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VistaGen’s Fasedienol Phase III Success Sends Shares Soaring Over 600%
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Shares of San Francisco-based biotech VistaGen (NASDAQ: VTGN) experienced a dramatic increase of over 600% by the end of trading yesterday, following the release of positive topline Phase III data for fasedienol, a novel rapid-onset nasal spray treatment for social anxiety disorder (SAD). The PALISADE-2 study demonstrated that fasedienol achieved…
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BioCity Biopharma Receives FDA IND Approval for CD3-EGFR BsAb BC3448
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China-based biotechnology company BioCity Biopharma has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its cluster of differentiation-3 (CD3) epidermal growth factor receptor (EGFR)-targeted bispecific antibody (BsAb), BC3448. With this approval, the company will now initiate a Phase I…
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Biogen and Sage Therapeutics Receive FDA Approval for Postpartum Depression Treatment Zurzuvae
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Biogen Inc., (NASDAQ: BIIB) and its partner Sage Therapeutics Inc., (NASDAQ: SAGE) have announced that the US Food and Drug Administration (FDA) has granted approval for Zurzuvae (zuranolone), marking it as the world’s first approved therapy for adults with postpartum depression (PPD). The approval is for Zurzuvae’s use as a…
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Astellas Pharma’s Izervay Receives FDA Approval for Geographic Atrophy Treatment
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Japan-based Astellas Pharma Inc., (TYO: 4503) has announced that it has received new market approval from the US FDA for its drug Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This approval reinforces the rationale behind Astellas’ July 2023 acquisition…
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Ascentage Pharma’s Lisaftoclax (APG-2575) Gets FDA Green Light for Phase III Study
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China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a regulatory Phase III clinical study for its novel Bcl-2 inhibitor, lisaftoclax (APG-2575). The study will evaluate the efficacy of lisaftoclax in combination with a Bruton’s tyrosine kinase…
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Grand Pharmaceutical Group Gets NMPA Approval for Generic Eplerenone for Hypertension
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of eplerenone, an aldosterone receptor antagonist. The drug, co-developed with Nanjing Cavendish Bioengineering Technology Co., Ltd., is indicated for the treatment of hypertension. Eplerenone:…
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CORXEL Gets CDE Approval for Phase III Presbyopia Trials of LNZ100 and LNZ101
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Shanghai-based CORXEL, formerly known as Ji Xing Pharmaceuticals, supported by RTW Investments, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct Phase III clinical trials for its LNZ100 (aceclidine) and LNZ101 (aceclidine/brimonidine) in presbyopia. Exclusive Rights and Licensing Deal with LENZ TherapeuticsJi Xing…
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ABM Therapeutics’ ABM-1310 Earns Orphan Drug Designation for BRAF V600 Mutant Glioblastoma
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Shanghai-based ABM Therapeutics Inc. has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its small molecule BRAF inhibitor, ABM-1310. This designation is in relation to the molecule’s potential use in treating BRAF V600 mutant glioblastoma (GBM), a rare and aggressive…
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Sumitomo Pharma and Otsuka’s Ulotaront Fails to Meet Primary Endpoint in Schizophrenia Trials
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Japan-based Sumitomo Pharma Co., Ltd (TYO: 4506) and Otsuka Pharmaceutical Co., Ltd (FRA: OS1) have revealed a setback in late-stage clinical trials for the potential first-in-class trace amine-associated receptor 1 (TAAR1) agonist, ulotaront, as a treatment for schizophrenia. Topline data from the Phase III DIAMOND 1 and DIAMOND 2 studies…
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Luye Pharma’s Parkinson’s Disease Treatment LY03003 Receives NMPA Review Acceptance
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Luye Pharma Group (HKG: 2186) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its once-weekly rotigotine extended-release microspheres for injection (LY03003), indicated for the treatment of Parkinson’s disease (PD), with a priority review status. LY03003: A Breakthrough in Dopamine StimulationHailed as the world’s…
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Abbisko Therapeutics Initiates Phase II Clinical Trial for Pimicotinib in Tendon Sheath Giant Cell Tumor
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the dosing of the first patient in a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib) in tendon sheath giant cell tumor (TGCT) in the United States. Phase III Study Design and ObjectivesThe upcoming randomized, double-blind, placebo-controlled…
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Astellas Pharma’s Zolbetuximab BLA Accepted by China’s CDE for Gastric Cancer Treatment
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) in China has accepted the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody (mAb), for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or…
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GSK’s Jemperli Receives FDA Approval for First-Line Treatment of Advanced Endometrial Cancer
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GSK plc (NYSE: GSK), a major UK pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has granted market approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab), as a first-line treatment for advanced or recurrent endometrial cancer. This indication is for patients who are to first…
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Viatris Inc. Secures FDA Nod for Generic Symbicort Equivalent, Breyna
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US-based Viatris Inc., (NASDAQ: VTRS) has announced that the US Food and Drug Administration (FDA) has approved the company’s Abbreviated New Drug Application (ANDA) for Breyna (budesonide + formoterol fumarate dihydrate), a generic version of AstraZeneca’s originator product Symbicort. This approval positions Viatris as the first company to offer an…
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RemeGen’s Novel Bispecific Antibody RC148 Receives Clinical Trial Approval
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical trial approval for its novel bispecific antibody (BsAb), RC148. This development marks a significant step forward in the company’s efforts to address the complex challenges of treating multiple solid tumors. RC148 Development and Phase I Study…
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Jiangsu Hengrui’s Camrelizumab and Apatinib Combo Accepted for FDA Review for HCC Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the US Food and Drug Administration (FDA) has accepted for review the Biologic License Application (BLA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or…
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Jacobio Pharma’s Glecirasib Enters Breakthrough Therapy Review for Pancreatic Cancer Treatment
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China-based Jacobio Pharma (HKG: 1167) has announced that its novel KRAS G12C inhibitor, glecirasib, has entered into the breakthrough therapy review process for the treatment of locally advanced or metastatic pancreatic cancer with the KRAS G12C mutation. The drug is being developed as a second-line treatment in combination with gemcitabine…
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Jiangsu Aidea’s ACC008 Demonstrates Non-Inferior Efficacy to Genvoya in Phase III HIV Study
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced the summary report of a Phase III clinical study for its fixed dose preparation ainuovirine, lamivudine, tenofovir disoproxil (ACC008) as a switch therapy for previously treated HIV-1 patients. The drug was previously approved to treat treatment-naïve HIV-1 patients in China in…
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Everest Medicines Completes Enrollment for Nefecon’s Phase III Extension Study in China
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China-based Everest Medicines (HKG: 1952) has announced the completion of patient enrollment for the China open-label extension (cOLE) of the Phase III NefIgArd study. This cOLE study provides an additional 9 months of treatment with Nefecon to all qualifying patients who have completed the NefIgArd study, aiming to evaluate the…
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Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density.…
