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    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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    INTERVIEW #SpeakPharma

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    "ICE is pioneering sustainability, innovation in bile acid research for neurodegenerative diseases”

    "ICE is pioneering sustainability, innovation in bile acid research for neurodegenerative diseases”

    This week, SpeakPharma interviews Roger Viney, Chief Commercial Officer of ICE Pharma, a world-leading manufacturer of specialty biliary acid products with a focus on innovation, environmental responsibility, and a strong company culture. Viney discusses the company’s ambitious sustainability targets, and its exciting research into bile acids’ potential in treating neurodegenerative diseases like Parkinson’s.  🔑 HIGHLIGHTS// focus on innovation, environmental responsibility, and a strong company culture ICE Pharma has set four strategic pillars to guide its sustainability efforts. Can you tell us what these four pillars are and how they contribute to the long-term resilience of the business and its supply chain? In 2022, we developed a comprehensive long-term sustainability strategy, accompanied by a short-term roadmap to guide our actions over the next three years. This outlines the strategic choices that will define our way forward and details the progress we are making against our roadmap. Our sustainability strategy is designed to bolster the long-term resilience of our business and supply chain, provide a source of fulfillment for our employees and enable our customers to continue developing and delivering treatments for hepatic and neurological diseases, as well as other conditions that respond to bile acid-based therapies. By contributing holistically to a healthier society and environment, our strategy aims to create long-term value. We aim to maximize our positive impact on health by opening our Biliary Acid Library of potential new molecules to further the development of these treatments. Additionally, we strive to reduce our environmental footprint by creating products with fewer raw materials, diversifying the animal sources we use, and exploring new plant-based bile acid derivatives. We have established clear targets along four strategic pillars, supported by robust ESG governance and leadership. Firstly, we are committed to fighting illness through product innovation. By providing innovative, safe, and high-quality pharmaceutical ingredients, we help our customers build a healthier society. Secondly, we focus on accelerating sustainable operations by monitoring and reducing our emissions, energy, and water consumption through robust ESG processes and accountability. Thirdly, we prioritize building strong relationships by managing our supply chain transparently, fostering strong supplier relationships, and adhering to responsible business practices. Lastly, we are dedicated to caring for people by cultivating a transformational and inclusive culture that ensures the well-being and development of our employees. 🔑 HIGHLIGHTS// Biliary Acid Library of potential new molecules / robust ESG governance and leadership / manage our supply chain transparently ICE Pharma has committed to an ambitious sustainability plan. Can you elaborate on specific targets it has set to reduce greenhouse gas (GHG) emissions and increase the use of renewable energy? Also, what significant investments have ICE made or plans to make to support these goals? ICE’s carbon footprint aligns with industry standards in the pharmaceutical and API sectors in terms of GHG emissions. We have set an internal target that is challenging yet achievable and aligned with our business objectives – a 20 percent reduction in Scope 1 and 2 emissions (majorly energy-related) and a 30 percent reduction in Scope 3 emissions (from solvents, reagents, and animal byproducts used as raw materials) by 2033. We plan to achieve these targets through two main approaches. For electric power, we aim to achieve 100 percent renewable energy utilization by 2030, and we are well on track to achieve this. We are heavily investing in renewable sources, either through sourcing green energy or through in-house investments in photovoltaic (PV) systems at our factories. Fortunately, the significant growth in installed renewable capacity across all geographies where we operate makes this goal both achievable and financially sustainable. However, a substantial portion of our energy consumption comes from generating heat involved in our processes. To counter this, we are focusing on energy efficiency, targeting over 90 percent of our energy consumption to be covered by ISO 50001 standards, and investing heavily in more efficient technologies. For Scope 3 emissions, our efforts are concentrated on further developing our processes to reduce the amount of chemicals used, improve our yields, and switch to animal-source raw materials with a smaller carbon footprint. 