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Pfizer’s Elrexfio Earns Accelerated FDA Approval for Relapsed/Refractory Multiple Myeloma
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This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r/rMM) in adults who have received at least four prior lines of therapy. The decision was based…
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Janssen’s Talvey Receives FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) announced last week that it received accelerated approval from the US Food and Drug Administration (FDA) for its first-in-class GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have…
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Telix Pharmaceuticals and Grand Pharma Initiate Phase III Trial for Illucix in China
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Australian biotechnology company Telix Pharmaceuticals Ltd (ASX: TLX) and its China market partner, Grand Pharmaceutical Group Limited (HKG: 0512), have announced the dosing of the first patient in a pivotal Phase III trial for TLX591-CDx (Illucix) in China. TLX591-CDx is a kit for the preparation of Gallium 68 (68Ga) PSMA-11,…
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Bio-Thera Solutions’ BAT8006 Shows Positive Phase I Results in Solid Tumor Treatment
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced positive Phase I clinical data for BAT8006 (Folate-Receptor-α-ADC) at the Bethune Obstetrics and Gynecology Forum in China. The study evaluated the safety and efficacy of the antibody-drug conjugate (ADC) in a dose escalation trial. BAT8006: A Promising ADC for Solid TumorsBAT8006 is…
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Vcanbio Receives Orphan Drug Designation for VUM02 in Idiopathic Pulmonary Fibrosis Treatment
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received orphan drug designation (ODD) from the US FDA for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product for the treatment of idiopathic pulmonary fibrosis (IPF). VUM02: An Innovative…
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Asieris Pharmaceuticals’ Hexvix Meets Primary Endpoint in Phase III Bladder Cancer Study
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed that a Phase III study for Hexvix (APL-1706) in bladder cancer diagnosis has successfully reached its primary endpoint. Study Design and OutcomesThe prospective, subject-controlled, multi-center Phase III study compared the detection rates of APL-1706 combined with blue light cystoscopy and…
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Sichuan Kelun-Biotech’s SKB264 Achieves Primary Endpoint in Phase III TNBC Study
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Sichuan Kelun Pharmaceutical Co., Ltd’s innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has announced that its Phase III clinical study for SKB264 (MK-2870) has reached its primary endpoint. The study, which is a randomized, controlled, open, multi-center trial, evaluated SKB264 in patients with irresectable local advanced,…
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Huadong Medicine’s HDM3001, a Biosimilar to Stelara, Accepted for Review by NMPA
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for HDM3001 (QX001S), a biosimilar version of Johnson & Johnson’s Stelara (ustekinumab), for the treatment of moderate to severe plaque psoriasis. Market Potential and Clinical ProgressThe originator drug, Stelara,…
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CanSino BiologicsLaunches Phase III Trial for DTcP Vaccine in Infants and Young Children
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CanSino Biologics Inc. a leading China-based vaccines specialist (HKG: 6185), has announced the initiation of a Phase III clinical study for its DTcP vaccine, targeting infants and young children under 2 years old. This development is accompanied by the enrollment of the first subjects in the trial. Quality Consistency and…
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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…
