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    Company profile for Novartis Pharmaceuticals Corporation

    Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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    About

    Our Pharma US Business Novartis Pharmaceuticals Corporation (NPC) – a US affiliate of Basel, Switzerland-based Novartis AG – is committed to the research and development and marketing of patent-protected medicines and treatments for helping patients and improving patient care. We do business responsibly and we adhere to the highest ethical standards as outlined in the Novartis Code of Conduct. At Novartis Pharmaceuticals ...
    Our Pharma US Business Novartis Pharmaceuticals Corporation (NPC) – a US affiliate of Basel, Switzerland-based Novartis AG – is committed to the research and development and marketing of patent-protected medicines and treatments for helping patients and improving patient care. We do business responsibly and we adhere to the highest ethical standards as outlined in the Novartis Code of Conduct. At Novartis Pharmaceuticals Corporation, we believe that all Americans deserve access to quality health care, including prescription medicines, health education about their disease or condition

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    Novartis Pharmaceuticals CorporationSwitzerland Flag
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "50 Years of Innovation: Mikart

    mic"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

    This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey? Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands? At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings 

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    17 Jul 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaQuality, Reliability, TrustQuality, Reliability, Trust

    Quality, Reliability, Trust
    Quality, Reliability, Trust

    reelQuality, Reliability, Trust

    This PharmaReel highlights Rochem’s capabilities in sourcing and supplying Generic APIs and Excipients, driven by Quality, Reliability, and Trust through fully cGMP-compliant operations. With over 30 years of experience and 16 offices worldwide, Rochem continues to develop partnerships across the US, China, Europe, and South America.

    Impressions: 3300

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired  Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord).  Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation. 
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    Impressions: 7375

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-veranova-carbogen-lead-adc-investments-axplora-polfa-tarchomin-famar-expand-european-footprint

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    10 Jul 2025
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    NEWS #PharmaBuzz

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    Novartis Scores Double Phase 3 Win in Sjögren's Syndrome
    Novartis Scores Double Phase 3 Win in Sjögren's Syndrome

    12 Aug 2025

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/novartis-scores-double-phase-3-win-sjogrens-syndrome-succeeding-where-others-failed

    FIERCE BIOTECH
    12 Aug 2025
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    Novartis Weighs Deal for Biotech Avidity Biosciences
    Novartis Weighs Deal for Biotech Avidity Biosciences

    09 Aug 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-weighs-deal-biotech-avidity-biosciences-ft-reports-2025-08-06/

    REUTERS
    09 Aug 2025
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    FDA Approves Novartis' Leqvio (Inclisiran) for First-Line Use
    FDA Approves Novartis' Leqvio (Inclisiran) for First-Line Use

    31 Jul 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/novartis-twice-yearly-leqvio-inclisiran-receives-fda-approval-for-new-indication-enabling-first-line-use-302519118.html

    PR NEWSWIRE
    31 Jul 2025
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    Novartis India Reports Rs. 27.62 Cr Net Profit in Q1 FY26
    Novartis India Reports Rs. 27.62 Cr Net Profit in Q1 FY26

    30 Jul 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/novartis-india-posts-q1-fy26-net-profit-at-rs-2762-cr-17503

    INDPHARMAPOST
    30 Jul 2025
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    Novartis Drops up to $1B+ for Drug Discovery Deal With Matchpoint
    Novartis Drops up to $1B+ for Drug Discovery Deal With Matchpoint

    26 Jul 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/07/24/3120941/0/en/Matchpoint-Therapeutics-Announces-Exclusive-Option-and-License-Agreement-with-Novartis-to-Develop-Oral-Inhibitors-for-Multiple-Inflammatory-Diseases.html

    GLOBENEWSWIRE
    26 Jul 2025
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    Analysis Group Explores HEOR Use in Rare Disease CGTs
    Analysis Group Explores HEOR Use in Rare Disease CGTs

    22 Jul 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/analysis-group-co-authors-examine-the-advancements-in-and-application-of-health-economics-and-outcomes-research-to-the-evaluation-of-cell-and-gene-therapies-for-rare-diseases-302511043.html

    PR NEWSWIRE
    22 Jul 2025
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    Drugs in Development

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    Matchpoint Announces Option and License Agreement with Novartis to Develop Oral Inhibitors

    Details:

    The agreement aims for the development and commercialization of oral covalent inhibitors directed at a transcription factor linked to a number of inflammatory diseases.