🔑 HIGHLIGHTS// internal target that is challenging yet achievable / 100 percent renewable energy utilization by 2030 ICE Pharma highlights its strong company culture as one of the secrets to its success. Can you speak on how you foster a collaborative and respectful work environment, and how these efforts contribute to the company’s overall success? At ICE Pharma, we place great emphasis on building a collaborative and respectful work environment, recognizing it as a key driver of innovation and success. Our culture is fostered by our Cultural Pillars: Unity, Evolution, and Achievement. These pillars shape our approach in several key areas. Firstly, we value diversity and inclusion. Operating across different cultural contexts and geographies, we have gathered a diverse range of ethnicities. We actively ensure that all voices are represented. This promotes a culture where everyone is respected for their unique perspectives. Secondly, recognizing employee contributions is fundamental to our approach. ICE Pharma celebrates achievements and milestones, ensuring that employees feel valued. We also support professional development and personal growth of employees through initiatives such as secondments and international mentoring programs, and financial support for excellence training courses. This creates motivation and loyalty, reinforcing a positive company atmosphere. Thirdly, we understand the importance of work-life balance. We promote policies that allow employees to maintain a healthy equilibrium between their professional and personal lives, with a special focus on parenthood. This respect for individual well-being translates into a happier, more engaged workforce. By fostering these values, we create a work environment that drives productivity, encourages innovation, and strengthens the company’s overall success. 🔑 HIGHLIGHTS// value diversity and inclusion / recognize employee contributions / understand the importance of work-life balance Considering the unique properties of bile acids, can you discuss how ICE Pharma is leveraging its technology to develop innovative drug delivery systems for emerging therapies or to address challenges with existing medications? We are thrilled about the expanding role of bile acids in medicine. ICE Pharma holds a unique position, being deeply involved in fundamental research, developing new bile acids, bringing them into clinical trials, and manufacturing generic medicines based on these compounds. Recent research has highlighted the role of bile acids as metabolic regulators, revealing their potential to treat a variety of diseases. They have emerged as an excellent class of molecules for targeting metabolic conditions such as type 2 diabetes, obesity, and non-alcoholic fatty liver disease (NAFLD). Bile acids are now known to act on several nuclear receptors, and it is becoming clear that their signaling properties are complex and extend beyond the FXR and TGR5 receptors, where most current research is focused. One particularly exciting area of interest is the potential of bile acids in treating neurodegenerative diseases. In collaboration with the Ferrier Institute, we have contributed to research on Parkinson’s disease. Mitochondrial dysfunction is a well-documented mechanism in both sporadic and familial Parkinson’s disease. Ursodeoxycholic acid (UDCA) has been identified as a bile acid that enhances mitochondrial function in multiple in vitro and in vivo models of Parkinson’s disease. Our studies indicate that modified novel bile acid molecules could lead to the development of more efficacious treatments that improve mitochondrial function and overall cellular health, presenting promising new therapeutic options for Parkinson’s disease. 🔑 HIGHLIGHTS// potential of bile acids in treating neurodegenerative diseases / contributed to research on Parkinson’s disease / present promising new therapeutic options Given ICE Pharma’s commitment to the highest quality and regulatory compliance standards, can you elaborate on how the company ensures that these standards are consistently maintained, especially when dealing with the complexities of animal-derived products? At ICE, we place great emphasis on controlling pathogens in our animal-derived products, ensuring safety and quality throughout the entire supply chain, from the collection of bile to the finished product. The bile is sourced exclusively from authorized countries, and each production batch is meticulously traced to certify that every animal has been raised and sacrificed according to specific guidelines. The initial step in bile processing involves a treatment that certifies the product as TSE/BSE Free. This is followed by at least two additional stages, based on experimental studies conducted by specialized laboratories, which are effective in inactivating viruses. Intermediates and the final product are handled in closed cycles or in contamination-controlled areas (ISO-8 cleanrooms). Beyond these fundamental aspects, ICE is deeply committed to keeping its dossiers up to date with the latest guidelines and constantly monitoring trends in analytical data to ensure consistent product quality. Where possible, we enhance this quality through a change control plan carefully managed by our Quality Assurance team. Staff training, predictive and preventive maintenance plans, equipment qualification, and process validation are crucial activities involving the entire workforce with the support of the Quality Unit. Our commitment to continuous improvement drives us to focus on digital globalization to ensure ever-greater transparency and reliability in the data that supports our work. As John Ruskin said, “quality is never an accident. It is always the result of intelligent effort.” We continue to follow this philosophy in our daily commitment. 🔑 HIGHLIGHTS// bile is sourced exclusively from authorized countries / each production batch is meticulously traced / ensure ever-greater transparency and reliability

