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Ratio Therapeutics Partners with Novartis on SSTR2 Radiotherapeutic for Cancer
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US-based Ratio Therapeutics Inc. has entered into a global exclusive licensing and cooperation agreement with Swiss pharmaceutical giant Novartis AG (NYSE: NVS) to develop a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer treatment. Details of the AgreementRatio will apply its radioligand therapy discovery and development expertise, along with its…
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Novartis’ Pluvicto Accepted for Review by China’s NMPA for Prostate Cancer Treatment
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The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted a marketing approval filing from Swiss pharmaceutical giant Novartis (NYSE: NVS) for its radioligand therapy (RLT), Pluvicto (177Lu vipivotide tetraxetan). This acceptance marks a significant step towards making this innovative treatment available to patients in…
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Schrödinger and Novartis Ink Deal to Accelerate Drug Discovery Candidates
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New York-based Schrödinger, Inc. (NASDAQ: SDGR), a leading software provider in accelerating drug discovery, has announced a strategic research collaboration and license agreement with Novartis (NYSE: NVS). This partnership is aimed at advancing multiple development candidates into Novartis’s portfolio for further development. Additionally, the two companies have reached an expanded…
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Shanghai Pharmaceutical Co., Ltd Secures Multiple Partnerships at CIIE
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At the 7th China International Import Expo (CIIE), China-based Shanghai Pharmaceutical Co., Ltd (SPH, SHA: 601607, HKG: 2607) announced a series of partnerships with prominent pharmaceutical companies, spanning domestic and international entities. Expanding Collaborations in Pharmaceutical InnovationFrance’s Sanofi (NASDAQ: SNY) has agreed to deepen its existing partnership with SPH, initially…
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Novartis Forges Partnerships at CIIE to Strengthen Radioligand Therapy Ecosystem in China
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At the 7th China International Import Expo (CIIE), Swiss pharmaceutical giant Novartis (NYSE: NVS) announced strategic partnerships with US medical device and life sciences company GE Healthcare Technologies Inc., (NASDAQ: GEHC), and Chinese firms Shanghai Pharmaceuticals Holding Co., Ltd (HKG: 2607, SHA: 601607; SPH) and C.Q. Pharmaceutical Holding Co., Ltd…
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Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential “first-in-class” trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies. Preclinical research results…
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Monte Rosa Therapeutics Strikes Licensing Deal with Novartis for VAV1 Degraders
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US-based Monte Rosa Therapeutics (NASDAQ: GLUE) has entered into a licensing agreement with Swiss pharmaceutical company Novartis (NYSE: NVS), granting Novartis exclusive global development and commercialization rights to Monte Rosa’s VAV1-targeted molecular glue degraders (MGDs), including the investigational drug MRT-6160. As per the agreement, Novartis will make an upfront payment…
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Novartis’s Kisqali Receives Positive CHMP Opinion for Early Breast Cancer Treatment in the EU
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Kisqali (ribociclib), a CDK4/6 inhibitor, for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth…
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Chengdu Baiyu Pharmaceutical Strikes Licensing Deal with Novartis for Unannounced Anti-Tumor Asset
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Chengdu Baiyu Pharmaceutical Co., Ltd., a Chinese pharmaceutical company, has entered into a licensing agreement with Swiss pharmaceutical giant Novartis (NYSE: NVS), according to the Xinhua News Agency. Under this deal, Novartis will acquire the global exclusive rights to develop and commercialize one of Baiyu’s small molecule anti-tumor assets, the…
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Novartis’s Brolucizumab Accepted for Review by China’s CDE for Potential DME Treatment
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The Center for Drug Evaluation (CDE) has indicated that Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its second market filing for brolucizumab accepted for review. The filing is anticipated to be for the treatment of visual impairment resulting from macular edema associated with diabetes (DME). Brolucizumab, recognized as…
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Eli Lilly China Appoints Yan Qiong as Vice President of Diabetes Business Unit
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Effective October 10, 2024, Yan Qiong will join the management team of Eli Lilly (NYSE: LLY) China as the vice president of the diabetes products business unit. She will report directly to Huzur Devletsah, the president and general manager of Lilly China. Yan Qiong brings nearly two decades of experience…
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CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
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Novartis’ Cemiplimab Approved in China for Moderate-to-Severe Atopic Dermatitis
