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    Company profile for Fujifilm Diosynth Biotechnologies

    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    About

    Fujifilm Diosynth Biotechnologies is an industry leading Biologics Contract Development and Manufacturing Organisation with locations in USA and UK. With extensive experience in the development and manufacture of biopharmaceuticals, we offer a comprehensive list of services from cell line and strain development, including our pAVEway; expression system, to process development, analytical development, clinical and commercial ma...
    Fujifilm Diosynth Biotechnologies is an industry leading Biologics Contract Development and Manufacturing Organisation with locations in USA and UK. With extensive experience in the development and manufacture of biopharmaceuticals, we offer a comprehensive list of services from cell line and strain development, including our pAVEway; expression system, to process development, analytical development, clinical and commercial manufacturing. Both sites are FDA-approved for the production of commercial products.

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    Belasis AvenueBillingham, TS23 1LHUnited Kingdom
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    INTERVIEW #SpeakPharma

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    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

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    09 Nov 2024
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    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    This year has seen pivotal advancements in medical innovation. The US Food and Drug Administration (FDA) has approved several groundbreaking therapies that promise to transform patient care across multiple therapeutic areas.Some of the therapies approved have revolutionary delivery mechanisms, while others are first-in-class treatments for previously unaddressed conditions. This week, PharmaCompass brings you a compilation of new pathbreaking approvals of 2024, including advancements in neurology, chronic conditions, mental health conditions, and innovative solutions for various other ailments.Lilly, Alpha Cognition, BMS transform neurological care with new Alzheimer’s, schizophrenia drugsThe neurological treatment landscape saw several major breakthroughs in 2024, particularly in the treatment of Alzheimer’s disease (AD). Eli Lilly’s Kisunla represents a significant advancement in treating early, symptomatic AD. Following decades of failed efforts, Kisunla’s approval, along with that of Eisai-Biogen’s Leqembi last year, marks a turning point in addressing AD.The drug works by targeting and clearing beta amyloid plaque from the brain, thereby attacking the disease’s underlying pathology, rather than just managing symptoms. Administered as an infusion every four weeks, Kisunla’s Medicare coverage makes it accessible to patients in the US who desperately need new treatment options. Alpha Cognition’s Zunveyl emerged as a promising new oral treatment for mild-to-moderate Alzheimer’s-related dementia. Only the second oral AD treatment approved by the FDA in over a decade, Zunveyl is a prodrug, or a biologically inactive compound that can be metabolized by the body to produce a drug. It remains inactive as it passes through the stomach and enhances cholinergic function in the brain.Perhaps one of the most exciting breakthroughs of 2024 was Bristol-Myers Squibb’s Cobenfy. This revolutionary antipsychotic medication for schizophrenia represents the first novel approach to treatment since the 1950s. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy works through cholinergic receptors, offering new hope to patients who struggle with the side effects of conventional treatments.Traditional antipsychotics have been associated with several mild and serious side effects such as weight gain, feeling unmotivated and sluggish, high rates of cardiac disease, and even early death. Cobenfy’s innovative mechanism of action has generated excitement in the medical community. Experts project Cobenfy to bring in US$ 7.5 billion in peak annual sales, thereby validating BMS’ recent, US$ 14-billion acquisition of Karuna Therapeutics.Verona, Sanofi’s drugs revolutionize COPD care; Madrigal’s Rezdiffra offers hope to MASH patients The landscape of chronic obstructive pulmonary disease (COPD) treatment saw remarkable advances in 2024. Verona Pharma’s Ohtuvayre brings the first new mechanism of action in over two decades for COPD treatment. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management.Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Dupixent is Sanofi’s best-selling drug. It is poised to cross over € 21 billion (US$ 23.5 billion) in sales by 2030, with COPD likely to contribute US$ 2.9 billion, predict analysts. Over 390 million people are living with COPD worldwide.In the field of liver disease, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring. This approval represents a breakthrough in a field that has been notorious for being a graveyard for failed programs. Rezdiffra offers hope to patients with this common liver condition, which primarily affects those with obesity or type 2 diabetes. The American Liver Foundation has termed this approval a “game-changing” moment in hepatology.For the rare disease community, Ipsen’s Iqirvo emerged as the first new medicine approved in nearly a decade for primary biliary cholangitis (PBC). This first-in-class peroxisome proliferator-activated receptor (PPAR) agonist offers new hope for the approximately 100,000 Americans affected by this condition, particularly women aged 30 to 60 years.A significant breakthrough for patients with hypoparathyroidism came with the approval of Ascendis’ Yorvipath, making it the only treatment for hypoparathyroidism in adults. By directly addressing the underlying hormone deficiency, Yorvipath helps stabilize calcium levels in the blood, reducing the treatment burden associated with managing symptoms through calcium and vitamin D supplements alone.In the realm of pulmonary medicine, Merck’s Winrevair emerged as the first new therapy for pulmonary arterial hypertension (PAH) in over a decade. As the first approved activin-signaling inhibitor therapy, Winrevair represents a novel approach to treating this rare but severe condition that doctors call a “ticking time bomb”. The drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.ARS Pharma launches nasal spray alternative to EpiPen, Eicos introduces med for severe frostbiteLeading the charge in innovative drug delivery is ARS Pharma’s Neffy, the first-ever nasal spray alternative to the EpiPen for treating severe allergic reactions. This groundbreaking advancement represents the first major innovation in anaphylaxis treatment in over a decade. For children and individuals with needle phobia, this nasal spray format addresses one of the most significant barriers to timely treatment of allergic emergencies. Speaking of emergency medicine, Eicos Sciences’ Aurlumyn made history as the first FDA-approved treatment for severe frostbite. This approval fills a critical gap in emergency care, offering a medical intervention that could prevent the need for amputation in severe cases.The cardiovascular space saw its first oral anti-hypertensive therapy that works through a new therapeutic pathway in almost 40 years. Idorsia’s Tryvio is a treatment for hypertension that offers new hope to patients whose blood pressure remains inadequately controlled on existing medications. Idorsia expects millions of patients to benefit from it.Our view This year, the pharmaceutical industry has taken a remarkable leap forward by addressing some of healthcare’s most challenging conditions. Treatments like BMS’ Cobenfy for schizophrenia and Madrigal’s Rezdiffra for MASH demonstrate the industry’s growing ability to translate science into practical therapies. With the growing use of artificial intelligence in the drug industry, we hope that these approvals are just a precursor to a bevy of pathbreaking therapies in the years to come. 
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    NEWS #PharmaBuzz