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    #SpeakPharma With ICE Pharma
    30 Sep 2024
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    2024 US Elections: Harris, Trump differ on abortion rights, ACA, public health spends; agree on need to cut drug prices

    2024 US Elections: Harris, Trump differ on abortion rights, ACA, public health spends; agree on need to cut drug prices

    The US is in the midst of yet another, or perhaps the most, polarizing Presidential election. The two candidates have highly divergent personas, records, visions and views. That gets reflected in their starkly different visions for the healthcare system.Healthcare is the second most important issue for voters in the 2024 US elections, with only the economy ranking higher, according to the Pew Research Center.In this week’s PharmaFlow, we look at the past approaches of both the contenders — Democratic presidential nominee Kamala Harris and Republican contender Donald Trump — towards healthcare, and what the two presidencies could mean for the US healthcare industry.Both Harris and Trump have a rare point of agreement — that the US government should act on reducing high drug prices. But have they spelt out how they will make healthcare more accessible? Our analysis should give you some answers.Abortion remains a pivotal issue, may shape broader discussions on healthcareTrump takes pride in the fact that he played an important role in overturning Roe v. Wade, a ruling that protected the abortion rights of women across America. Trump did that by selecting Supreme Court justices who were instrumental in overturning it. Two and a half years after Roe v. Wade was overturned, Trump faces an electorate that largely seems to favor abortion rights — according to Pew Research, 63 percent respondents say abortion should be legal in all or most cases, while 36 percent say it should be illegal in all or most cases.Candidates’ stances on abortion access, including the regulation on medications like mifepristone, are being scrutinized by both supporters and opponents of abortion rights. In June this year, the US Supreme Court had unanimously rejected a case to restrict access to the abortion drug mifepristone. The demand for its ban had been raised by an anti-abortion group in Texas.Of late, there have been reports of Republicans trying to distance themselves from aggressive anti-abortion ideas coming from its party men and allies. Aiming to carve-out a political middle ground, Trump has said that abortion policy should be made by the states. Despite Trump’s softening of stance, abortion rights is likely to not only affect voter turnout, but also shape broader discussions on healthcare and women’s rights.Affordable Care Act: Harris to strengthen it, Trump has ‘concepts of a plan’ to replace itHarris has been all for expanding and strengthening the Affordable Care Act (ACA). She has promised to “make affordable healthcare a right, not a privilege.”Trump, on the other hand, had made attempts during his presidency to repeal and replace the ACA, arguing that it provided “lousy healthcare.” While those efforts ultimately failed in the Senate, Trump succeeded in weakening the ACA by eliminating the individual mandate penalty through the 2017 Tax Cuts and Jobs Act.In a potential second term, Trump might renew efforts to dismantle or significantly alter the ACA. Although he has not presented a comprehensive replacement plan, he said during the Presidential debate held on September 9 that he has “concepts of a plan.”Drug prices: Harris to accelerate Medicare price cuts; Trump to focus on genericsHarris has had an aggressive stance on reducing prescription