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Novartis (SWX: NOVN, NYSE: NVS)’s Chinese arm has announced that it has received approval from the National Medical Products Administration (NMPA) for its drug candidate, cemiplimab, to be used in the treatment of adults and children aged 12 and over with moderate-to-severe atopic dermatitis (AD). The drug, known as cemiplimab…
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Voyager Therapeutics Secures Licensing Deal with Novartis for Gene Therapy Capsid
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Voyager Therapeutics Inc. (NASDAQ: VYGR), a U.S.-based biotechnology company, has announced a licensing agreement with Swiss pharmaceutical giant Novartis AG (NYSE: NVS). This agreement provides Novartis with access to a novel capsid from Voyager’s TRACER capsid discovery platform for its gene therapy program targeting an undisclosed rare neurologic disease. Under…
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Novartis Builds Two Radioligand Therapy Facilities in U.S. to Expand Cancer Treatment Capabilities
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Novartis AG (NYSE: NVS), a Swiss pharmaceutical giant listed on the NYSE under the ticker NVS, has commenced construction on two cutting-edge radioligand therapy (RLT) manufacturing facilities in the United States. The first initiative involves an expansion of the company’s current operations in Indianapolis, which will facilitate in-house production of…
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Novartis and Versant Ventures Launch Borealis Biosciences with a Focus on RNA Medicines for Kidney Diseases
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Novartis (NYSE: NVS), a Swiss pharmaceutical heavyweight, has joined forces with the US venture capital fund Versant Ventures to launch Borealis Biosciences, a cutting-edge biotech firm dedicated to pioneering next-generation RNA medicines for kidney diseases. Borealis emerges from incubation with a substantial USD 150 million in Series A financing, bolstered…
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Novartis Intensifies Legal Action Against FDA Over Entresto Generic Approval
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Novartis Inc. (NYSE: NVS) is intensifying its efforts to thwart the entry of generic competitors for its heart failure and hypertension medication, Entresto (valsartan + sacubitril), following the U.S. FDA’s approval of a generic version from India-based MSN Laboratories on July 24. A federal court judge in Delaware recently denied…
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Novartis’s Scemblix Receives FDA Priority Review for First-Line CML Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that the US Food and Drug Administration (FDA) has granted priority review status to Scemblix (asciminib) for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP). Scemblix, the first molecule to specifically target the ABL Myristoyl…
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Novartis Partners with Dren Bio to Develop Next-Generation Cancer Therapies
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Novartis (NYSE: NVS), a leading Swiss pharmaceutical company, has entered into a strategic collaboration with California-based biotech firm Dren Bio Inc. to leverage Dren’s expertise in developing bispecific antibodies for cancer treatment. Under this agreement, Novartis is particularly interested in utilizing Dren’s proprietary Targeted Myeloid Engager and Phagocytosis Platform. As…
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Novartis Delivers Strong Q2 2024 Results with 11% YoY Net Sales Increase
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has released its financial results for the second quarter of 2024, demonstrating sustained strong performance akin to the first quarter of this year. Net sales experienced a robust 11% year-on-year (YOY) increase in constant currency terms, reaching USD 12.5 billion for the quarter.…
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Pharmaceutical Giants Face UK Industry Code Breach Allegations, Including Novartis and Pfizer
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Several multinational pharmaceutical corporations have been reprimanded for violating the UK’s Prescription Medicines Code, a set of voluntary industry standards established by the Association of the British Pharmaceutical Industry (ABPI) and overseen by the Prescription Medicines Code of Practice Authority (PMCPA). The PMCPA has called out Novartis (NYSE: NVS), Pfizer…
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Novartis Launches Construction of First Radioligand Manufacturing Site in China
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Novartis AG (NYSE: NVS), the Swiss pharmaceutical giant, has initiated construction on its second manufacturing facility in China, marking a significant expansion in the country. The new site, known as the Novartis China Haiyan Radioligand Manufacturing Site, is located in Zhejiang province and represents an investment of approximately RMB 600…
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Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib) accepted for review by China’s National Medical Products Administration (NMPA). Scemblix is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor, which is filed for the treatment of chronic myeloid leukemia (CML). As the world’s…
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Novartis Moves Toward Full Ownership of MorphoSys with Shareholder Squeeze-Out
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Novartis AG (NYSE: NVS), the Swiss pharmaceutical giant, is proceeding to fully acquire MorphoSys AG (OTCMKTS: MPSYF) by initiating a squeeze-out of its minority shareholders. Novartis had made a public takeover offer of EUR 68 per share, valuing the company at an aggregate EUR 2.7 billion (USD 2.9 billion), in…
