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    About

    Our goal is to lead the way to a healthier future. But we also care about how we get there together. As a company whose products touch the lives and well being of people around the world, we hold ourselves to a high standard. And we expect others to hold us to that same high standard. We believe in operating openly, honestly and with the highest degree of ethics and integrity. This includes: making sure that the compa...
    Our goal is to lead the way to a healthier future. But we also care about how we get there together. As a company whose products touch the lives and well being of people around the world, we hold ourselves to a high standard. And we expect others to hold us to that same high standard. We believe in operating openly, honestly and with the highest degree of ethics and integrity. This includes: making sure that the company complies with all applicable laws and regulations globally.

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    One Merck Drive, P.O. Box 100 Whitehouse Station, NJ 08889-0100
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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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    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  
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    16 Jan 2025
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    NEWS #PharmaBuzz

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    Kennedy played key role in Gardasil vaccine case against Merck
    Kennedy played key role in Gardasil vaccine case against Merck

    20 Jan 2025

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    https://www.reuters.com/business/healthcare-pharmaceuticals/kennedy-played-key-role-vaccine-case-against-merck-2025-01-18/

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    Merck Sets Q4 And Full-Year 2024 Earnings Call For February 4
    Merck Sets Q4 And Full-Year 2024 Earnings Call For February 4

    16 Jan 2025

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    https://www.businesswire.com/news/home/20250116091826/en

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    Merck's HPV vaccine gets China approval for amid declining sales
    Merck's HPV vaccine gets China approval for amid declining sales

    08 Jan 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/merck-says-its-hpv-vaccine-men-was-approved-by-chinas-drug-regulator-2025-01-08/

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    Merck’s GARDASIL® Receives Expanded Approval for Males in China
    Merck’s GARDASIL® Receives Expanded Approval for Males in China

    08 Jan 2025

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    https://www.businesswire.com/news/home/20250107385832/en

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    WuXi Biologics to sell Irish vaccine site to Merck for $500M
    WuXi Biologics to sell Irish vaccine site to Merck for $500M

    07 Jan 2025

    // ENDPTS

    https://endpts.com/wuxi-biologics-to-sell-irish-vaccine-site-to-merck-for-500m/

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    07 Jan 2025
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    Merck to Participate in the 43rd Annual J.P. Morgan Conference
    Merck to Participate in the 43rd Annual J.P. Morgan Conference

    06 Jan 2025

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    https://www.businesswire.com/news/home/20250106531854/en

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    06 Jan 2025
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    Drugs in Development

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    Merck Licenses LM-299, An Anti-PD-1/VEGF Bispecific Antibody for Global Development

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    The agreement aims to develop, manufacture and commercialize LM-299, a novel investigational PD-1/VEGF bispecific antibody from LaNova.


    Lead Product(s): LM-299

    Therapeutic Area: Oncology Brand Name: LM-299

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

    Recipient: LaNova Medicines

    Deal Size: $3,288.0 million Upfront Cash: $588.0 million

    Deal Type: Licensing Agreement December 20, 2024

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    Lead Product(s) : LM-299

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Recipient : LaNova Medicines

    Deal Size : $3,288.0 million

    Deal Type : Licensing Agreement

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    Merck Licenses LM-299, An Anti-PD-1/VEGF Bispecific Antibody for Global Development

    Details : The agreement aims to develop, manufacture and commercialize LM-299, a novel investigational PD-1/VEGF bispecific antibody from LaNova.

    Brand Name : LM-299

    Molecule Type : Large molecule

    Upfront Cash : $588.0 million

    December 20, 2024

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    Merck Signs Up to $2 Bln Obesity Drug Deal with Chinese Biotech Hansoh

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    Under the agreement, Hansoh has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist.


    Lead Product(s): HS-10535

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: HS-10535

    Study Phase: PreclinicalProduct Type: Small molecule

    Recipient: Hansoh Pharma

    Deal Size: $2,012.0 million Upfront Cash: $112.0 million

    Deal Type: Licensing Agreement December 18, 2024

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    Lead Product(s) : HS-10535

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Preclinical

    Recipient : Hansoh Pharma

    Deal Size : $2,012.0 million

    Deal Type : Licensing Agreement

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    Merck Signs Up to $2 Bln Obesity Drug Deal with Chinese Biotech Hansoh

    Details : Under the agreement, Hansoh has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist.