drug costs. Her tie-breaking vote on the Inflation Reduction Act gave Medicare the power to negotiate lower drug prices with pharmaceutical companies.Harris has pledged to accelerate those negotiations, once she becomes President, to cover more drugs and further lower prices for Americans. She also intends to extend the US$ 35 cap on insulin and the US$ 2,000 cap on out-of-pocket spending for seniors to all Americans, not just those on Medicare.Harris plans to make permanent the Biden-Harris tax credit enhancements that have already lowered healthcare premiums by an average of about US$ 800 a year for millions of Americans. This move would ensure continued accessibility to health insurance for a broader segment of the population.However, her stance on insurance companies and Big Pharma, including her support for “march-in” rights, might face resistance from pharmaceutical companies concerned about maintaining incentives for innovation.On the issue of drug pricing, Trump’s record is mixed. While he took credit for some decreases in prescription drug prices during his presidency, his administration’s most significant regulatory changes often favored pharmaceutical companies.Trump did issue a rule setting up a path to import drugs from Canada and other countries, but this initiative has faced significant hurdles, including pushback from Canadian authorities.Trump’s stance on drug pricing for a potential second term appears to focus on increasing generic and biosimilar competition, importing drugs made in the US but sold overseas back to the US, and capping out-of-pocket insulin costs. While he has criticized Big Pharma for putting profits above people, his administration’s policies had often aligned with industry interests.Harris appears committed to drug control; Trump had cut public health fundsMental health and substance abuse are the other areas where Harris has shown strong commitment. Having prosecuted drug traffickers, she has demonstrated her commitment to curbing the opioid epidemic.In the White House, she helped direct more than US$ 150 billion to disrupt the flow of illicit drugs and delivered billions of dollars in investments to states to fund lifesaving programs. Under a Harris administration, we might see increased funding for addiction treatment programs and continued efforts to make overdose-reversal drugs like naloxone more accessible.During his presidency, Trump had significantly reduced funding for public health programs. His administration had suggested budget cuts to the Centers for Disease Control and Prevention (CDC) and other public health agencies, justifying them as measures for fiscal responsibility.Our viewGiven her record, a Harris presidency could lead to increased insurance coverage. However, it might also come with increased regulation and price controls. More aggressive drug price negotiations could pressure pharmaceutical companies’ profit margins, potentially affecting R&D budgets. Stricter vigilance on the pharmaceutical industry could lead to more litigation and regulatory challenges for drug companies. But in the long run, this might also improve public trust in drug companies and in the healthcare systems.Under a second Trump term, reduced public health funding could create challenges for community health providers and public health initiatives. An emphasis on generic competition could pressure brand-name drug manufacturers, but create opportunities for generic drug makers.
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    https://www.pharmacompass.com/radio-compass-blog/2024-us-elections-harris-trump-differ-on-abortion-rights-aca-public-health-spends-agree-on-need-to-cut-drug-prices

