NCE

Oragenics Appoints William “Frank” Peacock MD as Chief Clinical Officer

Retrieved on: 
onsdag, maj 22, 2024
CTE, Principal, Patient, Metabolism, Baylor College of Medicine, Emergency medicine, Phase, Human, JAMA Cardiology, Chronic traumatic encephalopathy, Traffic, TBI, Common, Concussion, Emergency department, Baylor University, Efficacy, Animal, Blood, NCE, Nasal cavity, Biomarker, Post-concussion syndrome, DSM-IV codes, Brain, Research, Cardiology, Acute coronary syndrome, Traumatic brain injury, Pharmaceutical industry

SARASOTA, Fla., May 22, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. William “Frank” Peacock as its Chief Clinical Officer, who will conduct its anticipated Phase II clinical trial for treating concussion in the Emergency Department (“ED”).

Key Points: 
  • SARASOTA, Fla., May 22, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. William “Frank” Peacock as its Chief Clinical Officer, who will conduct its anticipated Phase II clinical trial for treating concussion in the Emergency Department (“ED”).
  • Dr. Peacock is currently the Vice Chair for Emergency Medicine Research at Baylor College of Medicine and a past Professor at the Cleveland Clinic Lerner College of Medicine.
  • “I am excited to join Oragenics as its Chief Clinical Officer at such an important and pivotal time in the company’s clinical program.
  • We are currently working with Avance Clinical, CRO, for our Phase II trial,” stated Michael Redmond, President of Oragenics.

Oragenics Partners with Avance Clinical for Phase II Concussion Trial in Australia

Retrieved on: 
tisdag, maj 7, 2024
Contract research organization, Brain, Traumatic brain injury, NCE, Common, Food and Drug Administration, Therapeutic Goods Administration, Food, Partnership, Science, TBI, Concussion, Incidence, Patient, CTE, Head Injuries, DSM-IV codes, Chronic traumatic encephalopathy, Clinical trial, European Medicines Agency, Traffic, Pharmaceutical industry

This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion.

Key Points: 
  • This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion.
  • An Oragenics Phase I clinical trial, recently completed in Australia under the management of Avance Clinical, demonstrated that ONP-002 is safe and well-tolerated.
  • "Concussion remains a significant unmet medical need," said Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance Clinical.
  • Michael Redmond, President of Oragenics, added, "Our collaboration with Avance Clinical during the Phase I trial was instrumental, and we are confident in their ability to execute an effective Phase II trial that will pave the way for future treatment protocols for concussion."

Successful FDA Inspection at Dipharma Facility in Kalamazoo, MI, USA

Retrieved on: 
tisdag, maj 7, 2024
Regulatory Agencies, FDA, NCE, New chemical entity, PAI, Food, API, QC, CDMO, Patient, CGMP, EIR

At the closing meeting the inspectors congratulated the Dipharma team members on the Current Good Manufacturing Practices (CGMP) Systems they created and their overall commitment to quality.

Key Points: 
  • At the closing meeting the inspectors congratulated the Dipharma team members on the Current Good Manufacturing Practices (CGMP) Systems they created and their overall commitment to quality.
  • "The successful closure of the FDA's Pre-Approval Inspection (PAI) marks a significant achievement for our US facility, Dipharma Inc. Congratulations to the whole team for this great accomplishment," stated Jorge Nogueira, Chief Executive Officer of Dipharma Francis.
  • "This inspection, the first conducted by the FDA at our US facility, underscores the Dipharma Group's unwavering commitment to continuously improve our GMP Systems and uphold the highest quality standards.
  • Dipharma Inc.’s Kalamazoo facility provides world-class CDMO services and API supplies for the Group’s pre-clinical and clinical customers.

Newron Announces Positive Top-line Results From Potentially Pivotal Phase II/III Study 008A With Evenamide in Schizophrenia Patients

Retrieved on: 
tisdag, april 30, 2024
Mental Health, Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Clinical Global Impression, Clozapine, NCE, XETRA, Safety, Psychiatry, MD, PANSS, Common, Extrapyramidal system, CNS, Schizophrenia, Vomiting, Incidence, Patient, Peripheral nervous system, Evenamide, Headache, Positive, Medication, Pharmaceutical industry

Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America.

