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Cutia Therapeutics’ CU-10201 Enters Priority Review for Acne Treatment in China
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Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its CU-10201, a 4% minocycline foam agent for external use, has entered into priority review for the treatment of non-nodular moderate to severe acne vulgaris in individuals aged 9 and above in China. CU-10201: A Novel Pediatric Dosage Form for…
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NMPA Greenlights Oricell Therapeutics’ OriCAR-017 for Clinical Trials in Multiple Myeloma
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The National Medical Products Administration (NMPA) has indicated on its website that Oricell Therapeutics Co., Ltd’s GPRC5D-targeted chimeric antigen receptor (CAR)-T cell therapy, OriCAR-017, has been granted approval for clinical trials. The therapy is intended for the treatment of recurrent refractory multiple myeloma (R/R MM). GPRC5D as a Therapeutic Target…
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Lee’s Pharmaceutical’s Subsidiary Completes Phase III Study for Myopia Treatment NVK002
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced the completion of the last patient visit in the one-year Phase III bridging study, Mini-CHAMP, for its NVK002—an atropine external use eye solution for myopia progression. Parallel Phase III Clinical Trials for NVK002In addition to…
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Novartis Reports Positive Phase III Results for Remibrutinib in Chronic Spontaneous Urticaria
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has announced positive data from the Phase III trials for remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, which is under development to treat chronic spontaneous urticaria (CSU). The Phase III REMIX-1 and REMIX-2 studies successfully met all primary and secondary endpoints, showing…
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Novo Nordisk’s Wegovy Demonstrates 20% Reduction in Cardiovascular Events in SELECT Trial
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Denmark-based pharmaceutical giant Novo Nordisk A/S (NYSE: NVO) has released topline data supporting the use of its anti-obesity drug Wegovy (semaglutide). The data originates from the SELECT cardiovascular outcomes trial, which enrolled an extensive cohort of 17,604 adults suffering from obesity and established cardiovascular disease (CVD), but without diabetes. This…
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Lynk Pharmaceuticals’ LNK01001 Shows Positive Results in Atopic Dermatitis Phase II Study
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China-based Lynk Pharmaceuticals Co., Ltd has announced that its Phase II clinical study for LNK01001 in atopic dermatitis (AD) has yielded positive major results. The study, a randomized, double-blinded, placebo-controlled, multi-center trial, enrolled 150 patients and included high-dose and low-dose groups of LNK01001 alongside a placebo group. Study Design and…
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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…
