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    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    With Fermion, start the journey of your innovative API.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    About

    We are a global leader in providing integrated services, superior drug delivery technologies & manufacturing solutions to help life science innovators develop & launch successful pharmaceuticals, biologics and consumer health products, enabling a better customer journey from product development to patient. With over 85 years of experience in the industry, Catalent supports partners in introducing 200 new products and manufactu...
    We are a global leader in providing integrated services, superior drug delivery technologies & manufacturing solutions to help life science innovators develop & launch successful pharmaceuticals, biologics and consumer health products, enabling a better customer journey from product development to patient. With over 85 years of experience in the industry, Catalent supports partners in introducing 200 new products and manufacturing over 70 billion doses/year. We have grown to become a vibrant community of approximately 15,000 employees, including around 2,400 scientists and technicians, supporting over 7,000 products for over 1,000 customers.

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    NEWS #PharmaBuzz

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    Regulatory conditions on Novo $16.5 billion Catalent deal fulfilled
    Regulatory conditions on Novo $16.5 billion Catalent deal fulfilled

    16 Dec 2024

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    https://www.catalent.com/catalent-news/catalent-and-novo-holdings-fulfill-all-regulatory-closing-conditions-for-pending-transaction/

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    Novo holding Clears Catalent Buy & 3 Novo Nordisk Sites Acquisitions
    Novo holding Clears Catalent Buy & 3 Novo Nordisk Sites Acquisitions

    14 Dec 2024

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    https://www.catalent.com/catalent-news/catalent-and-novo-holdings-fulfill-all-regulatory-closing-conditions-for-pending-transaction/

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    Novo Holdings' $16.5 bln Catalent buy wins EU antitrust approval
    Novo Holdings' $16.5 bln Catalent buy wins EU antitrust approval

    09 Dec 2024

    // PRESS RELEASE

    https://www.catalent.com/catalent-news/catalent-and-novo-holdings-receive-european-commission-unconditional-approval-for-pending-transaction/

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    09 Dec 2024
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    Novo Holdings set to win EU nod for $16.5 bln Catalent deal
    Novo Holdings set to win EU nod for $16.5 bln Catalent deal

    23 Nov 2024

    // REUTERS

    https://www.reuters.com/markets/deals/eu-antitrust-regulators-set-okay-165-bln-novo-holdings-catalent-deal-source-says-2024-11-22/

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    23 Nov 2024
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    EU regulators quiz Novo Nordisk, Catalent rivals on $16.5 bln deal
    EU regulators quiz Novo Nordisk, Catalent rivals on $16.5 bln deal

    13 Nov 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulators-quiz-novo-nordisk-catalent-rivals-165-bln-deal-2024-11-13/

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    13 Nov 2024
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    Catalent Reports First Quarter Fiscal 2025 Results
    Catalent Reports First Quarter Fiscal 2025 Results

    05 Nov 2024

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    https://www.businesswire.com/news/home/20241105555610/en

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    05 Nov 2024
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    Drugs in Development

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    Siren Biotechnology and Catalent Partner to Manufacture AAV Gene Therapies for Cancer

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    The partnership aims to support the development and manufacturing of Siren Biotechnology’s AAV immuno-gene therapies, being developed for the treatment of cancer.


    Lead Product(s): AAV-based Therapy

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Cell and Gene therapy

    Sponsor: Siren Biotechnology

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership May 08, 2024

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    Lead Product(s) : AAV-based Therapy

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Siren Biotechnology

    Deal Size : Undisclosed

    Deal Type : Partnership

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    Siren Biotechnology and Catalent Partner to Manufacture AAV Gene Therapies for Cancer

    Details : The partnership aims to support the development and manufacturing of Siren Biotechnology’s AAV immuno-gene therapies, being developed for the treatment of cancer.

    Brand Name : Undisclosed

    Molecule Type : Cell and Gene therapy

    Upfront Cash : Undisclosed

    May 08, 2024

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    Melt Pharmaceuticals Announces Exclusive Development and License Agreement with Catalent for its Zydis® Fast-Dissolve Technology for Use in MELT-300 fo...

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    Under the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis® orally disintegrating tablet fast-dissolve technology with MELT-300 (midazolam), a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery.


