Intercept Pharmaceuticals

Intercept Announces New Data to be Presented at the European Association for the Study of the Liver (EASL) Congress 2024

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星期三, 五月 29, 2024
Patient, Primary biliary cholangitis, Hepatology, Ursodeoxycholic acid, EASL, Congress, Intercept Pharmaceuticals, Cirrhosis, Senior, PBC, Research, Abstract, Liver disease, Intercept, Biomarker, Alkaline phosphatase, Head, Therapy, Bezafibrate, Medical imaging

MORRISTOWN, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced nine abstracts related to primary biliary cholangitis (PBC) and alcohol-related liver disease will be presented at EASL Congress 2024.

Key Points: 
  • MORRISTOWN, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced nine abstracts related to primary biliary cholangitis (PBC) and alcohol-related liver disease will be presented at EASL Congress 2024.
  • The congress will be held from June 5-8 in Milan, Italy.
  • “We are thrilled to present our latest research in PBC at this year’s EASL Congress,” said Sangeeta Sawhney, Senior Vice President and Head of U.S. Research & Development at Intercept.
  • A full list of sessions at EASL Congress 2024 is available at www.easlcongress.eu .

Anavex Life Sciences Announces Expansion of Leadership Team

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星期三, 五月 22, 2024
Marketing, Drug, Gen-Probe, European Medicines Agency, FDA, Drug development, North Carolina State University, Senior, Rett syndrome, HCV, Therapy, Pharmacology, Clinical research, Ritonavir, MD, James Madison University, Ipilimumab, AbbVie, CNS, Clinical pharmacology, Bristol Myers Squibb, New Drug Application, Arena Pharmaceuticals, Nobel Prize, Schizophrenia, Nivolumab, Amylin Pharmaceuticals, Yale University, Molecular biology, Pharmacokinetics, Doctor of Philosophy, Acer, Rochester Institute of Technology, Research and development, University, Overalls, Pramlintide, Intercept Pharmaceuticals, DSM-IV codes, Assistant, EMA, DMPK, Roche, Development, Central nervous system, Pharmaceutical industry

“The most important part of building a long-term, commercially sustainable, growing business is putting the right players on the field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

Key Points: 
  • “The most important part of building a long-term, commercially sustainable, growing business is putting the right players on the field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
  • Prior to Anavex Dr. Lopez-Talavera held key leadership positions at Fractyl Health, Intercept Pharmaceuticals, AbbVie, Bristol Myers Squibb and Roche.
  • Dr. Edwards brings to Anavex 18 years of experience in various aspects of drug development including DMPK (drug metabolism and pharmacokinetics), Clinical Pharmacology, and Clinical Science.
  • Before joining Anavex, Dr. Edwards served as Vice President of Clinical Science at Acer Therapeutics, and positions of increasing responsibility at Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Amylin Pharmaceuticals, and Arena Pharmaceuticals.

Intercept Presents New Sub-Analyses of Phase 3 POISE Data Showcasing the Effect of OCA on Key Liver Biomarkers and Fibrosis in Patients with PBC at Digestive Disease Week® 2024

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星期一, 五月 20, 2024
Patient, DDW, Primary biliary cholangitis, Hepatology, ALT, Ursodeoxycholic acid, OCA, Liver, Safety, Intercept Pharmaceuticals, Cirrhosis, PBC, Biomarker, Alkaline phosphatase, Gastrointestinal disease, Therapy, ALP, Medical imaging

MORRISTOWN, N.J., May 20, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, is presenting two new sub-analyses from its Phase 3 POISE study in primary biliary cholangitis (PBC), at Digestive Disease Week® (DDW) 2024 in Washington, D.C. One analysis evaluated the effect of obeticholic acid (OCA) on alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, liver biomarkers associated with poor clinical outcomes; the other evaluated the effect of OCA on aminotransferase to platelet ratio index (APRI) score, a non-invasive test that can predict liver fibrosis progression.

