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Novartis’ Pluvicto Gains Expanded FDA Approval for Prostate Cancer Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received expanded indication approval from the US Food and Drug Administration (FDA) for its radioligand therapy (RLT) Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The PSMA-targeted therapy is now approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients who have been…
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Novartis’ Fabhalta Approved by FDA for C3 Glomerulopathy Treatment
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Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan, marketed as Fabhalta, has received approval from the US Food and Drug Administration (FDA) for the treatment of adults with C3 glomerulopathy (C3G). This marks the first and only approved therapy specifically targeting this rare kidney disease, which is characterized by a poor…
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Novartis’ Cosentyx Approved by NMPA for Moderate to Severe Hidradenitis Suppurativa
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Swiss giant Novartis’ (NYSE: NVS) Cosentyx (secukinumab) has secured another indication approval from China’s National Medical Products Administration (NMPA), this time for the treatment of moderate to severe hidradenitis suppurativa (HS). This IL-17A-targeted therapy previously gained approval in China for moderate-to-severe plaque psoriasis, ankylosing spondylitis, and active psoriatic arthritis (PsA).…
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Kyorin Pharmaceutical Licenses KRP-M223 to Novartis for Global Development
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Japan-based Kyorin Pharmaceutical Co., Ltd. announced a licensing agreement with Novartis (NYSE: NVS), granting the Swiss pharmaceutical giant exclusive global development, manufacturing, and commercialization rights to its KRP-M223. Under the agreement, Kyorin retains an option to commercialize the drug in Japan and manufacture it for the Japanese market, while Novartis…
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Novartis to Acquire Anthos Therapeutics for $3.1B, Boosting Factor XI Inhibitor Portfolio
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Swiss pharma giant Novartis (NYSE: NVS) announced plans to acquire Anthos Therapeutics, Inc., a cardiometabolic-focused biopharma co-founded with Blackstone Life Sciences in 2019, in a deal valued at up to USD 3.1 billion. The transaction underscores Novartis’ commitment to expanding its pipeline in thrombosis and cardiovascular diseases. Acquisition TermsAnthos shareholders…
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Bio-Thera’s Biosimilars BAT2306 and BAT2506 Accepted for Review by NMPA and EMA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that the market filings for its biosimilars BAT2306 and BAT2506 have been accepted for review by China’s National Medical Products Administration (NMPA) and the European Medicines Agency (EMA), respectively. BAT2306 is a biosimilar version of Novartis’ (NYSE: NVS) Cosentyx (secukinumab), while BAT2506 is…
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Novartis to Defend Entresto Patent After CAFC Ruling
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Novartis (NYSE: NVS) has revealed a favorable decision by the US Court of Appeals for the Federal Circuit (CAFC), affirming the validity of the Entresto (sacubitril/valsartan) combination patent. This decision comes as the pediatric exclusivity period for the combination patent is set to expire in July 2025. The Swiss pharmaceutical…
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Novartis Announces Positive Results from Phase III STEER Study on SMA Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive topline results from the Phase III STEER study, which was designed to assess the efficacy and safety of its intrathecal onasemnogene abeparvovec (OAV101 IT) in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2. The study focused on patients aged two…
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BioAge Labs and Novartis Partner to Discover Aging-Related Therapeutic Targets
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US-based BioAge Labs, Inc. has announced a strategic research partnership with Swiss pharmaceutical giant Novartis (NYSE: NVS). This multi-year collaboration aims to identify and validate novel therapeutic drug targets by delving into the biological mechanisms that underpin aging-related diseases and the beneficial effects of physical exercise. The partnership is designed…
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UCB’s Minzasolmin Fails to Meet Endpoints in ORCHESTRA Study for Early Parkinson’s
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Belgium-based biopharmaceutical company UCB (EBR: UCB) has announced the disappointing results of the ORCHESTRA proof-of-concept (POC) study for minzasolmin, an alpha-synuclein misfolding inhibitor co-developed with Swiss pharmaceutical giant Novartis (NYSE: NVS). The study was designed to assess the efficacy of minzasolmin in treating early Parkinson’s disease, but it failed to…
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Siemens Healthineers AG Acquires Advanced Accelerator Applications to Boost PETNET Solutions
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Germany-based Siemens Healthineers AG (ETR: SHL) has announced the completion of its acquisition of Advanced Accelerator Applications (AAA) Molecular Imaging from Novartis (NYSE: NVS). This strategic move is anticipated to significantly enhance Siemens’ PETNET Solutions sector, strengthening its position in the field of positron emission tomography (PET) and radiopharmaceuticals. Enhancing…
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Novartis’ Kisqali Shows Sustained Efficacy in NATALEE Study at SABCS 2024
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Swiss pharmaceutical giant Novartis (NYSE: NVS) presented updated results from the pivotal Phase III NATALEE study for its Kisqali (ribociclib) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study provides significant insights into the efficacy of Kisqali in combination with endocrine therapy (ET) for patients with receptor-positive/human epidermal…
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Novartis’ Fabhalta Demonstrates Positive Results in APPULSE-PNH Phase IIIb Study
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Swiss pharmaceutical major Novartis (NYSE: NVS) has released positive topline results from the APPULSE-PNH Phase IIIb study for its complement inhibitor Fabhalta (iptacopan). This study marks a significant milestone in the evaluation of Fabhalta’s efficacy and safety in treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH). APPULSE-PNH Study Design and…
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Tasly Pharma Receives NMPA Approval for Generic Lioresal (Baclofen) Oral Solution
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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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Novartis Secures Global Rights to PTC Therapeutics’ Huntington’s Disease Treatment PTC518
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has entered into a global license and collaboration agreement with US firm PTC Therapeutics (NASDAQ: PTCT), obtaining development, manufacturing, and commercialization rights to PTC518, an HTT mRNA splice modulator targeting Huntington’s disease. Financial Terms and Milestones of the AgreementUnder the terms of the agreement,…
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Novartis’s Kisqali Approved by EC for Adjuvant Treatment of High-Risk Early Breast Cancer
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced that it has received marketing approval from the European Commission (EC) for its CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early…
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Novartis Expands Gene Therapy Portfolio with Acquisition of Kate Therapeutics
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced the acquisition of US-based Kate Therapeutics, Inc., a pre-clinical biotech firm specializing in adeno-associated virus (AAV)-based gene therapies for muscle and heart diseases, for a substantial USD 1.1 billion. This strategic move allows Novartis to gain access to Kate’s pre-clinical gene therapy…
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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…