    Lead Product(s): Midazolam,Ketamine Hydrochloride

    Therapeutic Area: Neurology Brand Name: Melt-300

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Melt Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement September 26, 2023

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    Lead Product(s) : Midazolam,Ketamine Hydrochloride

    Therapeutic Area : Neurology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Melt Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Melt Pharmaceuticals Announces Exclusive Development and License Agreement with Catalent for its Z...

    Details : Under the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis® orally disintegrating tablet fast-dissolve technology with MELT-300 (midazolam), a sublingual, needle- and opioid-free patented formulation for procedural sedation du...

    Brand Name : Melt-300

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    September 26, 2023

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    MindMed Announces Exclusive License Agreement with Catalent for its Patented Zydis® Fast-Dissolve Technology for Use with MM-120

    Details:

    Under the agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead candidate MM-120 (lysergide D-tartrate), which is currently in Phase 2 for generalized anxiety disorder.


    Lead Product(s): Lysergide D-tartrate

    Therapeutic Area: Psychiatry/Psychology Brand Name: MM-120

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Mind Medicine

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement August 03, 2023

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    Lead Product(s) : Lysergide D-tartrate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Mind Medicine

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    MindMed Announces Exclusive License Agreement with Catalent for its Patented Zydis® Fast-Dissolve...

    Details : Under the agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead candidate MM-120 (lysergide D-tartrate), which is currently in Phase 2 for generalized anxiety disorder.

    Brand Name : MM-120

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    August 03, 2023

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    Harm Reduction Therapeutics and Catalent Sign Commercial Supply Agreement for Naloxone Nasal Spray to Reverse Opioid Overdoses

    Details:

    Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™, for the emergency treatment of known or suspected opioid overdose.


    Lead Product(s): Naloxone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Rivive

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Harm Reduction Therapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement March 23, 2023

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    Lead Product(s) : Naloxone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Harm Reduction Therapeutics

    Deal Size : Undisclosed

    Deal Type : Agreement

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    Harm Reduction Therapeutics and Catalent Sign Commercial Supply Agreement for Naloxone Nasal Spray...

    Details : Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™, for the emergency treatment of known or suspected opioid overdose.

    Brand Name : Rivive

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    March 23, 2023

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    Catalent and Grünenthal Announce Successful Collaboration to Facilitate Expedited Clinical Development Timelines

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    The collaboration leads to the successful reformulation of an investigational, orally dosed small molecule in Grünenthal’s pipeline to improve its bioavailability. Phase 1 studies of the molecule will be supported by using the Catalent Xpress Pharmaceutics™ platform.


    Lead Product(s): Undisclosed

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Small molecule

    Sponsor: Grunenthal

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration March 15, 2023

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Neurology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Grunenthal

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Catalent and Grünenthal Announce Successful Collaboration to Facilitate Expedited Clinical Develo...

    Details : The collaboration leads to the successful reformulation of an investigational, orally dosed small molecule in Grünenthal’s pipeline to improve its bioavailability. Phase 1 studies of the molecule will be supported by using the Catalent Xpress Pharmace...

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    March 15, 2023

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    Incannex Engages Catalent to Develop and Manufacture cGMP-Grade Psilocybin Drug Products for Clinical Trials and Potential Commercial Use

    Details:

    PSI-GAD (psilocybin) reacts agonistically with serotonin (5-hydroxytryptamine) type 2A (5-HT2A) receptors to produce a “mystical-like” hallucinatory effect due to induced frontal hyper-frontality, which in turn mediates its anti-depressant and anti-anxiety effects.


    Lead Product(s): Psilocybine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Incannex Healthcare

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 06, 2023

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    Lead Product(s) : Psilocybine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Incannex Healthcare

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Incannex Engages Catalent to Develop and Manufacture cGMP-Grade Psilocybin Drug Products for Clini...

    Details : PSI-GAD (psilocybin) reacts agonistically with serotonin (5-hydroxytryptamine) type 2A (5-HT2A) receptors to produce a “mystical-like” hallucinatory effect due to induced frontal hyper-frontality, which in turn mediates its anti-depressant and anti-a...

