Life Science Alliance

Overeating and starving both damage the liver: Cavefish provide new insight into fatty liver disease

Retrieved on: 
Thursday, March 14, 2024
Fatty liver disease, Cirrhosis, Liver failure, Life Science Alliance, Type, DSM-IV codes, Liver, Obesity, Exercise, Gene expression, FNRS, Disease, Assistant, Iowa State University, Associate, National Science Foundation, Zebrafish, Research, Food, NIH, Human, Biology, Atrophy, Type 2 diabetes, Mexican, NSF, Starvation, Fruit, Medical research, Liver disease, Bangladesh Technical Education Board, Animal, Dietary supplement

KANSAS CITY, Mo., March 14, 2024 /PRNewswire/ -- Fatty liver, which can lead to liver damage and disease, can occur from both overeating and starvation. Now, new research shows how naturally starvation-resistant cavefish, unlike other animals, are able to protect their liver and remain healthy. The findings have implications for understanding and potentially addressing liver conditions in humans.

Key Points: 
  • KANSAS CITY, Mo., March 14, 2024 /PRNewswire/ -- Fatty liver, which can lead to liver damage and disease, can occur from both overeating and starvation.
  • Now, new research shows how naturally starvation-resistant cavefish, unlike other animals, are able to protect their liver and remain healthy.
  • "We have discovered for the first time an organism – cavefish—that can avoid fatty liver under starvation conditions," said Cobham.
  • "Fatty liver can result in complications like liver cirrhosis and liver failure.

Life Science Alliance Renews Partnership with HighWire Press for 3 Years

Retrieved on: 
Tuesday, January 16, 2024
Life Science Alliance, Research, Partnership, HighWire, LSA, MPS, RFP, Highwire, Product management, Credit, SVP

PRINCETON, N.J., Jan. 16, 2024 /PRNewswire-PRWeb/ -- From its first published issue, LSA has partnered with HighWire Press to make life science research openly accessible on a fast, reliable, and discoverable platform. Following a competitive tender process, LSA's board of managers voted unanimously to stay with HighWire for the next 3 years.

Key Points: 
  • HighWire Press, a provider of technology solutions for the scholarly industry, is pleased to announce that Life Science Alliance (LSA) has continued its hosting partnership, renewing their contract for another 3 years.
  • PRINCETON, N.J., Jan. 16, 2024 /PRNewswire-PRWeb/ -- From its first published issue, LSA has partnered with HighWire Press to make life science research openly accessible on a fast, reliable, and discoverable platform.
  • Following a competitive tender process, LSA's board of managers voted unanimously to stay with HighWire for the next 3 years.
  • He said, "We are excited to continue our partnership with Life Science Alliance.

European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, October 31, 2022
Safety, NINDS, Leber's hereditary optic neuropathy, Vomiting, LHON, JAMA Network Open, Vamorolone, Microdeletion syndrome, EC, Vitamin D deficiency, Cystic fibrosis, CMO, Dissociative, Patient, UK, Time, Foundation, EMA, JAMA, NCATS, Review, JAMA Neurology, Committee for Medicinal Products for Human Use, DMD, European Medicines Agency, Orphan drug, Food and Drug Administration Amendments Act of 2007, Life Science Alliance, CHMP, FDA, National, Defense, National Institutes of Health, Adolescence, Food, PIM, NIAMS, NDA, Muscular dystrophy, Company, Duchenne muscular dystrophy, Union, European Commission, MAA, Vaccine, Pharmaceutical industry, Wood drying, MD, Duchenne

Pratteln, Switzerland, October 31, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

Key Points: 
  • Pratteln, Switzerland, October 31, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
  • Subject to EC approval, expected later in 2023, vamorolone will receive marketing authorization in all member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
  • Santhera has submitted a new drug application (NDA) to the U.S. FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of DMD.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, October 27, 2022
JAMA Neurology, Life expectancy, Union, Muscular dystrophy, PIM, European Medicines Agency, UK, Vamorolone, NINDS, FDA, Dissociative, Ventilation, National Institutes of Health, MAA, Foundation, JAMA Network Open, Inflammation, CEO, Vitamin D deficiency, Food, Patient, Maintenance, Life Science Alliance, Cardiomyopathy, NDA, Heart, Orphan drug, Duchenne muscular dystrophy, Defense, EMA, NIAMS, Company, Weakness, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Doctor of Philosophy, Safety, Disease, LHON, DMD, National, European Commission, Leber's hereditary optic neuropathy, Adolescence, NCATS, Fibrosis, Microdeletion syndrome, Prednisone, Cystic fibrosis, Vomiting, Caregiver, Time, Pharmaceutical industry, Duchenne, MD

Completion of the vamorolone NDA submission is a major step towards our goal of bringing this investigational therapy to patients living with DMD, and represents a vital milestone for Santhera, said Dario Eklund, CEO of Santhera.

