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BioPharma Drug Approval

FDA Clears World's First Single-use 5mm Laparoscope with Auto-Focus

"The addition of the auto-focus capability will truly enhance the likelihood of swift adoption in the surgical marketplace. This would especially be true i...

October 06, 2022 | News

Transcenta Received IND Clearance from FDA

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, resear...

October 05, 2022 | News

Chinese NMPA Approves Study of Telix Kidney Cancer Imaging Candidate

The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (...

September 28, 2022 | News

Menarini and SciClone to Develop and Commercialize Vaborem® in China to Treat Antimicrobial Resistant Infections

Vaborem®, a patented combination of meropenem and vaborbactam, is expected to address the rising prevalence of carbapenem-resistant Klebsiella pneumo...

September 21, 2022 | News

WuXi Biologics' Drug Substance and Drug Product Facilities Again Approved by U.S. FDA and EMA

After passing online Pre-Approval Inspection (PAI), WuXi Biologics received EMA GMP certificates for the commercial manufacturing of two biologics develope...

September 20, 2022 | News

KOAG Receives FDA Clearance for Vascette® HP Hemostatic Pad for Vascular Closure

Vascette® is a unique, topical closure pad incorporating a proprietary, plant-derived hemostatic foam. The Vascette® patent-pending technology supp...

August 25, 2022 | News

Nuance Pharma Announces Clearance of IND Application for Ensifentrine Pivotal Clinical Trials for COPD in China

Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") combining bronchodilator and anti-inflam...

August 21, 2022 | News

FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients

"This approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing red blood cell transfusions," ...

August 18, 2022 | News

Bridge Biotherapeutics Receives FDA Authorization to Proceed with Phase 2 Study of BBT-877

Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company developing novel drugs for cancer, fibrosis and inflammation, announ...

August 17, 2022 | News

Taiwan FDA accepts New Drug Application for Xerava for treatment of cIAI

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative ph...

August 11, 2022 | News

MedAlliance SELUTION SLR Receives Second FDA IDE Approval

This comes only a few months after the company received IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications (May 2022). Enr...

August 10, 2022 | News

Lynk Pharmaceuticals Announces IND Approval of LNK01004 for Atopic Dermatitis in China

LNK01004 is a novel kinase inhibitor that can simultaneously inhibit multiple cytokine-induced signaling pathways in vitro and in vivo. LNK01004 is tissue-...

August 04, 2022 | News

Armata Pharmaceuticals Announces Clearance of IND for Prosthetic Joint Infections

Second indication for AP-SA02 which targets Staphylococcus aureus including MRSA Potential to significantly improve PJI patient outcomes Expands Armata...

August 03, 2022 | News

Polpharma Biologics Announces FDA File Acceptance for Review of Natalizumab, First Proposed Biosimilar to Tysabri®

The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as the reference medicine, Ty...

July 26, 2022 | News

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