Key Points: 
  • Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America.
  • 291 patients were randomized to treatment either with evenamide or placebo as add-on to their current antipsychotic therapy.
  • Two hundred and eighty of the 291 patients completed the study with only three patients discontinuing the study due to adverse events, two of them on evenamide and one patient on placebo who died during the study.
  • Ravi Anand, MD, Chief Medical Officer of Newron, stated: “The results seen in study 008A with evenamide are ground-breaking and unique from many perspectives.

Announcing the Accreditation of Anderson College's Medical Office Administrator Program

Retrieved on: 
fredag, april 19, 2024
Medicine, NCE, Electronic health record, EMR, Quality assurance, Pathology, Student, Business, History, Curriculum, Office management, Anderson University, Accreditation, MOA, Workforce, Health information management, Knowledge, Nursing

TORONTO, April 19, 2024 /CNW/ - Anderson College of Health, Business and Technology is proud to announce that its Medical Office Administrator program has received accreditation status from The Canadian College of Health Information Management (CCHIM).

Key Points: 
  • TORONTO, April 19, 2024 /CNW/ - Anderson College of Health, Business and Technology is proud to announce that its Medical Office Administrator program has received accreditation status from The Canadian College of Health Information Management (CCHIM).
  • Announcing the Accreditation of Anderson College's Medical Office Administrator Program.
  • "Our college is proud to announce the accreditation of the Medical Office Administrator Program offered by Anderson College," states Jeff Nesbitt, CEO & Registrar of the CCHIM.
  • Students can learn more by visiting Anderson College's Medical Office Administrator program .

Patent Allowance Granted for ALA-002 Composition by US Patent and Trademark Office

Retrieved on: 
onsdag, mars 27, 2024
Research, Social anxiety, Composition, Brain, NCE, IPON, Environment, Patent, Incidence, Patient, University, Hyperthermia, Autism spectrum, MDXX, The central science, United States patent law, General Population (album), Test, IP, OTC, Spectrum, MDMA, Intellectual property, FDA, ASD, Food, Pharmaceutical industry

Preclinical testing has shown that the administration of ALA-002 results in significantly lowered incidence of hyperthermia, the major adverse event elicited by racemic generic MDMA.

Key Points: 
  • Preclinical testing has shown that the administration of ALA-002 results in significantly lowered incidence of hyperthermia, the major adverse event elicited by racemic generic MDMA.
  • PharmAla’s patent application included in-vivo experimental animal data, which is generally held to be stronger evidence than computational, or in-silico, modeling.
  • The Company intends to pursue its own clinical research with the novel composition, either alone or with an out-licensing partner.
  • “We are incredibly pleased that USPTO has issued an allowance for the granting of the Composition of Matter patent for ALA-002.

Verrica Pharmaceuticals Announces that YCANTH™ Receives New Chemical Entity Status and Orange Book Listing from the FDA

Retrieved on: 
tisdag, mars 26, 2024
The Orange Book, NCE, Orange Book, Dermatology, Skin, Patent, Therapy, FDA, Approved drug, Food, Pharmaceutical industry

WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company’s lead product, YCANTH™, has received New Chemical Entity (“NCE”) Status and a listing in the Orange Book from the U.S. Food and Drug Administration (“FDA”), providing a minimum five years of regulatory exclusivity.

Key Points: 
  • The Company’s U.S. patents and pending patent applications related to YCANTH™ are projected to expire between 2034 and 2041, excluding any patent term adjustment or patent term extension
    WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company’s lead product, YCANTH™, has received New Chemical Entity (“NCE”) Status and a listing in the Orange Book from the U.S. Food and Drug Administration (“FDA”), providing a minimum five years of regulatory exclusivity.
  • “We could not be more pleased to announce YCANTH™ has been granted NCE Status by the FDA,” said Ted White, Verrica’s President and Chief Executive Officer.
  • “Today’s announcement represents the continued execution of our Company’s comprehensive intellectual property strategy to maximize the patent and regulatory protections surrounding YCANTH™ and further underscores the product’s innovation and intrinsic value in the dermatology market.
  • While NCE status will provide YCANTH™ with a minimum of five years of protection, we anticipate our full patent portfolio to provide protection from generic competition for the next decade and potentially beyond.”
    Formally described as the Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is an FDA publication that provides a list of drugs approved as safe and effective and also serves as the regulatory resource for information on drug marketing availability, bioequivalence, drug substitution, and patent and exclusivity data.1 The Orange Book also lists patents covering those drugs, approved methods of their use, and regulatory exclusivities to which they may be entitled.