Key Points: 
  • Completion of the vamorolone NDA submission is a major step towards our goal of bringing this investigational therapy to patients living with DMD, and represents a vital milestone for Santhera, said Dario Eklund, CEO of Santhera.
  • With the completion of the rolling NDA submission, Santhera and ReveraGen have also applied for priority review.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.
  • The development of ReveraGens lead compound, vamorolone, has been supported through partnerships with foundations worldwide, including Muscular Dystrophy Association USA, Parent Project Muscular Dystrophy, Foundation to Eradicate Duchenne, Save Our Sons, JoiningJack, Action Duchenne, CureDuchenne, Ryans Quest, Alexs Wish, DuchenneUK, Pietros Fight, Michaels Cause, Duchenne Research Fund, and Defeat Duchenne Canada.

Santhera and ReveraGen Announce Presentations on Long-Term Efficacy and Bone Health in DMD During Vamorolone Treatment at the 2022 World Muscle Society Congress

Retrieved on: 
Monday, October 10, 2022
National Institutes of Health, Congress, Body mass index, Life Science Alliance, Vamorolone, WMS, Prednisone, NCATS, NINDS, Patient, Muscular dystrophy, JAMA Neurology, Orphan drug, Cystic fibrosis, NIAMS, DMD, UK, Duchenne muscular dystrophy, Adolescence, Company, ADT, LHON, Doctor of Philosophy, Leber's hereditary optic neuropathy, National, Muscle, PIM, Safety, Foundation, Dissociative, FDA, JAMA Network Open, Defense, European Commission, Pharmaceutical industry, Online gambling, Duchenne, MD

Santhera is hosting an on-site scientific exhibit (booth #4, located in the Ballroom Salon) where medical representatives of the Company will be present throughout the conference.

Key Points: 
  • Santhera is hosting an on-site scientific exhibit (booth #4, located in the Ballroom Salon) where medical representatives of the Company will be present throughout the conference.
  • Vamorolone is an investigational medicine and is currently not approved for use by any health authority.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.
  • ReveraGen has also received generous support from the US Department of Defense CDMRP, National Institutes of Health (NCATS, NINDS, NIAMS), and European Commission (Horizons 2020).

Santhera Submits Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, October 3, 2022
Review, JAMA Network Open, Duchenne muscular dystrophy, Vamorolone, NCATS, Weakness, NDA, PIM, MAA, Vitamin D deficiency, Food and Drug Administration Amendments Act of 2007, National, EMA, Life Science Alliance, Vomiting, Time, Patient, Life expectancy, European Medicines Agency, Adolescence, Leber's hereditary optic neuropathy, Foundation, CMO, Microdeletion syndrome, Inflammation, DMD, JAMA Neurology, NINDS, Food, NIAMS, Prednisone, Fibrosis, FDA, Dissociative, LHON, Heart, JAMA, Company, Maintenance, Cystic fibrosis, National Institutes of Health, Ventilation, Disease, European Commission, Defense, Muscular dystrophy, Safety, Cardiomyopathy, Orphan drug, UK, Pharmaceutical industry, Wood drying, Duchenne, EU, MD

Pratteln, Switzerland, October3, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

Key Points: 
  • Pratteln, Switzerland, October3, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
  • Duchenne is a debilitating disease with patients in need for effective and well-tolerated therapies, said Shabir Hasham, MD, CMO of Santhera.
  • In the U.S., Santhera expects to complete the filing of the new drug application (NDA) for vamorolone in DMD to the Food and Drug Administration (FDA) in Q4-2022.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

Santhera Updates on Ongoing NDA Submission for Vamorolone

Retrieved on: 
Wednesday, June 29, 2022
Review, Vitamin D deficiency, FDA, Life Science Alliance, Dissociative, Duchenne muscular dystrophy, Vamorolone, Patient, European Medicines Agency, Time, LHON, MAA, Orphan drug, DMD, Company, UK, Vomiting, CMO, PIM, EMA, JAMA Network Open, Food, Leber's hereditary optic neuropathy, Communication, Microdeletion syndrome, Cystic fibrosis, Agency, Safety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NDA, Pharmaceutical industry, Vaccine

Santhera commenced the NDA filing as a rolling submission in March 2022 following a successful pre-NDA meeting with the FDA.