    Lead Product(s): Undisclosed

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Other Small Molecule

    Recipient: Matchpoint Therapeutics

    Deal Size: $1,000.0 million Upfront Cash: $60.0 million

    Deal Type: Licensing Agreement July 24, 2025

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Immunology

    Highest Development Status : Preclinical

    Recipient : Matchpoint Therapeutics

    Deal Size : $1,000.0 million

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Matchpoint Announces Option and License Agreement with Novartis to Develop Oral Inhibitors

    Details : The agreement aims for the development and commercialization of oral covalent inhibitors directed at a transcription factor linked to a number of inflammatory diseases.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : $60.0 million

    July 24, 2025

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    ProFound Therapeutics Announces Multi-Year Strategic Collaboration with Novartis

    Details:

    The collaboration of ProFound with Novartis to discover and develop novel therapeutics for cardiovascular disease leveraging its ProFoundry Platform.


    Lead Product(s): Undisclosed

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Discovery PlatformProduct Type: Protein

    Recipient: ProFound Therapeutics

    Deal Size: $775.0 million Upfront Cash: $25.0 million

    Deal Type: Collaboration June 26, 2025

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Discovery Platform

    Recipient : ProFound Therapeutics

    Deal Size : $775.0 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    ProFound Therapeutics Announces Multi-Year Strategic Collaboration with Novartis

    Details : The collaboration of ProFound with Novartis to discover and develop novel therapeutics for cardiovascular disease leveraging its ProFoundry Platform.

    Product Name : Undisclosed

    Product Type : Protein

    Upfront Cash : $25.0 million

    June 26, 2025

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    Novartis Completes Acquisition of Regulus Therapeutics

    Details:

    Through the acquisition, Novartis will levarage Regulus pipeline, which includes RGLS8429 (farabursen), a potential next-gen oligonucleotide targeting miR-17 for the treatment of ADPKD.


    Lead Product(s): Farabursen

    Therapeutic Area: Genetic Disease Brand Name: RGLS8429

    Study Phase: Phase IProduct Type: Oligonucleotide

    Recipient: Regulus Therapeutics

    Deal Size: $1,700.0 million Upfront Cash: $800.0 million

    Deal Type: Acquisition June 25, 2025

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    Lead Product(s) : Farabursen

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase I

    Recipient : Regulus Therapeutics

    Deal Size : $1,700.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Novartis Completes Acquisition of Regulus Therapeutics

    Details : Through the acquisition, Novartis will levarage Regulus pipeline, which includes RGLS8429 (farabursen), a potential next-gen oligonucleotide targeting miR-17 for the treatment of ADPKD.

    Product Name : RGLS8429

    Product Type : Oligonucleotide

    Upfront Cash : $800.0 million

    June 25, 2025

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    Novartis Acquires Regulus and Farabursen for ADPKD Treatment

    Details:

    Through the acquisition, Novartis will levarage Regulus pipeline, which includes RGLS8429 (farabursen), a potential next-gen oligonucleotide targeting miR-17 for the treatment of ADPKD.


    Lead Product(s): Farabursen

    Therapeutic Area: Genetic Disease Brand Name: RGLS8429

    Study Phase: Phase IProduct Type: Oligonucleotide

    Recipient: Regulus Therapeutics

    Deal Size: $1,700.0 million Upfront Cash: $800.0 million

    Deal Type: Acquisition April 30, 2025

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    Lead Product(s) : Farabursen

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase I

    Recipient : Regulus Therapeutics

    Deal Size : $1,700.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Novartis Acquires Regulus and Farabursen for ADPKD Treatment

    Details : Through the acquisition, Novartis will levarage Regulus pipeline, which includes RGLS8429 (farabursen), a potential next-gen oligonucleotide targeting miR-17 for the treatment of ADPKD.

