Against a contentious backdrop of a gender gap in the life sciences, a lawyer who spent more than eight years managing intellectual property at San Diego’s Synthetic Genomics (SGI) has sued the…
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Denmark’s Aarhus University to Use Signatera(TM) ctDNA Technology in Longitudinal Study
SAN CARLOS, Calif., Sept. 20, 2017 /PRNewswire/ — Natera, Inc., (NASDAQ: NTRA), a global leader in cell-free DNA testing, has entered into a research collaboration with Denmark’s Aarhus University to leverage the company’s Signatera™ (RUO) personalized liquid biopsy technology to evaluate circulating tumor DNA (ctDNA) as a useful biomarker in the diagnosis and treatment of bladder cancer. Signatera™ was recently launched for research use only (RUO) for oncology researchers and biopharmaceutical companies, and is not for use in diagnostic procedures. It is expected to be available for clinical use next year.
The study will evaluate over 400 prospectively obtained plasma samples from patients who underwent treatment for bladder cancer, and whose blood was collected serially through chemotherapy and surgery. Sequencing data from each patient’s tumor will be provided by Aarhus University and run through the Signatera™ proprietary ctDNA bioinformatics pipeline, resulting in custom ctDNA assays being designed for each patient. Personalized ctDNA analysis will be performed at multiple time points per patient to correlate ctDNA levels with clinical outcomes.
“Aarhus University’s significant expertise in bladder cancer research, as well as its extensive repository of longitudinal patient tumor and blood samples, make it an ideal partner,” said Jimmy Lin, MD, PhD, MHS, Chief Science Officer, Oncology, at Natera. “We expect that this study, plus additional research efforts in other cancer types, will help us build toward clinically validating Signatera. If validated, Signatera could enable earlier diagnosis, more precise monitoring, better determination of prognosis, and individualized treatment of disease.”
“We are pleased to collaborate with Natera on this important research project involving a challenging cancer with high recurrence and mortality rates,” said Dr. Lars Dyrskjøt Andersen, Professor, Department of Clinical Medicine at Aarhus University. “We expect that this study will provide new insights that may help improve patient outcomes. We have a long track record in translational bladder cancer research, and we anticipate that this collaboration with Natera will significantly accelerate development of molecular diagnostic tests for this disease.”
Signatera™ differs from currently available liquid biopsy tests, which test for a generic panel of genes independent of an individual’s tumor. It provides a customized blood test tailored to match the mutations found in an individual’s tumor tissue, which maximizes sensitivity and specificity. Signatera™ also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies. A recent study of patients with early stage non-small cell lung cancer (NSCLC) showed the value of Natera’s customized ctDNA analysis for use in cancer research. The study, which was featured on the cover of the journal Nature, demonstrated Signatera’s™ potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.1
About Aarhus University
Aarhus University is a prestigious research institution located in Aarhus, Denmark. Founded in 1928, it is Denmark’s second oldest university and its largest, with 42,500 enrolled students, 11,500 staff members, and a budget of 840 million Euros. Aarhus University’s ambition is to be a globally oriented university with a commitment to excellence in research and education, and a strong engagement with the development community. Owing to its size and impressive results as a research-intensive university, Aarhus has a strong reputation and influence across the entire spectrum of disciplines locally, nationally, and globally. For more information, visit www.au.dk/en/.
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit www.natera.com.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release.
Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to Natera’s efforts to develop and commercialize new product offerings, Natera’s ability to successfully increase demand for and grow revenues for its product offerings, whether the results of clinical studies will support the use of its product offerings, Natera’s expectations of the reliability, accuracy and performance of its screening tests, or of the benefits of its screening tests and product offerings to patients, providers and payers.
Additional risks and uncertainties are discussed in greater detail in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Natera’s Form 10-Q for the quarter ended June 30, 2017. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company’s website at www.natera.com in the “Investor Relations” section, and on the SEC’s website at www.sec.gov.
Mike Brophy, CFO, Natera, 650-249-9091 x1471, Mbrophy@natera.com
Barbara Sullivan, Sullivan & Associates, 714-374–6174, email@example.com
Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545, 446–451 (2017) http://doi.org/10.1038/nature22364
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SAN DIEGO, Sept. 20, 2017 /PRNewswire/ — Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, and its research collaborators will present eight posters related to investigational antibiotic ZOLYD™ (fosfomycin for injection, also known as ZTI-01), at ID Week 2017 to be held October 4-8, 2017 in San Diego.