    Brand Name : HS-10535

    Molecule Type : Small molecule

    Upfront Cash : $112.0 million

    December 18, 2024

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    FDA Approves VTAMA® Cream for Adults and Kids Aged 2+ with Atopic Dermatitis

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    Vtama (tapinarof) cream is an aryl hydrocarbon receptor agonist steroid-free, topical cream, for the treatment of atopic dermatitis in adults & children 2 years of age & above.


    Lead Product(s): Tapinarof

    Therapeutic Area: Dermatology Brand Name: Vtama

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 16, 2024

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    Lead Product(s) : Tapinarof

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    FDA Approves VTAMA® Cream for Adults and Kids Aged 2+ with Atopic Dermatitis

    Details : Vtama (tapinarof) cream is an aryl hydrocarbon receptor agonist steroid-free, topical cream, for the treatment of atopic dermatitis in adults & children 2 years of age & above.

    Brand Name : Vtama

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 16, 2024

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    KEYTRUDA® Approved in China for Resectable NSCLC with Chemotherapy and Surgery

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    Keytruda (pembrolizumab) is an anti-PD-1 therapy, indicated for the first-line treatment of patients with stage II, IIIA, or IIIB non-small cell lung cancer.


    Lead Product(s): Pembrolizumab,Cisplatin,Gemcitabine

    Therapeutic Area: Oncology Brand Name: Keytruda

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 16, 2024

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    Lead Product(s) : Pembrolizumab,Cisplatin,Gemcitabine

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    KEYTRUDA® Approved in China for Resectable NSCLC with Chemotherapy and Surgery

    Details : Keytruda (pembrolizumab) is an anti-PD-1 therapy, indicated for the first-line treatment of patients with stage II, IIIA, or IIIB non-small cell lung cancer.

    Brand Name : Keytruda

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    December 16, 2024

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    FDA Grants Breakthrough Designation to Sacituzumab for Advanced NSCLC with EGFR Mutations

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    SKB264 (sacituzumab tirumotecan) is a TROP-2 targeting ADC, being investiated in adult with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer.


    Lead Product(s): Sacituzumab Tirumotecan

    Therapeutic Area: Oncology Brand Name: SKB264

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

    Sponsor: Sichuan Kelun-Biotech Biopharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 03, 2024

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    Lead Product(s) : Sacituzumab Tirumotecan

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Sichuan Kelun-Biotech Biopharmaceutical

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    FDA Grants Breakthrough Designation to Sacituzumab for Advanced NSCLC with EGFR Mutations

    Details : SKB264 (sacituzumab tirumotecan) is a TROP-2 targeting ADC, being investiated in adult with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer.

    Brand Name : SKB264

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    December 03, 2024

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    Merck’s WINREVAIR™ Hits Endpoint in Phase 3 ZENITH Trial for Pulmonary Hypertension

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    Winrevair (sotatercept), an activin signaling inhibitor therapy, being evaluated for the treatment of adults with pulmonary arterial hypertension functional class III or IV at high risk of mortality.


    Lead Product(s): Sotatercept

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Winrevair

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 25, 2024

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    Lead Product(s) : Sotatercept

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Merck’s WINREVAIR™ Hits Endpoint in Phase 3 ZENITH Trial for Pulmonary Hypertension

    Details : Winrevair (sotatercept), an activin signaling inhibitor therapy, being evaluated for the treatment of adults with pulmonary arterial hypertension functional class III or IV at high risk of mortality.

    Brand Name : Winrevair

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 25, 2024

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    Merck Says Keytruda Injection On Par with Approved IV Version in Trial

    Details:

    MK-3475A (pembrolizumab, PD-1 inhibitor with berahyaluronidase alfa) in combination with chemotherapy is being investigated for adult patients with metastatic non-small cell lung cancer.