    Product Name : RGLS8429

    Product Type : Oligonucleotide

    Upfront Cash : $800.0 million

    April 30, 2025

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    CareMed Chosen As Specialty Pharmacy Partner For VANRAFIA

    Details:

    The partnership aims to distribute Novartis' Vanrafia (atrasentan HCl) through CareMed. It is indicated for the treatment of proteinuria in adults with primary immunoglobulin A nephropathy.


    Lead Product(s): Atrasentan

    Therapeutic Area: Nephrology Brand Name: Vanrafia

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: CareMed

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership April 07, 2025

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    Lead Product(s) : Atrasentan

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : CareMed

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    CareMed Chosen As Specialty Pharmacy Partner For VANRAFIA

    Details : The partnership aims to distribute Novartis' Vanrafia (atrasentan HCl) through CareMed. It is indicated for the treatment of proteinuria in adults with primary immunoglobulin A nephropathy.

    Product Name : Vanrafia

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    April 07, 2025

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    Novartis has Completed the Acquisition of Anthos

    Details:

    Through the acquisition, Novartis will strengthen its cardiovascular portfolio with Anthos' MAA868 (abelacimab), a potential monoclonal antibody for the treatment of atrial fibrillation.


    Lead Product(s): Abelacimab

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: MAA868

    Study Phase: Phase IIIProduct Type: Antibody

    Recipient: Anthos Therapeutics

    Deal Size: $3,075.0 million Upfront Cash: $925.0 million

    Deal Type: Acquisition April 03, 2025

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    Lead Product(s) : Abelacimab

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Recipient : Anthos Therapeutics

    Deal Size : $3,075.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Novartis has Completed the Acquisition of Anthos

    Details : Through the acquisition, Novartis will strengthen its cardiovascular portfolio with Anthos' MAA868 (abelacimab), a potential monoclonal antibody for the treatment of atrial fibrillation.

    Product Name : MAA868

    Product Type : Antibody

    Upfront Cash : $925.0 million

    April 03, 2025

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    Novartis Gets FDA Approval for Vanrafia® to Reduce Proteinuria in IgAN

    Details:

    Vanrafia (atrasentan HCl) is an investigational oral endothelin A receptor antagonist (ERA), which is approved for IgAN and early-stage development for other rare kidney diseases.


    Lead Product(s): Atrasentan

    Therapeutic Area: Nephrology Brand Name: Vanrafia

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 02, 2025

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    Lead Product(s) : Atrasentan

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Novartis Gets FDA Approval for Vanrafia® to Reduce Proteinuria in IgAN

    Details : Vanrafia (atrasentan HCl) is an investigational oral endothelin A receptor antagonist (ERA), which is approved for IgAN and early-stage development for other rare kidney diseases.

    Product Name : Vanrafia

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    April 02, 2025

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    FDA Approves Novartis' Pluvicto for PSMA+ mCRPC Before Chemotherapy

    Details:

    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen, which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.


    Lead Product(s): 177Lu-vipivotide Tetraxetan,68Ga-PSMA-11

    Therapeutic Area: Oncology Brand Name: Pluvicto

    Study Phase: Approved FDFProduct Type: Radiolabelled Compounds

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 28, 2025

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    Lead Product(s) : 177Lu-vipivotide Tetraxetan,68Ga-PSMA-11

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FDA Approves Novartis' Pluvicto for PSMA+ mCRPC Before Chemotherapy

    Details : Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen, which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.

    Product Name : Pluvicto

    Product Type : Radiolabelled Compounds

    Upfront Cash : Inapplicable

    March 28, 2025

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    Novartis’ Fabhalta® FDA Approved for C3 Glomerulopathy (C3G) Treatment

    Details:

    Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is now approved by FDA for the treatment of patients withC3 glomerulopathy.


    Lead Product(s): Iptacopan HCl

    Therapeutic Area: Nephrology Brand Name: Fabhalta

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 20, 2025

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    Lead Product(s) : Iptacopan HCl

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Novartis’ Fabhalta® FDA Approved for C3 Glomerulopathy (C3G) Treatment

    Details : Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is now approved by FDA for the treatment of patients withC3 glomerulopathy.