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    26 Sep 2024
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    Merck’s Keytruda Combo Fails in Phase III Colorectal Cancer Study
    Merck’s Keytruda Combo Fails in Phase III Colorectal Cancer Study

    26 Sep 2024

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    https://www.merck.com/news/merck-provides-update-on-phase-3-keyform-007-trial-evaluating-investigational-fixed-dose-combination-of-favezelimab-and-pembrolizumab-for-patients-with-previously-treated-pd-l1-positive-microsatellite/

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    Merck To Present Tulisokibart Data At UEG Week 2024
    Merck To Present Tulisokibart Data At UEG Week 2024

    26 Sep 2024

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    Merck bags options on Evaxion's AI-designed vaccine candidates
    Merck bags options on Evaxion's AI-designed vaccine candidates

    26 Sep 2024

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    https://www.fiercebiotech.com/biotech/merck-bags-options-evaxions-ai-designed-vaccine-candidates-offering-small-upfront-and-big

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    Merck's KEYTRUDA Approved In Japan For NSCLC And Carcinoma
    Merck's KEYTRUDA Approved In Japan For NSCLC And Carcinoma

    25 Sep 2024

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    https://www.businesswire.com/news/home/20240925068572/en

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    FDA challenges broad use of PD-1 drugs in stomach cancer
    FDA challenges broad use of PD-1 drugs in stomach cancer

    24 Sep 2024

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/ahead-adcomm-fda-challenges-pd-1-drug-classs-broad-use-stomach-cancer-patients

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    24 Sep 2024
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    Merck Receives Positive EU CHMP Opinions for KEYTRUDA
    Merck Receives Positive EU CHMP Opinions for KEYTRUDA

    20 Sep 2024

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    https://www.businesswire.com/news/home/20240919651678/en

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    Drugs in Development

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    Organon Pays up to $1.2B to Acquire Dermavant and its Steroid-Free Skin Cream Vtama

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    Through the acquisition, Organon will leverage the Dermavant pipeline, which includes Vtama (tapinarof) cream. It is indicated for the treatment of f plaque psoriasis in adults.


    Lead Product(s): Tapinarof

    Therapeutic Area: Dermatology Brand Name: Vtama

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Dermavant Sciences

    Deal Size: $1,200.0 million Upfront Cash: $175.0 million

    Deal Type: Acquisition September 18, 2024

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    Lead Product(s) : Tapinarof

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Recipient : Dermavant Sciences

    Deal Size : $1,200.0 million

    Deal Type : Acquisition

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    Organon Pays up to $1.2B to Acquire Dermavant and its Steroid-Free Skin Cream Vtama

    Details : Through the acquisition, Organon will leverage the Dermavant pipeline, which includes Vtama (tapinarof) cream. It is indicated for the treatment of f plaque psoriasis in adults.

    Brand Name : Vtama

    Molecule Type : Small molecule

    Upfront Cash : $175.0 million

    September 18, 2024

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    Ten-Year Data for KEYTRUDA Shows Survival Benefit vs. Ipilimumab in Advanced Melanoma

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    Keytruda (Pembrolizumab) is a IV infused PD-1 inhibitor antibody, it is indicated for several tumor or malignancy, including advanced melanoma.


    Lead Product(s): Pembrolizumab

    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 September 15, 2024

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    Lead Product(s) : Pembrolizumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Ten-Year Data for KEYTRUDA Shows Survival Benefit vs. Ipilimumab in Advanced Melanoma

    Details : Keytruda (Pembrolizumab) is a IV infused PD-1 inhibitor antibody, it is indicated for several tumor or malignancy, including advanced melanoma.

    Brand Name : Keytruda

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 15, 2024

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    KEYTRUDA Plus LENVIMA Improves Progression-Free Survival in Hepatocellular Carcinoma

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    Keytruda (Pembrolizumab) is a PD-1 inhibitor antibody, being evaluated with Lenvima (lenvatinib) for unresectable, non-metastatic hepatocellular carcinoma.


    Lead Product(s): Pembrolizumab,Lenvatinib

    Therapeutic Area: Oncology Brand Name: Keytruda

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Eisai

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 14, 2024

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    Lead Product(s) : Pembrolizumab,Lenvatinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Eisai

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    KEYTRUDA Plus LENVIMA Improves Progression-Free Survival in Hepatocellular Carcinoma

    Details : Keytruda (Pembrolizumab) is a PD-1 inhibitor antibody, being evaluated with Lenvima (lenvatinib) for unresectable, non-metastatic hepatocellular carcinoma.

    Brand Name : Keytruda

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 14, 2024

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    Merck Reports Positive Results from Phase 3 Trial of GARDASIL®9 in Japanese Males

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    Gardasil (recombinant human papillomavirus quadrivalent vaccine), pentavalent rotavirus vaccine and other agreed products from MSD.


