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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Viatris to the U.S. FDA. Original Data : FDA Website

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    About

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to co...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

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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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    VLOG #PharmaReel

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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

    #Phispers by PHARMACOMPASS
    26 Sep 2024
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    NEWS #PharmaBuzz

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    Viatris Announces the Pricing Terms of Maximum Tender Offer
    Viatris Announces the Pricing Terms of Maximum Tender Offer

    18 Sep 2024

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    18 Sep 2024
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    Viatris Announces Early Tender Results And Increase In Pending Tender Offer
    Viatris Announces Early Tender Results And Increase In Pending Tender Offer

    17 Sep 2024

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    https://www.prnewswire.com/news-releases/viatris-announces-early-tender-results-and-increase-of-pending-maximum-tender-offer-302251136.html

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    17 Sep 2024
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    Viatris to Report Third Quarter 2024 Financial Results on November 7, 2024
    Viatris to Report Third Quarter 2024 Financial Results on November 7, 2024

    16 Sep 2024

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    https://www.prnewswire.com/news-releases/viatris-to-report-third-quarter-2024-financial-results-on-november-7-2024-302249244.html

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    16 Sep 2024
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    Viatris Announces Expiration, Results Of Any And All Cash Offers
    Viatris Announces Expiration, Results Of Any And All Cash Offers

    10 Sep 2024

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    https://www.prnewswire.com/news-releases/viatris-announces-expiration-and-results-of-any-and-all-cash-tender-offers-302244424.html

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    10 Sep 2024
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    Viatris Announces Pricing Terms Of Any And All Cash Tender Offers
    Viatris Announces Pricing Terms Of Any And All Cash Tender Offers

    10 Sep 2024

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    https://www.prnewswire.com/news-releases/viatris-announces-the-pricing-terms-of-pending-any-and-all-cash-tender-offers-302243931.html

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    10 Sep 2024
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    Viatris Announces Cash Tender Offers for Certain Outstanding Notes
    Viatris Announces Cash Tender Offers for Certain Outstanding Notes

    04 Sep 2024

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    https://www.prnewswire.com/news-releases/viatris-announces-cash-tender-offers-for-certain-outstanding-notes-302237700.html

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    Calliditas’ Partner Viatris Pharma Starts Phase III Trial with Nefecon in Japan

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    Nefecon is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity, indicated for IgA nephropathy.


    Lead Product(s): Budesonide

    Therapeutic Area: Nephrology Brand Name: Nefecon

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 05, 2024

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    Viatris

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    Lead Product(s) : Budesonide

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Calliditas’ Partner Viatris Pharma Starts Phase III Trial with Nefecon in Japan

    Details : Nefecon is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity, indicated for IgA nephropathy.

    Brand Name : Nefecon

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 05, 2024

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    Viatris Announces the Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in the United States

    Details:

    Ryzumvi (phentolamine mesylate) is an alpha adrenergic blocker, which is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.


    Lead Product(s): Phentolamine Mesylate

    Therapeutic Area: Ophthalmology Brand Name: Ryzumvi

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 01, 2024

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    Viatris

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    Lead Product(s) : Phentolamine Mesylate

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Viatris Announces the Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in the United ...

    Details : Ryzumvi (phentolamine mesylate) is an alpha adrenergic blocker, which is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.

    Brand Name : Ryzumvi

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 01, 2024

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    Idorsia and Viatris Successfully Close the Transaction for The Global Research and Development Collaboration

    Details:

    The collaboration aims to focus on the ongoing clinical development and commercialization of ACT-246475 (selatogrel), a fast-acting, reversible, and highly selective P2Y12 inhibitor. It is being evaluated for the patients with Acute Myocardial Infarction.


    Lead Product(s): Selatogrel

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: ACT-246475

    Study Phase: Phase IIIProduct Type: Small molecule

    Recipient: Idorsia Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: $350.0 million

    Deal Type: Collaboration March 18, 2024

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    Viatris

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    Lead Product(s) : Selatogrel

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Recipient : Idorsia Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Idorsia and Viatris Successfully Close the Transaction for The Global Research and Development Col...

    Details : The collaboration aims to focus on the ongoing clinical development and commercialization of ACT-246475 (selatogrel), a fast-acting, reversible, and highly selective P2Y12 inhibitor. It is being evaluated for the patients with Acute Myocardial Infarction...

