Pharmaceuticals
ObvioHealth Partners with Anatara Lifesciences to Launch First-of-its-kind Decentralized Clinical Trial in Australia
NEW YORK, Sept. 30, 2021 /PRNewswire/ -- ObvioHealth, a global Virtual Research Organization (VRO), today announces the launch of a first-of-its kind clinical trial inAustralia, using a combination of in-home data collection methods that will reduce, and in some cases, eliminate the need for fo...
2021-09-30 07:00
1695
I-Mab Announces Acceptance of IND Application from China NMPA for Phase 2 Clinical Trial of Enoblituzumab in Combination with Pembrolizumab in Solid Tumors
SHANGHAI and GAITHERSBURG, Md., Sept. 28, 2021 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of China Nati...
2021-09-28 20:00
4663
Bo'ao Winhealth Rare Disease Medical Center and Ali Health Jointly Launched the "Global Drug Information Platform for Rare Diseases"
BEJING, Sept. 27, 2021 /PRNewswire/ -- On September 25, 2021 in Beijing, China, the "Global Drug Information Platform for Rare Diseases" was successfully kicked off at Ali Center inBeijing. Jointly built by Bo'ao Winhealth Rare Disease Medical Center and Ali Health, the Platform aims at addressin...
2021-09-27 21:00
3881
Immunoforge Inc. receives U.S. FDA ODD for Treatment of Polymyositis
SEOUL, South Korea, Sept. 27, 2021 /PRNewswire/ -- Immunoforge (Co-CEOs Sung-min Ahn,Kiho Chang), a company specializing in developing new drugs for rare musculoskeletal diseases, has reported that their new drug candidate PF1801 has received Orphan Drug Designation (ODD) from the U.S. FDA for th...
2021-09-27 21:00
1840
Senhwa Announces Acceptance of Early Positive COVID-19 Phase II Study Abstract for Presentation at the ISIRV-WHO Conference
* Early Positive Phase 2 efficacy and safety data are both statistically significant and clinically meaningful. * No SAE related to Silmitasertib was reported. * Silmitasertib is a host-directed antiviral and an anti-inflammatory investigational therapy expected to be effective against eme...
2021-09-27 19:20
3318
Kintor Pharma Announces Brazil's ANVISA Approves Phase III Clinical Trial of Proxalutamide for the Treatment of Hospitalized COVID-19 Patients
SUZHOU, China, Sept. 26, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that onSeptember 22 the Brazilian Health Regulatory Agency (ANVISA) ...
2021-09-26 23:09
6414
Boan Biotech to Present the Pre-clinical Data of Its Proprietary CD3+ T-cell Engager Platform and CEA/CD3 Bispecific Antibody at World Bispecific Summit
Sept. 25, 2021, BOSTON /PRNewswire/ -- Boan Biotech, a subsidiary of Luye Pharma Group, will orally present the pre-clinical data of its proprietary CD3+ T-cell engager platform and CEA/CD3 bispecific antibody at World Bispecific Summit 2021. The annual World Bispecific Summit aiming to promote ...
2021-09-26 10:12
2454
New Drug Application for Cadonilimab (PD-1/CTLA-4 Bi-Specific Antibody) for the Treatment of Relapsed or Metastatic Cervical Cancer Accepted by NMPA
HONG KONG, Sept. 23, 2021 /PRNewswire/ -- Akeso, Inc. (the Company, 9926.HK) announces that the National Medical Products Administration (the NMPA) ofChina has officially accepted the new drug application for the world's first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and d...
2021-09-24 09:18
4039
Ascentage Pharma's MDM2-p53 Inhibitor Alrizomadlin (APG-115) Granted Fast Track Designation by the US FDA for the Treatment of Relapsed/Refractory Unresectable or Metastatic Melanoma
SUZHOU, China, and ROCKVILLE, MD, Sept 22, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its novel MDM2-p53 inhibitor alrizomadlin (A...
2021-09-23 07:40
2233
Clover's COVID-19 Vaccine Candidate Demonstrates 79% Efficacy Against Delta in Global Phase 2/3 SPECTRA Trial Dominated by Variants of Concern and Interest
* Trial enrolled over 30,000 adult & elderly participants across 4 continents; 100% of SARS-CoV-2 strains observed in efficacy analysis were variants (Delta was predominant strain) * Primary and secondary efficacy endpoints were successfully met * 100% efficacy against severe COVID-19 & hosp...
