BioPharma APAC - Leading Source of Biopharmaceutical Intelligence in Asia Pacific

BioPharma Drug Approval

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

Daewoong Pharmaceutical Gets First Korean US FDA Fast-Track for New Idiopathic Pulmonary Fibrosis Drug

As many Korean pharmaceutical manufacturers are currently attempting to develop new drugs for idiopathic pulmonary fibrosis, Daewoong Pharmaceutical's new ...

July 21, 2022 | News

China CDE Grants Breakthrough Therapy Designation (BTD) to Neurophth's NR082 in LHON

NR082 (rAAV2-ND4), a recombinant adeno-associated viral vector, serotype 2, containing human ND4 codon-optimized gene under the control of the cy...

July 18, 2022 | News

Singapore Based SCG Cell Therapy Announces U.S FDA Clearance

ingapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) ...

July 12, 2022 | News

Brii Biosciences Announces Commercial Launch of its Amubarvimab/Romlusevimab Combination Therapy for COVID-19 in China

Brii Bio progressed the combination therapy from discovery to global Phase 3 data readout and first regulatory approval by the China NMPA in les...

July 07, 2022 | News

Australian developed VIRALEZE™ nasal spray relaunched by LloydsPharmacy in the UK

Extensive antiviral testing undertaken at the globally renowned Scripps Research Institute in the United States show that VIRALEZE&trad...

July 01, 2022 | News

GSK's Zejula (niraparib) Tablet approved in Singapore for first-line and recurrent monotherapy maintenance treatment in advanced ovarian cancer

GlaxoSmithKline (GSK) Singapore today announced that Health Sciences Authority has approved Zejula (niraparib) Tablet, an oral, on...

June 29, 2022 | News

Stay Connected