    Lead Product(s): Human Papillomavirus 9-Valent Vaccine, Recombinant

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Gardasil 9

    Study Phase: ApprovedProduct Type: Vaccine

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 11, 2024

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    Lead Product(s) : Human Papillomavirus 9-Valent Vaccine, Recombinant

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Merck Reports Positive Results from Phase 3 Trial of GARDASIL®9 in Japanese Males

    Details : Gardasil (recombinant human papillomavirus quadrivalent vaccine), pentavalent rotavirus vaccine and other agreed products from MSD.

    Brand Name : Gardasil 9

    Molecule Type : Vaccine

    Upfront Cash : Not Applicable

    September 11, 2024

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    Ifinatamab Deruxtecan Shows Promising Response Rates in Extensive-Stage SCLC

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    I-DXd (ifinatamab deruxtecan) is an engineered potential first-in-class B7-H3 directed ADC. It is being developed for extensive-stage small cell lung cancer.


    Lead Product(s): Ifinatamab Deruxtecan

    Therapeutic Area: Oncology Brand Name: I-DXd

    Study Phase: Phase IIProduct Type: Large molecule

    Recipient: Daiichi Sankyo

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 07, 2024

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    Lead Product(s) : Ifinatamab Deruxtecan

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Recipient : Daiichi Sankyo

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Ifinatamab Deruxtecan Shows Promising Response Rates in Extensive-Stage SCLC

    Details : I-DXd (ifinatamab deruxtecan) is an engineered potential first-in-class B7-H3 directed ADC. It is being developed for extensive-stage small cell lung cancer.

    Brand Name : I-DXd

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 07, 2024

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    Merck and EyeBio Initiate Phase 2b/3 Trial for Restoret™ in Diabetic Macular Edema

    Details:

    Restoret (MK-3000), a first-in-class tetravalent, tri-specific antibody and late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration.


    Lead Product(s): MK-3000

    Therapeutic Area: Ophthalmology Brand Name: Restoret

    Study Phase: Phase II/ Phase IIIProduct Type: Large molecule

    Sponsor: Merck & Co

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 04, 2024

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    Lead Product(s) : MK-3000

    Therapeutic Area : Ophthalmology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Merck & Co

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Merck and EyeBio Initiate Phase 2b/3 Trial for Restoret™ in Diabetic Macular Edema

    Details : Restoret (MK-3000), a first-in-class tetravalent, tri-specific antibody and late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration.

    Brand Name : Restoret

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 04, 2024

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    European Commission Approves KEYTRUDA® with Padcev® for Urothelial Carcinoma

    Details:

    Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an ADC, is indicated for treating adults with locally advanced or metastatic urothelial carcinoma.


    Lead Product(s): Pembrolizumab,Enfortumab Vedotin

    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 September 03, 2024

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    Lead Product(s) : Pembrolizumab,Enfortumab Vedotin

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    European Commission Approves KEYTRUDA® with Padcev® for Urothelial Carcinoma

    Details : Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an ADC, is indicated for treating adults with locally advanced or metastatic urothelial carcinoma.

    Brand Name : Keytruda

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 03, 2024

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    Merck Doses First Patient in Phase III Oral Cladribine Study for Myasthenia Gravis

    Details:

    Mavenclad (Cladribine) is a orally administered DNA synthesis inhibitor. It is being evaluated in for the treatment of Generalized Myasthenia Gravis.


    Lead Product(s): Cladribine

    Therapeutic Area: Immunology Brand Name: Mavenclad

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 29, 2024

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    Lead Product(s) : Cladribine

    Therapeutic Area : Immunology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Merck Doses First Patient in Phase III Oral Cladribine Study for Myasthenia Gravis

    Details : Mavenclad (Cladribine) is a orally administered DNA synthesis inhibitor. It is being evaluated in for the treatment of Generalized Myasthenia Gravis.

    Brand Name : Mavenclad

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 29, 2024

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    Merck Starts Phase 3 Trial of Bomedemstat for Essential Thrombocythemia Treatment

    Details:

    MK-3543 (bomedemstat) is an investigational orally available small molecule that inhibits LSD1. It is under phase 3 clinical development for the treatment of essential thrombocythemia.