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Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
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Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
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Novartis Halts Development of KRAS Inhibitor Opnurasib Due to Competitive Market
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has reportedly halted the development of its Phase III KRAS inhibitor candidate, opnurasib, citing an increasingly competitive landscape in the sector. The drug was under development for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). This decision comes in the…
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Yantai Dongcheng Pharmaceutical Receives NMPA Approval for SSTR2 Targeted Radioactive Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate, 177LuLNC1010. This investigational therapy is a somatostatin receptor 2 (SSTR2) targeted radioactive drug designed for the…
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Novartis’ Fabhalta Shows Promise in Late-Stage C3 Glomerulopathy Trial
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Novartis AG (NYSE: NVS), a leading Swiss pharmaceutical company, last week announced positive preliminary data from a late-stage study for its complement inhibitor Fabhalta (iptacopan) in patients with the ultra-rare kidney disease C3 glomerulopathy (C3G). The study showed that compared to placebo, iptacopan achieved a 35.1% reduction in proteinuria and…
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Novartis’ Atrasentan Shows Significant Reduction in Proteinuria in IgA Nephropathy Trial
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Novartis AG (NYSE: NVS), a Swiss pharmaceutical company, last week presented interim results for the primary endpoint of a Phase III trial for atrasentan in patients with IgA nephropathy (IgAN). The trial indicated that the endothelin A (ETA) receptor antagonist demonstrated a 36.1% reduction in proteinuria at 36 weeks compared…
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Porton Pharma Solutions Invests €50 Million in Slovenian R&D Expansion
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China-based Contract Development and Manufacturing Organization (CDMO) Porton Pharma Solutions Ltd has inaugurated a new research and development (R&D) center in Mengeš, Slovenia, marking a significant step in the company’s global expansion strategy. The investment, totaling €50 million ($54.1 million), encompasses the acquisition and comprehensive renovation of the facility, which…
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Novartis Shakes Up Executive Suite with Appointments and Transitions
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The president of Novartis (NYSE: NVS)’ International Business Unit has this week declared a series of significant personnel changes. Ingrid Zhang, currently serving as the China president for the Swiss pharmaceutical giant, has been appointed as the Chief Business Officer (CCO) of Novartis International Business Unit. She will lead the…
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Novartis Inks Deal to Acquire Mariana Oncology, Bolstering Radioligand Therapy Portfolio
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Swiss pharmaceutical giant Novartis (NYSE: NVS) is poised to expand its oncology portfolio by acquiring Mariana Oncology, a US-based specialist in radioligand therapy (RLT). The agreement is subject to customary closing conditions and includes a substantial upfront payment of USD 1 billion, plus potential milestone payments of up to USD…
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U.S. Judge Dismisses Johnson & Johnson and Bristol-Myers Squibb Lawsuits Against Drug-Pricing Provisions in Inflation Reduction Act
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In a recent legal development, a U.S. federal court judge has rejected the legal challenges brought by pharmaceutical giants Johnson & Johnson (J&J; NYSE: JNJ) and Bristol-Myers Squibb (BMS; NYSE: BMY) against the drug-price negotiations outlined in President Joe Biden’s Inflation Reduction Act (IRA). The companies had filed separate lawsuits…
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Novartis’s Iptacopan (Fabhalta) Receives Marketing Approval in China for PNH Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received marketing approval from China for its iptacopan (trade name: Fabhalta) for the treatment of adult paroxysmal nocturnal hemoglobinuria (PNH) in patients previously untreated with complement inhibitor. PNH is a rare and life-threatening blood disorder characterized by anemia, hemoglobinuria, bone marrow failure, and…
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Novartis Receives Positive Interim Results for Antimalarial Coartem in Infants
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced interim results from a Phase II/III clinical trial for its antimalarial drug Coartem (artemether + lumefantrine) in infants with uncomplicated Plasmodium falciparum malaria. The trial data indicates that the tablet formulation meets pharmacokinetic (PK), efficacy, and safety requirements, achieving the primary PK…
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Novartis Becomes First MNC to Publicly Adjust China CRDMO Partnerships in Response to BioSecure Act
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has reportedly become the first multinational corporation to publicly acknowledge actively revising its partnerships with China-based Contract Research, Development, and Manufacturing Organizations (CRDMOs) in light of the proposed BioSecure Act in the United States. During a press call with US media accompanying the company’s…