Key Points: 
  • Santhera commenced the NDA filing as a rolling submission in March 2022 following a successful pre-NDA meeting with the FDA.
  • In its conclusions from this meeting, the FDA considered the proposed clinical efficacy and safety data sufficient to support an NDA filing of vamorolone for the treatment of DMD.
  • Therefore, Santhera will discuss with the Agency the status and updated timelines for completing the NDA filing by Q4-2022.
  • The Company plans to complete the rolling submission of its filing for approval for vamorolone with the U.S. FDA.

Life Science Alliance journal publishes results of plitidepsin in patients with COVID-19, which includes additional data on its antiviral activity against Delta and Omicron variants

Retrieved on: 
Tuesday, January 11, 2022
Lung, Patient, Pneumonia, Mount Sinai, Life Science Alliance, MSE, European Molecular Biology Organization, Clinical trial, COVID-19, Icahn School of Medicine at Mount Sinai, Severe acute respiratory syndrome coronavirus 2, Safety, Therapeutic index, PHM, National university, Disease, Department, EMBO, Animal, Rockefeller University, Cold, Viral load, Company, Internal medicine, G.H. Raisoni Department of Microbiology and Biotechnology, European, Hospital, Phase, Hospital das Clínicas, Cold Spring Harbor Laboratory, PharmaMar, Delta, Pulse oximetry, Coronavirus, Omicron, Pharmaceutical industry, Microbiology

MADRID, Jan. 11, 2022 /PRNewswire/ -- PharmaMar (MSE:PHM) has announced today the publication of an article in the Life Science Alliance journal, entitled "Pre-clinical and randomized phase I studies of plitidepsin in adults hospitalized with COVID-19"[1] which includes a study on the in vitro activity of plitidepsin against the main SARS-CoV-2 variants, including the current Omicron variant.

Key Points: 
  • - PharmaMar confirms in vitroactivity of plitidepsin against several variants, including Delta and Omicron.
  • - The Life Science Alliance journal is co-founded by the Rockefeller University, the European Molecular Biology Organization (EMBO) and Cold Spring Harbor Laboratory.
  • The article also reviews data from the APLICOV-PC clinical trial, which demonstrated the safety of plitidepsin in patients with COVID-19 requiring hospital admission.
  • Jos Mara Fernndez Sousa-Faro, Ph.D., PharmaMar's Chairman stated "all the data we have seen so far with plitidepsin corroborate our initial hypothesis about its antiviral activity.

Life Science Alliance journal publishes results of plitidepsin in patients with COVID-19, which includes additional data on its antiviral activity against Delta and Omicron variants

Retrieved on: 
Tuesday, January 11, 2022
Lung, Patient, Pneumonia, Mount Sinai, Life Science Alliance, MSE, Clinical trial, COVID-19, Icahn School of Medicine at Mount Sinai, Severe acute respiratory syndrome coronavirus 2, Therapeutic index, Safety, PHM, Disease, Department, Animal, Viral load, Internal medicine, G.H. Raisoni Department of Microbiology and Biotechnology, Phase, Hospital, Hospital das Clínicas, PharmaMar, Delta, Pulse oximetry, Coronavirus, Omicron, Pharmaceutical industry, Microbiology

According to the final data published in this article, plitidepsin has been shown to have a potent antiviral activity in all variants at very low (nanomolar) concentrations, with a positive in vitro therapeutic index.

Key Points: 
  • According to the final data published in this article, plitidepsin has been shown to have a potent antiviral activity in all variants at very low (nanomolar) concentrations, with a positive in vitro therapeutic index.
  • Laboratory in vivo studies have also demonstrated a preferential distribution of plitidepsin to lung tissue, which is the organ primarily affected in patients with COVID-19.
  • The article also reviews data from the APLICOV-PC clinical trial, which demonstrated the safety of plitidepsin in patients with COVID-19 requiring hospital admission.
  • Jos Mara Fernndez Sousa-Faro, Ph.D., PharmaMar's Chairman stated "all the data we have seen so far with plitidepsin corroborate our initial hypothesis about its antiviral activity.

Off-Target Immune System Response Could Predict COVID-19 Severity

Retrieved on: 
Thursday, September 9, 2021

Patients with these elevated levels of autoimmune antibodies were five to seven times more likely to develop severe disease than those whose antibodies levels were stable.

Key Points: 
  • Patients with these elevated levels of autoimmune antibodies were five to seven times more likely to develop severe disease than those whose antibodies levels were stable.
  • Publishing in the journal Life Science Alliance online Sept. 9, the team's latest work is based on the nature of antibodies, they explain, immune proteins that target invading bacteria and viruses.
  • Levels of anti-DNA and anti- phosphatidylserine antibodies were then strongly linked to severity of illness.
  • "Our study adds evidence to the underlying premise of the disease that the misguided immune system's response is doing more damage than the actual viral infection itself."