Aemetis Approved by USCIS for $200 million of EB-5 Investment in Biogas, SAF and Carbon Sequestration Projects

Retrieved on: 
torsdag, mars 21, 2024
Ethanol, USDA, NCE, Natural gas, Oil, Growth, Authority, Unemployment, EB-5, ATC, Aviation, Biofuel, Carbon, Sugar, CO2, USCIS, JCE, Region, RD, Renewable natural gas, Engineering, RNG, SAF, Renewable energy

Citizenship and Immigration Services (USCIS) of $200 million of EB-5 program investment for the Riverbank sustainable aviation fuel (SAF) production plant, the dairy renewable natural gas (RNG) project, the carbon sequestration project, and energy efficiency upgrades to the Keyes ethanol plant.

Key Points: 
  • Citizenship and Immigration Services (USCIS) of $200 million of EB-5 program investment for the Riverbank sustainable aviation fuel (SAF) production plant, the dairy renewable natural gas (RNG) project, the carbon sequestration project, and energy efficiency upgrades to the Keyes ethanol plant.
  • The Riverbank plant was recently granted Authority to Construct (ATC) air permits and is designed to produce 78 million gallons per year of SAF for the aviation market.
  • Aemetis has already secured more than $3 billion of contracts to supply airlines with SAF.
  • The Project’s two primary locations are the Aemetis Advanced Fuels Keyes 65 million gallon per year ethanol plant and the Riverbank Industrial Complex.

Psyence Biomedical Ltd. Issues Shareholder Letter Recapping Recent Progress and Outlining Key Future Milestones

Retrieved on: 
tisdag, mars 12, 2024
Psilocybin, Hospice, Letter, Growth, Newcourt, Psychotherapy, Mental health, Research, Fungus, Contract research organization, Adjustment disorder, NCE, Phase, Optimism, Intellectual property, Patent, Therapy, Medicine, PBM, Pharmaceutical industry

Our merger with Newcourt and subsequent listing on Nasdaq confers numerous benefits to our company.

Key Points: 
  • Our merger with Newcourt and subsequent listing on Nasdaq confers numerous benefits to our company.
  • While other companies are exploring synthetic psilocybin, Psyence is the world’s first Nasdaq traded biopharmaceutical company researching a nature-derived (non-synthetic) psilocybin candidate.
  • Furthermore, Psyence is the only publicly traded company to research a non-synthetic psilocybin candidate to treat Adjustment Disorder in the context of Palliative Care.
  • To reflect this exciting new chapter in our company’s evolution, we have created a new investor presentation, which can be found here .

MMS Hires Pharmaceutical Industry Veteran James Zee for Global Biometrics Leadership in Europe Amid Strong Regional Growth

Retrieved on: 
torsdag, april 4, 2024
Data Management, Technology, Pharmaceutical, Professional Services, Biometrics, Medical Devices, Genetics, Artificial Intelligence, Clinical Trials, Science, Biotechnology, Software, Data Analytics, Health, Research, MSD, American City Business Journals, Growth, AstraZeneca, Data science, Novartis, Patient, Roche, MMS, RWD, AI, Statistics, Data management, Drug development, NCE, FSP, Zee, Fine chemical

MMS, a leading, data-focused clinical research organization (CRO), announced today that the company has expanded its biometrics leadership within European operations by hiring James Zee as Director of Global Statistical Programming.

Key Points: 
  • MMS, a leading, data-focused clinical research organization (CRO), announced today that the company has expanded its biometrics leadership within European operations by hiring James Zee as Director of Global Statistical Programming.
  • Based in the United Kingdom (UK), Zee brings 25 years of experience across several leading pharmaceutical companies, including AstraZeneca, MSD, Novartis, Roche, and others.
  • With extended drug development experience, Zee helps to guide the statistical programming team at MMS to support some of the timely execution and evolving regulations for the development of NCEs.
  • Since 2020, the global biometrics CRO has experienced 133 percent growth in Europe.