    Brand Name : ACT-246475

    Molecule Type : Small molecule

    Upfront Cash : $350.0 million

    March 18, 2024

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    Idorsia and Viatris Enter Into a Significant Global Research and Development Collaboration

    Details:

    The collaboration aims to focus on the ongoing clinical development and commercialization of ACT-246475 (selatogrel), a fast-acting, reversible, and highly selective P2Y12 inhibitor. It is being evaluated for the patients with Acute Myocardial Infarction.


    Lead Product(s): Selatogrel

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: ACT-246475

    Study Phase: Phase IIIProduct Type: Small molecule

    Recipient: Idorsia Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration February 27, 2024

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    Viatris

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    Lead Product(s) : Selatogrel

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Recipient : Idorsia Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Collaboration

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    Idorsia and Viatris Enter Into a Significant Global Research and Development Collaboration

    Details : The collaboration aims to focus on the ongoing clinical development and commercialization of ACT-246475 (selatogrel), a fast-acting, reversible, and highly selective P2Y12 inhibitor. It is being evaluated for the patients with Acute Myocardial Infarction...

    Brand Name : ACT-246475

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    February 27, 2024

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    Viatris and Theravance Biopharma Announce Positive Top-Line Results from YUPELRI® (revefenacin) Phase III Trial in China for the Treatment of Chronic O...

    Details:

    YUPELRI® (revefenacin) inhalation solution is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease.


    Lead Product(s): Revefenacin

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Yupelri

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 13, 2023

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    U.S.A
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    Lead Product(s) : Revefenacin

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris and Theravance Biopharma Announce Positive Top-Line Results from YUPELRI® (revefenacin) P...

    Details : YUPELRI® (revefenacin) inhalation solution is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease.

    Brand Name : Yupelri

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 13, 2023

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    Theramex Announces Agreement to Acquire the European Rights to Duphaston® and Femoston® from Viatris, Inc.

    Details:

    Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (estradiol/dydrogesterone) to Theramex.


    Lead Product(s): Dydrogesterone

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Duphaston

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Theramex

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Divestment October 10, 2023

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    06

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    Lead Product(s) : Dydrogesterone

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Theramex

    Deal Size : Undisclosed

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Theramex Announces Agreement to Acquire the European Rights to Duphaston® and Femoston® from Via...

    Details : Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (estradiol/dydrogesterone) to Theramex.

    Brand Name : Duphaston

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 10, 2023

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    Viatris Announces Agreements on Remaining Planned Divestitures; Upon Closing Would Achieve its Original Total Target of a Multiple Above 12x on 2022 Est...

    Details:

    Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (sstradiol/dydrogesterone) to Theramex and its Women's Healthcare business, primarily related to oral and injectable contraceptives, to Insud Pharma.


    Lead Product(s): Dydrogesterone

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Duphaston

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Theramex

    Deal Size: $3,370.0 million Upfront Cash: Undisclosed

    Deal Type: Divestment October 01, 2023

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    Viatris

    U.S.A
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    Lead Product(s) : Dydrogesterone

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Theramex

    Deal Size : $3,370.0 million

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Viatris Announces Agreements on Remaining Planned Divestitures; Upon Closing Would Achieve its Ori...

    Details : Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (sstradiol/dydrogesterone) to Theramex and its Women's Healthcare business, primarily related to oral and injectable contraceptives, ...

    Brand Name : Duphaston

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 01, 2023

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    Ocuphire Pharma and Viatris Announce FDA Approval of RYZUMVI™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologicall...

    Details:

    Ryzumvi (phentolamine ophthalmic solution) 0.75% is a preservative-free ophthalmic solution and a nonselective alpha adrenergic antagonist, which is investigated for Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists.


    Lead Product(s): Phentolamine Mesylate

    Therapeutic Area: Ophthalmology Brand Name: Ryzumvi

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Ocuphire Pharma

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 27, 2023

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    Viatris

    U.S.A
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    Lead Product(s) : Phentolamine Mesylate

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Recipient : Ocuphire Pharma

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Ocuphire Pharma and Viatris Announce FDA Approval of RYZUMVI™ (Phentolamine Ophthalmic Solution)...