“Zavante welcomes the opportunity to present in a peer review forum detailed results from our pivotal ZEUS Phase 2/3 clinical trial,” said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics. “In the ZEUS study, ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with complicated urinary tract infections, and we believe these data support our forthcoming new drug application for U.S. registration.”
ZEUS was a multicenter, randomized, double-blind Phase 2/3 trial designed to evaluate the safety and efficacy of ZOLYD for the treatment of hospitalized adults with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), versus piperacillin/tazobactam. New positive ZEUS results to be presented at ID Week include a post-hoc analysis of the primary outcome (defined as clinical cure plus microbiologic eradication at the test-of-cure visit) based upon molecular strain typing of bacterial pathogens in both treatment arms.
The ID Week poster presentations also feature the ZEUS safety and efficacy data in a subset of patients with infections caused by resistant bacteria. In vitro studies evaluating activity of ZOLYD combined with meropenem or cefepime in different resistance models will also be presented at the meeting.
In addition to the company’s poster presentations, Dr. Ellis-Grosse will participate in a symposium titled, “New Antibiotics: What’s in the Pipeline?” on Thursday, October 5th, from 2:00 p.m. to 3:30 p.m. Pacific Time and a meet-the-professor session titled, “Pipeline 2.0,” on Friday, October 6th, from 7:00 a.m. to 8:15 a.m. Pacific Time.
Poster details for the meeting are as follows. The complete program can be accessed at the ID Week 2017 website at www.idweek.org.
Friday, October 6, 2017, 12:30 p.m. – 2:00 p.m.
Session 147 – Expanded Spectrum – New Antimicrobial Susceptibility Testing
- Poster 1224: In vitro Activity of Fosfomycin, Alone and Combined with Cefepime and Meropenem, Against Carbapenemase-Producing Gram-Negative Bacteria
Session 167 – Preclinical Study with New Antibiotics and Antifungals
- Poster 1517: ZTI-01 Treatment Improves Survival of Animals Infected with Multidrug Resistant Pseudomonas aeruginosa
- Poster 1523: Fosfomycin (FOS) Plus Meropenem (MER) Suppresses Resistance Emergence Against P. aeruginosa (PA) PAO1 in the Hollow Fiber Infection Model (HFIM)
Saturday, October 7, 2017, 12:30 p.m. – 2:00 p.m.
Session 231 – Clinical Study with New Antibiotics and Antifungals
- Poster 1830: Phenotypic Antibiotic Resistance in ZEUS: Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP)
- Poster 1833: Per Pathogen Outcomes from the ZEUS study, a Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 (fosfomycin for injection) versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP)
- Poster 1837: Safety Results from the ZEUS Study: Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP) who Received Intravenous Fosfomycin (ZTI-01)
- Poster 1845: Intravenous Fosfomycin (ZTI-01) for the Treatment of Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP): Results from a Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults (ZEUS)
- Poster 1848: Population Pharmacokinetic (PPK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Data from Healthy Subjects and Patients with Complicated Urinary Tract Infections (cUTI)
About ZOLYD (fosfomycin for injection, also known as ZTI-01)
ZOLYD is an investigational, first-in-class injectable epoxide antibiotic with a broad spectrum of activity in vitro against Gram-negative and Gram-positive bacteria, including activity against most multi-drug resistant strains that are of particular concern to public health. ZOLYD has a differentiated mechanism of action that acts at an earlier step in cell wall synthesis inhibition, providing activity against pathogens that are often resistant to other classes of antibiotics. Zavante recently reported that ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS clinical trial in hospitalized patients with cUTI, including AP.
The U.S. Food and Drug Administration has granted Fast Track and Qualified Infectious Disease Product designations for the investigation of ZOLYD for cUTI, hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP) infections, acute bacterial skin and skin structure infections (ABSSSI), and complicated intra-abdominal infections (cIAI). These designations make ZOLYD eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act.
ZOLYD is an investigational medication that has not been approved by the FDA for any indication.
About Zavante Therapeutics, Inc.
