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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its drug Columvi (glofitamab). Roche is seeking FDA approval for the use of Columvi in combination with gemcitabine and oxaliplatin (GemOx) for the…
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Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has announced its intention to sell all holdings in Teva Takeda Pharma Limited and its wholly owned subsidiary Teva Takeda Yakuhin Ltd. to JKI, a company established by a fund managed and operated by J-Will. This strategic move aligns with Teva’s Pivot to…
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US-based Dewpoint Therapeutics Inc. has entered into a strategic partnership with Japan-headquartered Mitsubishi Tanabe Pharma Corporation (MTPC) to enhance the development of Dewpoint’s novel TDP-43 small molecule condensate modulator (c-mod) for amyotrophic lateral sclerosis (ALS). This collaboration aims to address the mislocalization of the TAR DNA-binding protein 43 (TDP-43), a…
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UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has reported receiving a new indication approval from the US Food and Drug Administration (FDA) for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The approval is for the use of Imfinzi in treating adult patients with limited-stage small cell lung cancer (LS-SCLC)…
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US pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced the commencement of the Phase III MOVE-NOW study for its oral antiviral COVID-19 medicine, Lagevrio (molnupiravir), in adults with COVID-19 who are at high risk for disease progression. This trial marks a significant step in the ongoing development and…
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China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has indicated that the Category 1 drug RG002, developed by Suzhou-based mRNA therapeutics company RinuaGene, has been approved for clinical study in cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) associated with human papillomavirus (HPV) 16 and/or…
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has revealed a positive readout from the open-label, randomized Phase III SURMOUNT-5 study. The study assessed the weight loss effects of Zepbound (tirzepatide) compared to Wegovy (semaglutide) in adult patients with obesity or overweight, who have at least one weight-related medical…
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Sino-US biotech company Phanes Therapeutics Inc. has announced that it has received another Fast Track designation from the US Food and Drug Administration (FDA) for its bispecific antibody (bsAb) PT217. This designation is specifically for the treatment of patients with metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC). Earlier…
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The National Medical Products Administration (NMPA) in China has indicated on its website that CGeneTech (Suzhou, China) Co., Ltd.’s Category 1 drug, cetagliptin, has been granted marketing approval. This DPP-4 inhibitor is intended to improve blood sugar control in adult patients with type 2 diabetes (T2D). Phase III Clinical Trial…
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that their co-developed drug, Leqembi (lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, has been approved by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico. This approval marks another milestone in the treatment…
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Shanghai Escugen, a China-based biopharmaceutical company, has announced receiving the green light from the National Medical Products Administration (NMPA) to proceed with a second Phase III study for its antibody drug conjugate (ADC), ESG401. The study will focus on unresectable locally advanced, recurrent, or metastatic PD-L1 negative triple negative breast…
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Global healthcare giant Johnson & Johnson (J&J; NYSE: JNJ) has announced the submission of two supplementary Biologic License Applications (sBLAs) to the US Food and Drug Administration (FDA) for its drug Tremfya (guselkumab). The applications seek to expand the indications for children aged 6 years and older with moderate-to-severe plaque…
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Holland-based Merus N.V. (NASDAQ: MRUS) has announced that it has received FDA approval for its bispecific antibody (BsAb), Bizengri (zenocutuzumab-zbco), targeting HER2 and HER3 for the treatment of adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that are advanced, unresectable, or metastatic and harbor a neuregulin 1 (NRG1)…
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France-based Ipsen (EPA: IPN) has announced that it has received marketing clearance from the National Medical Products Administration (NMPA) of China for its drug odevixibatto, trading under the name Bylvay. The drug is indicated for treating itching in patients with progressive familial intrahepatic cholestasis (PFIC) who are aged six months…
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China-based Tasly Pharma Co., Ltd (SHA: 600535) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Swiss pharmaceutical giant Novartis’ (NYSE: NVS) Lioresal (baclofen) in the form of an oral solution. This Category 3 chemical drug is now approved…
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for review of its Category 1 therapeutic biologic product, the recombinant plasmid hepatocyte growth factor injection. This development signifies a step forward in the potential approval process for…
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced the receipt of clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug HSK46575, which is intended for the treatment of prostate cancer. HSK46575: A Promising Oral Small Molecule InhibitorHSK46575 has demonstrated significant therapeutic…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, (HKG: 6990), a leading biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its novel drug candidate, SKB500. This development marks a significant step forward in the advancement of the company’s pipeline. SKB500:…
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Sweden-based Cinclus Pharma has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug candidate, linaprazan, which is indicated for the treatment of gastroesophageal reflux disease (GERD). The drug is expected to be commercialized in China in 2025, marking a significant milestone for…
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted a market filing for its HLX11, a biosimilar version of Perjeta (pertuzumab). The company is seeking regulatory approval for…