    Details : Ryzumvi (phentolamine ophthalmic solution) 0.75% is a preservative-free ophthalmic solution and a nonselective alpha adrenergic antagonist, which is investigated for Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists.

    Brand Name : Ryzumvi

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 27, 2023

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    Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment ...

    Details:

    The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.


    Lead Product(s): Abacavir,Dolutegravir Sodium,Lamivudine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 05, 2023

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    Viatris

    U.S.A
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    Lead Product(s) : Abacavir,Dolutegravir Sodium,Lamivudine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolute...

    Details : The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 05, 2023

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    Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

    Details:

    Copaxone Depot, a long-acting glatiramer acetate designed to be administered as an intramuscular injection, is being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS).


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: WhisperJECT

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Mapi Pharma

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 07, 2023

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    Viatris

    U.S.A
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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Mapi Pharma

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for th...

    Details : Copaxone Depot, a long-acting glatiramer acetate designed to be administered as an intramuscular injection, is being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS).

    Brand Name : WhisperJECT

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 07, 2023

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    FDA Orange Book

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    01

    Brand Name : Idarubicin

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Idarubicin

    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    4-Demethoxydaunomycin

    Viatris

    Dosage Form : Idarubicin 10Mg 10Ml 1 Units P...

    Dosage Strength : 1 vial EV 10 mg/10 ml

    Packaging :

    Brand Name : Idarubicin

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    Brand Name : Abirateron Viatris

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Abirateron Viatris

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Viatris

    Dosage Form : Filmtabl

    Dosage Strength : 1000mg

    Packaging :

    Brand Name : Abirateron Viatris

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    03

    Brand Name : Abirateron Viatris

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Abirateron Viatris

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Viatris

    Dosage Form : Filmtabl

    Dosage Strength : 500mg

    Packaging :

    Brand Name : Abirateron Viatris

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    04

    Brand Name : Mucomyst

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 10 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    05

    Brand Name : Mucomyst

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 1 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    06

    Brand Name : Mucomyst

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Effervescent tablet

    Dosage Strength : 200 mg

    Packaging : Plastic pipe 25...

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    07

    Brand Name : Mucomyst

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Mucomyst

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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Effervescent tablet

    Dosage Strength : 200 mg

    Packaging : Plastic pipe 4 2...

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    08

    Brand Name : Mucomyst

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Mucomyst

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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 5 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    09

    Brand Name : ACETYLSALICYLIC ACID...

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : ACETYLSALICYLIC ACID...

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    Regulatory Info :

    Registration Country : Italy

    Acetylsalicylic acid

    Viatris

    Dosage Form : Gastro-Resistant Tablets

    Dosage Strength : 100 mg

    Packaging : 30 UNITS 100 MG - ...

    Brand Name : ACETYLSALICYLIC ACID MYLAN

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Brand Name : Cyclokapron

    U.S.A
    Discovery on Target
    Not Confirmed
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    Brand Name : Cyclokapron

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum tranexamicum

    Viatris

    Dosage Form : Tabl

    Dosage Strength : 500mg

    Packaging :

    Brand Name : Cyclokapron

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    FDA

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    01

    FDA Audited

    USA
    Formnext Forum
    Not Confirmed
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    FDA Audited

    USA
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    Formnext Forum
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-04-16

    Viatris

    City : Greensboro

    State : NC

    Country/Area : US

    Zip : 27406-4600

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-04-16

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    FDA Audited

    USA
    Formnext Forum
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    FDA Audited

    USA
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    Formnext Forum
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-30

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-30

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    FDA Audited

    USA
    Formnext Forum
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    FDA Audited

    USA
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    Formnext Forum
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-02-17

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-02-17

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    FDA Audited

    USA
    Formnext Forum
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    USA
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    Formnext Forum
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2010-12-09

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2010-12-09

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    FDA Audited

    USA
    Formnext Forum
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    FDA Audited

    USA
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    Formnext Forum
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-28

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-28

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-02-02

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-02-02

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-03-21

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-03-21

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-04-24

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-04-24

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    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

    Viatris

    City : Rockford

    State : IL

    Country/Area : US

    Zip : 61103-1201

    District : CHI

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

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    District Decision : No Action Indicated

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    Viatris

    City : Rockford

    State : IL

    Country/Area : US

    Zip : 61103-1287

    District : CHI

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

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