Zavante Therapeutics, Inc. is a privately-held, late clinical-stage biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients. Additional information is available at www.zavante.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Such statements may be preceded by the words such as “believe” and similar words. Forward-looking statements contained in this press release include statements about the company’s belief that data from the ZEUS study will be sufficient to support a new drug application (NDA) for U.S. registration of ZOLYD. Forward-looking statements are not historical facts or assurances of the company’s future performance, but are based on management’s current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and may be outside of the company’s control. Because the company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements, you should not rely on any such forward-looking statements. Important factors that could cause the company’s actual results to differ materially from those indicated in this release include, among others, the following: whether the results of the ZEUS clinical trial are deemed by FDA to be sufficient to support approval of an NDA for ZOLYD in the treatment of patients with cUTI; unanticipated delays that may occur, or unanticipated findings that may emerge, in analyzing the safety or efficacy data from the ZEUS clinical trial; the company’s ability to successfully complete necessary manufacturing and related development activities for ZOLYD on time and at reasonable costs; the company’s ability to obtain additional financing required to complete development activities and prepare for the commercialization of ZOLYD, if approved by FDA; and potential changes in the FDA’s regulatory policies that could negatively impact FDA approval of an NDA for ZOLYD or the Fast Track or QIDP designations granted by FDA for ZOLYD. Forward-looking statements contained in this press release are based only on information currently available to the company and speak only as of the date made. Zavante undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
ZOLYD and ZAVANTE are trademarks or registered trademarks of Zavante Therapeutics, Inc.
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SOURCE Zavante Therapeutics, Inc.
Trovagene Strengthens Board of Directors with Appointment of Oncology Development Veteran Dr. Athena Countouriotis
Dr. Athena Countouriotis joins Trovagene’s Board of Directors, bringing significant experience in oncology clinical development and orphan indications
SAN DIEGO, Sept. 20, 2017 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced the expansion and strengthening of its Board of Directors with the appointment of Athena Countouriotis, M.D.
Dr. Countouriotis brings significant experience leading clinical development programs, from preclinical through clinical stages, and approval. Over the course of her career, she has been involved in multiple clinical programs, with a focus within oncology, both hematologic and solid tumor indications, that have supported regulatory approvals in the U.S. and Europe. Dr. Countouriotis currently serves as Senior Vice President, Chief Medical Officer at Adverum Biotechnologies. Prior to joining Adverum, she served as Senior Vice President and Chief Medical Officer at Halozyme Therapeutics. Dr. Countouriotis was Chief Medical Officer at Ambit Biosciences through the initial development of quizartinib, a small molecule FLT3 inhibitor for the treatment of Acute Myeloid Leukemia, and ultimate acquisition of the company by Daiichi Sankyo. Dr. Countouriotis also worked at both Pfizer and Bristol-Meyers Squibb in various roles leading clinical development of oncology focused therapeutics. She holds a M.D. from Tufts University School of Medicine, completed her pediatric residency at the University of California, Los Angeles, and did additional training at Fred Hutchinson Cancer Research Center in the pediatric hematology-oncology program.
“We are pleased to welcome Dr. Countouriotis to our Board of Directors,” said Bill Welch, Chief Executive Officer of Trovagene. “Dr. Countouriotis has incredible expertise in the clinical development of oncology therapeutics, including multiple compounds in leukemia such as Sprycel, Mylotarg, Bosulif and Quizartinib, which is a FLT3 inhibitor in AML. We look forward to her contributions and guidance as we continue to advance PCM-075 for the treatment of patients with hematologic and solid tumor cancers.”
“It is an exciting time at Trovagene as we embark on moving PCM-075 into the clinic in AML. This a great time to join the Board of Directors and share my expertise with the company, and I look forward to working with the Trovagene team,” added Dr. Countouriotis.
PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple hematologic and solid solid tumor cancers. Studies have shown that inhibition of PLK1 can lead to tumor cell death, including multiple Phase 2 studies in Acute Myeloid Leukemia (AML) where response rates of up to 30% have been observed. A Phase 1 open-label, dose escalation safety study of PCM-075 has been completed in patients with advanced metastatic solid tumor cancers, and published in Investigational New Drugs. Trovagene plans to initiate a Phase 1b/2 clinical trial with PCM-075 in AML, since it has shown significant advantages over prior PLK1 inhibitors evaluated in this indication, including a higher selectivity, greater potency, oral bioavailability and shorter half-life. PCM-075 has demonstrated synergy in preclinical studies with over 10 chemotherapeutic and target agents used in hematologic and solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK-1 inhibitor, PCM-075, with other compounds has the potential for improved clinical efficacy in Acute Myeloid Leukemia (AML), Castration-Resistant Prostate Cancer (CRPC), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer (TNBC) and Adrenocortical Carcinoma (ACC).
