Ōtsuka

Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment

Retrieved on: 
Thursday, March 21, 2024
Health, General Health, Conference, Worldwide, Bill, Commercialization, Medication, Disease, Tuberculosis, Fungal infection, COVID-19, Patient, QBS, Bacteria, Safety, TB, Ōtsuka, Pharmaceutical industry

Otsuka Pharmaceutical Development & Commercialization, Inc., and our parent company Otsuka Pharmaceutical, Co. Ltd., announce that interim data from a Phase 2b/c trial exploring quabodepistat (QBS), in combination with delamanid and bedaquiline, for the treatment of pulmonary tuberculosis (TB) is positive and may shorten the duration of TB treatment for patients.

Key Points: 
  • Otsuka Pharmaceutical Development & Commercialization, Inc., and our parent company Otsuka Pharmaceutical, Co. Ltd., announce that interim data from a Phase 2b/c trial exploring quabodepistat (QBS), in combination with delamanid and bedaquiline, for the treatment of pulmonary tuberculosis (TB) is positive and may shorten the duration of TB treatment for patients.
  • QBS is an investigational anti-tuberculosis compound which has a new mechanism of action that interferes with the cell-wall structure of the bacteria causing TB.1,2 Worldwide, TB is the second leading infectious fatal disease after COVID-19 .
  • The three-drug QBS-based arms were well-tolerated, with no serious treatment emergent adverse events reported, related to the regimens.3
    The ongoing study, supported by Otsuka and the Bill & Melinda Gates Foundation, is being held across six clinical research sites in South Africa.
  • Full results of this phase 2b/c, randomized trial are expected by the end of 2024.2,3

Silver Creek Pharmaceuticals Appoints Mark Corrigan, M.D. As President

Retrieved on: 
Monday, February 12, 2024
Cornell University, Acquisition, SAN, Sunovion, Merck, Research, Pharmacia & Upjohn, MD, Drug development, Growth, Research and development, University, Ōtsuka, Therapy, Advanz Pharma, Psychiatry, Development, Cell, Medical research, Pharmaceutical industry

SAN FRANCISCO, Feb. 12, 2024 /PRNewswire/ -- Silver Creek Pharmaceuticals, a clinical-stage biotechnology company focused on the selective targeting of naturally-occurring growth factors to promote cell survival and growth, has appointed Mark Corrigan, MD, as President.

Key Points: 
  • Dr. Corrigan brings over three decades of life sciences leadership experience to Silver Creek.
  • SAN FRANCISCO, Feb. 12, 2024 /PRNewswire/ -- Silver Creek Pharmaceuticals, a clinical-stage biotechnology company focused on the selective targeting of naturally-occurring growth factors to promote cell survival and growth, has appointed Mark Corrigan, MD, as President.
  • "We are pleased to welcome Dr. Corrigan to lead Silver Creek through its next phase of growth," said Tim Throsby, Silver Creek's Chairman of the Board.
  • "The elegance and innovation behind Silver Creek's Smart Growth Factor™ platform is very compelling, and the pre-clinical data around scp776 is equally impressive.

Aurinia Pharmaceuticals Announces Collaboration Partner Otsuka Filed New Drug Application (NDA) for LUPKYNIS® (Voclosporin) in Japan

Retrieved on: 
Monday, November 13, 2023
Research, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, NDA, Sale, Food, Nephritis, Patient, FDA, Autoimmune disease, Ōtsuka, SLE, Lupus nephritis, Physician, Lupus, Pharmaceutical industry, LN, Aurinia

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis (LN).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis (LN).
  • LN is a complication of the autoimmune disease systemic lupus erythematosus (SLE) that seriously impacts the kidneys.
  • Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
  • As part of the agreement, Aurinia is eligible to receive a payment of $10 million upon approval in Japan along with low double-digit royalties on net sales once launched.

Daiya appoints Hajime Fujita as Chief Executive Officer

Retrieved on: 
Tuesday, November 21, 2023
Acquisition, Consumer, Business plan, Marketing, Otsuka Pharmaceutical, Management, Online shopping, Daiya, Ōtsuka

VANCOUVER, BC, Nov. 21, 2023 /PRNewswire/ -- The Board of Directors at Daiya Foods has announced the appointment of Hajime Fujita to the role of Chief Executive Officer.

