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Roche’s Columvi Supplemental sBLA Accepted by FDA for Relapsed DLBCL Treatment
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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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Teva Pharmaceutical to Divest Holdings in Teva Takeda Pharma to JKI
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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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Eyebright Medical Technology Aims to Raise RMB 300 Million for Contact Lens Production Expansion
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China-based ophthalmic medical device manufacturer, Eyebright Medical Technology Co., Ltd (SHA: 688050), has announced plans to raise up to RMB 300 million (USD 41.3 million) through a private placement of 3,787,878 shares. The capital raised will be allocated towards the construction project of a contact lens and injection mold processing…
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Cambrex Partners with Eli Lilly to Enhance Clinical Development for Biotech Collaborators
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US-based contract development and manufacturing organization (CDMO) Cambrex has reached an agreement with Eli Lilly & Co., (NYSE: LLY), to enhance the clinical development capabilities for the US giant’s biotech collaborators. This partnership aims to provide a comprehensive suite of services to support early-stage biotech innovation. Cambrex’s Role in Lilly…
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Dewpoint Therapeutics Partners with Mitsubishi Tanabe Pharma to Develop ALS Treatment
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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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AstraZeneca’s Imfinzi Receives FDA Approval for Limited-Stage Small Cell Lung Cancer
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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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Eli Lilly & Co. Expands Wisconsin Manufacturing Facility with $3 Billion Investment
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US pharmaceutical major Eli Lilly & Co. (NYSE: LLY) has announced the expansion of its manufacturing facility in Kenosha County, Wisconsin, with a substantial capital investment of USD 3 billion. This significant expansion, acquired earlier this year, is part of Lilly’s strategic plan to enhance its global parenteral (injectable) product…
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Amgen Expands Biomanufacturing Footprint in North Carolina with Second Facility
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US biotech company Amgen (NASDAQ: AMGN) has announced plans to construct a second drug substance manufacturing facility in Holly Springs, North Carolina, raising its total biomanufacturing investment in the region to USD 1.5 billion. This new plant, costing USD 1 billion, follows Amgen’s previously announced commitment of USD 550 million…
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Merck Initiates Phase III MOVE-NOW Study for Lagevrio COVID-19 Antiviral
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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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CDE Approves RinuaGene’s mRNA-Based RG002 for Clinical Study in Cervical Dysplasia
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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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Burning Rock Ltd Reports Q3 2024 Financials with Revenue Growth and R&D Reduction
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China-based medtech firm Burning Rock Ltd (NASDAQ: BNR) has released its financial results for the third quarter of 2024. The company reported Q3 revenues of RMB 128.6 million (USD 18.3 million), marking a year-on-year (YOY) increase of 0.8%. Research and development (R&D) expenses saw a significant decline of 41.3% YOY,…
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Novavax to Sell Czech Manufacturing Facility to Novo Nordisk for $200 Million
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US-based Novavax, Inc. (NASDAQ: NVAX) has reached an agreement to sell its manufacturing facility located in Bohumil, Czech Republic, to Denmark-based Novo Nordisk A/S (NYSE: NVO) for a total consideration of USD 200 million. The transaction involves the transfer of assets, including a 150,000-square foot state-of-the-art recombinant protein manufacturing facility,…
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Eli Lilly’s Zepbound Outperforms Wegovy in SURMOUNT-5 Weight Loss Study
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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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Phanes Therapeutics’ PT217 Earns FDA Fast Track Designation for Neuroendocrine Prostate Cancer
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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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CGeneTech’s Cetagliptin Receives NMPA Approval for Type 2 Diabetes Treatment in China
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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 and Biogen’s Leqembi Approved in Mexico for Early Alzheimer’s Disease Treatment
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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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AstraZeneca Appoints Iskra Reic as EVP, International, Amid Leon Wang’s Investigation in China
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced the appointment of Iskra Reic, Ph.D., as Executive Vice President (EVP), International. Reic will be responsible for overseeing the overall strategy and driving sustainable growth across key regions including China, Asian and Eurasian markets, the Middle East & Africa,…
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Shanghai Escugen Receives NMPA Approval for Second Phase III Trial of ESG401 in TNBC
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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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Johnson & Johnson Submits sBLAs to FDA for Tremfya Indications in Pediatric Psoriasis and Arthritis
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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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GSK plc Expands Pipeline with Rgenta Therapeutics Partnership for RNA-Targeted Splice Modulators
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GSK plc (NYSE: GSK), a leading global pharmaceutical company, continues to bolster its pipeline through strategic external partnerships. The US major has recently signed an agreement with US biotech Rgenta Therapeutics to discover and develop novel RNA-targeted small molecule splice modulators, adding to its earlier antibody drug conjugate (ADC) option…