    Lead Product(s): Pembrolizumab,Berahyaluronidase Alfa,Pemetrexed

    Therapeutic Area: Oncology Brand Name: MK-3475A

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 19, 2024

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    Merck & Co

    U.S.A
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    Lead Product(s) : Pembrolizumab,Berahyaluronidase Alfa,Pemetrexed

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Merck Says Keytruda Injection On Par with Approved IV Version in Trial

    Details : MK-3475A (pembrolizumab, PD-1 inhibitor with berahyaluronidase alfa) in combination with chemotherapy is being investigated for adult patients with metastatic non-small cell lung cancer.

    Brand Name : MK-3475A

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 19, 2024

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    Toragen Updates Phase 1 TGN-S11 Data for HPV-Associated Stage 4 Cancers

    Details:

    TGN-S11 is an E5 oncogene protein Inhibitor small molecule drug candidate, which is being evaluated in combination with pembrolizumab for the treatment of HPV-Induced Cancer.


    Lead Product(s): TGN-S11,Pembrolizumab

    Therapeutic Area: Oncology Brand Name: TGN-S11

    Study Phase: Phase IProduct Type: Small molecule

    Recipient: Toragen

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 18, 2024

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    U.S.A
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    Lead Product(s) : TGN-S11,Pembrolizumab

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Recipient : Toragen

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Toragen Updates Phase 1 TGN-S11 Data for HPV-Associated Stage 4 Cancers

    Details : TGN-S11 is an E5 oncogene protein Inhibitor small molecule drug candidate, which is being evaluated in combination with pembrolizumab for the treatment of HPV-Induced Cancer.

    Brand Name : TGN-S11

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 18, 2024

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    Merck Signs Up to $3.3 Billion Cancer Drug Deal with China-Based Lanova

    Details:

    Merck will acquire the global rights to develop and market LM-299, a novel investigational PD-1/VEGF bispecific antibody, for the treatment of advanced solid tumours.


    Lead Product(s): LM-299

    Therapeutic Area: Oncology Brand Name: LM-299

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

    Recipient: LaNova Medicines

    Deal Size: $3,288.0 million Upfront Cash: $588.0 million

    Deal Type: Licensing Agreement November 16, 2024

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    Merck & Co

    U.S.A
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    U.S.A
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    Lead Product(s) : LM-299

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Recipient : LaNova Medicines

    Deal Size : $3,288.0 million

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Merck Signs Up to $3.3 Billion Cancer Drug Deal with China-Based Lanova

    Details : Merck will acquire the global rights to develop and market LM-299, a novel investigational PD-1/VEGF bispecific antibody, for the treatment of advanced solid tumours.

    Brand Name : LM-299

    Molecule Type : Large molecule

    Upfront Cash : $588.0 million

    November 16, 2024

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    Merck Gains EU CHMP Opinion for KEYTRUDA® in Unresectable Malignant Pleural Mesothelioma

    Details:

    FDA has already approved Keytruda (Pembrolizumab) in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic MPM.


    Lead Product(s): Pembrolizumab,Pemetrexed

    Therapeutic Area: Oncology Brand Name: Keytruda

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 15, 2024

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    10

    Merck & Co

    U.S.A
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    Cosmoprof
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    Merck & Co

    U.S.A
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    Lead Product(s) : Pembrolizumab,Pemetrexed

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Merck Gains EU CHMP Opinion for KEYTRUDA® in Unresectable Malignant Pleural Mesothelioma

    Details : FDA has already approved Keytruda (Pembrolizumab) in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic MPM.

    Brand Name : Keytruda

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 15, 2024

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    01

    Brand Name : REGU-MATE SOLUTION 0...

    U.S.A
    Cosmoprof
    Not Confirmed
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    Brand Name : REGU-MATE SOLUTION 0...