Key Points: 
  • “When treating PBC, it’s imperative to assess other biomarkers beyond ALP, such as ALT and AST, as well as potential liver fibrosis, which can be done via non-invasive measures like APRI.
  • Patients were randomized to one of three groups in the trial: placebo, OCA 10 mg, or OCA 5 mg for six months, titrated to 10 mg based on clinical response.
  • The study included a 12-month double-blind phase, as well as a long-term safety extension phase up to five years.
  • A post hoc analysis was conducted to determine the impact of OCA on APRI in patients with PBC from the Phase 3 POISE trial.

Intercept Presents New Data Demonstrating the Impact of OCA-Bezafibrate Combination Therapy on ALP and Metabolic Outcomes After Six Months of Treatment at Digestive Disease Week® 2024

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星期六, 五月 18, 2024
LDL, DDW, Patient, Primary biliary cholangitis, Hepatology, Ursodeoxycholic acid, OCA, Safety, Intercept Pharmaceuticals, Serum, PBC, MD, Harvard Medical School, Associate, UDCA, Gastrointestinal disease, Therapy, ALP, Bezafibrate, Pharmaceutical industry

MORRISTOWN, N.J., May 18, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, is presenting new data from a planned six-month analysis of its ongoing Phase 2 study 747-213 evaluating a fixed-dose combination of obeticholic acid (OCA) and bezafibrate in patients with primary biliary cholangitis (PBC) at Digestive Disease Week® (DDW) 2024 in Washington, D.C. Results from the study show that six-month administration of OCA and bezafibrate has the potential to normalize alkaline phosphatase (ALP), a serum biomarker of PBC-related liver damage that has been correlated with improved transplant-free and decompensation-free survival.

Key Points: 
  • Results from the study show that six-month administration of OCA and bezafibrate has the potential to normalize alkaline phosphatase (ALP), a serum biomarker of PBC-related liver damage that has been correlated with improved transplant-free and decompensation-free survival.
  • “I am encouraged by the findings from this six-month analysis of the fixed-dose combination of OCA and bezafibrate,” said Alan Bonder, MD, Medical Director of Liver Transplant, BIDMC, and Associate Professor of Medicine, Harvard Medical School.
  • The objectives of this study were to evaluate change in ALP from baseline to Month 6, as well as changes in lipid panel over the same time period.
  • We look forward to presenting these data in further depth at DDW 2024.”
    The company is continuing its two ongoing Phase 2 studies (747-213 / NCT04594694 , 747-214 / NCT05239468 ), which are exploring a range of therapeutic doses and formulations for the combination of OCA and bezafibrate.

Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference

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星期四, 五月 9, 2024
Bezafibrate, Gastrointestinal disease, Learning, Intercept, Abstract, Aspartic acid, Primary biliary cholangitis, Fibrosis, Intercept Pharmaceuticals, Therapy, Senior, Liver, Obeticholic acid, DDW, Hepatology, PBC, Risk, Head, Pharmaceutical industry

MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024.

Key Points: 
  • MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024.
  • “These data, along with new analyses from our landmark Phase 3 POISE trial, showcase our continued commitment to helping improve the lives of people living with PBC.
  • A full list of sessions at DDW 2024 is available at www.ddw.org .
  • Attendees of DDW can visit Intercept at booths #3741 and #3828 throughout the meeting.

Sagimet Biosciences Announces Appointment of Thierry Chauche as Chief Financial Officer

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星期一, 五月 6, 2024
University, CFO, FASN, Inflammation, École des ponts ParisTech, Compensated emancipation, Alexion Pharmaceuticals, Employment, Intercept Pharmaceuticals, Novartis, Engineering, Patient, Black–Scholes model, Acquisition, MBA, Sanofi, SAN, Strategic planning, Management

SAN MATEO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the appointment of Thierry Chauche as Chief Financial Officer, effective today, May 6, 2024.

Key Points: 
  • SAN MATEO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the appointment of Thierry Chauche as Chief Financial Officer, effective today, May 6, 2024.
  • “We are thrilled to welcome Thierry to our executive leadership team in the role of CFO.
  • Thierry brings a proven track record in corporate finance in the biopharmaceutical sector, bringing expertise in corporate planning and strategy, investor relations, financing, and M&A,” said Dave Happel, CEO of Sagimet.
  • Before Provention Bio, Mr. Chauche was the Vice President and Head of Strategic Financial Planning & Analysis at Alexion Pharmaceuticals.

