Behavioral neuroscience

Tonix Pharmaceuticals Hosted KOL Webinar on Positive Phase 3 Fibromyalgia Trial for Tonmya™, Plans to File NDA for FDA Approval in Second Half of 2024

Retrieved on: 
Wednesday, February 14, 2024

CHATHAM, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, held a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, and the path to file for FDA approval in the second half of 2024. The webinar was held on January 31, 2024 and hosted by Alliance Global Partners (A.G.P.).

Key Points: 
  • The webinar was held on January 31, 2024 and hosted by Alliance Global Partners (A.G.P.).
  • As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia.
  • Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya™ for the management of fibromyalgia.
  • “We are now an important step closer to bringing a new, first-line treatment to fibromyalgia patients that offers broad symptom relief and favorable tolerability for chronic use and adherence.”

Tonix Pharmaceuticals Announces KOL Webinar to Discuss Positive Phase 3 Fibromyalgia Data, Sponsored by A.G.P.

Retrieved on: 
Thursday, January 25, 2024

CHATHAM, N.J., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of TNX-102 SL for the management of fibromyalgia.

Key Points: 
  • CHATHAM, N.J., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of TNX-102 SL for the management of fibromyalgia.
  • The webinar will feature two esteemed thought leaders in the field of fibromyalgia and will be hosted by Alliance Global Partners.
  • Lesley Arnold, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine

Aventi Group Announces Dean Nadorozny as VP Operations and Ajay Sharma as VP Finance

Retrieved on: 
Tuesday, January 9, 2024

The company warmly welcomes Dean Nadorozny as the new VP Operations and Ajay Sharma as VP Finance, marking a significant enhancement in its leadership dynamics.

Key Points: 
  • The company warmly welcomes Dean Nadorozny as the new VP Operations and Ajay Sharma as VP Finance, marking a significant enhancement in its leadership dynamics.
  • Of Dean's hire, Jeff Thompson, President and Co-Founder of Aventi Group, says, "We're thrilled to have Dean Nadorozny join the Aventi Group executive leadership team.
  • When asked about the addition of Ajay to the team, Sridhar Ramanathan, COO and Co-Founder of Aventi Group, says, "We are delighted to welcome Ajay Sharma as Vice President of Finance at Aventi Group.
  • Overall, the appointments of Dean Nadorozny and Ajay Sharma to Aventi Group's Executive Leadership Team are set to significantly bolster our operational and financial strategies.

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

Retrieved on: 
Monday, November 6, 2023

REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

Key Points: 
  • REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.
  • Participants also required a diagnosis that met The International Psychogeriatric Association’s (IPA) provisional definition of agitation in patients with cognitive impairment or dementia.
  • “Agitation associated with dementia due to Alzheimer’s disease can be very challenging and emotionally distressing for patients and family members caring for them.
  • The trial had high rates of patients completing the trial: 86.8% of the brexpiprazole group and 88.9% of the placebo group.

Arbutus Appoints Two New Executives

Retrieved on: 
Monday, July 10, 2023

WARMINSTER, Pa., July 10, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced the appointment of Dr. Karen Sims as Chief Medical Officer and Mr. Christopher Naftzger as General Counsel and Chief Compliance Officer. Mr. Naftzger succeeds Dr. Elizabeth Howard who will continue in an advisory role with respect to the on-going patent infringement litigations. Both Dr. Sims and Mr. Naftzger will report directly to William Collier, Arbutus President and Chief Executive Officer, effective immediately.

Key Points: 
  • Both Dr. Sims and Mr. Naftzger will report directly to William Collier, Arbutus President and Chief Executive Officer, effective immediately.
  • “Karen has played an integral role in the clinical development of AB-729, our lead RNAi therapeutic, during her six-year tenure at Arbutus, and has continued to advance our pipeline of HBV programs.
  • Prior to joining Arbutus, Dr. Sims held multiple positions during her seven-year tenure at Bristol-Myers Squibb (NYSE: BMY).
  • Christopher Naftzger joins Arbutus with more than 25 years of legal experience, including over a decade of experience serving as senior in-house counsel with life science companies.

