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    Aurigene reports Positive Ph 1 trial for CAR-T cell therapy in India

    09 Oct 2024

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    Dr. Reddy's, Aurigene, And Kainomyx Announce Potential Malaria Drug Partnership

    20 Aug 2024

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    Aurigene to Provide Cell Therapy Discovery Services

    01 Jul 2024

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    Aurigene Pharmaceutical Services is a CRO/CDMO with over two decades of experience. It offers a range of services for new therapeutics, from drug discovery, clinical research and development to manufacturing APIs and formulations at commercial scales. It has development laboratories from discovery to clinical phase 3 and cGMP manufacturing sites in the UK, Mexico, the USA and India. Its technology platforms include cytotoxic APIs, carbohydrates, steroids, PEG derivatives, prostaglandins, peptides and oligonucleotides. Its large molecule discovery services include ADC, MAB, MRNA and CART-T. Aurigene's two R&D centers are USFDA inspected.

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    39-40 Hosur Road KIADB Industrial Area, Joggers Ln, Phase 2, Electronic City, ...
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    CPhI India 2024

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    CORPORATE CONTENT #SupplierSpotlight

    Corporate Presentation

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    Analytical Chemistry

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    Toxicology

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    Antibody Drug Conjugate (ADC)

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    Process Development

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    cGMP Development and Manufacturing Services

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    Discovery, Development and Manufacturing Services

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    Formulation Development Services

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    Custom Peptide Synthesis

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    High Potent API (HPAPI) Manufacturing Services

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    NEWS #PharmaBuzz

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    Aurigene reports Positive Ph 1 trial for CAR-T cell therapy in India
    Aurigene reports Positive Ph 1 trial for CAR-T cell therapy in India

    09 Oct 2024

    // PRESS RELEASE

    https://www.aurigene.com/aurigene-oncology-limited-announces-promising-results-of-phase-1-study-for-indias-first-trial-for-novel-autologous-car-t-cell-therapy-for-multiple-myeloma/

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    09 Oct 2024
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    Dr. Reddy's, Aurigene, And Kainomyx Announce Potential Malaria Drug Partnership
    Dr. Reddy's, Aurigene, And Kainomyx Announce Potential Malaria Drug Partnership

    20 Aug 2024

    // PRESS RELEASE

    https://www.aurigeneservices.com/sites/default/files/2024-08/Media%20note-%20DRL-APSL%20partnership%20with%20Kainomyx.pdf

    PRESS RELEASE
    20 Aug 2024
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    Aurigene to Provide Cell Therapy Discovery Services
    Aurigene to Provide Cell Therapy Discovery Services

    01 Jul 2024

    // PRESS RELEASE

    https://www.aurigeneservices.com/sites/default/files/2024-07/APSL%20Edity%20Media%20note.pdf

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    01 Jul 2024
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    Aurigene Opens Biologics Facility For Process, Clinical Manufacturing
    Aurigene Opens Biologics Facility For Process, Clinical Manufacturing

    03 Jun 2024

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    https://www.aurigeneservices.com/sites/default/files/2024-06/Genomevalley-facility-press%20release-final-3rd-June-2024.pdf

    PRESS RELEASE
    03 Jun 2024
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    Aurigene & Vipergen Partner to Co-Market & Offer DEL Screening to Customers
    Aurigene & Vipergen Partner to Co-Market & Offer DEL Screening to Customers

    19 Apr 2024

    // PRESS RELEASE

    https://www.aurigeneservices.com/sites/default/files/2024-04/APSL%20Vipergen%20Partnership_Media%20Note.pdf

    PRESS RELEASE
    19 Apr 2024
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    Dr Reddy's arm rolls AI&ML assisted drug discovery platform Aurigene.AI
    Dr Reddy's arm rolls AI&ML assisted drug discovery platform Aurigene.AI

    04 Apr 2024

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    https://www.aurigeneservices.com/sites/default/files/2024-04/Aurigene-Pharma-Aurigene.AI_.pdf

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    04 Apr 2024
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    Drugs in Development

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    Virtual BoothAurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

    Dr. Reddy's, Aurigene, Kainomyx Partner For Affordable Anti-Malarial Drug

    Details:

    Kainomyx has agreed to lead the technical strategy and associated aspects for drug discovery and clinical phases, Aurigene has agreed to focus on developing cost-effective and scalable drug chemistry.


    Lead Product(s): Undisclosed

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: DiscoveryProduct Type: Undisclosed

    Sponsor: Kainomyx

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement August 20, 2024

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Discovery

    Partner/Sponsor/Collaborator : Kainomyx

    Deal Size : Undisclosed

    Deal Type : Agreement

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    Dr. Reddy's, Aurigene, Kainomyx Partner For Affordable Anti-Malarial Drug

    Details : Kainomyx has agreed to lead the technical strategy and associated aspects for drug discovery and clinical phases, Aurigene has agreed to focus on developing cost-effective and scalable drug chemistry.