    Product Name : Fabhalta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 20, 2025

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    Novartis Phase III Data Shows Efficacy of Onasemnogene Abeparvovec in SMA

    Details:

    Zolgensma (onasemnogene abeparvovec) is USFDA approved, one time gne therapy that acts as SMN1 gene stimulant. It is indicated for the treatment of spinal muscular atrophy.


    Lead Product(s): Onasemnogene Abeparvovec

    Therapeutic Area: Genetic Disease Brand Name: Zolgensma

    Study Phase: Phase IIIProduct Type: Cell and Gene therapy

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 19, 2025

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    Lead Product(s) : Onasemnogene Abeparvovec

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Novartis Phase III Data Shows Efficacy of Onasemnogene Abeparvovec in SMA

    Details : Zolgensma (onasemnogene abeparvovec) is USFDA approved, one time gne therapy that acts as SMN1 gene stimulant. It is indicated for the treatment of spinal muscular atrophy.

    Product Name : Zolgensma

    Product Type : Cell and Gene therapy

    Upfront Cash : Inapplicable

    March 19, 2025

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    FDA Orange Book

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    01

    Brand Name : TAVIST ALLERGY/SINUS...

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : TAVIST ALLERGY/SINUS...

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : TAVIST ALLERGY/SINUS/HEA...

    Dosage Strength : 500MG;EQ 0.25MG BASE;30M...

    Approval Date : 2001-03-01

    Application Number : 21082

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    Brand Name : MIOCHOL

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : MIOCHOL

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    RLD : Yes

    TE Code :

    ACETYLCHOLINE CHLORIDE

    Novartis Pharmaceuticals Corporation

    Dosage Form : FOR SOLUTION; OPHTHALMIC

    Proprietary Name : MIOCHOL

    Dosage Strength : 20MG/VIAL **Federal Regi...

    Approval Date : 1982-01-01

    Application Number : 16211

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    03

    Brand Name : ACYLANID

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : ACYLANID

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    RLD : No

    TE Code :

    ACETYLDIGITOXIN

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYLANID

    Dosage Strength : 0.1MG

    Approval Date : 1982-01-01

    Application Number : 9436

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    Brand Name : TEKAMLO

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : TEKAMLO

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    RLD : No

    TE Code :

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : TEKAMLO

    Dosage Strength : EQ 150MG BASE;EQ 5MG BAS...

    Approval Date : 2010-08-26

    Application Number : 22545

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    Brand Name : TEKAMLO

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : TEKAMLO

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    RLD : No

    TE Code :

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : TEKAMLO

    Dosage Strength : EQ 150MG BASE;EQ 10MG BA...

    Approval Date : 2010-08-26

    Application Number : 22545

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    06

    Brand Name : TEKAMLO

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : TEKAMLO

    Switzerland
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    RLD : No

    TE Code :

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : TEKAMLO

    Dosage Strength : EQ 300MG BASE;EQ 5MG BAS...

    Approval Date : 2010-08-26

    Application Number : 22545

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    07

    Brand Name : TEKAMLO

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : TEKAMLO

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    RLD : No

    TE Code :

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : TEKAMLO

    Dosage Strength : EQ 300MG BASE;EQ 10MG BA...

    Approval Date : 2010-08-26

    Application Number : 22545

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Market
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    08

    Brand Name : AMTURNIDE

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : AMTURNIDE

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    RLD : No

    TE Code :

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMTURNIDE

    Dosage Strength : EQ 150MG BASE;EQ 5MG BAS...

    Approval Date : 2010-12-21

    Application Number : 200045

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    09

    Brand Name : AMTURNIDE

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : AMTURNIDE

    Switzerland
    ACS Fall 2025
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    RLD : No

    TE Code :

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMTURNIDE

    Dosage Strength : EQ 300MG BASE;EQ 5MG BAS...

    Approval Date : 2010-12-21

    Application Number : 200045

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    Brand Name : AMTURNIDE

    Switzerland
    ACS Fall 2025
    Not Confirmed
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    Brand Name : AMTURNIDE

    Switzerland
    ACS Fall 2025
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    RLD : No

    TE Code :

    ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

    Novartis Pharmaceuticals Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMTURNIDE

    Dosage Strength : EQ 300MG BASE;EQ 5MG BAS...

    Approval Date : 2010-12-21

    Application Number : 200045

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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