BioXcel Therapeutics Announces Positive Topline Results From TRANQUILITY II Phase 3 Trial of BXCL501 for Acute Treatment of Alzheimer’s Disease-Related Agitation

Retrieved on: 
Thursday, June 29, 2023

Efficacy for this dose was supported by a number of secondary measures, including CGI-I and ACES.

Key Points: 
  • Efficacy for this dose was supported by a number of secondary measures, including CGI-I and ACES.
  • The primary endpoint was not met for the 40 mcg dose, with a 5.7 point reduction from baseline in PEC score.
  • “Today, there are approximately 100 million Alzheimer’s-related agitation episodes in the U.S. annually, and there are no episodic treatment options for these patients.
  • We believe that our data from TRANQUILITY II show that BXCL501 has the potential to treat acute episodes of agitation in patients with mild to moderate Alzheimer’s disease, if approved.

Matthew Iannelli Appointed Chief Information Security Officer of TerraScale Inc.

Retrieved on: 
Monday, January 23, 2023

SANTA MONICA, Calif., Jan. 23, 2023 /PRNewswire-PRWeb/ -- TerraScale, a five-time award-winning green development, infrastructure and finance firm formed with the goal of accelerating the transition to a more sustainable planet, today named Matthew Iannelli as chief information security officer of TerraScale Inc. Iannelli will serve under the leadership of Danny Hayes, CEO and co-founder of TerraScale Inc.

Key Points: 
  • "TerraScale is building cybersecurity and technology solutions that are mission critical for governments, businesses, and citizens globally.
  • Iannelli has world-class experience necessary to design and execute complex cybersecurity and technology systems that can be depended upon," said Hayes.
  • "It is an honor and privilege to have such an accomplished and respected leader join the TerraScale team.
  • "Cybersecurity is at the heart of all TerraScale green infrastructure projects," said Iannelli.

RAPTbaby™ Announces Sound Machine That Supports Infant Brain Development While Promoting Sleep

Retrieved on: 
Wednesday, January 18, 2023

Today RAPTbaby , the children’s division of RAPT Ventures, Inc. (RVI), is announcing its inaugural product, the Smarter Sleep sound machine.

Key Points: 
  • Today RAPTbaby , the children’s division of RAPT Ventures, Inc. (RVI), is announcing its inaugural product, the Smarter Sleep sound machine.
  • Smarter Sleep is the first product specifically designed to give parents the ability to support both sleep and the cognitive development that should occur in their sleeping baby’s brain.
  • To provide both benefits, the RVI team composed a variety of soothing background tracks that induce sleep-promoting alpha and delta brain waves.
  • Applying that knowledge to the infant products market, Dr. Benasich and the RAPTbaby team developed the Smarter Sleep.

Cedars-Sinai Medical Center Joins Phase I Clinical Study of ABVC BioPharma’s Medication for Treating Depression in Cancer Patients

Retrieved on: 
Wednesday, November 2, 2022

The Phase I study is open label and will be conducted with 12 cancer patients with moderate to severe depressive symptoms.

Key Points: 
  • The Phase I study is open label and will be conducted with 12 cancer patients with moderate to severe depressive symptoms.
  • The main objective of the study is to evaluate the safety of PDC-1421, the primary active ingredient in ABV-1601.
  • The Company then intends to compare results of the Phase II study of ABV-1601 to Wellbutrin XL, a commonly used medicine to treat cancer patients suffering with depression.
  • We are delighted to receive IRB approval from Cedars-Sinai Medical Center, a prestigious hospital in the United States, for the Phase I study of ABV-1601 for depression in cancer patients, said Dr. Howard Doong, ABVC BioPharmas chief executive officer.

Anjarium Biosciences Appoints Gaurav Shah as Chairperson and Douglas Fambrough as Non-executive Director

Retrieved on: 
Tuesday, October 18, 2022

Gaurav Shah is also named as Chairperson of the Board.

Key Points: 
  • Gaurav Shah is also named as Chairperson of the Board.
  • Stephen Yoo, Anjarium's Chief Executive Officer, said: "I am thrilled that Gaurav and Doug, two highly experienced biotech leaders, will be joining the Anjarium Board.
  • Gaurav Shah, Chairperson of the Board, commented: "I am delighted to join the Board of Directors at Anjarium.
  • Gaurav Shah is an experienced gene therapy leader with over 15 years of experience in the biopharmaceutical industry.