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Konruns Pharmaceutical’s KC1036 Enters Phase II Trial for Ewing’s Sarcoma in Adolescents
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced the first patient dosing in a Phase II clinical study of its KC1036 for adolescents aged 12 and above with advanced Ewing’s sarcoma (ES). Drug DetailsKC1036 is a Category 1.1 chemical drug and a tyrosine kinase inhibitor (TKI) targeting AXL, VEGFR2, and…
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Hengrui Pharma Submits Ivarmacitinib Ointment for AD Treatment Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the submission of a marketing filing for its ivarmacitinib ointment to the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the drug’s use as a topical treatment for mild to moderate atopic dermatitis (AD) in adults. Drug ProfileIvarmarcitinib…
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Bristol Myers Squibb’s Opdualag Fails to Meet Primary Endpoint in Melanoma Study
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US pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) provided an update on the RELATIVITY-098 study for its Opdualag (nivolumab and relatlimab-rmbw). The Phase III study, which evaluated the drug as an adjuvant treatment for patients with completely resected stage III-IV melanoma, failed to meet its primary endpoint of recurrence-free survival…
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Hengrui’s Vunakizumab Receives NMPA Approval for nr-axSpA Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its IL-17A monoclonal antibody (mAb), vunakizumab. The Chinese company plans to study the drug as a treatment for non-radiographic axial spondyloarthritis (nr-axSpA). Drug BackgroundVunakizumab is intended…
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Betta Pharma Files for EMA Approval of ALK Inhibitor Ensartinib
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Betta Pharmaceuticals (SHE: 300558) announced the initiation of a market approval filing with the European Medicines Agency (EMA) for its anaplastic lymphoma kinase (ALK) inhibitor, ensartinib. The drug is under co-development with Betta affiliate Xcovery. The Chinese firm is seeking EMA approval for the drug’s use as a first-line treatment…
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Lee Kai and Yangshun Partner on Polyvinyl Alcohol Embolization Microspheres
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Chinese companies Shanghai Lee Kai Technology Co., Ltd (Kai Medtech) and Hangzhou Yangshun Medical Technology Co., Ltd have entered into a collaboration for the market promotion and application of Yangshun’s polyvinyl alcohol embolization microspheres. The financial terms of the agreement were not disclosed. Collaboration DetailsThe partnership aims to accelerate the…
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SciClone’s Vibativ Approved by NMPA for HABP/VABP Treatment
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China-based SciClone Pharmaceuticals Inc. announced that it has received market approval from the National Medical Products Administration (NMPA). The approval allows its Vibativ (telavancin) to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by sensitive isolates of Staphylococcus aureus. Drug DetailsVibativ is a rapidly bactericidal glycopeptide antibiotic with bactericidal activity…
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Accropeutics Doses First Patient in AC-101 Phase Ib UC Study
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Accro Bioscience (Suzhou) limited, better known as Accropeutics, a clinical-stage biotech operating out of New York, US, and Suzhou, China, announced the first patient dosing in a Phase Ib study. The study is designed to assess the safety and efficacy of its RIPK2 inhibitor AC-101 in moderate to severe ulcerative…
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Sanofi and J&J’s E. coli Vaccine Fails Phase III Study
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France-based Sanofi (NASDAQ: SNY) and US giant Johnson & Johnson’s (J&J, NYSE: JNJ) vaccine candidate for extraintestinal pathogenic E. coli failed to meet expectations in a Phase III study. An independent data monitoring committee (IDMC) determined that the vaccine was insufficiently effective at preventing invasive E. coli disease (IED) compared…
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Antengene’s Xpovio Included in Taiwan’s NHI Drug List for Myeloma Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that its Xpovio (selinexor), the world’s first FDA-approved oral XPO1 inhibitor, has been included in Taiwan’s National Health Insurance (NHI) drug list. The approved indication is for use in combination with bortezomib and dexamethasone in adults previously treated with one therapy for…
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Merck’s Zerbaxa Approved by China’s NMPA for Complex Infections
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US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its antibiotic Zerbaxa (ceftolozane, tazobactam). The fixed-dose combination antibiotic medication is approved to treat a range of complex infections in both adult and pediatric…
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Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy
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Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds). Drug DetailsEvrysdi is a survival…
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Pfizer’s Adcetris Gets New FDA Approval for Lymphoma Treatment
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US giant Pfizer (NYSE: PFE) has announced that it has received another indication approval from the US FDA for its Adcetris (brentuximab vedotin). The antibody-drug conjugate (ADC) can now be used in combination with lenalidomide and a rituximab product. It is approved for the treatment of adult patients with relapsed…
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Lundbeck’s Amlenetug Receives FDA Fast Track for Multiple System Atrophy
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Denmark-based pharma company Lundbeck A/S (VIE: LUNB) has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its investigational drug amlenetug. The drug is expected to provide a new treatment option for patients with multiple system atrophy (MSA). Drug DetailsAmlenetug is…
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OnCusp Therapeutics’ CUSP06 Receives FDA Fast Track for Ovarian Cancer
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Sino-US company OnCusp Therapeutics Inc. has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its CUSP06. CUSP06 is a Cadherin-6 targeting antibody-drug conjugate (CDH6 ADC). The targeted indication for this therapy is platinum-resistant ovarian cancer (PROC). Drug DetailsCUSP06, the CDH6…
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Boao Airport Customs Releases First Batch of Modulen IBD for Crohn’s Disease Management
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The Boao Airport Customs under Haikou Customs has released the first batch of 96 pieces of Modulen IBD, a nutritionally complete powdered feed. This product is for the dietary management of people with Crohn’s Disease. The release indicates the implementation of a policy. The policy allows designated medical institutions within…
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Astellas Pharma’s Izervay Gets FDA Approval for GA Treatment Without Dosing Limit
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the US Food and Drug Administration (FDA) has approved its label extension application for Izervay (avacincaptad pegol intravitreal solution). The approval allows the drug to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) without any limitation on the duration…
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Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
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Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin, a biosimilar version of Johnson & Johnson (J&J)’s auto-immune disease drug Stelara (ustekinumab), has been accepted for review by the National Medical Products Administration (NMPA). The Chinese firm is seeking approval for its use in…
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Bayer’s Acoramidis (Beyonttra) Gets EMA Marketing Approval for ATTR-CM Treatment in EU
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Germany-headquartered Bayer (ETR: BAYN) has received marketing approval from the European Medicines Agency (EMA) for its drug acoramidis, commercially known as Beyonttra. This near-complete (≥90%) transthyretin (TTR) stabilizer can now be used to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) in the European Union (EU).…
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Livzon Pharmaceutical’s JP-1366 Approved for Peptic Ulcer Study by NMPA
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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) has obtained approval from the National Medical Products Administration (NMPA) for its JP-1366 injection to conduct clinical studies in the treatment of peptic ulcer bleeding. This is a significant step forward for the company in the field of gastrointestinal therapeutics. About JP-1366JP-1366 is…
