CNS

Global Active Pharmaceutical Ingredients (APIs) Market Analysis/Forecast Report, 2022 & 2023-2027 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 10, 2023

The "Active Pharmaceutical Ingredients (APIs) Market, Global Forecast 2023-2027, Industry Trends, Growth, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Active Pharmaceutical Ingredients (APIs) Market, Global Forecast 2023-2027, Industry Trends, Growth, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.
  • Global Active Pharmaceutical Ingredients (APIs) market was at US$ 190.5 Billion in 2022 and will surpass US$ 261.3 Billion by 2027, expanding at a CAGR of 6.52 from 2022 to 2027.
  • Active Pharmaceutical Ingredients (API) of good quality is core to manufacturing effective and safe essential drugs.
  • Some prominent players in the global active pharmaceutical ingredients market are Sanofi SA, F. Hoffmann-LA Roche Ltd, Pfizer, Abbott, Bayer AG, Merck & Co. Inc, Boehringer Ingelheim Gmbh, GlaxoSmithKline Plc, Novartis AG, Eli Lilly Company, and Teva Pharmaceutical.

Vistagen Announces Completion of Last Patient, Last Visit in Phase 2 Clinical Trial of PH94B for the Treatment of Adjustment Disorder with Anxiety

Retrieved on: 
Tuesday, January 10, 2023

The exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults.

Key Points: 
  • The exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults.
  • The primary endpoint is the change from baseline in anxiety level as measured by the Hamilton Anxiety Rating Scale (HAM-A) at the end of Week 4 of treatment with PH94B or placebo.
  • This is a major milestone for our team,” stated Shawn Singh, Chief Executive Officer of Vistagen.
  • Vistagen is dedicated to developing treatments to address the escalating mental health crisis.

Virpax Pharmaceuticals Engages Destum Partners to Direct Strategic Global Partnering Efforts

Retrieved on: 
Tuesday, January 10, 2023

Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, today announced that the Company has engaged Destum Partners, Inc. to serve as the exclusive advisor for the Company's partnering and licensing efforts in strategic global markets.

Key Points: 
  • Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, today announced that the Company has engaged Destum Partners, Inc. to serve as the exclusive advisor for the Company's partnering and licensing efforts in strategic global markets.
  • Additionally, Destum Partners will work with Virpax on identifying a partner in the animal health market for its Rx product candidate, Probudur™, a long-acting local anesthetic indicated for postoperative pain management.
  • “We have engaged Destum Partners to lead our global strategic partnering and licensing efforts for our two potential OTC product candidates as well as supporting Virpax in the animal health care market for Probudur,” stated Anthony Mack, Chairman and CEO of Virpax.
  • We look forward to working alongside the Virpax team in developing, partnering and licensing opportunities for what we believe to be a strong pipeline of drug product candidates,” commented Matthew Vanderberg, Managing Director and Partner at Destum Partners.

Asia Pacific Cell & Gene Research Growing 50% Faster than ROW

Retrieved on: 
Friday, February 3, 2023

SYDNEY, AU, Feb 3, 2023 - (ACN Newswire) - Novotech, the leading Asia Pacific focused biotech specialist CRO and recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award, said the number of cell & gene therapy trials in the region was growing 50% faster than ROW.

Key Points: 
  • SYDNEY, AU, Feb 3, 2023 - (ACN Newswire) - Novotech, the leading Asia Pacific focused biotech specialist CRO and recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award, said the number of cell & gene therapy trials in the region was growing 50% faster than ROW.
  • Novotech, which has extensive experience in cell & gene therapy clinical trials, is sponsoring the 6th Annual Cell And Gene Therapy Innovation Summit in Berlin, Germany (15-16 February 2023).
  • The latest data shows Asia Pacific is the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region.
  • The region already accounts for over a third of cell & gene therapy trial activity and shows a nearly 50% faster growth rate in cell & gene therapy trials compared to ROW between 2016 and 2021.

Vial Announces New Central Nervous System Scientific Advisory Board Member, Dr. Jacqueline French of the Epilepsy Study Consortium and NYU Grossman School of Medicine.

Retrieved on: 
Friday, January 13, 2023

Dr. French is a professor of neurology at the NYU Grossman School of Medicine, co-director of epilepsy clinical trials for NYU Langone Health's Comprehensive Epilepsy Center, and president, director, and founder of The Epilepsy Study Consortium.

Key Points: 
  • Dr. French is a professor of neurology at the NYU Grossman School of Medicine, co-director of epilepsy clinical trials for NYU Langone Health's Comprehensive Epilepsy Center, and president, director, and founder of The Epilepsy Study Consortium.
  • After receiving her medical education at Brown University, she completed a residency in neurology at Mount Sinai Hospital in New York.
  • Thereafter, she pursued further training through a fellowship in EEG and epilepsy at Mount Sinai Hospital and Yale University.
  • We are pleased to welcome Dr. French as she is an esteemed leader in clinical neurology research," said Simon Burns, CEO and Co-founder of Vial.

Jupiter Neurosciences, Inc. Announces Appointment of New Chief Financial Officer

Retrieved on: 
Thursday, January 12, 2023

"We are excited to announce Saleem joining our team and bringing his experience as a public company CFO to our Company.

Key Points: 
  • "We are excited to announce Saleem joining our team and bringing his experience as a public company CFO to our Company.
  • "I'm excited and privileged to have the opportunity to work alongside the entire Jupiter team," said Mr. Elmasri, newly appointed Chief Financial Officer.
  • Titan Advisory Services LLC is a boutique advisory firm focused on providing collaborative and customized financial operations and CFO services to early-stage companies.
  • From PwC, Mr. Elmasri transitioned to lead advisory practices at boutique consulting firms, specializing in transaction and complex accounting advisory.