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Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
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The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS) for its radioligand therapy (RLT) Lutathera (lutetium Lu 177 dotatate) for the treatment of SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients aged 12 and older. This expansion of the drug’s original indication for adult patients…
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Novartis Reports 11% YOY Sales Growth in Q1 2024, Led by Entresto and Cosentyx
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has reported an 11% year-on-year (YOY) increase in constant currency terms during the first quarter of 2024, reaching USD 11.8 billion in sales. The growth was driven by strong performances across all key brands and geographies. The top-selling and growth-driving drugs included hypertension therapy…
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Novartis’s Kesimpta Shows Sustained Efficacy in 6-Year Relapsing MS Study
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has this week unveiled six-year efficacy data for its anti-CD20 drug Kesimpta (ofatumumab) in the treatment of recently diagnosed relapsing multiple sclerosis (MS) in treatment-naive patients. The data shows that first-line continuous Kesimpta treatment, as compared to a teriflunomide regimen switched to Kesimpta, resulted…
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Novartis’s Fabhalta Shows Promise in Phase III IgA Nephropathy Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive preliminary results from a Phase III clinical trial of its complement inhibitor Fabhalta (iptacopan) for the treatment of IgA nephropathy (IgAN). The trial data showed that after a nine-month treatment period, the Factor B inhibitor Fabhalta reduced proteinuria by 38.3% when…
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Novartis Announces Layoffs to Streamline Operations and Boost Portfolio Value
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Swiss pharmaceutical giant Novartis (NYSE: NVS) is gearing up for a strategic restructuring that will result in the layoff of up to 680 staff members across its Swiss and US development teams. This move, reported by Endpoints News, comes on the heels of similar announcements from industry peers Bayer (ETR:…
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EMA Panel Backs Novartis’s Fabhalta for PNH Treatment, Awaits EC Decision
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Novartis’s (NYSE: NVS) Factor B inhibitor Fabhalta (iptacopan) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults with hemolytic anemia. The European Commission (EC) is anticipated to make a…
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AstraZeneca to Acquire Fusion Pharmaceuticals in a Deal Valued at USD 2.4 Billion
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based pharmaceutical giant, has announced its intention to acquire Fusion Pharmaceuticals (NASDAQ: FUSN), a Canada-based developer of radioconjugate (RC) therapies, in a deal valued at up to USD 2.4 billion, including upfront and potential contingent value payments. The acquisition is expected to be finalized in…
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Novartis Acquires IFM Due for $90 Million, Expanding STING-Inhibitor Pipeline
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has announced the acquisition of IFM Due, a subsidiary of US biopharmaceutical company IFM Therapeutics, for an upfront payment of $90 million, with potential milestone payments totaling up to $745 million. This acquisition builds on a 2019 agreement in which Novartis financed IFM…
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MSD Partners with IDEAYA Biosciences to Develop Combination Therapy for Endometrial Cancer
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with IDEAYA Biosciences (NASDAQ: IDYA), a US-based biotechnology company, to clinically develop the combination of MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) with IDEAYA’s potential first-in-class poly (ADP-ribose) glycohydrolase (PARG) inhibitor IDE161. The collaboration focuses on treating microsatellite instability-high (MSI-high)…
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Novartis Gene Therapy Zolgensma Shows Continued Benefits in Broader SMA Patient Group
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented Phase III data this week, demonstrating that the clinical benefits of its gene therapy Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy (SMA) extend beyond patients up to 2 years of age. The new study has shown similar benefits in older children, including…
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Sandoz Agrees to $265 Million Settlement in U.S. Generic Drug Antitrust Case
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Sandoz (SIX: SDZ), the Swiss-based pharmaceutical company, announced this week that its U.S. subsidiaries have reached a settlement in a generic drug antitrust class action, agreeing to pay $265 million to the plaintiffs. The settlement is subject to court approval and includes a provision allowing Sandoz to withdraw if a…
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Novartis Begins Review of 70% Stake in Indian Unit, Strategic Options Under Consideration
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Novartis (NYSE: NVS) has initiated a review process concerning its 70.68% stake in Novartis India Ltd., with any strategic decisions to be approved by the board of directors as necessary. The Swiss pharmaceutical giant cautioned that the assessment may not conclude in 2024 and emphasized that no transaction is guaranteed…
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FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
