Rivastigmine Patch to Myung In Pharm for South Korea Commercialization

The agreement for the collaboration was signed at a ceremony attended by executives from both sides. Dianbo Liu, Chairman of the Board of Directors of Luye...

February 06, 2024 | News

Acepodia Gains FDA Clearance for ACE2016, Initiates Phase 1 Study on Solid Tumor Treatment

This clearance marks a significant milestone for Acepodia, allowing the initiation of a Phase 1, first-in-human clinical trial to assess th...

February 05, 2024 | News

Biosyngen's BST02 Granted FDA Fast Track for Liver Cancer Treatment

Fast track is a process designed to facilitate development, and accelerate the review of drugs to treat serious or life-threatening conditions and fill an ...

February 02, 2024 | News

Vertex's Breakthrough VX-548: Transforming Pain Management with Rapid Relief and Safety, A New Era in Acute Pain Solutions

Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from ...

January 31, 2024 | News

CellVax Therapeutics Receives FDA Clearance for FK-PC101 Cancer Immunotherapy IND

FK-PC101 is CellVax's novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatec...

January 30, 2024 | News

Oricell's OriCAR-017 CAR-T Therapy IND Cleared by FDA for Relapsed/Refractory Multiple Myeloma

OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D. The therapy leverages Oricell's proprietary platforms including Ori®Ab...

January 30, 2024 | News

Eisai Seeks Approval in Japan for Ultrahigh-Dose Mecobalamin in ALS

This application is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), a Phase III trial to evaluate e...

January 29, 2024 | News

Nanoform Achieves Key Milestone in Clinical Trials for Enhanced Enzalutamide

These were from a relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutamide) tablet formulation, an alternative to the amorp...

January 29, 2024 | News

Bristol Myers Squibb's Abecma CAR T Therapy Earns Favorable CHMP Opinion for Earlier Lines in Multiple Myeloma

Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, significantly improv...

January 26, 2024 | News

EMA grants Orphan Drug Designation to GC Biopharma's Sanfilippo Syndrome (Type A) Treatment

GC1130A has previously achieved notable milestones by securing both Rare Pediatric Disease designation (RPDD) and Orphan Drug Designation (ODD) from the U....

January 24, 2024 | News

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