About Trovagene, Inc.
Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics. Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. For more information, please visit https://www.trovagene.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene’s strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
VP, Corporate Communications
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SOURCE Trovagene, Inc.
– Datavant aggregates and analyzes biomedical data to lower the time, cost, and risk of drug development- Tech industry veteran and former LiveRamp CEO Travis May to lead Datavant- Founders Fund joins Softbank Vision Fund in supporting mission of Roivant and Datavant
SAN FRANCISCO and BASEL, Switzerland, Sept. 20, 2017 /PRNewswire/ — Roivant Sciences, a global healthcare company focused on realizing the full value of promising biomedical research to improve the lives of patients and their families, today announced the launch of Datavant, a new company focused on employing artificial intelligence to improve the clinical trial process.
Datavant will be led by Travis May, a Silicon Valley technology veteran with a history of building industry-leading data companies. Mr. May was the co-founder and CEO of LiveRamp, an identity resolution provider offering data onboarding.
“As a technologist looking at the biopharma industry, it’s surprising and disconcerting how little data is shared as compared to other industries,” said Mr. May. “Biopharmaceutical data is siloed across big pharma companies, universities, healthcare consortia, CROs, research groups, hospital systems, regulatory bodies, patient registries, genomics companies, and EMRs. There is tremendous potential to apply analytics to this data more effectively, improve drug development, and ultimately save lives.”
Incubated by Roivant, Datavant has already compiled data from 85 different datasets comprising over 20 million patient visits. When appropriately joined and analyzed, these datasets can be used to inform the design and operations of clinical development programs – improving likelihood of success and time to market, and reducing the cost of clinical trials. Datavant is launching with initial financing led by Roivant and including a significant personal investment from Mr. May.
Datavant has also built a scientific and data science advisory board that includes:
- Daniel Burch, MD, Chief Medical Officer of PPD Biotech
- Emiko Higashi, Founder and Managing Director of Tohmon Capital Partners LLC
- Min Li, PhD, SVP and Head of Neurosciences R&D at GlaxoSmithKline; former Professor of Neuroscience at Johns Hopkins University
- Andrew Lo, PhD, Charles E. and Susan T. Harris Professor at the MIT Sloan School of Management
- Atul Pande, MD, Former SVP, Head of Neurosciences R&D at GlaxoSmithKline
- Eric Perakslis, PhD, SVP, R&D Informatics at Takeda Pharmaceuticals; former CIO and Chief Scientist (Informatics) at FDA; former Executive Director of the Harvard Medical School Center for Biomedical Informatics
- Frank Rockhold, PhD, Professor of Biostatistics and Bioinformatics at the Duke Clinical Research Institute
- Bryan Spielman, Former EVP at Medidata
“Despite the best efforts of consortia and data sharing initiatives, clinical trial data remains under-optimized today, reducing the odds of success for clinical trials and adding significant cost to the drug development process,” said Eric Perakslis. “I’m excited by Datavant’s approach to using sophisticated analytics and AI to unlock the potential of patient-level data, and believe it can ultimately improve the drug development process and bring value to patients.”
“Today’s announcement represents another step forward in achieving Roivant’s long-term goal of reducing the time and cost of the drug development process,” said Vivek Ramaswamy, Founder and CEO of Roivant Sciences.
Roivant recently completed a $1.1 billion equity investment led by the SoftBank Vision Fund. Founders Fund also participated in that round.
“We are impressed by Roivant’s bold vision for transforming healthcare, and see Datavant as an integral part of that vision,” said Founders Fund partner Brian Singerman. “Few sectors need innovation more than healthcare and Datavant is uniquely positioned to have a significant impact on the way medicines are developed across the industry.”
Datavant is dedicated to accelerating the discovery, development, and commercialization of new medicines through machine learning. We aim to partner with biomedical research institutions to eliminate silos of information and unlock insights from healthcare data.
Datavant is backed by Roivant Sciences, a global family of healthcare companies focused on innovative approaches to realizing the full value of promising biomedical research and shortening the timeline and cost of pharmaceutical development. Datavant is combining leading data scientists with Roivant’s biopharmaceutical research expertise to provide analytic solutions to our partners.
About Roivant Sciences
Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. We partner with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients.
We advance our drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also pursues its mission by incubating and launching innovative healthcare companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit roivant.com.
+1 (646) 495-5310
+1 (765) 490-9385
SOURCE Roivant Sciences