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    Fujifilm Diosynth Opens Billingham, UK Microbial Manufacturing Facility
    Fujifilm Diosynth Opens Billingham, UK Microbial Manufacturing Facility

    20 Aug 2024

    // CONTRACT PHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2024-08-20/fujifilm-diosynth-opens-billingham-uk-microbial-manufacturing-facility/?widget=listSection

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    20 Aug 2024
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    Fujifilm Diosynth's restructuring may leave 240 out of work
    Fujifilm Diosynth's restructuring may leave 240 out of work

    17 Apr 2024

    // Zoey Becker FIERCE PHARMA

    https://www.fiercepharma.com/manufacturing/cdmo-fujifilm-diosynths-new-restructuring-plan-may-leave-240-us-and-uk-staffers-out

    Zoey Becker FIERCE PHARMA
    17 Apr 2024
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    Fujifilm plots another $1.2B expansion, hiring spree at NC site
    Fujifilm plots another $1.2B expansion, hiring spree at NC site

    12 Apr 2024

    // Fraiser Kansteiner FIERCE PHARMA

    https://www.fiercepharma.com/pharma/fujifilm-diosynth-blueprints-12b-expansion-nc-plant-where-it-aims-employ-1400-2031#:~:text=Fujifilm%20is%20investing%20%241.2%20billion,company%20said%20in%20a%20release.