    Brand Name : Undisclosed

    Molecule Type : Undisclosed

    Upfront Cash : Undisclosed

    August 20, 2024

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    Fermenta Biotech Licenses Its Proprietary Enzymatic Technology for Manufacturing Molnupiravir to Aurigene Pharma

    Details:

    Fermenta Biotech will exclusively license its biocatalytic technology for synthesis of Molnupiravir (Molflu) and supply its enzyme Candida Antarctica B Lipase (CAL B) to Aurigene. Molnupiravir API manufactured by Aurigene will be utilised by Dr Reddy’s for its formulation.


    Lead Product(s): Molnupiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Molflu

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Fermenta Biotech Limited

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 21, 2022

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    Lead Product(s) : Molnupiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Fermenta Biotech Limited

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

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    Fermenta Biotech Licenses Its Proprietary Enzymatic Technology for Manufacturing Molnupiravir to A...

    Details : Fermenta Biotech will exclusively license its biocatalytic technology for synthesis of Molnupiravir (Molflu) and supply its enzyme Candida Antarctica B Lipase (CAL B) to Aurigene. Molnupiravir API manufactured by Aurigene will be utilised by Dr Reddy’s...

    Brand Name : Molflu

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    January 21, 2022

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    Beroni Initiates Manufacture of its Novel, Potential Anti-Cancer Drug PENAO

    Details:

    This next-generation adenine nucleotide translocase (ANT) inhibitor, PENAO, was shown to be safe and well-tolerated in a phase I clinical trial conducted in Australia where encouraging efficacy data was observed.


    Lead Product(s): PENAO,Sirolimus

    Therapeutic Area: Oncology Brand Name: PENAO

    Study Phase: Phase I/ Phase IIProduct Type: Small molecule

    Sponsor: PENAO Pty Ltd

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement August 18, 2021

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    Lead Product(s) : PENAO,Sirolimus

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : PENAO Pty Ltd

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Beroni Initiates Manufacture of its Novel, Potential Anti-Cancer Drug PENAO

    Details : This next-generation adenine nucleotide translocase (ANT) inhibitor, PENAO, was shown to be safe and well-tolerated in a phase I clinical trial conducted in Australia where encouraging efficacy data was observed.

    Brand Name : PENAO

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    August 18, 2021

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    GARDP, Dr. Reddy’s and Aurigene Pharmaceutical Services Limited Sign MOU for Antibiotic Access Through Collaborative Model

    Details:

    Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.


    Lead Product(s): Zoliflodacin,Ceftriaxone,Azithromycin

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: The Global Antibiotic Research and Development Partnership

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement December 17, 2020

    Aurigene

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    Lead Product(s) : Zoliflodacin,Ceftriaxone,Azithromycin

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : The Global Antibiotic Research and Development Partnership

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    GARDP, Dr. Reddy’s and Aurigene Pharmaceutical Services Limited Sign MOU for Antibiotic Access T...

    Details : Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    December 17, 2020

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    Services

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    API Manufacturing

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    Drug Product Manufacturing

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    Injectable / Parenteral

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    Pharma Service : Drug Product Manufacturing

    Aurigene Pharmaceutical Services

    Aurigene Pharmaceutical Services provides formulation development and clinical and commercial manufacturing of injectable and parenteral formulations. It provides the clinical supply of a wide range of liquid, lyophilized, and complex injectables.

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    Category : Injectable / Parenteral

    Sub Category : Clinical Supply

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    Pharma Service : Drug Product Manufacturing

    CLINICAL MANUFACTURING FOR INJECTABLES

    Aurigene Pharmaceutical Services provides formulation development and clinical and commercial manufacturing of injectable and parenteral formulations. It provides the clinical supply of a wide range of liquid, lyophilized, and complex injectables.

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    LIQUID & LYOPHILIZED INJECTIONS

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    Pharma Service : Drug Product Manufacturing

    Aurigene Pharmaceutical Services

    Aurigene Pharmaceutical Services is a leading CRO/CDMO that provides end-to-end solutions. Its formulation manufacturing capabilities based out of India & USA include liquid & lyophilized injections, prefilled syringes & powder for reconstitution.

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    Category : Injectable / Parenteral

    Sub Category : Overview

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    Virtual BoothAurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

    Pharma Service : Drug Product Manufacturing

    LIQUID & LYOPHILIZED INJECTIONS

    Aurigene Pharmaceutical Services is a leading CRO/CDMO that provides end-to-end solutions. Its formulation manufacturing capabilities based out of India & USA include liquid & lyophilized injections, prefilled syringes & powder for reconstitution.

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    API & Drug Product Development

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