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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…
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Eli Lilly Licenses OliX Pharma’s OLX75016 for MASH and Cardiometabolic Diseases
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Eli Lilly & Co. (NYSE: LLY) has signed a licensing agreement with OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a South Korea-based RNAi therapeutics developer, to jointly develop and commercialize OLX75016, an investigational drug targeting metabolic-associated steatohepatitis (MASH) and other cardiometabolic indications. Drug ProfileOLX75016, derived from a genome-wide association study (GWAS), is…
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Lion TCR’s Liocyx-M00 Therapy Receives FDA Clearance for HBV-Related HCC Study
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Singapore-based clinical-stage biotechnology company Lion TCR, backed by Chinese investors, has received clearance from the US Food and Drug Administration (FDA) to initiate a global, multi-center Phase II study for its Liocyx-M00 therapy. The treatment involves autologous T-cells transfected with mRNA encoding hepatitis B surface antigen (HBsAg) specific toll cell…
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Hainan Poly Pharm’s Generic ProHance Wins FDA Approval in US
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced that the US Food and Drug Administration (FDA) has approved its generic version of Bracco’s ProHance (gadoteridol), making it the first and currently only ProHance generic available in the US. The approved strengths include 1.3965 g/5 mL, 2.793 g/10 mL, 4.1895…
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J&J’s Rybrevant and Talvey Win Separate NMPA Approvals in China
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US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s National Medical Products Administration (NMPA) for two of its biologics: Rybrevant (amivantamab) for non-small cell lung cancer (NSCLC) and Talvey (talquetamab) for multiple myeloma. The approvals mark J&J’s latest expansion in China’s oncology market. Rybrevant…
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Degron Therapeutics’ DEG6498 Receives FDA Clearance for Clinical Trials
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China-based Degron Therapeutics, a developer of molecular glue-based drugs, announced that the U.S. Food and Drug Administration (FDA) has granted clinical clearance for DEG6498, its molecular glue degrader (MGD) targeting human antigen R (HuR). The drug will enter early-stage trials to assess its safety and efficacy in solid tumors. Drug…
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Bio-Thera Solutions’ BAT1006 Wins NMPA Approval for HER2+ Breast Cancer Trial
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China’s Bio-Thera Solutions Ltd (SHA: 688177) has received clinical trial approval from the National Medical Products Administration (NMPA) for BAT1006, its recombinant humanized monoclonal antibody, in combination with trastuzumab and chemotherapy for HER2-positive unresectable or metastatic breast cancer patients previously treated with antibody-drug conjugates (ADCs). Drug ProfileBAT1006 targets the extracellular…
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China Resources Double-Crane Pharmaceutical Co., Ltd Receives NMPA Approval for Generic Purinethol
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Stason Pharmaceuticals Inc.’s Purinethol (mercaptopurine). The drug, classified as a Category 2.2 chemical drug, is now approved for the treatment of children with…
