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Gilead’s Magrolimab Phase III Trial for AML Faces Partial Hold by FDA
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Gilead (NASDAQ: GILD) has announced that the US Food and Drug Administration (FDA) has imposed a partial hold on recruitment for a Phase III trial of its investigational anti-CD47 biologic, magrolimab, in acute myeloid leukemia (AML). The company has not disclosed the reason behind the FDA’s decision but has indicated…
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Pfizer’s RSV Vaccine Abrysvo Receives FDA Authorization for Maternal Immunization
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The US Food and Drug Administration (FDA) has authorized the use of Pfizer’s (NYSE: PFE) respiratory syncytial virus (RSV) vaccine, Abrysvo, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD in infants through active immunization of pregnant women between 32 and 36 weeks of gestation. This marks…
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J&J’s Teclistamab Granted Priority Review in China for Relapsed Multiple Myeloma
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson’s (J&J, NYSE: JNJ) teclistamab has been granted priority review for the treatment of recurrent or refractory multiple myeloma in China. The drug is being considered for conditional approval due to its breakthrough therapy designation (BTD) status, given…
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Amgen’s Lumakras Faces Full Registration Review by FDA for KRAS-Mutated NSCLC
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The US Food and Drug Administration (FDA) is scheduled to review an application submitted by Amgen (NASDAQ: AMGN) for the full registration of its pioneering KRASG12C inhibitor, Lumakras (sotorasib), in October this year. The treatment targets locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). Amgen announced this…
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AstraZeneca’s Forxiga Demonstrates Clinical Benefits in Heart Failure and COPD Patients
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced evidence that its SGLT2 inhibitor, Forxiga (dapagliflozin), provides significant clinical benefits in patients with heart failure (HF) with preserved ejection fraction (pEF) and chronic obstructive pulmonary disease (COPD). This announcement highlights the potential of Forxiga in treating these conditions and underscores…
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AstraZeneca’s Forxiga Gains New Indication Approval in China for Chronic Heart Failure
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UK-based pharmaceutical major AstraZeneca plc (AZ, NASDAQ: AZN) has announced that China’s National Medical Products Administration (NMPA) has granted a new indication approval for its SGLT-2 inhibitor, Forxiga (dapagliflozin). The drug is now approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits…
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MSD’s Welireg Meets Primary Endpoint in Phase III RCC Study but Misses OS Milestone
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed that the ongoing Phase III study evaluating the first-in-class HIF-2α inhibitor Welireg (belzutifan) in previously treated advanced renal cell carcinoma (RCC) has shown statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus, meeting its primary endpoint. However,…
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HutchMed’s Sovleplenib Achieves Primary and Secondary Endpoints in ESLIM-01 Phase III Trial
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China-based biopharmaceutical company HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib has successfully met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia (ITP). The trial was…
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Grand Pharmaceutical Group Initiates Phase I Study for Sepsis Treatment APAD
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the enrollment and dosing of the first subject in a Phase I study for APAD, a small-molecule compound targeting sepsis with a novel mechanism of action. The study is a randomized, double-blind, dosage escalation, placebo-controlled trial designed to assess the safety,…
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HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Gastric Cancer
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN) and approved in China on July 12, is to be awarded breakthrough therapy designation (BTD) in China. The BTD status is specifically for savolitinib’s use as a third-line treatment…
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Humanwell Healthcare Initiates Phase IIa Clinical Study for IPF Drug HW021199
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced the commencement of a Phase IIa clinical study for its Category 1 chemical drug, HW021199, in the treatment of idiopathic pulmonary fibrosis (IPF). The drug’s target has not been disclosed, other than to note that there is no market-approved product…
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GSK’s RSV Vaccine Arexvy Launches in US Pharmacies Ahead of 2023/24 Season
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GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical giant, has announced that its respiratory syncytial virus (RSV) vaccine, Arexvy, is now available at all major pharmacies in the US. The vaccine received approval in the country earlier this year and was subsequently recommended by the Advisory Committee on Immunization Practices (ACIP)…
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GC Biopharma Presents Data Showing Higher Thrombotic Risk with Roche’s Hemlibra
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South Korea’s GC Biopharma (KRX: 006280) has presented evidence suggesting that Roche’s (SWX: ROG) hemophilia therapy, Hemlibra (emicizumab), may display a higher proportion of thrombotic adverse events (AEs) compared to coagulation factor VIII replacements. This finding is based on an analysis of US data reported to the FDA Adverse Event…
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Moderna Announces Immunogenicity of Updated COVID-19 Vaccine Against New Variants
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Moderna (NASDAQ: MRNA) has announced preliminary data indicating that an updated version of its SARS-CoV-2 vaccine is immunogenic against the EG.5 and FL.1.5.1 variants, recently renamed Eris and Fornax by the World Health Organization (WHO), with Eris being classified as a variant of interest (VOI). This development marks a significant…
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Luye Pharma Launches Rykindo in US, a First for Chinese CNS Drug
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China-based Luye Pharma Group (HKG: 2186) has announced the official commercial operation of its Rykindo (risperidone) extended-release injectable suspension in the United States. Developed on Luye Pharma’s microsphere technology platform, Rykindo is administered via intramuscular injection once every two weeks, utilizing long-acting and extended-release microsphere technology to deliver the active…
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CSPC Pharmaceutical Group Receives FDA Approval for NBL-028 Bispecific Antibody Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from the US FDA to conduct a clinical study for its bispecific antibody (BsAb), NBL-028, which targets CLDN6 and CD137. The initial focus of the study will be on advanced tumors with CLDN6 expression,…
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CanSino Biologics Receives Halal Certificate for COVID-19 Vaccine in Indonesia
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received a halal certificate from Indonesia’s LPPOM MUI for its recombinant novel coronavirus vaccine, which uses an adenovirus type 5 vector. This certification is a significant step for the company as it seeks to expand its vaccine’s reach…
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Innovent Biologics’ Tafolecimab Receives NMPA Approval for Hypercholesterolemia Treatment
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China-based Innovent Biologics Inc. (HKG: 1801) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its tafolecimab (IBI306), a recombinant fully human anti-PCSK-9 monoclonal antibody (mAb). The approved indication is for primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia, as well as mixed…
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European Commission Approves AbbVie’s Aquipta for Migraine Prevention in Adults
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its drug Aquipta (atogepant), marking a significant milestone in the prevention of migraine in adults with four or more migraine days per month. Aquipta becomes the first once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist to receive…
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BMS Announces Positive Phase I/II Results for Repotrectinib in ROS1-Positive NSCLC
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Bristol-Myers Squibb (BMS, NYSE: BMY) has released new data from a Phase I/II trial featuring the ROS1/TRK blocker repotrectinib, which is being investigated for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The company celebrated the results, highlighting that the next-generation tyrosine kinase inhibitor (TKI)…
