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MarkLogic Launches Pharma Research Hub to Accelerate Drug Research and Results

dataversity | May 17, 2019

According to a recent press release, “MarkLogic Corporation, the next generation data platform provider for simplifying data integration, today announced the MarkLogic® Pharma Research Hub to enable pharmaceutical companies to lower drug trial costs and accelerate research. This is achieved by helping researchers quickly and easily find, synthesize and share high-quality data – including, genetic, proteomic, drug, textual, binary and clinical trial data – within a single cloud service. The MarkLogic Pharma Research Hub uses machine learning and other advanced technologies including semantics, fuzzy matching, relevance ranking and rich metadata to manage, organize and retrieve information. As a fully managed cloud service, the Pharma Research Hub can be set up in minutes and ingests data 10x faster than custom-developed solutions – with zero IT management burden.” The release goes on, “By working with five of the largest global pharmaceutical companies and other leaders in the healthcare ecosystem, MarkLogic has long used its Data Hub technology to help solve pharmaceutical companies’ business and data challenges by: (1) Enabling search and visualization of relationships: View, navigate, and search the graph of connections in data by leveraging all inherent relationships. Visualizing these relationships in data, such as how a researcher is connected to institutions and peers, or how a gene, drug target and metabolic pathway are related, can lead to faster discoveries. (2) Leveraging machine learning: Users get better search results on higher quality data. MarkLogic’s Smart Mastering feature uses machine learning to find and consolidate related and duplicate items and to construct a knowledge graph of all data. Data quality rules are applied as data is loaded. This high-quality, mastered data dramatically improves search results and enables better downstream bioinformatics and AI analysis.”

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Aeris: Benchtop XRD for pharmaceutical solid form analysis

Is solid form characterization critical in your line of work, but you lack expertise in X-ray diffraction (XRD)? Do you need an efficient tool to support you with lead optimization? Do you need an easy way to validate the stability of your solid form following processing?

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NanoTemper Technologies Unveils Biotinylated Target Labeling Kit, Empowering Scientists in Pharma Industry to Tackle Challenging Drug Targets

Businesswire | June 30, 2023

NanoTemper Technologies, creator of biophysical tools for drug discovery, today, proudly announced the launch of their highly anticipated Biotinylated Target Labeling Kit, expanding the molecular interaction analysis toolkit for scientists working with complex or undruggable targets, filling a vital gap in screening and hit validation workflows in the pharma industry. This new kit combined with NanoTemper’s exclusive Spectral Shift technology is the preferred orthogonal method for scientists utilizing surface plasmon resonance (SPR), who predominantly use biotinylated proteins for affinity screening or binding affinity assays. “Now, direct comparison of binding affinities from an immobilized method to the in-solution, immobilization-free technique of Spectral Shift is possible,” says Regina Borovac, Consumables Product Manager at NanoTemper Technologies. “And, not only that, it enables those who already use Spectral Shift to analyze a broader range of interactions, tackling even more projects involving complex targets.” Spectral Shift is a growing power in molecular affinity measurements Because of Spectral Shift’s early success in removing roadblocks for scientists who have found difficulty finding candidates for their complex targets, NanoTemper is continuing to invest in creating products that empower scientists to do more with Spectral Shift technology. "We’ve put Spectral Shift technology into Dianthus, our affinity screening instrumentation, and Monolith X, our instrumentation for molecular interactions, and they’ve now become a necessity for anyone tackling challenging disease targets,” comments Jocelyn Davé, Chief Product Officer at NanoTemper Technologies. “When it comes to addressing difficult and undruggable targets, there is no other company with the ability to outperform SPR in this category." About NanoTemper Technologies Our mission at NanoTemper Technologies is to create biophysical tools for scientists in drug discovery and development who need to tackle challenging characterizations. Working with scientists striving to make a difference in the world gets us excited. If you’re facing challenges with affinity screening, molecular interactions, or protein stability, let’s talk.

