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BioPharma Clinical Trials

Menarini Group's ORSERDU® (Elacestrant) Study Advances in Metastatic Breast Cancer

ORSERDU (elacestrant) was approved by the FDA in January 2023 for advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor (...

May 30, 2023 | News

Bristol Myers Squibb receives positive CHMP opinion for Opdivo as neoadjuvant treatment for high-risk non-small cell lung cancer

If approved, Opdivo with chemotherapy would be the first and only neoadjuvant immunotherapy-based option authorized to treat patients with non-sm...

May 29, 2023 | Regulatory

HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharma Collaborate on Parkinson's Therapy

HanAll Biopharma Co., Ltd. (KRX: 009420.KS) and Daewoong Pharmaceutical Co., Ltd. (KRX: 069620.KS) announced that they have entered into a co-developm...

May 26, 2023 | News

Catalent Enhances Cryogenic Capabilities in Japan Facility for Cell and Gene Therapy Development

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational ...

May 25, 2023 | News

Antengene's ATG-022 Receives Orphan Drug Designations for Gastric and Pancreatic Cancers

Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases o...

May 24, 2023 | News

PharmAbcine's Novel Antibody Approved for Clinical Trial in nAMD

The Phase I clinical trial is an open-label, multi-center, single and multiple ascending-dose study to assess safety, tolerability, MTD (maximum tolerated ...

May 24, 2023 | News

Genome & Company Advances Phase II Trial After Positive Interim Analysis, Proceeds to Second Stage

Genome & Company (CEO: Pae, Jisoo), a global leading microbiome therapeutics developer, announced that this phase II trial (NCT05419362) will continue ...

May 22, 2023 | News

Antengene Clears U.S. IND for Phase I Trial of ATG-031 Antibody

- ATG-031, discovered and developed in-house by Antengene, is the world's first anti-CD24 antibody to advance to the clinic in oncolog...

May 18, 2023 | News

Sirnaomics to Receive HK$8M Subsidy for Clinical Translational Catalyst Plan

The subsidy comes under HKSTP's Clinical Translational Catalyst ("CTC") programme dedicated to catalysing clinical translation to bring innovative, life-ch...

May 18, 2023 | News

Boan Biotech's BA1202 Approved for Clinical Trial

Boan Biotech announced today that its BA1202, a CEACAM5 (CEA)/CD3 bispecific antibody, has been approved for a clinical trial by the Center for Drug Evalua...

May 17, 2023 | News

Antengene Announces NDA Submission for XPOVIO® in Indonesia

"In just six months, we have submitted NDAs for XPOVIO® in three ASEAN countries, Malaysia, Thailand and Indonesia, supporting...

May 17, 2023 | News

Crystal Formulation Services' GMP facility passes remote US audit, marks global expansion milestone.

The audit was focused to confirm that the GMP manufacturing facility of CFS meets the US GMP regulations, and to ensure the compliance in manufacturing and...

May 15, 2023 | News

Novavax's COVID-Influenza Combo and High-dose COVID Vaccine Show Strong Immune Responses in Phase 2

This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID Preliminary topline im...

May 10, 2023 | News

Ascletis approved for Phase IIa clinical trial of ASC10 for RSV infection in China

--Respiratory syncytial virus (RSV) infection treatment remains huge unmet medical needs and there is no effective drug for treatment globally so far --Do...

May 09, 2023 | News

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