Key Points: 
  • VANCOUVER, BC, Nov. 21, 2023 /PRNewswire/ -- The Board of Directors at Daiya Foods has announced the appointment of Hajime Fujita to the role of Chief Executive Officer.
  • Mr Fujita, a former Director at Daiya will lead all global operations throughout North America and the brand's continued international expansion.
  • Mr Fujita was a key player in Otsuka's acquisition of Daiya in 2017 before joining Daiya himself and serving as Director, Financial Planning and Analysis from 2018 to 2021.
  • Chief Marketing Officer, Melanie Domer will assume a new role as Chief Commercial Officer, overseeing marketing and sales while John Kelly, VP, Consumer Marketing assumes the role of Chief Marketing Officer.

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
Research, Mental Health, Neurology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Behavioral neuroscience, Attention, Headache, Incidence, CMAI, Food, Mini–Mental State Examination, DSM-IV codes, Brexpiprazole, OPDC, MD, Psychiatry, Food and Drug Administration Amendments Act of 2007, Deficit spending, Verbal aggression, Dementia, Multimedia, Medicine, Interview, Pneumonia, Somnolence, Lundbeck, Locomotion, Commercialization, JAMA Neurology, Cachexia, Screaming, Caregiver, Passive-aggressive behavior, Aggression, Saint Louis University School of Medicine, MMSE, Heart, Ōtsuka, Akathisia, Contra body movement, Agitation, Medication, Tearing, Anxiety, IPA, Patient, Diagnosis, Disease, Restless, Pharmaceutical industry, Nursing, Birth control

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.

Mydecine Provides Q4 2023 Business Update

Retrieved on: 
Thursday, October 26, 2023
Psilocybin, Government, FDA, MDMA, CAD, Half-life, University, MAPS, Canadian government scientific research organizations, Invention, OTC, Research, CSE, Drug development, University of Alberta Faculty of Extension, PTSD, University of Alberta, Drug discovery, Partnership, Probability, API, Ōtsuka, Safety, Burn, AI, MYIG, Patient, Mental health, Pharmaceutical industry

The Company has spent the past few months diligently working to simplify its business model, streamline workflow and processes, and reduce burn rate while increasing output and efficiencies in order to ensure the Company's future success.

Key Points: 
  • The Company has spent the past few months diligently working to simplify its business model, streamline workflow and processes, and reduce burn rate while increasing output and efficiencies in order to ensure the Company's future success.
  • Through this process, the Company has made a number of strategic decisions that it believes will substantially benefit shareholders and increase the probability of long-term success.
  • The University of Alberta consistently rates in the top five in the world for AI drug development.
  • Through adversity, Mydecine has become a more robust, well-managed, streamlined, efficient, and productive organization with a high likelihood of success.

Pioneers and Innovators in Psilocybin Treatments and How Big Pharma Wants in on the Game

Retrieved on: 
Thursday, October 19, 2023
Post-traumatic stress disorder, Big Pharma, FDA, CAD, KAYS, Patent, Food, Oregon Health Authority, Therapy, Sacredness, COMPASS, DSM-IV codes, News, Pharma, FDT, US Foods, Research, Initial, OTCQB, Psilocybin, Yoga, Breakthrough therapy, Private placement, Good, Ōtsuka, Eating, Anorexia nervosa, Depression, OHA, Medication, Anxiety, Investment, Patient, Neuropsychiatry, TRD, Pulse, Mental health, Pharmaceutical industry, Nursing

As psilocybin and other alternative health innovators try to shape the future of mental health, Pharma and traditional healthcare investors are watching and waiting to get their share.

Key Points: 
  • As psilocybin and other alternative health innovators try to shape the future of mental health, Pharma and traditional healthcare investors are watching and waiting to get their share.
  • (OTCQB: KAYS) is the only U.S. public company engaged in securing an Oregon Health Authority ("OHA") license to open a psilocybin treatment center.
  • Kaya Holdings just announced that it has closed an additional round of bridge financing targeted to complete KAYS' planned psilocybin treatment center in Portland, Oregon.
  • Reporting on the Mindset Pharma deal, Psychedelicspotlight.com said , "Big Pharma has certainly taken note of the potential therapeutic benefits of psychedelics.

