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Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Omicron XBB.1.5-adapted monovalent version of the SARS-CoV-2 vaccine Comirnaty, developed in partnership by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX). The vaccine is intended for use in children…
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Dizal Pharmaceutical’s Golidocitinib Earns Priority Review for r/r PTCL Treatment in China
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its drug golidocitinib has been included in the priority review list for the treatment of recurrent or refractory peripheral T-cell lymphoma (r/r PTCL) in patients who have received at least one standard treatment. The priority status indicates the drug’s filing…
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AIM Vaccine Co., Ltd Launches Phase III Trial for 23-Valent Pneumococcal Vaccine
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the commencement of a Phase III clinical study for its 23-valent pneumococcal polysaccharide vaccine. The study is designed as a randomized, blind, similar vaccine-controlled trial, expected to enroll 1920 healthy subjects aged two years and older. Targeting Invasive Pneumococcal DiseasesThe 23-valent…
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CSPC Pharmaceutical’s Biosimilar Ozempic Equivalent Gets NMPA Clinical Trial Approval
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its biosimilar version of Novo Nordisk’s (NYSE: NVO) GLP-1 analog Ozempic (semaglutide) has obtained clinical trial approval from the National Medical Products Administration (NMPA). The upcoming trial will assess the use of CSPC’s biosimilar in maintaining blood sugar control in…
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Jiangsu Yahong Meditech Gets NMPA Approval for APL1401 Ulcerative Colitis Trial
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib clinical study for its drug candidate APL1401. The study, which is set to be a…
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Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
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Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC) for an indication extension of its SMN2 splicing modifier Evrysdi (risdiplam). The drug is now approved for infants up to 2 months of age with a clinical diagnosis of spinal muscular atrophy (SMA) type 1,…
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MSD’s Keytruda Gains EC Approval for First-Line HER2-Positive Gastric Cancer Treatment
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The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab). The drug is now approved in combination with trastuzumab, originator Roche’s (SWX: ROG) Herceptin, and chemotherapy as a first-line therapy against locally advanced unresectable or metastatic HER2-positive…
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BMS’ Reblozyl Expands Indication to Include First-Line MDS-Related Anemia Treatment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has received an indication extension approval from the US Food and Drug Administration (FDA) for its first-in-class drug Reblozyl (luspatercept). The drug is now approved as a first-line treatment for low- to intermediate-risk myelodysplastic syndromes (MDS)-related anemia in adults who may require regular red blood…
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ImmunoTech Biopharm’s EAL Earns Breakthrough Therapy Designation for HCC Recurrence Prevention
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The Center for Drug Evaluation (CDE) in China has indicated on its website that Immunotech Biopharm Ltd, a specialist in chimeric antigen receptor T-cell (CAR-T) therapies, has received breakthrough therapy designation (BTD) status for its EAL (amplified activated lymphocytes) product. This designation recognizes EAL’s potential use in the prevention of…
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Harbour BioMed’s HBM9033 ADC Receives US FDA IND Clearance for Clinical Trials
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China-based Harbour BioMed (HKG: 2142) has announced receiving Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HBM9033. This ADC specifically targets human mesothelin (MSLN), a tumor-associated antigen that is upregulated in various solid tumors, including mesothelioma, ovarian, lung, breast,…
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Janssen Submits Indication Extension Application for Balversa in Urothelial Carcinoma Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension application to the US Food and Drug Administration (FDA) for its FGFR kinase inhibitor Balversa (erdafitinib). The application seeks to expand the use of Balversa as a treatment for locally advanced or metastatic urothelial carcinoma…
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Zhejiang Huahai Pharmaceutical Receives FDA Approval for Generic Vyvanse
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Japan firm Takeda’s (TYO: 4502) Vyvanse (lisdexamfetamine). Vyvanse is a medication used to treat attention-deficit hyperactivity disorder (ADHD). Lisdexamfetamine’s…
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Boehringer Ingelheim Submits Three INDs for Survodutide Phase III Trials in China
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Germany-based Boehringer Ingelheim (BI) has announced the submission of three Investigational New Drug (IND) filings for regulatory Phase III global multi-center studies in China for its novel glucagon receptor/GLP-1 receptor dual agonist, survodutide. The drug is co-developed with Zealand Pharma, marking a significant step in advancing the drug’s clinical development.…
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Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review with the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Rybrevant (amivantamab). The submission seeks approval for Rybrevant in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or…
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MSD Initiates Phase III Trial for PCSK9 Inhibitor MK-0616 in LDL Cholesterol Reduction
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has commenced Phase III development for its experimental proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, MK-0616, focusing on low-density lipoprotein (LDL) cholesterol reduction in adults with and without heterozygous familial hypercholesterolemia (HeFH). This marks a significant milestone as MK-0616 becomes the first oral…
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Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
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The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US Food and Drug Administration (FDA) for Tyruko (natalizumab), marking it as the first biosimilar version referencing Biogen’s (NASDAQ: BIIB) blockbuster biologic Tysabri. Both monoclonal antibodies (mAbs) are indicated for treating Crohn’s disease and relapsing forms…
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Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its third-generation antibody drug conjugate (ADC), STRO-002, in advanced malignant solid tumors. STRO-002: A Third-Generation ADC Targeting FRαSTRO-002, originated by US firm Sutro Biopharma Inc.,…
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Youcare Pharmaceutical’s YKYYO17 Receives Ethical Approval for COVID-19 Treatment Study
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China-based Youcare Pharmaceutical Group (SHA: 688658) has received ethical approval from the China-Japan Friendship Hospital to conduct a Phase II/III study assessing the efficacy and safety of its YKYYO17 aerosol inhalation agent as a potential treatment for mild-to-moderate COVID-19. The drug candidate is a broad-spectrum coronavirus membrane fusion inhibitor polypeptide…
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Novartis Defends Entresto Patents as Generic Approvals Trigger Legal Response
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On August 24, 2023, generic versions of Novartis’ (NYSE: NVS) heart failure therapy Entresto (sacubitril, valsartan) received market approvals, with Chinese firms Nanjing F&S Pharmatech Co., Ltd and CSPC Pharmaceutical Group Ltd (HKG: 1093) receiving the honors. This development prompted a statement from Novartis on August 28, 2023, asserting that…
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Jiangsu Hengrui Submits Market Approval Filing for SHR0302 in Ankylosing Spondylitis
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing has been made in China for its drug candidate SHR0302, intended to treat active ankylosing spondylitis in patients who have responded poorly to non-steroidal anti-inflammatory drugs (NSAIDs). Phase II/III Study Results Support FilingThe filing is…