    Fraiser Kansteiner FIERCE PHARMA
    12 Apr 2024
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    FUJIFILM Diosynth Expands Manufacturing Agreement with Argenx for Efgartigimod
    FUJIFILM Diosynth Expands Manufacturing Agreement with Argenx for Efgartigimod

    25 Mar 2024

    // PRESS RELEASE

    https://fujifilmdiosynth.com/about/news/fujifilm-diosynth-biotechnologies-expands-manufacturing-agreement-with-argenx-for-efgartigimod-a-mab-for-the-treatment-of-severe-autoimmune-diseases/

    PRESS RELEASE
    25 Mar 2024
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    FUJIFILM Diosynth Biotechnologies Appoints Richard McAvoy as CFO
    FUJIFILM Diosynth Biotechnologies Appoints Richard McAvoy as CFO

    11 Mar 2024

    // PRESS RELEASE

    https://fujifilmdiosynth.com/about/news/fujifilm-diosynth-biotechnologies-appoints-richard-mcavoy-as-chief-financial-officer/

    PRESS RELEASE
    11 Mar 2024
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    FUJIFILM Diosynth Announces Renewable Energy Denmark Manufacturing Site
    FUJIFILM Diosynth Announces Renewable Energy Denmark Manufacturing Site

    29 Feb 2024

    // PRESS RELEASE

    https://fujifilmdiosynth.com/about/news/fujifilm-diosynth-biotechnologies-announces-renewable-energy-ppa-with-better-energy-for-denmark-manufacturing-site-2/

    PRESS RELEASE
    29 Feb 2024
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    Drugs in Development

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    FUJIFILM Diosynth Biotechnologies Enters into an Agreement with Argenx to Manufacture Efgartigimod, a Monoclonal Antibody (mAb) for the Treatment of Sev...

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    Under the agreement, FUJIFILM Diosynth Biotechnologies will provide drug substance manufacturing of efgartigimod (Vyvgart) at its large-scale biomanufacturing facility in Hillerod, Denmark.


    Lead Product(s): Efgartigimod

    Therapeutic Area: Immunology Brand Name: Vyvgart

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Argenx

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement October 27, 2022

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    Lead Product(s) : Efgartigimod

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Argenx

    Deal Size : Undisclosed

    Deal Type : Agreement

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    FUJIFILM Diosynth Biotechnologies Enters into an Agreement with Argenx to Manufacture Efgartigimod...

    Details : Under the agreement, FUJIFILM Diosynth Biotechnologies will provide drug substance manufacturing of efgartigimod (Vyvgart) at its large-scale biomanufacturing facility in Hillerod, Denmark.

    Brand Name : Vyvgart

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    October 27, 2022

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    Amid Low Vaccine Demand, Novavax Pulls Out Of Fujifilm Manufacturing Deal And Inks $185M Settlement

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    Novavax has been suffering from lower-than-expected demand for its COVID-19 vaccine (Nuvaxovid). Because of which Novavax will pay Fujifilm Diosynth Biotechnologies in a settlement tied to the "termination of manufacturing activity" at its CDMO partner.


    Lead Product(s): NVX-CoV2373,Matrix-M1

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuvaxovid

    Study Phase: ApprovedProduct Type: Vaccine

    Sponsor: Novavax

    Deal Size: $185.0 million Upfront Cash: Undisclosed

    Deal Type: Termination September 30, 2022

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    Lead Product(s) : NVX-CoV2373,Matrix-M1

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Novavax

    Deal Size : $185.0 million

    Deal Type : Termination

    DEALS_DEV arrow-down

    Amid Low Vaccine Demand, Novavax Pulls Out Of Fujifilm Manufacturing Deal And Inks $185M Settlemen...

    Details : Novavax has been suffering from lower-than-expected demand for its COVID-19 vaccine (Nuvaxovid). Because of which Novavax will pay Fujifilm Diosynth Biotechnologies in a settlement tied to the "termination of manufacturing activity" at its CDMO partner.

    Brand Name : Nuvaxovid

    Molecule Type : Vaccine

    Upfront Cash : Undisclosed

    September 30, 2022

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    Atara Biotherapeutics Announces the Completion of the Acquisition of Its Cell Therapy Manufacturing Facility & Commencement of Long-Term Strategic Partn...