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    ALTRENOGEST

    Merck & Co

    Dosage Form : SOLUTION

    Dosage Strength : 2.2MG/ML

    Packaging : 150 ML/1 L

    Brand Name : REGU-MATE SOLUTION 0.22%

    Approval Date :

    Application Number : 641987

    Regulatory Info :

    Registration Country : Canada

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    02

    Brand Name : PARACILLIN SP

    U.S.A
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    Brand Name : PARACILLIN SP

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    AMOXICILLIN TRIHYDRATE

    Merck & Co

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 800MG/G

    Packaging : 250G/1000G

    Brand Name : PARACILLIN SP

    Approval Date :

    Application Number : 2281376

    Regulatory Info :

    Registration Country : Canada

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    03

    Brand Name : OTOMAX

    U.S.A
    Cosmoprof
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    Brand Name : OTOMAX

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    BETAMETHASONE (BETAMETHASONE VALERATE)

    Merck & Co

    Dosage Form : OINTMENT

    Dosage Strength : 1MG/G

    Packaging : 7.5/12.5/15/30/215...

    Brand Name : OTOMAX

    Approval Date :

    Application Number : 817112

    Regulatory Info :

    Registration Country : Canada

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    04

    Brand Name : TOPAGEN

    U.S.A
    Cosmoprof
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    Brand Name : TOPAGEN

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    BETAMETHASONE (BETAMETHASONE VALERATE)

    Merck & Co

    Dosage Form : SPRAY

    Dosage Strength : 0.284MG/ML

    Packaging : 70ML

    Brand Name : TOPAGEN

    Approval Date :

    Application Number : 602841

    Regulatory Info :

    Registration Country : Canada

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    05

    Brand Name : DOLOREX

    U.S.A
    Cosmoprof
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    Brand Name : DOLOREX

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    BUTORPHANOL (BUTORPHANOL TARTRATE)

    Merck & Co

    Dosage Form : SOLUTION

    Dosage Strength : 10MG/ML

    Packaging : 10ML/50ML

    Brand Name : DOLOREX

    Approval Date :

    Application Number : 2462923

    Regulatory Info :

    Registration Country : Canada

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    06

    Brand Name : METRICURE

    U.S.A
    Cosmoprof
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    Brand Name : METRICURE

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    CEPHAPIRIN BENZATHINE

    Merck & Co

    Dosage Form : SUSPENSION

    Dosage Strength : 640MG/19G

    Packaging : 19G

    Brand Name : METRICURE

    Approval Date :

    Application Number : 2237680

    Regulatory Info :

    Registration Country : Canada

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    07

    Brand Name : P.G. 600

    U.S.A
    Cosmoprof
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    Brand Name : P.G. 600

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    CHORIONIC GONADOTROPIN

    Merck & Co

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 200UNIT/VIAL

    Packaging : 1X25/5X5 ML

    Brand Name : P.G. 600

    Approval Date :

    Application Number : 803472

    Regulatory Info :

    Registration Country : Canada

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    08

    Brand Name : CHORULON

    U.S.A
    Cosmoprof
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    Brand Name : CHORULON

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    Regulatory Info :

    Registration Country : Canada

    CHORIONIC GONADOTROPIN

    Merck & Co

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 1000UNIT/ML

    Packaging : 5ML/10ML

    Brand Name : CHORULON

    Approval Date :

    Application Number : 781851

    Regulatory Info :

    Registration Country : Canada

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    09

    Brand Name : P.G. 600 - 5D

    U.S.A
    Cosmoprof
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    Brand Name : P.G. 600 - 5D

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    CHORIONIC GONADOTROPIN

    Merck & Co

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 1000UNIT/VIAL

    Packaging : 10ML/25ML

    Brand Name : P.G. 600 - 5D

    Approval Date :

    Application Number : 2355973

    Regulatory Info :

    Registration Country : Canada

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    10

    Brand Name : PLANATE

    U.S.A
    Cosmoprof
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    Brand Name : PLANATE

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    CLOPROSTENOL (CLOPROSTENOL SODIUM)

    Merck & Co

    Dosage Form : SOLUTION

    Dosage Strength : 175MCG/2ML

    Packaging : 20ML

    Brand Name : PLANATE

    Approval Date :

    Application Number : 2137631

    Regulatory Info :

    Registration Country : Canada

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