    Lead Product(s): Bomedemstat

    Therapeutic Area: Oncology Brand Name: MK-3543

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 27, 2024

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    Lead Product(s) : Bomedemstat

    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 Starts Phase 3 Trial of Bomedemstat for Essential Thrombocythemia Treatment

    Details : MK-3543 (bomedemstat) is an investigational orally available small molecule that inhibits LSD1. It is under phase 3 clinical development for the treatment of essential thrombocythemia.

    Brand Name : MK-3543

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 27, 2024

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    Merck's WINREVAIR™ Approved by European Commission for Pulmonary Hypertension

    Details:

    Winrevair (sotatercept) is the first activin signaling inhibitor therapy, which is approved for the treatment of adults with pulmonary arterial hypertension.


    Lead Product(s): Sotatercept

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Winrevair

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 26, 2024

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    Lead Product(s) : Sotatercept

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Merck's WINREVAIR™ Approved by European Commission for Pulmonary Hypertension

    Details : Winrevair (sotatercept) is the first activin signaling inhibitor therapy, which is approved for the treatment of adults with pulmonary arterial hypertension.

    Brand Name : Winrevair

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    August 26, 2024

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    Brand Name : Vaxneuvance

    U.S.A
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    Brand Name : Vaxneuvance

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    Regulatory Info :

    Registration Country : Switzerland

    15-valent pneumococcal polysaccharide CRM conjugat...

    Merck & Co

    Dosage Form : Inj Susp

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    Brand Name : Vaxneuvance

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    Brand Name : Vaxneuvance

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    15-valent pneumococcal polysaccharide CRM conjugat...

    Merck & Co

    Dosage Form : Inj Susp

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    Brand Name : Vaxneuvance

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    03

    Brand Name : Campral

    U.S.A
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    Brand Name : Campral

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acamprosatum

    Merck & Co

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 300mg

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    Brand Name : Campral

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    Brand Name : Campral

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acamprosatum

    Merck & Co

    Dosage Form : Filmtablet

    Dosage Strength : 300mg

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    Brand Name : Campral

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    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Fosavance weekly tab...

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    Brand Name : Fosavance weekly tab...

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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Dosage Strength : 70/2800

    Packaging :

    Brand Name : Fosavance weekly tablets

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    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Fosavance weekly tab...

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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Dosage Strength : 70/2800

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    Brand Name : Fosavance weekly tablets

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    Brand Name : Fosavance weekly tab...

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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Dosage Strength : 70/5600

    Packaging :

    Brand Name : Fosavance weekly tablets

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    Brand Name : Fosavance weekly tab...

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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Dosage Strength : 70/5600

    Packaging :

    Brand Name : Fosavance weekly tablets

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    Brand Name : Famax

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    Regulatory Info :

    Registration Country : Italy

    Alendronate Sodium Trihydrate

    Merck & Co

    Dosage Form : Alendronic Acid 70Mg 4 Units' ...

    Dosage Strength : 4 CPR 70 mg

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    Brand Name : Famax

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    Registration Country : Italy

    Alendronate Sodium Trihydrate

    Merck & Co

    Dosage Form : Alendronic Acid 10Mg 14 Joined...

    Dosage Strength : 14 CPR 10 mg

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    Brand Name : Famax

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    01

    PRODUCT 8198 TABLETING AID T

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ASC 2024
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    PRODUCT 8198 TABLETING AID T

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3796

    Submission : 1980-05-01

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    POLYVINYL ACETATE-CROTONIC ACID COP...

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ASC 2024
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    POLYVINYL ACETATE-CROTONIC ACID COP...

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF Inactive-api
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11859

    Submission : 1996-02-16

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    ABOUT THIS PAGE

    Contact Merck & Co and get a quotation

    Merck & Co is a supplier offers 106 products (APIs, Excipients or Intermediates).

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