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Kinnate Biopharma Announces Restructuring and Job Cuts Amid Financial Pressures
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US-based Kinnate Biopharma Inc., (NASDAQ: KNTE), a company dedicated to the development of small-molecule cancer drugs, has announced significant corporate restructuring due to financial stress. This includes a reduction of 70% of its workforce, leaving the company with only 28 employees. Pipeline Program AdjustmentsAs part of the restructuring, three pipeline…
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Jiangsu Hengrui Medicine Wins NMPA Approval for Two Novel Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates: the injectable SHR-3032 and HRS-7085 tablets. Details of the Investigational DrugsThe Category 1 drug SHR-3032 is under development…
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Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
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The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and Everest Medicines’ (HKG: 1952) cefepime-taniborbactam are slated for priority reviews. These drugs target specific patient populations: teenage patients aged 12 years and above with refractory, moderate to severe atopic dermatitis (AD) who…
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EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead’s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized…
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Eli Lilly Partners with Boundless Bio to Develop CHK1 Inhibitor for Solid Tumors
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Eli Lilly (NYSE: LLY) has announced a partnership with precision oncology specialist Boundless Bio to clinically develop Boundless’s CHK1-targeting small-molecule inhibitor (SMI) BBI-355 in combination with Lilly’s CDK4/6 inhibitor Verzenio (abemaciclib). This collaboration aims to target locally advanced or metastatic solid tumors with oncogene amplifications, with Boundless highlighting its candidate…
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NHSA Clears Retagliptin and Ambroxol for National Reimbursement Drug List Inclusion
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The National Healthcare Security Administration (NHSA) has completed a review of the National Reimbursement Drug List (NRDL) adjustment formality review results for retagliptin and ambroxol. Both drugs, first approved for marketing in China in June 2023 and July 2019 respectively, have been deemed eligible for the filing requirement stipulating “new…
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FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
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The US Food and Drug Administration (FDA) has granted priority review status to an indication extension application filed by Merck, Sharp & Dohme (MSD; NYSE: MRK) for its oral HIF-2α inhibitor Welireg (belzutifan). The application seeks approval for the treatment of advanced renal cell carcinoma (RCC) in adults who have…
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Kangtai Biological Expands Global Reach with Varicella Vaccine Licensing Deals
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Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a China-based biopharmaceutical company, has entered into licensing agreements with undisclosed pharmaceutical companies in Pakistan and India. These strategic partnerships aim to strengthen the regulatory filing, marketing, and distribution of Kangtai Bio’s varicella attenuated live vaccines in both countries. Vaccine Description and…
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