2021-09-22 18:56
2711
Samsung Biologics showcases its newest CDO process platform, S-Cellerate™, at BPI 2021, offering expedited timeline to IND and BLA
INCHEON, South Korea, Sept. 22, 2021 /PRNewswire/ -- Samsung Biologics, a global contract development and manufacturing organization (CDMO), introduced its proprietary technology platform, S-CellerateTM, at the BioProcess International Conference (BPI 2021) to offer clients an integrated and seam...
2021-09-22 18:00
2209
New Therapy to Treat Advanced Small Cell Lung Cancer ZEPZELCA® (lurbinectedin) Approved in Singapore
Highlights: * ZEPZELCA® (lurbinectedin) is the first new therapy approved in Singapore to treat 2L metastatic small cell lung cancer (SCLC) in 20 years * ZEPZELCA provisional approval represents an important advance for adult patients whose metastatic SCLC has progressed on or after platinum-...
2021-09-22 14:30
2328
Koji Tanabe, CEO of I Peace, Inc. honored by World Biz Magazine with "Top 100 Innovation CEO" Award
PALO ALTO, Calif., Sept. 21, 2021 /PRNewswire/ -- Koji Tanabe, Founder and CEO
of I Peace, Inc. (https://www.ipeace.com
2021-09-22 02:00
1986
FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis
RALEIGH, N.C., Sept. 21, 2021 /PRNewswire/ -- Mayne Pharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved LEXETTE® (halobetasol propionate) foam, 0.05% for use in adolescents. LEXETTE, a super potent topical corticosteroid, is now approved for the treatment ...
2021-09-21 22:00
5086
Alterity Announces Presentation of Biomarker Data at the International Parkinson and Movement Disorder Society Congress 2021
MELBOURNE, Australia and SAN FRANCISCO, Sept. 20, 2021 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative conditions, today announced that data was present...
2021-09-20 22:51
7600
Bionomics Prepares BNC210 for Start of Phase 2 Acute Treatment of Social Anxiety Disorder Trial
* Rapid oral absorption of BNC210 novel tablet formulation potentially well-suited for acute treatment of anxiety in patients with Social Anxiety Disorder * Phase 2 clinical trial on target to start by end of 2021 and expected to read out topline data by end of 2022 ADELAIDE, Australia, Sept....
2021-09-20 18:00
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Appealing Data of CARsgen Therapeutics' CAR-T (CT041) in Advanced Gastric Cancer Presented at ESMO
SHANGHAI, Sept. 19, 2021 /PRNewswire/ -- On September 19, 2021, CARsgen Therapeutics (stock code: 2171.HK) disclosed the latest progress of the investigator-initiated trial (IIT) of Claudin18.2 (CLDN18.2) CAR-T (CT041) for the treatment of digestive system tumors. Results of this trial have been ...
2021-09-20 08:24
10107
2021 CSCO | Henlius will Release Four Oral Presentations of Two Upcoming Commercial Products: Novel anti-PD-1 mAb Serplulimab and Bevacizumab Biosimilar
SHANGHAI, Sept. 18, 2021 /PRNewswire/ -- The 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) will be held online and in-person from 25th to 29th September 2021. In this meeting, Henlius will release 4 study results of 2 products to be commercialized, the novel anti-PD-1 mAb ser...
2021-09-18 20:00
12512
InnoCare and Keymed Jointly Announce Approval of Clinical Trial of CD20xCD3 Bispecific Antibody CM355
BEIJING, Sept. 17, 2021 /PRNewswire/ -- InnoCare Pharma (HKEX: 09969) and Keymed Biosciences (HKEX: 02162) jointly announced today that the Investigational New Drug (IND) of CM355, a CD20xCD3 bispecific antibody developed by a joint venture between the two companies called Tiannuojiancheng Pharm...
2021-09-17 20:00
5844
The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab for First-Line Treatment of sqNSCLC Accepted by China's NMPA, Phase 3 MRCT Met its Primary Endpoint
SHANGHAI, Sept. 17, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of Serplulimab Injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with carboplatin and albumin-bound ...
2021-09-17 20:00
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