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    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across...
    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative bioph

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    INTERVIEW #SpeakPharma

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    “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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    Pfizer doesn't expect major vaccine policy changes in 2025
    Pfizer doesn't expect major vaccine policy changes in 2025

    18 Dec 2024

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    https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-forecasts-2025-profit-line-with-expectations-2024-12-17/

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    Pfizer Declares First-Quarter 2025 Dividend
    Pfizer Declares First-Quarter 2025 Dividend

    12 Dec 2024

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    https://www.businesswire.com/news/home/20241211645444/en

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    Pfizer’s Ibrance Improves Survival in New Breast Cancer Indication
    Pfizer’s Ibrance Improves Survival in New Breast Cancer Indication

    12 Dec 2024

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    https://www.biospace.com/drug-development/pfizers-ibrance-improves-survival-in-new-breast-cancer-indication

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    Lilly CEO says tax & Regulation reform, drug affordability focuses
    Lilly CEO says tax & Regulation reform, drug affordability focuses

    11 Dec 2024

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    https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-ceo-says-tax-regulation-reform-drug-affordability-are-focuses-under-trump-2024-12-10/

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    11 Dec 2024
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    Amazon, Pfizer, RFK Jr Discuss Climate Health Risks Collaboration
    Amazon, Pfizer, RFK Jr Discuss Climate Health Risks Collaboration

    11 Dec 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/amazon-pharmacy-exec-hopeful-rfk-jr-is-an-ally-2024-12-11/

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    11 Dec 2024
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    Pfizer Webcast On Dec 17 For 2025 Financial Guidance
    Pfizer Webcast On Dec 17 For 2025 Financial Guidance

    10 Dec 2024

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    https://www.businesswire.com/news/home/20241210056613/en

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    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's be...
    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative bioph
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    Pfizer Inc

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative bioph

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    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative bioph
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    Pfizer Inc

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative bioph

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    Drugs in Development

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    Zai Lab and Pfizer Collaborate on XACDURO® for Novel Antibacterial Applications

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    The collaboration aims for the commercialisation of novel antibacterial drug Xacduro (sulbactam-durlobactam) for the treatment of carbapenem-resistant Acinetobacter baumannii, in mainland China.


    Lead Product(s): Sulbactam,Durlobactam

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Zai Lab

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration November 21, 2024

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    Lead Product(s) : Sulbactam,Durlobactam

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Recipient : Zai Lab

    Deal Size : Undisclosed

    Deal Type : Collaboration

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    Zai Lab and Pfizer Collaborate on XACDURO® for Novel Antibacterial Applications

    Details : The collaboration aims for the commercialisation of novel antibacterial drug Xacduro (sulbactam-durlobactam) for the treatment of carbapenem-resistant Acinetobacter baumannii, in mainland China.

    Brand Name : Xacduro

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    November 21, 2024

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    EU Approves Pfizer’s HYMPAVZI™ for Severe Hemophilia A/B Without Inhibitors

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    Hympavzi (marstacimab) is a human mAb IgG1 that targets TFPI approved as a subcutaneous treatment for severe hemophilia A or moderately severe to severe hemophilia B in 12 years and above patients.


    Lead Product(s): Marstacimab

    Therapeutic Area: Genetic Disease Brand Name: Hympavzi

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 20, 2024

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    Lead Product(s) : Marstacimab

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    EU Approves Pfizer’s HYMPAVZI™ for Severe Hemophilia A/B Without Inhibitors

    Details : Hympavzi (marstacimab) is a human mAb IgG1 that targets TFPI approved as a subcutaneous treatment for severe hemophilia A or moderately severe to severe hemophilia B in 12 years and above patients.

    Brand Name : Hympavzi

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 20, 2024

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    TRIANA and Pfizer Partner to Discover Novel Molecular Glue Degraders

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    The collaboration aims to discover novel molecular glue degraders for multiple targets in several disease areas, including oncology.


    Lead Product(s): Undisclosed

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Discovery PlatformProduct Type: Small molecule

    Recipient: TRIANA Biomedicines

    Deal Size: $1,549.0 million Upfront Cash: $49.0 million

    Deal Type: Collaboration October 15, 2024

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Oncology

    Highest Development Status : Discovery Platform

    Recipient : TRIANA Biomedicines

    Deal Size : $1,549.0 million

    Deal Type : Collaboration

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    TRIANA and Pfizer Partner to Discover Novel Molecular Glue Degraders

    Details : The collaboration aims to discover novel molecular glue degraders for multiple targets in several disease areas, including oncology.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : $49.0 million

    October 15, 2024

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    IsomAb and Pfizer Partner on PAD Development Candidate Collaboration

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    IsomAb collaborates with Pfizer Ignite to support preclinical development and IND-enabling studies for ISM-001 for the treatemnt of chronic limb threatening ischaemia.


    Lead Product(s): ISM-001

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: ISM-001

    Study Phase: PreclinicalProduct Type: Large molecule

    Recipient: IsomAb

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration October 15, 2024

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    Lead Product(s) : ISM-001

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Preclinical

    Recipient : IsomAb

    Deal Size : Undisclosed

    Deal Type : Collaboration

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    IsomAb and Pfizer Partner on PAD Development Candidate Collaboration

    Details : IsomAb collaborates with Pfizer Ignite to support preclinical development and IND-enabling studies for ISM-001 for the treatemnt of chronic limb threatening ischaemia.