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The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO: 4502)’s Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE). This marks Eohilia as the first and currently only oral therapy available for EoE patients aged 11 and older. Previously, Novartis (NYSE: NVS)’s…
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Novartis to Acquire MorphoSys for €2.7 Billion in Strategic Oncology Expansion
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Switzerland-based Novartis (NYSE: NVS) has announced a voluntary public takeover offer to acquire Germany-based biopharmaceutical firm MorphoSys (FSE: MOR; NASDAQ: MOR) for €2.7 billion. The transaction is anticipated to finalize in the first half of 2024, pending the fulfillment of customary conditions. By acquiring MorphoSys, Novartis aims to incorporate two…
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Novartis and Fudan University Shanghai Cancer Center Renew Partnership to Drive Precision Cancer Treatments
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Novartis (NYSE: NVS), the Swiss pharmaceutical colossus, has renewed its memorandum of understanding with Fudan University Shanghai Cancer Center, signaling a continuation of their strategic partnership. The two entities have committed to an extensive collaboration in scientific research, platform development, and other key areas, with a particular focus on advancing…
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Novartis Sees Robust Growth in Innovative Medicines with 2023 Financials Reflecting a Shift Toward R&D Focus
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, reported a substantial leap in its global sales for the last financial year, amassing USD 45.4 billion—a 10% year-on-year (YOY) increase in constant currency terms, as per the 2023 financials released this week. This achievement marks Novartis’s inaugural annual report following the strategic…
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Novartis Lutathera Combo Therapy Shows Significant Progress in GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced preliminary results from a Phase III study that evaluated the efficacy of radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) in combination with the symptom-control drug octreotide as a first-line therapy for SSTR+ well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The clinical…
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Novartis Acquires Calypso Biotech for USD 250 Million to Bolster IL-15 Pipeline
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Novartis (NYSE: NVS) has finalized an agreement to acquire Netherlands-based Calypso Biotech, a 2013 spinout from Merck that specializes in targeting interleukin-15 (IL-15). Under the terms of the deal, Calypso will receive an upfront payment of USD 250 million, along with potential milestone payments totaling up to USD 175 million.…
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Cytokinetics Attracts Big Pharma Interest Amid Aficamten’s Phase III Success
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Cytokinetics (NASDAQ: CYTK), a specialist in cardiovascular diseases, is reportedly attracting interest from multiple Big Pharma companies keen on its promising pipeline in cardiovascular and neuromuscular diseases. Sources indicate that Novartis (NYSE: NVS) was initially leading the charge against competitors AstraZeneca (AZ, NASDAQ: AZN) and Johnson & Johnson (J&J, NYSE:…
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Alphabet’s Isomorphic Labs Inks Pharma Partnerships with Eli Lilly and Novartis
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Isomorphic Labs, a drug discovery company under the umbrella of Google’s parent group Alphabet (NASDAQ: GOOGL), has entered into its inaugural pharmaceutical collaborations, signing separate agreements with Eli Lilly (NYSE: LLY) and Novartis (NYSE: NVS). These partnerships are aimed at discovering small-molecule therapeutics for multiple undisclosed targets. Under the terms…
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Novartis’s Cosentyx Secures Additional Indication for Psoriatic Arthritis in China
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Swiss pharmaceutical giant Novartis (SWX: NOVN) has announced that its drug Cosentyx (secukinumab), which targets IL-17A, has received an additional indication approval from the National Medical Products Administration (NMPA) in China. The drug is now approved for the treatment of active psoriatic arthritis (PsA), adding to its existing indications in…
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International Society for Cell & Gene Therapy Comments on FDA’s CAR-T Investigation
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The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration’s (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. The FDA launched the inquiry in November following 20 reported cases of patients developing these malignancies after…
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Novartis Strikes Deal with Argo Biopharma for Global Rights to siRNA Drug Candidates
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Argo Biopharma, a Shanghai-based developer of small interfering RNA (siRNA) drugs, has secured a licensing agreement with Novartis (NYSE: NVS), the Swiss pharmaceutical giant. The deal grants Novartis global rights to a Phase I drug candidate and ex-Greater China rights to another program currently in Phase I/IIa. In return, Argo…
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Novartis to Fully Acquire SanReno Therapeutics to Expand Kidney Drug Portfolio in China
