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EMA’s CHMP Recommends Approval for BMS’s Opdivo/Yervoy Combo in mCRC
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch…
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Boston Scientific Expands Neuromodulation Portfolio with Axonics Acquisition
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Boston Scientific Corporation (NYSE: BSX), a leading player in the medical device industry, has announced the completion of its acquisition of Axonics, Inc. (NASDAQ: AXNX) for a substantial USD 3.7 billion. This strategic transaction is set to bolster Boston Scientific’s presence in the field of sacral neuromodulation (SNM), enhancing the…
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Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
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Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal…
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Peijia Medical Achieves First Compassionate Use of Taurus Trio TAVR System in Hong Kong
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Peijia Medical Ltd (HKG: 9996), a leading medical device company, has announced the completion of its first compassionate use case utilizing the Taurus Trio transcatheter aortic valve replacement (TAVR) system in Hong Kong. This milestone marks a significant step in the application of the company’s advanced cardiovascular technology in the…
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Sanofi’s Dupixent sBLA for Chronic Spontaneous Urticaria Accepted by FDA for Review
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French pharmaceutical giant Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Dupixent (dupilumab). The application seeks to expand the monoclonal antibody’s (mAb) indication to treat adults and pediatric patients aged 12 years and older with chronic…
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Novo Nordisk Launches Semaglutide for Weight Management in China
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Denmark-based healthcare giant Novo Nordisk A/S (NYSE: NVO) has announced the official market launch of semaglutide in China for long-term weight management. Globally, Novo Nordisk markets the glucagon-like peptide-1 receptor agonist (GLP-1RA) under the trade name Wegovy for weight loss, expanding access to this treatment for individuals seeking to manage…
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Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…
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Exegenesis Bio’s Gene Therapy EXG110 Earns Orphan Drug Status for Fabry Disease
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Exegenesis Bio, a leading provider of epigenetics experimental and analytical services headquartered in Hangzhou, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary gene therapy, EXG110, which is indicated for the treatment of Fabry disease. This designation highlights…
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Shenzhen Weiguang Biological Partners with SUAT to Boost Life Science and Health Industry
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Shenzhen Weiguang Biological Products Co., Ltd. (SHE: 002880), a prominent blood products manufacturer in China, has entered into a strategic partnership with Shenzhen University of Advanced Technology (SUAT). This collaboration, focused on the life and health sector, aims to foster the integration of industry and education, enhance cooperation among industry,…
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Janssen-Cilag’s Lazcluze-Rybrevant Combo Receives Positive EMA Opinion for NSCLC Treatment
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Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
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Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
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C-Ray Therapeutics Secures Over $100 Million in Series A+ Financing for Radiopharmaceuticals
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C-Ray Therapeutics, a specialist in radiopharmaceuticals headquartered in Chengdu, has announced the successful completion of a Series A+ financing round, raising over USD 100 million. The funding was co-led by Shenzhen Capital Group’s Manufacturing Transformation and Upgrading New Materials Fund and Tailong Capital, with additional contributions from GL Ventures, 3SBio…
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BioNTech Acquires Biotheus for $800 Million, Enhancing Oncology Pipeline
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BioNTech (NASDAQ: BNTX), the biotech giant recognized for its role in developing the COVID-19 vaccine, has acquired Biotheus for an upfront payment of $800 million, with additional milestone payments potentially reaching up to $150 million. Founded in 2018 and headquartered in Zhuhai, China, Biotheus has developed eight clinical-stage products and…
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Suzhou Ribo Life Science Receives EU Approval for Phase II Trial of RBD5044
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Suzhou Ribo Life Science Co., Ltd. and its subsidiary Ribocure Pharmaceuticals AB have announced that their novel siRNA drug, RBD5044, has received approval to commence Phase II clinical trials in the European Union. This represents a significant step forward in the development of RNA interference therapies targeting lipid metabolism. RBD5044:…
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Ascentage Pharma Submits Application for Lisaftoclax, a Novel Oral Bcl-2 Inhibitor
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Ascentage Pharma (HKG: 6855) has announced that its proprietary oral Bcl-2 selective inhibitor, Lisaftoclax (APG-2575), has submitted its market application, which has been officially accepted by regulatory authorities. The formulation is being produced in collaboration with Xuantai Pharmaceutical. This innovative treatment targets patients suffering from refractory or relapsed chronic lymphocytic…
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C-Ray Therapeutics Secures Over $100 Million in A+ Round Financing
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C-Ray Therapeutics (Chengdu) Co., Ltd., an innovative enterprise in the field of radioactive medicines, has successfully completed over $100 million in A+ round financing. This funding round was jointly led by Shenzhen Capital Group’s New Materials Fund and Tailong Investment, with participation from notable investors including Hillhouse Ventures, SiBiono GeneTech,…
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Bliss Bio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
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Bliss Bio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors,…
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Merck KGaA Reports 3.8% Organic Growth in Q3 2024 Financials
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Merck KGaA (NYSE: MRK), the German multinational science and technology company, has released its financial results for the third quarter of 2024, reporting net sales of EUR 5.266 billion (USD 5.55 billion), marking an organic growth of 3.8%. The company’s performance reflects a steady increase in sales across its business…
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Impact Therapeutics Secures $34.5 Million in Series D++ Financing for Senaparib Commercialization
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China-based biopharmaceutical company Impact Therapeutics has reportedly secured RMB 250 million (USD 34.5 million) in a Series D++ financing round, co-led by a globally renowned industry investment institution and a prominent insurance fund. The funds raised will be directed towards the commercialization of its core product, senaparib, a PARP1 inhibitor,…
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GSK’s Blenrep Shows Survival Benefit in Phase III Multiple Myeloma Study
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UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