    Brand Name : ISM-001

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    October 15, 2024

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    FDA Approves Pfizer’s HYMPAVZI™ For Hemophilia A Or B Without Inhibitors

    Details:

    Hympavzi (marstacimab) is a human mAb IgG1 that targets TFPI approved as a subcutaneous treatment for severe hemophilia A or moderately severe to severe hemophilia B in 12 years and above patients.


    Lead Product(s): Marstacimab

    Therapeutic Area: Genetic Disease Brand Name: Hympavzi

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 11, 2024

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    Lead Product(s) : Marstacimab

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Approves Pfizer’s HYMPAVZI™ For Hemophilia A Or B Without Inhibitors

    Details : Hympavzi (marstacimab) is a human mAb IgG1 that targets TFPI approved as a subcutaneous treatment for severe hemophilia A or moderately severe to severe hemophilia B in 12 years and above patients.

    Brand Name : Hympavzi

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    October 11, 2024

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    Strong Cresemba® Sales in Asia Trigger Milestone Payment to Basilea

    Details:

    Cresemba (isavuconazonium sulfate) is the prodrug of isavuconazole which is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.


    Lead Product(s): Isavuconazonium Sulfate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Basilea Pharmaceutica

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement October 10, 2024

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    Pfizer Inc

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    Lead Product(s) : Isavuconazonium Sulfate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Recipient : Basilea Pharmaceutica

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Strong Cresemba® Sales in Asia Trigger Milestone Payment to Basilea

    Details : Cresemba (isavuconazonium sulfate) is the prodrug of isavuconazole which is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.

    Brand Name : Cresemba

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 10, 2024

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    Biohaven Initiates Pivotal Trial of Novel Investigational Drug For Treatment of Migraine

    Details:

    BHV-2100 is a potentially first-in-class, potent, selective, orally administered TRPM3 antagonist, a novel, non-sedating non-opioid treatment for migraine and pain.


    Lead Product(s): BHV-2100

    Therapeutic Area: Neurology Brand Name: BHV-2100

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 30, 2024

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    Biohaven Pharmaceuticals

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    Lead Product(s) : BHV-2100

    Therapeutic Area : Neurology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Biohaven Initiates Pivotal Trial of Novel Investigational Drug For Treatment of Migraine

    Details : BHV-2100 is a potentially first-in-class, potent, selective, orally administered TRPM3 antagonist, a novel, non-sedating non-opioid treatment for migraine and pain.

    Brand Name : BHV-2100

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 30, 2024

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    Japan Approves PADCEV™ with KEYTRUDA® for Unresectable Urothelial Carcinoma

    Details:

    Padcev (enfortumab vedotin), a nectin-4 inhibitor ADC in combination with keytruda, a PD-1 inhibitor. It is being evaluated for the treatment of locally advanced or metastatic urothelial cancer.


    Lead Product(s): Enfortumab Vedotin,Pembrolizumab

    Therapeutic Area: Oncology Brand Name: Padcev

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Astellas Pharma

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 24, 2024

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    Pfizer Inc

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    Lead Product(s) : Enfortumab Vedotin,Pembrolizumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Recipient : Astellas Pharma

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Japan Approves PADCEV™ with KEYTRUDA® for Unresectable Urothelial Carcinoma

    Details : Padcev (enfortumab vedotin), a nectin-4 inhibitor ADC in combination with keytruda, a PD-1 inhibitor. It is being evaluated for the treatment of locally advanced or metastatic urothelial cancer.

    Brand Name : Padcev

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 24, 2024

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    Biohaven Reports Positive Results for Troriluzole in Spinocerebellar Ataxia

    Details:

    BHV-4157 (troriluzole ) is a third-generation novel prodrug that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. It is being evaluated for Spinocerebellar Ataxia.


    Lead Product(s): Troriluzole

    Therapeutic Area: Genetic Disease Brand Name: BHV-4157

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 23, 2024

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    Biohaven Pharmaceuticals

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    Lead Product(s) : Troriluzole

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Biohaven Reports Positive Results for Troriluzole in Spinocerebellar Ataxia

    Details : BHV-4157 (troriluzole ) is a third-generation novel prodrug that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. It is being evaluated for Spinocerebellar Ataxia.

    Brand Name : BHV-4157

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 23, 2024

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    Valneva and Pfizer Report Positive Phase 2 Booster Results for Lyme Disease Vaccine

    Details:

    VLA15, an alum-adjuvanted intramuscular vaccine, which is currently undergoing clinical development for the treatment of Lyme disease.


    Lead Product(s): VLA15

    Therapeutic Area: Infections and Infectious Diseases Brand Name: VLA15

    Study Phase: Phase IIIProduct Type: Vaccine

    Recipient: Valneva

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 03, 2024

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    Pfizer Inc

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    Lead Product(s) : VLA15

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Recipient : Valneva

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Valneva and Pfizer Report Positive Phase 2 Booster Results for Lyme Disease Vaccine

    Details : VLA15, an alum-adjuvanted intramuscular vaccine, which is currently undergoing clinical development for the treatment of Lyme disease.

    Brand Name : VLA15

    Molecule Type : Vaccine

    Upfront Cash : Not Applicable

    September 03, 2024

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