Relmada Therapeutics Appoints Fabiana Fedeli from M&G Investments to its Board of Directors

Retrieved on: 
Thursday, January 12, 2023

In her current role at M&G Investments, which Ms. Fedeli joined in 2021, she leads a team of over 100 investment professionals with assets deployed across the globe.

Key Points: 
  • In her current role at M&G Investments, which Ms. Fedeli joined in 2021, she leads a team of over 100 investment professionals with assets deployed across the globe.
  • Prior to joining M&G Investments, Ms. Fedeli served as Global Head of Fundamental Equities, Managing Director, at Robeco Asset Management, from 2013-2021.
  • On behalf of the entire Board, we look forward to working closely with Fabiana to further enhance long-term shareholder value."
  • "I am thrilled to be joining Relmada's Board at this exciting time in the Company's corporate evolution," said Ms. Fedeli.

KemPharm Announces Promotion of Sven Guenther, Ph.D., to Chief Scientific Officer and Christal Mickle, M.A., to Chief Product Development Officer

Retrieved on: 
Wednesday, January 11, 2023

CELEBRATION, Fla., Jan. 11, 2023 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a rare disease therapeutics company focused on the development of treatments for rare central nervous system (CNS) disorders, neurodegenerative diseases, lysosomal storage disorders and related treatment areas, announced the promotions of Sven Guenther, Ph.D., to Chief Scientific Officer, and Christal M.M. Mickle, M.A., to Chief Product Development Officer. Ms. Mickle, a co-founder of KemPharm, and Dr. Guenther have been members of KemPharm’s leadership team since the early days of the Company.

Key Points: 
  • Mickle, M.A., to Chief Product Development Officer.
  • Ms. Mickle, a co-founder of KemPharm, and Dr. Guenther have been members of KemPharm’s leadership team since the early days of the Company.
  • Dr. Guenther was one of the first members of KemPharm, most recently serving as the company’s Executive Vice President of Research and Development.
  • As Chief Scientific Officer, he will continue to lead KemPharm’s research team and play a central role in the advancement of the company’s pipeline.

VIVUS Announces Key Management Updates to Support Global Expansion Strategy

Retrieved on: 
Tuesday, January 10, 2023

CAMPBELL, Calif., Jan. 10, 2023 (GLOBE NEWSWIRE) -- VIVUS LLC today announced the promotion of Santosh T. Varghese, MD, to President VIVUS Global Pharmaceutical Development.

Key Points: 
  • CAMPBELL, Calif., Jan. 10, 2023 (GLOBE NEWSWIRE) -- VIVUS LLC today announced the promotion of Santosh T. Varghese, MD, to President VIVUS Global Pharmaceutical Development.
  • With more than 25 years of U.S. and global pharmaceutical industry experience, including more than a decade at VIVUS, Dr. Varghese will continue to serve as the company’s Chief Medical Officer.
  • “His numerous accomplishments and successful track record at VIVUS encapsulates his importance to our team.
  • Prior to joining VIVUS, Mr. Giacometti held increasing responsibilities at Takeda, most recently serving as Global Commercial Lead for its stem cells therapy and before that its gastroenterology portfolio.

Neurocrine Biosciences and Voyager Therapeutics Enter Strategic Collaboration for Development and Commercialization of Voyager’s GBA1 Program and Other Next-Generation Gene Therapies for Neurological Diseases

Retrieved on: 
Monday, January 9, 2023

SAN DIEGO and CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) and Voyager Therapeutics, Inc. (Nasdaq: VYGR) today announced the formation of a new strategic collaboration to advance multiple gene therapies for the treatment of neurological diseases. The collaboration includes Voyager’s preclinical, intravenously administered GBA1 gene therapy program for Parkinson’s disease and other GBA1-mediated diseases, which combines a GBA1 gene replacement payload with novel capsids from Voyager’s TRACERTM (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) platform. In addition, Neurocrine Biosciences and Voyager have agreed to collaborate on three new gene therapy programs directed to rare CNS targets, each also leveraging Voyager’s novel TRACER capsids. The collaboration builds upon the long-standing strategic partnership between Neurocrine Biosciences and Voyager and continues to combine Voyager’s expertise in novel capsid discovery, payload design, and neuropharmacology with Neurocrine Biosciences’ expertise in neuroscience and the clinical and commercial development of therapies for patients suffering from serious neurological diseases.

Key Points: 
  • In addition, Neurocrine Biosciences and Voyager have agreed to collaborate on three new gene therapy programs directed to rare CNS targets, each also leveraging Voyager’s novel TRACER capsids.
  • The collaboration builds upon the long-standing strategic partnership between Neurocrine Biosciences and Voyager and continues to combine Voyager’s expertise in novel capsid discovery, payload design, and neuropharmacology with Neurocrine Biosciences’ expertise in neuroscience and the clinical and commercial development of therapies for patients suffering from serious neurological diseases.
  • Regarding the GBA1 gene therapy program, Neurocrine Biosciences has agreed to fund development through the completion of a first Phase 1 trial.
  • Neurocrine Biosciences and Voyager have agreed that, following the completion of the transaction, Jude Onyia, Ph.D., Chief Scientific Officer at Neurocrine Biosciences, will join Voyager’s Board of Directors.