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Genexine’s Eftansomatropin Alfa Achieves Phase III Endpoints in Growth Hormone Deficiency Trial
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South Korea-based Genexine (KOSDAQ: 095700) has announced that its long-acting growth hormone product candidate, eftansomatropin alfa (GX-H9; TJ101), has achieved Phase III endpoints in a clinical trial conducted in China. The study, CTJ101PGHD301, demonstrated the safety and efficacy of the drug in children with growth hormone deficiency. Eftansomatropin Alfa’s Efficacy…
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AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an indication extension approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its orphan drug Soliris (eculizumab). The drug is now approved as a treatment for generalized myasthenia gravis (gMG) in pediatric patients who…
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AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
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The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors…
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Bayer Funds Landmark Trials for Kerendia in Heart Failure Treatment Expansion
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Germany-based pharmaceutical company Bayer (ETR: BAYN) has announced funding for three investigator-sponsored collaborative studies aimed at expanding its late-stage clinical development program of the mineralocorticoid receptor antagonist (MRA) Kerendia (finerenone) for heart failure (HF). These new trials will broaden the patient pool to include those with reduced (HfrEF), mildly reduced…
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EMA and FDA Review AbbVie’s Skyrizi for Ulcerative Colitis Indication Extension
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The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted for review indication extension filings for AbbVie’s (NYSE: ABBV) interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of moderately to severely active ulcerative colitis (UC). This development marks a further expansion of Skyrizi’s potential applications…
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Shandong Buchang Pharmaceuticals’ BC001 for mCRC Accepted for Review by NMPA
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its investigational injectable product BC001. The product is intended for use in first and second-line metastatic colorectal cancer (mCRC) patients who have experienced…
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Sirnaomics’ STP707 siRNA Drug Shows Promising Results in Phase I Solid Tumor Study
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has revealed that all patients have been dosed in a Phase I clinical study for its siRNA drug candidate STP707, which targets multiple solid tumors. The study is designed to assess the safety, tolerability, and anti-tumor activity of STP707 in six dose…
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Servier Group’s Pancreatic Cancer Therapy Onivyde Launches in Major Chinese Cities
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France-based Servier has announced the first prescriptions for its pancreatic cancer therapy, Onivyde (irinotecan), in 10 hospitals across major cities in China, including Tianjin, Beijing, Shanghai, Nanjing, Fuzhou, and Guangzhou. The drug is used to treat metastatic pancreatic cancer after gemcitabine treatment, in combination with 5-fluorouracil (5-FU) plus leucovorin (LV).…
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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…
