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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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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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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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Simcere Pharmaceutical Group Secures Exclusive Rights to CMAB009 in China
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Simcere Pharmaceutical Group Ltd (HKG: 2096) has announced that its subsidiary, Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd, has entered into a cooperation agreement with Taizhou Mabtech Pharmaceutical Ltd, a subsidiary of Mabpharm Ltd (HKG: 2181), focusing on the molecule CMAB009. Under the terms of the deal, Simcere Zaiming has obtained…
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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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CytoMed Therapeutics Partners with CNK Therapeutics for CAR Gene Grafting Technology
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Singapore-based cell therapy developer CytoMed Therapeutics Ltd (NASDAQ: GDTC) has announced the signing of a memorandum of understanding (MoU) with China’s Hangzhou CNK Therapeutics Co., Ltd. The agreement grants CytoMed a license to utilize CNK’s PiggyBac technology, enabling the permanent grafting of the Chimeric Antigen Receptor (CAR) gene into its…
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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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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)…
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Seagen’s Tukysa Meets Primary Endpoint in Phase III Study for HER2+ Breast Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has announced an update on an ongoing Phase III oncology study involving a combination therapy that includes the HER2 inhibitor Tukysa (tucatinib), one of Seagen’s four marketed drugs that attracted Pfizer’s interest. The trial successfully met…
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Gracell Biotechnologies Reports Q2 2023 Financials, Highlights GC012F in Melanoma Treatment
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Suzhou-based biotech company Gracell Biotechnologies Inc., (NASDAQ: GRCL) has reported its financial results for the second quarter of 2023. The report highlights the company’s core product, GC012F, which has shown excellent data in multiple melanoma (MM) studies, as a key focus of their strategy moving forward. Clinical Trials and Development…
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Gilead Sciences Enters Collaboration with Tentarix Biotherapeutics for Polyspecific Antibodies
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Gilead Sciences (NASDAQ: GILD) has announced the initiation of three collaboration programs with US-based Tentarix Biotherapeutics, focusing on the discovery and development of conditional polyspecific antibodies for oncology and inflammatory diseases. The collaboration underscores Gilead’s commitment to advancing innovative treatments in these therapeutic areas. Financial Terms and Acquisition RightsUnder the…
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J&J Subsidiary Janssen Wins FDA Approval for Akeega in BRCA-Positive mCRPC Treatment
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The US Food & Drug Administration (FDA) has granted marketing approval to Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen for its oral drug Akeega (niraparib + abiraterone) in combination with prednisone. This treatment is designated for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).…
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Medivir’s Fostrox in Combination with Lenvima Shows Promise in Phase IIa HCC Trial
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Sweden-based Medivir (STO: MVIR) has released interim data from a Phase IIa trial evaluating the combination of its experimental drug fostrox with Japan partner Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC). The trial focuses on patients for whom current first- or second-line…
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Pfizer’s Elrexfio Earns Accelerated FDA Approval for Relapsed/Refractory Multiple Myeloma
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This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r/rMM) in adults who have received at least four prior lines of therapy. The decision was based…
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Janssen’s Talvey Receives FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) announced last week that it received accelerated approval from the US Food and Drug Administration (FDA) for its first-in-class GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have…
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Telix Pharmaceuticals and Grand Pharma Initiate Phase III Trial for Illucix in China
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Australian biotechnology company Telix Pharmaceuticals Ltd (ASX: TLX) and its China market partner, Grand Pharmaceutical Group Limited (HKG: 0512), have announced the dosing of the first patient in a pivotal Phase III trial for TLX591-CDx (Illucix) in China. TLX591-CDx is a kit for the preparation of Gallium 68 (68Ga) PSMA-11,…
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Bio-Thera Solutions’ BAT8006 Shows Positive Phase I Results in Solid Tumor Treatment
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced positive Phase I clinical data for BAT8006 (Folate-Receptor-α-ADC) at the Bethune Obstetrics and Gynecology Forum in China. The study evaluated the safety and efficacy of the antibody-drug conjugate (ADC) in a dose escalation trial. BAT8006: A Promising ADC for Solid TumorsBAT8006 is…
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Medtronic Partners with APMG to Advance Orthopedic Treatment Services in China
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US-based Medtronic Inc., (NYSE: MDT) has entered into a partnership with China’s private healthcare group Asia Pacific Medical Group (APMG) with the aim of enhancing the implementation and promotion of advanced orthopedic and extrasomatic diagnosis and treatment services in China. Launch of AiBLE Digital Intelligence Orthopedics Integrated SolutionIn a significant…