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Novartis (NYSE: NVS), a Swiss pharmaceutical giant, has announced plans to acquire the remaining shares in SanReno Therapeutics, a Shanghai-based developer of kidney drugs. This move is aimed at bolstering Novartis’s kidney product portfolio in China. The financial details of the transaction have not been disclosed. SanReno Therapeutics was established…
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GenScipt Subsidiary Legend Biotech Finalizes Licensing Deal with Novartis for DLL3 CAR-T Therapies
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GenScipt Biotech Corp., a China-based Contract Development and Manufacturing Organization (CDMO) (HKG: 1548), has announced that the closing conditions for a licensing agreement between its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), and the Swiss pharmaceutical giant Novartis AG (NYSE: NVS) have been met. The agreement, initially revealed in November 2023,…
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FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
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The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing for Xolair (omalizumab), marking it as the first treatment in the U.S. aimed at reducing allergic reactions associated with accidental food exposure in patients with food allergies. The FDA granted biologic breakthrough therapy designation (BTD)…
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Jiangsu Hengrui Medicine Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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Novartis Reports Kisqali Success in Reducing Recurrence Risk in Early Breast Cancer
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Novartis (NYSE: NVS) has announced an update on the late-stage trial for its CDK4/6 inhibitor Kisqali (ribociclib) in early breast cancer. Data from 78.3% of patients who completed treatment showed a significant reduction in the risk of recurrence, with 30% and 24.5% decreases for stage II and stage III tumors,…
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Novartis’ Fabhalta Wins FDA Nod as First-in-Class Treatment for Paroxysmal Nocturnal Hemoglobinuria
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has secured regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class orphan drug Fabhalta (iptacopan) as an oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH). The approval was granted based on Phase III clinical data that demonstrated a significant…
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Novartis Invests USD 86.4 Million in New Radiotherapy Facility in China
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has invested over 600 million Chinese yuan (approximately USD 86.4 million) to establish a new radiotherapy production facility in China. Located in Haiyan, Zhejiang province—roughly 60 miles from Shanghai—the new plant is slated to become operational by 2026, enhancing Novartis’ capacity for local production.…
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CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
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Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance…
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Novartis Acquires HDAC6 Inhibitor CKD-510 from CKD Pharmaceutical in a $1.31 Billion Deal
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Swiss pharmaceutical major Novartis (NYSE: NVS) announced last week that it has struck a deal to acquire the HDAC6 small-molecule inhibitor (SMI) CKD-510 from South Korea’s Chong Kun Dang (CKD) Pharmaceutical. The transaction includes an upfront payment of USD 80 million, with the potential for up to USD 1.23 billion…
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Novartis Pharma AG Partners with Legend Biotech Corp. for CAR-T Therapies in $1.1 Billion Deal
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China-based Legend Biotech Corp., (NASDAQ: LEGN) has secured a second multinational partnership for its chimeric antigen receptor (CAR) T cell therapies with Novartis Pharma AG (NYSE: NVS) in a landmark USD 1.1 billion deal. The Swiss pharmaceutical giant has acquired exclusive global development, manufacturing, and commercialization rights to certain assets…
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Chiesi Farmaceutici and Shanghai Pharmaceutical Partner on Distribution at CIIE
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Among the series of deals secured by multinational corporations at the 6th China International Import Expo (CIIE), Italy-based Chiesi Farmaceutici S.p.A. has inked a partnership with Shanghai Pharmaceuticals Co., Ltd (SHA: 601607, HKG: 2607). This strategic alliance aims to capitalize on Shanghai Pharmaceutical’s extensive distribution network. As reported by Shine,…
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Novartis’ Remibrutinib Meets Milestones in Late-Stage Chronic Spontaneous Urticaria Studies
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that two late-stage studies for its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, used in the treatment of chronic spontaneous urticaria (CSU), have successfully met all primary and secondary endpoints at the 12-week mark of a 52-week trial. After three months of treatment…
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Sandoz Enters Euro Debt Market with $2.1 Billion Eurobond Issuance
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Switzerland-based Sandoz (SWX: SDZ), a leader in the generics and biosimilars market, has successfully entered the Euro debt capital market by issuing three inaugural Eurobond debt instruments, raising EUR 2.0 billion (USD 2.1 billion). This capital will be combined with a previous CHF issuance to repay a bridge loan of…
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Novartis’ Cosentyx Gains FDA Approval for Hidradenitis Suppurativa Treatment