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    FUJIFILM will provide Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its promising pipeline, including tabelecleucel (tab-cel®), ATA188, and allogeneic CAR T therapies.


    Lead Product(s): Tabelecleucel

    Therapeutic Area: Immunology Brand Name: Tab-cel

    Study Phase: Phase IIIProduct Type: Cell and Gene therapy

    Sponsor: Atara Biotherapeutics

    Deal Size: Undisclosed Upfront Cash: $100.0 million

    Deal Type: Partnership April 04, 2022

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    Lead Product(s) : Tabelecleucel

    Therapeutic Area : Immunology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Atara Biotherapeutics

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Atara Biotherapeutics Announces the Completion of the Acquisition of Its Cell Therapy Manufacturin...

    Details : FUJIFILM will provide Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its promising pipeline, including tabelecleucel (tab-cel®), ATA188, and allogeneic...

    Brand Name : Tab-cel

    Molecule Type : Cell and Gene therapy

    Upfront Cash : $100.0 million

    April 04, 2022

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    Atara Biotherapeutics Enters Strategic Manufacturing Partnership with Fujifilm

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    Under the agreement with FUJIFILM, will acquire Atara’s T-Cell Operations and Manufacturing facility. Atara with access to the flexible capacity needed to manufacture clinical and commercial stage allogeneic cell therapies for its pipeline, including tabelecleucel (tab-cel®).


    Lead Product(s): Tabelecleucel

    Therapeutic Area: Immunology Brand Name: Tab-cel

    Study Phase: Phase IIIProduct Type: Cell and Gene therapy

    Recipient: Atara Biotherapeutics

    Deal Size: $100.0 million Upfront Cash: $100.0 million

    Deal Type: Partnership January 26, 2022

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    Lead Product(s) : Tabelecleucel

    Therapeutic Area : Immunology

    Highest Development Status : Phase III

    Recipient : Atara Biotherapeutics

    Deal Size : $100.0 million

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Atara Biotherapeutics Enters Strategic Manufacturing Partnership with Fujifilm

    Details : Under the agreement with FUJIFILM, will acquire Atara’s T-Cell Operations and Manufacturing facility. Atara with access to the flexible capacity needed to manufacture clinical and commercial stage allogeneic cell therapies for its pipeline, including t...

    Brand Name : Tab-cel

    Molecule Type : Cell and Gene therapy

    Upfront Cash : $100.0 million

    January 26, 2022

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    aTyr Pharma and FUJIFILM Diosynth Biotechnologies Announce Manufacturing Agreement for aTyr’s Lead Therapeutic Candidate ATYR1923

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    Under the terms of the agreement, FUJIFILM Diosynth Biotechnologies will support process development and scale up of ATYR1923, including the manufacture of bulk drug substance for additional clinical trials in ILD.


    Lead Product(s): ATYR1923

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: ATYR1923

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

    Sponsor: aTyr Pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement November 30, 2021

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    Lead Product(s) : ATYR1923

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : aTyr Pharma

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    aTyr Pharma and FUJIFILM Diosynth Biotechnologies Announce Manufacturing Agreement for aTyr’s Le...

    Details : Under the terms of the agreement, FUJIFILM Diosynth Biotechnologies will support process development and scale up of ATYR1923, including the manufacture of bulk drug substance for additional clinical trials in ILD.

    Brand Name : ATYR1923

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    November 30, 2021

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    Fujifilm Diosynth Biotechnologies Expands Its Partnership with Novavax to Manufacture Covid-19 Vaccine Candidate at its Billingham Site

    Details:

    FUJIFILM's site in Billingham, UK will manufacture antigen component of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. Billingham plans to begin production of the first batch at beginning of Q1, 2021.


    Lead Product(s): NVX-COV2373,Matrix-M

    Therapeutic Area: Infections and Infectious Diseases Brand Name: NVX-COV2373

    Study Phase: Phase I/ Phase IIProduct Type: Vaccine

    Sponsor: Novavax

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership August 17, 2020

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    Lead Product(s) : NVX-COV2373,Matrix-M

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Novavax

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Fujifilm Diosynth Biotechnologies Expands Its Partnership with Novavax to Manufacture Covid-19 Vac...