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PHARMACY MARKET, PHARMA TECH

Timber Pharmaceuticals to be Acquired by LEO Pharma

Globenewswire | August 22, 2023

Timber Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to be acquired by LEO US Holding, Inc. a wholly-owned subsidiary of LEO Pharma A/S, in a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones described below. All of the issued and outstanding shares of capital stock and other equity interests of Timber will be converted into the right to receive the initial upfront consideration, less the payments for certain outstanding warrants that contain a Black Scholes cash payout value. For example, based on a current estimate of the Black Scholes value of such warrants of approximately $5.1 million, subject to change based on the assumptions detailed below, Timber expects the initial amount per share to be paid to Timber stockholders to be approximately $2.62 based on approximately 3.4 million shares of Timber common stock and restricted stock issued and outstanding as of August 20, 2023. The current estimated value to stockholders is based on an implied value assigned to certain outstanding warrants based on Black Scholes option pricing model as of August 18, 2023. This value will not be finalized until the closing of the merger and is subject to increase or decrease based on certain variables, including the actual trading price of Timber at the time of the merger and the trading volatility of Timber common stock prior to the merger. The CVRs that Timber stockholders will receive provide for the payment of up to an additional $22 million with respect to specific milestones for TMB-001, of which up to $12 million is related to FDA approval of TMB-001 by October 1, 2025 for the treatment of congenital ichthyosis, and up to $10 million of which is related to the first achievement of TMB-001 net sales exceeding $100 million within four consecutive calendar quarters by December 31, 2028. As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions. The payments of the CVRs are subject to certain deductions relating to the repayment of 50% of the bridge loan provided by LEO Pharma to Timber in connection with the merger. John Koconis, Chairman and Chief Executive Officer of Timber, said, “We are very pleased to deliver a transaction that will maximize long term value for Timber’s shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases. “LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber’s portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease. “Finally, I would like to sincerely thank our dedicated team at Timber for their tireless efforts, and the clinical investigators, medical professionals, patients and families whose personal contributions have been instrumental in shaping our understanding of TMB-001.” The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the fourth quarter of 2023, subject to customary closing conditions, including approval by the holders of a majority of the shares of Timber’s common stock. Following completion of the transaction, Timber will become a privately held company and shares of Timber’s common stock will no longer be listed on any public market. Timber will file a Current Report on Form 8-K with the Securities and Exchange Commission (“SEC”) that will include a copy of the merger agreement and the CVR agreement and will contain a more detailed description of the merger and the consideration to be received by Timber stockholders. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, LEO Pharma generated net sales of DKK 10.6 billion. About Timber Pharmaceuticals, Inc. Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.

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Mitsubishi Tanabe Pharma America Highlights Latest Research in Parkinson's Disease at EAN and WPC 2023 Congresses

prnewswire | July 06, 2023

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of seven abstracts in Parkinson's disease (PD) at the 9th Congress of the European Academy of Neurology (EAN), which was held in Budapest, July 1-3, and the 6th World Parkinson Congress (WPC), being held in Barcelona, July 4-7. "Our presence at EAN and WPC this year underscores MTPA's dedication to investigating potential treatment options to tackle the current unmet needs and challenges of Parkinson's disease," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "We're excited to share our progress with the global scientific community, including the presentation of key findings from a number of clinical trials evaluating ND0612 in people with Parkinson's disease experiencing motor fluctuations." Clinical development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), MTPA's parent company. If regulatory approval for ND0612 is obtained, MTPA intends to commercialize the therapy in the U.S. Presentations at EAN Presentations highlighted findings from two ongoing studies of investigational ND0612 in people with PD with motor fluctuations, including topline results from the Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial evaluating the efficacy, safety and tolerability of ND0612, in addition to three-year outcomes from the Phase 2b open-label BeyoND study evaluating the long-term safety of ND0612. Additionally, results were shared from an open-label pharmacokinetic study assessing the relative bioavailability of levodopa when administered with ND0612 vs. oral levodopa/carbidopa (LD/CD). Summary of results from a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612 (Nelson Lopes, M.D.; NeuroDerm) ePoster #EPO-610 Continuous subcutaneous levodopa/carbidopa infusion for PD: Summary of results from the 3-Year data from the BeyoND study (Nelson Lopes, M.D.; NeuroDerm) ePresentation #EPR-282 Relative bioavailability of levodopa administered as a subcutaneous infusion with ND0612 versus oral IR levodopa/carbidopa (Sophia Sopromadze, M.D.; NeuroDerm) ePresentation #EPR-066 Presentations at WPC New data from a post-hoc analysis from the 28-day open-label Study 006 will be presented, evaluating the early efficacy of investigational ND0612 in reducing motor fluctuations in study participants treated with a 24-hour ND0612 infusion regimen, along with findings from four case studies describing the long-term (up to five years) experience of participants in the Phase 2b BeyoND study receiving ND0612 treatment. Additional presentations will highlight the development of a Motor Fluctuations Patient Journey Map (MFPJM) for people with PD to describe the holistic patient experience from pre-diagnosis through hospice care with a focus on motor fluctuations, and details on enrollment characteristics of randomized study participants in the Phase 3 BouNDless study. All posters will be on display in the Exhibit Hall during Poster Session 1 from 11:30 a.m. – 1:30 p.m. CEST on July 5. About ND0612 ND0612 is an investigative drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for people with Parkinson's disease (PD) experiencing motor fluctuations. About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to commercialize approved pharmaceutical products in North America. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. About NeuroDerm, Ltd. NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates.