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC

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星期四, 二月 29, 2024
Therapy, Senior, Ursodeoxycholic acid, Pamlab, New Drug Application, FDA, Food, Shanda, PDUFA, Regulatory affairs, Database, PBC, Communication, Hepatology, Cirrhosis, Intercept, Primary biliary cholangitis, Patient, UDCA, Obeticholic acid, Intercept Pharmaceuticals, Advisory Committee, Pharmaceutical industry

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.
  • In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application.
  • The precedent-setting sNDA for Ocaliva is intended to satisfy the post-marketing requirements to confirm a clinical benefit in patients with PBC.
  • Intercept and Alfasigma remain committed to supporting people living with PBC and look forward to advancing discussions with the agency.

Ally Bridge Group Announces Key Promotions and New Appointment

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星期一, 三月 4, 2024
Other Health, Banking, General Health, Professional Services, Pharmaceutical, Public Relations, Investor Relations, Science, Biotechnology, Communications, Finance, Other Science, Health, ABG, Investment, Stifel, Financial analyst, Growth, CRG, History, Business, Pharming, Intercept Pharmaceuticals, Jefferies, Pharmaceutical industry

Ally Bridge Group (“ABG”), a leading global healthcare investment firm focused on high-impact life science innovation, today announced several key promotions within its investment team and a new appointment to drive the firm’s future growth and expansion as it celebrates its 10th anniversary.

Key Points: 
  • Ally Bridge Group (“ABG”), a leading global healthcare investment firm focused on high-impact life science innovation, today announced several key promotions within its investment team and a new appointment to drive the firm’s future growth and expansion as it celebrates its 10th anniversary.
  • Kevin and Andrew have demonstrated a track record of successful investments and exits for ABG’s Private Equity strategy amidst challenging market conditions.
  • Previously, he was a Managing Director at Leon Capital Group, overseeing capital formation and investor relations for private fund offerings and investments.
  • Prior to that, Zain worked with Kevin Reilly at CRG, where he led capital formation and investor relations across various funds.

Prothena Appoints David Ford to Newly Created Chief People Officer Position

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星期一, 三月 4, 2024
Research, Pharmaceutical, Oncology, Mental Health, Genetics, Clinical Trials, Science, Cardiology, Biotechnology, Neurology, Other Science, Health, Therapy, Doctor of Philosophy, Multimedia, Culture, Overalls, Intercept Pharmaceuticals, Management

Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that it has named David Ford to a newly created position of Chief People Officer, reporting to Prothena President and Chief Executive Officer Gene Kinney, PhD.

Key Points: 
  • Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that it has named David Ford to a newly created position of Chief People Officer, reporting to Prothena President and Chief Executive Officer Gene Kinney, PhD.
  • In this role, Mr. Ford will be responsible for people, culture, and human resources strategy to drive the company’s vision and overall growth strategy.
  • View the full release here: https://www.businesswire.com/news/home/20240304692974/en/
    “As we continue to advance our late-stage clinical pipeline in protein dysregulation addressing both neurodegenerative and rare peripheral amyloid diseases, we are expanding our human resources capabilities and adding the newly created position of Chief People Officer to our leadership team.
  • We’re thrilled to welcome David as a new Prothenian as he brings an exceptional level of expertise to help lead us through this exciting time,” said Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena.

Prothena Announces Appointment of Daniel G. Welch as Director and Chair Designate

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星期三, 二月 21, 2024
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Science, Oncology, Therapy, Pfizer, Gilead Sciences, Multimedia, B.A, University, Sofinnova, Annual general meeting, PLC, Chairperson, Élan, Hyperion, Patient, Novartis, Intercept Pharmaceuticals, Horizon Therapeutics, Chair, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240221419945/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240221419945/en/
    Upon election by the shareholders at Prothena’s Annual General Meeting later this year, the Board intends to appoint Mr. Welch as Chair of the Board.
  • Dr. Ekman will step down as Chair and continue to serve on the board as Chair Emeritus, following the anticipated appointment of Mr. Welch.
  • The entire Prothena Board expresses their sincere gratitude for Dr. Ekman’s valuable service as Chair.
  • Dr. Harfstrand has been a director since 2015 and the entire Prothena Board acknowledges and appreciates his positive impact during his service.