    Details : FUJIFILM's site in Billingham, UK will manufacture antigen component of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. Billingham plans to begin production of the first batch at beginning of Q1, 2021.

    Brand Name : NVX-COV2373

    Molecule Type : Vaccine

    Upfront Cash : Undisclosed

    August 17, 2020

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    BARDA drafts Fujifilm Diosynth into its vaccine production effort, offering to also accelerate capacity expansion

    Details:

    FUJIFILM Diosynth Biotechnologies' College Station, Texas, site will support COVID-19 vaccine manufacturing, and Speed up U.S. government program to begin delivering millions of doses of COVID-19 vaccine to U.S. population.


    Lead Product(s): NVX-COV2373,Matrix-M

    Therapeutic Area: Infections and Infectious Diseases Brand Name: NVX-COV2373

    Study Phase: Phase I/ Phase IIProduct Type: Vaccine

    Sponsor: BARDA

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration August 03, 2020

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    Lead Product(s) : NVX-COV2373,Matrix-M

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : BARDA

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    BARDA drafts Fujifilm Diosynth into its vaccine production effort, offering to also accelerate cap...

    Details : FUJIFILM Diosynth Biotechnologies' College Station, Texas, site will support COVID-19 vaccine manufacturing, and Speed up U.S. government program to begin delivering millions of doses of COVID-19 vaccine to U.S. population.

    Brand Name : NVX-COV2373

    Molecule Type : Vaccine

    Upfront Cash : Undisclosed

    August 03, 2020

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    FUJIFILM Diosynth Biotechnologies Texas Facility to Support COVID-19 Vaccine Candidate Manufacturing

    Details:

    FUJIFILM Diosynth will support COVID-19 vaccine candidate manufacturing, as part of Operation Warp Speed, a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population.


    Lead Product(s): NVX-COV2373,Matrix-M

    Therapeutic Area: Infections and Infectious Diseases Brand Name: NVX-COV2373

    Study Phase: Phase IProduct Type: Vaccine

    Sponsor: U.S Government

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration July 27, 2020

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    Lead Product(s) : NVX-COV2373,Matrix-M

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : U.S Government

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    FUJIFILM Diosynth Biotechnologies Texas Facility to Support COVID-19 Vaccine Candidate Manufacturi...

    Details : FUJIFILM Diosynth will support COVID-19 vaccine candidate manufacturing, as part of Operation Warp Speed, a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population.

    Brand Name : NVX-COV2373

    Molecule Type : Vaccine

    Upfront Cash : Undisclosed

    July 27, 2020

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    Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate

    Details:

    The Agreement aims to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.


    Lead Product(s): NVX-COV2373,Matrix-M

    Therapeutic Area: Infections and Infectious Diseases Brand Name: NVX-COV2373

    Study Phase: Phase IProduct Type: Vaccine

    Recipient: Novavax

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement July 23, 2020

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    Fujifilm Diosynth Biotechnologies

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    Lead Product(s) : NVX-COV2373,Matrix-M

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I

    Recipient : Novavax

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vacci...

    Details : The Agreement aims to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

    Brand Name : NVX-COV2373

    Molecule Type : Vaccine

    Upfront Cash : Undisclosed

    July 23, 2020

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    Fujifilm to Begin Clinical Trials Testing Avigan in COVID-19 Patients in Kuwait

    Details:

    Avigan (favipiravir) is an antiviral medication largely used to treat influenza in Japan. It was approved in the country in 2014 and became a generic drug in 2019.


    Lead Product(s): Favipiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Avigan

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Dr. Reddy\'s Laboratories

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 21, 2020

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    Fujifilm Diosynth Biotechnologies

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    Lead Product(s) : Favipiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Dr. Reddy\'s Laboratories

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Fujifilm to Begin Clinical Trials Testing Avigan in COVID-19 Patients in Kuwait

    Details : Avigan (favipiravir) is an antiviral medication largely used to treat influenza in Japan. It was approved in the country in 2014 and became a generic drug in 2019.

    Brand Name : Avigan

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 21, 2020

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