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The US Food and Drug Administration (FDA) has issued regulatory approval for Novartis’ (NYSE: NVS) IL-17A-targeting drug Cosentyx (secukinumab) for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (HS). This approval positions Cosentyx as a new entrant in the HS biologic therapy market, potentially challenging AbbVie’s (NYSE: ABBV) Humira…
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Novartis Announces Positive Interim Results for Atrasentan in IgA Nephropathy Phase III Study
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Novartis (NYSE: NVS), a global healthcare company, has released interim results from an ongoing Phase III study for its endothelin A receptor antagonist (ERA) atrasentan, indicating a significant milestone in the treatment of IgA nephropathy (IgAN), a rare kidney disease. The trial successfully met its primary endpoint, demonstrating a clinically…
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Novartis’ Pluvicto Demonstrates Positive Phase III Results in mCRPC Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has released encouraging data from a Phase III study for its radioligand therapy (RLT) Pluvicto (177Lu vipivotide tetraxetan). The study focused on patients with prostate-specific membrane antigen (PSMA)-positive progressive metastatic castration-resistant prostate cancer (mCRPC), a challenging form of the disease. Primary Endpoint and Risk…
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Novartis Q3 Earnings Reflect Strong Growth Post-Sandoz Spinoff
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Novartis (NYSE: NVS) has released its Q3 2023 financial results, marking the first report since the company sharpened its focus on innovative medicines following the spinoff of Sandoz (SWX: SDZ) earlier this month. The financials reveal a robust performance with net sales reaching USD 34.0 billion for the first nine…
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Novartis’ Kisqali Plus Endocrine Therapy Shows Improved Survival in Early Breast Cancer Study
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Switzerland-based pharmaceutical company Novartis (NYSE: NVS) has announced additional results from an ongoing Phase III study evaluating the CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy for stage II and III HR+/HER2- early breast cancer (EBC). The findings confirm that the combination therapy significantly improves invasive disease-free survival (iDFS)…
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Novartis Halts Phase II Clinical Study for MIJ821 in Major Depressive Disorder
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has decided to hold the Phase II clinical study for its drug candidate MIJ821, which is being developed to treat major depressive disorder (MDD) with suicidal ideation, as noted by a company spokesperson in an email to overseas media. This marks the second…
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Sandoz Becomes Independent After Spin-Off from Novartis
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Switzerland-based generic and biosimilar drug maker Sandoz (SWX: SDZ) officially became a fully independent company last week, completing its separation from Novartis (NYSE: NVS) as previously announced. The decision to spin off Sandoz was first presented in 2022, aimed at establishing a global leader in generics and biosimilars while allowing…
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Novartis’ Lutathera Meets Primary Endpoint in Phase III Trial for GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement…
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Novartis’s Aimovig Approved by China’s NMPA for Preventive Migraines Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aimovig (erenumab), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), which can now be used as a preventive treatment for adult migraines in China. Phase III…
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BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
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China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene…
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Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
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Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive…
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Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of its CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy (ET) as an adjuvant treatment for HR+/HER2- early breast cancer (EBC). The data, recorded for up to three years, indicated that Kisqali reduced the risk…
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Sandoz Inks Deal with Samsung Bioepis for Ustekinumab Biosimilar SB17
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The Sandoz (SWX: SDZ) unit of Switzerland-based Novartis (NYSE: NVS) has announced the in-licensing of ustekinumab biosimilar SB17 from South Korea’s Samsung Bioepis. The agreement covers the markets of Canada, the European Economic Area (EEA), Switzerland, UK, and the US. The biosimilar references Johnson & Johnson (J&J; NYSE: JNJ) subsidiary…
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Novartis Sees 15% Global Sales Growth and Significant Investment in China for 2006
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Novartis, a multinational pharmaceutical giant, has reported a robust sales revenue of nearly US$275.7 million in the China market for the year 2006. This figure comes as part of a broader global sales increase of 15%, propelling the company’s total global revenue to US$37 billion, with net income soaring by…