Xenon Pharmaceuticals Expands Leadership on its Board of Directors with Appointments of Gillian M. Cannon and Justin Gover

Retrieved on: 
Tuesday, August 8, 2023
Temple University, Drug discovery, Head, University of Bristol, Merck, Commercial Operating System, Biotechnology Innovation Organization, Otsuka Pharmaceutical, BIO, University, Ōtsuka, GW, Honours degree, GW Pharmaceuticals, Genetic distance, Corcept Therapeutics, Organization, UCB, Villalba v Merrill Lynch & Co Inc, Cannabidiol, Mazda North American Operations, Drexel University, Epilepsy, Neuroscience, INSEAD, Justin, Roivant Sciences, Therapy, Doctor of Philosophy, Sale, Defense Innovation Board, DSM-IV codes, Jazz Pharmaceuticals, University of Edinburgh, Pharmaceutical industry, Xenon

VANCOUVER, British Columbia, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced two new appointments to its Board of Directors: Dr. Gillian M. Cannon and Mr. Justin Gover.

Key Points: 
  • VANCOUVER, British Columbia, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced two new appointments to its Board of Directors: Dr. Gillian M. Cannon and Mr. Justin Gover.
  • Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “On behalf of our Board of Directors, I am delighted to welcome Gillian and Justin to our Board.
  • Gillian brings a vast knowledge of commercializing novel medicines and leading successful neuroscience franchises at large pharmaceutical companies.
  • Mr. Gover currently serves on the Board of Directors for CURE Epilepsy and Rady Children’s Institute for Genomic Medicine.

Farallon Capital Urges Exelixis Shareholders to Support Change by Electing Its Three Highly Qualified Director Candidates

Retrieved on: 
Wednesday, May 3, 2023
Biotechnology, Finance, Health, Professional Services, Oncology, Business development, Optimism, Society, Ōtsuka, Telephone, Perception, Confidentiality, Judgement, Capital allocation line, ASCO, Internet, Farallon, OF, American Society of Clinical Oncology, Patient, Janssen Pharmaceuticals, Our Boarding House, Conference, EXEL, Risk management, Fine chemical, Pharmaceutical industry, Management, Cryptocurrency, Exelixis

Lack of a Clearly Articulated R&D and Capital Allocation Strategy: Exelixis has failed to communicate a coherent R&D strategy to the investment community.

Key Points: 
  • Lack of a Clearly Articulated R&D and Capital Allocation Strategy: Exelixis has failed to communicate a coherent R&D strategy to the investment community.
  • We appreciate that Exelixis responded to our call to return capital (even if belatedly), but it should distribute even more to ensure more focus.
  • At every turn, Exelixis has sought to minimize change and preserve its discretion to resist outside influence.
  • We urge shareholders to vote “FOR” each of the Farallon Nominees on the WHITE Proxy Card and to “WITHHOLD” on Lance Willsey.

Glass Lewis Recommends Aurinia Shareholders Vote “FOR” ALL Company Director Nominees at 2023 Annual Meeting

Retrieved on: 
Friday, April 28, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, 1836 U.S. Patent Office fire, BY, Partnership, Ōtsuka, ALL, Eastern Time Zone, Telephone, Policy, OR, Merrell Dow Pharmaceuticals Inc. v. Thompson, LN, Internet, Holiday, Patient, Professional Football Compensation Committee, Our Boarding House, Growth, Capital requirement, Proxy, LUMI, Compensated emancipation, Annual general meeting, Holding company, Audit, Management, Pharmaceutical industry, Internet service provider, EU, Aurinia

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (“Aurinia” or the “Company”) today announced that Glass Lewis & Co. (“Glass Lewis”), a leading independent proxy advisor, has recommended that Aurinia shareholders vote FOR ALL proposals at the Company’s 2023 Annual General Meeting (the “Meeting”), including the re-election to the Board of Directors (the “Board”) of all eight incumbent directors and the approval of the Company’s say-on-pay resolution.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (“Aurinia” or the “Company”) today announced that Glass Lewis & Co. (“Glass Lewis”), a leading independent proxy advisor, has recommended that Aurinia shareholders vote FOR ALL proposals at the Company’s 2023 Annual General Meeting (the “Meeting”), including the re-election to the Board of Directors (the “Board”) of all eight incumbent directors and the approval of the Company’s say-on-pay resolution.
  • Glass Lewis is an independent proxy advisor to institutional investors, covering 30,000 shareholder meetings each year, across approximately 100 global markets.
  • The Board encourages all shareholders eligible to vote at the Meeting to do so today using the instructions provided below.
  • Our Board and management team have the right skills and expertise to continue to unlock value for all shareholders.