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 06, 2023

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    Catalent and Ethicann Sign Development and License Agreement for New Fast-Dissolve Cannabinoid-Based Treatments

    Details:

    Under the terms of the license agreement, Catalent and Ethicann will develop Ethicann’s clinical drug pipeline using Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology including EPI-002 (cannabinoid) candidate to treat MS spasticity.


    Lead Product(s): Cannabinoid

    Therapeutic Area: Musculoskeletal Brand Name: EPI-002

    Study Phase: PreclinicalProduct Type: Small molecule

    Sponsor: Ethicann Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 12, 2023

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    Lead Product(s) : Cannabinoid

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Ethicann Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Catalent and Ethicann Sign Development and License Agreement for New Fast-Dissolve Cannabinoid-Bas...

    Details : Under the terms of the license agreement, Catalent and Ethicann will develop Ethicann’s clinical drug pipeline using Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology including EPI-002 (cannabinoid) candidate to treat MS sp...

    Brand Name : EPI-002

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    January 12, 2023

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    Acorda Therapeutics Announces New Agreement with Catalent for Long-Term Global Supply of INBRIJA®

    Details:

    INBRIJA® (levodopa) is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa. INBRIJA utilizes ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation.


    Lead Product(s): Etilevodopa

    Therapeutic Area: Neurology Brand Name: Inbrija

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Acorda Therapeutics

    Deal Size: $10.0 million Upfront Cash: Undisclosed

    Deal Type: Agreement January 05, 2023

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    Lead Product(s) : Etilevodopa

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Acorda Therapeutics

    Deal Size : $10.0 million

    Deal Type : Agreement

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    Acorda Therapeutics Announces New Agreement with Catalent for Long-Term Global Supply of INBRIJA®

    Details : INBRIJA® (levodopa) is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa. INBRIJA utilizes ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inha...

    Brand Name : Inbrija

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    January 05, 2023

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    Sarepta and Catalent Expand Strategic Manufacturing Partnership With Commercial Supply Agreement for Duchenne Muscular Dystrophy Gene Therapy Candidate

    Details:

    SRP-9001 (delandistrogene moxeparvovec) is an investigational gene transfer therapy intended to deliver SRP-9001 to muscle tissue for the targeted production of essential components of dystrophin.


    Lead Product(s): Delandistrogene Moxeparvovec

    Therapeutic Area: Genetic Disease Brand Name: SRP-9001

    Study Phase: Phase IIIProduct Type: Cell and Gene therapy

    Sponsor: Sarepta Therapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement January 05, 2023

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    Lead Product(s) : Delandistrogene Moxeparvovec

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Sarepta Therapeutics

    Deal Size : Undisclosed

    Deal Type : Agreement

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    Sarepta and Catalent Expand Strategic Manufacturing Partnership With Commercial Supply Agreement f...

    Details : SRP-9001 (delandistrogene moxeparvovec) is an investigational gene transfer therapy intended to deliver SRP-9001 to muscle tissue for the targeted production of essential components of dystrophin.

    Brand Name : SRP-9001

    Molecule Type : Cell and Gene therapy

    Upfront Cash : Undisclosed

    January 05, 2023

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    Exelixis and Catalent Enter into New License Agreement for Three Antibody-Drug Conjugate Programs

    Details:

    Exelixis will fund the development work conducted by Catalent until development candidate selection is complete, after which Exelixis will assume responsibility for conducting preclinical, clinical, and commercial activities.


    Lead Product(s): Antibody-drug Conjugate

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: DiscoveryProduct Type: Large molecule

    Sponsor: Exelixis

    Deal Size: Undisclosed Upfront Cash: $30.0 million

    Deal Type: Licensing Agreement November 03, 2022

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    Lead Product(s) : Antibody-drug Conjugate

    Therapeutic Area : Oncology

    Highest Development Status : Discovery

    Partner/Sponsor/Collaborator : Exelixis

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

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    Exelixis and Catalent Enter into New License Agreement for Three Antibody-Drug Conjugate Programs

    Details : Exelixis will fund the development work conducted by Catalent until development candidate selection is complete, after which Exelixis will assume responsibility for conducting preclinical, clinical, and commercial activities.

    Brand Name : Undisclosed

    Molecule Type : Large molecule

    Upfront Cash : $30.0 million

    November 03, 2022

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