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Pharmacy Market

NanoTemper Technologies Unveils Biotinylated Target Labeling Kit, Empowering Scientists in Pharma Industry to Tackle Challenging Drug Targets

Businesswire | June 30, 2023

NanoTemper Technologies, creator of biophysical tools for drug discovery, today, proudly announced the launch of their highly anticipated Biotinylated Target Labeling Kit, expanding the molecular interaction analysis toolkit for scientists working with complex or undruggable targets, filling a vital gap in screening and hit validation workflows in the pharma industry. This new kit combined with NanoTemper’s exclusive Spectral Shift technology is the preferred orthogonal method for scientists utilizing surface plasmon resonance (SPR), who predominantly use biotinylated proteins for affinity screening or binding affinity assays. “Now, direct comparison of binding affinities from an immobilized method to the in-solution, immobilization-free technique of Spectral Shift is possible,” says Regina Borovac, Consumables Product Manager at NanoTemper Technologies. “And, not only that, it enables those who already use Spectral Shift to analyze a broader range of interactions, tackling even more projects involving complex targets.” Spectral Shift is a growing power in molecular affinity measurements Because of Spectral Shift’s early success in removing roadblocks for scientists who have found difficulty finding candidates for their complex targets, NanoTemper is continuing to invest in creating products that empower scientists to do more with Spectral Shift technology. "We’ve put Spectral Shift technology into Dianthus, our affinity screening instrumentation, and Monolith X, our instrumentation for molecular interactions, and they’ve now become a necessity for anyone tackling challenging disease targets,” comments Jocelyn Davé, Chief Product Officer at NanoTemper Technologies. “When it comes to addressing difficult and undruggable targets, there is no other company with the ability to outperform SPR in this category." About NanoTemper Technologies Our mission at NanoTemper Technologies is to create biophysical tools for scientists in drug discovery and development who need to tackle challenging characterizations. Working with scientists striving to make a difference in the world gets us excited. If you’re facing challenges with affinity screening, molecular interactions, or protein stability, let’s talk.

Read More

PHARMACY MARKET, PHARMA TECH

Timber Pharmaceuticals to be Acquired by LEO Pharma

Globenewswire | August 22, 2023

Timber Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to be acquired by LEO US Holding, Inc. a wholly-owned subsidiary of LEO Pharma A/S, in a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones described below. All of the issued and outstanding shares of capital stock and other equity interests of Timber will be converted into the right to receive the initial upfront consideration, less the payments for certain outstanding warrants that contain a Black Scholes cash payout value. For example, based on a current estimate of the Black Scholes value of such warrants of approximately $5.1 million, subject to change based on the assumptions detailed below, Timber expects the initial amount per share to be paid to Timber stockholders to be approximately $2.62 based on approximately 3.4 million shares of Timber common stock and restricted stock issued and outstanding as of August 20, 2023. The current estimated value to stockholders is based on an implied value assigned to certain outstanding warrants based on Black Scholes option pricing model as of August 18, 2023. This value will not be finalized until the closing of the merger and is subject to increase or decrease based on certain variables, including the actual trading price of Timber at the time of the merger and the trading volatility of Timber common stock prior to the merger. The CVRs that Timber stockholders will receive provide for the payment of up to an additional $22 million with respect to specific milestones for TMB-001, of which up to $12 million is related to FDA approval of TMB-001 by October 1, 2025 for the treatment of congenital ichthyosis, and up to $10 million of which is related to the first achievement of TMB-001 net sales exceeding $100 million within four consecutive calendar quarters by December 31, 2028. As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions. The payments of the CVRs are subject to certain deductions relating to the repayment of 50% of the bridge loan provided by LEO Pharma to Timber in connection with the merger. John Koconis, Chairman and Chief Executive Officer of Timber, said, “We are very pleased to deliver a transaction that will maximize long term value for Timber’s shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases. “LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber’s portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease. “Finally, I would like to sincerely thank our dedicated team at Timber for their tireless efforts, and the clinical investigators, medical professionals, patients and families whose personal contributions have been instrumental in shaping our understanding of TMB-001.” The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the fourth quarter of 2023, subject to customary closing conditions, including approval by the holders of a majority of the shares of Timber’s common stock. Following completion of the transaction, Timber will become a privately held company and shares of Timber’s common stock will no longer be listed on any public market. Timber will file a Current Report on Form 8-K with the Securities and Exchange Commission (“SEC”) that will include a copy of the merger agreement and the CVR agreement and will contain a more detailed description of the merger and the consideration to be received by Timber stockholders. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, LEO Pharma generated net sales of DKK 10.6 billion. About Timber Pharmaceuticals, Inc. Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.

Read More

Business Insights

Mitsubishi Tanabe Pharma America Highlights Latest Research in Parkinson's Disease at EAN and WPC 2023 Congresses

prnewswire | July 06, 2023

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of seven abstracts in Parkinson's disease (PD) at the 9th Congress of the European Academy of Neurology (EAN), which was held in Budapest, July 1-3, and the 6th World Parkinson Congress (WPC), being held in Barcelona, July 4-7. "Our presence at EAN and WPC this year underscores MTPA's dedication to investigating potential treatment options to tackle the current unmet needs and challenges of Parkinson's disease," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "We're excited to share our progress with the global scientific community, including the presentation of key findings from a number of clinical trials evaluating ND0612 in people with Parkinson's disease experiencing motor fluctuations." Clinical development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), MTPA's parent company. If regulatory approval for ND0612 is obtained, MTPA intends to commercialize the therapy in the U.S. Presentations at EAN Presentations highlighted findings from two ongoing studies of investigational ND0612 in people with PD with motor fluctuations, including topline results from the Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial evaluating the efficacy, safety and tolerability of ND0612, in addition to three-year outcomes from the Phase 2b open-label BeyoND study evaluating the long-term safety of ND0612. Additionally, results were shared from an open-label pharmacokinetic study assessing the relative bioavailability of levodopa when administered with ND0612 vs. oral levodopa/carbidopa (LD/CD). Summary of results from a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612 (Nelson Lopes, M.D.; NeuroDerm) ePoster #EPO-610 Continuous subcutaneous levodopa/carbidopa infusion for PD: Summary of results from the 3-Year data from the BeyoND study (Nelson Lopes, M.D.; NeuroDerm) ePresentation #EPR-282 Relative bioavailability of levodopa administered as a subcutaneous infusion with ND0612 versus oral IR levodopa/carbidopa (Sophia Sopromadze, M.D.; NeuroDerm) ePresentation #EPR-066 Presentations at WPC New data from a post-hoc analysis from the 28-day open-label Study 006 will be presented, evaluating the early efficacy of investigational ND0612 in reducing motor fluctuations in study participants treated with a 24-hour ND0612 infusion regimen, along with findings from four case studies describing the long-term (up to five years) experience of participants in the Phase 2b BeyoND study receiving ND0612 treatment. Additional presentations will highlight the development of a Motor Fluctuations Patient Journey Map (MFPJM) for people with PD to describe the holistic patient experience from pre-diagnosis through hospice care with a focus on motor fluctuations, and details on enrollment characteristics of randomized study participants in the Phase 3 BouNDless study. All posters will be on display in the Exhibit Hall during Poster Session 1 from 11:30 a.m. – 1:30 p.m. CEST on July 5. About ND0612 ND0612 is an investigative drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for people with Parkinson's disease (PD) experiencing motor fluctuations. About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to commercialize approved pharmaceutical products in North America. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. About NeuroDerm, Ltd. NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates.

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