Shionogi

ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV

Retrieved on: 
Monday, April 8, 2024
Research, Infectious Diseases, FDA, LGBTQ+, AIDS, Pharmaceutical, Consumer, Health, Science, Other Science, ARV, Week, DANCE, ViiV Healthcare, Pfizer, TANGO, HIV, GSK, Ageing, Safety, Subtypes of HIV, Shionogi, Food, Pharmaceutical industry

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.1

Key Points: 
  • ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.1
    In the U.S., 20 percent of new HIV diagnoses in 2020 were among young people aged 13-24.2 This expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12- and 18-years old living with HIV and underscores ViiV Healthcare’s ongoing commitment to bringing more therapeutic options to young people.
  • Lynn Baxter, Head of North America at ViiV Healthcare, said: "This expanded indication for Dovato brings an oral, two-drug, single-tablet regimen to adolescents living with HIV, providing a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment.
  • As a leader in HIV, ViiV Healthcare is proud of our focused efforts to improve and expand care for children and adolescents and we remain committed to addressing the existing treatment gaps in these communities.”
    The approval is supported by data from the DANCE study which evaluated Dovato in treatment-naïve adolescents as well as evidence from well-controlled trials in adults living with HIV, GEMINI-1 and GEMINI-2 (treatment-naïve adults) and TANGO (treatment-experienced adults).1 Results from the DANCE study, which included adolescents between 12- and 18-years old weighing at least 25 kg with HIV-1 RNA 1000 to ≤500,000 c/mL, showed that 26/30 participants achieved and maintained viral suppression at Week 48.1 The safety and efficacy data in adolescents from the DANCE study were comparable to those observed in adults.1 Exposures for components of Dovato were higher but were not clinically significant.1

ViiV Healthcare and The American Academy of HIV Medicine Announce Fellowship to Improve HIV Prevention in Key Communities

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, FDA, AIDS, Health, Training, Pharmaceutical, Other Education, Other Philanthropy, Philanthropy, Research, Infectious Diseases, Education, Science, Clinical Trials, Acquisition, Pre-exposure prophylaxis, Pfizer, Incidence, Shionogi, Woman, Medicine, Fungal infection, GSK, CROI, HIV Medicine, Notifiable disease, Emergency medicine, Dawn, Conference, Gynaecology, Mentorship, Preceptor, Patient, MPH, ViiV Healthcare, HIV, Obstetrics, American Academy, Pharmaceutical industry

Today, ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, and the American Academy of HIV Medicine (AAHIVM) jointly announced the launch of The Dr.

Key Points: 
  • Today, ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, and the American Academy of HIV Medicine (AAHIVM) jointly announced the launch of The Dr.
  • Dawn K. Smith HIV Prevention Clinical Fellowship.
  • The fellowship will provide comprehensive HIV training to non-infectious disease clinicians serving communities disproportionately affected by HIV.
  • Dawn K. Smith HIV Prevention Clinical Fellowship, experienced HIV clinicians will provide that training in priority populations and areas, with a special emphasis on pre-exposure prophylaxis (PrEP).”
    The Dr.

ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses

Retrieved on: 
Monday, March 4, 2024
Health, Infectious Diseases, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Pfizer, Shionogi, 1991 World Sportscar Championship, Aes, Rilpivirine, Fungal infection, GSK, CROI, Absorption, ISR, Cabotegravir, Data, Conference, Administration, Safety, Necrosis, CAB, MPH, Medicine, Half-life, Erythema, Plasma, ViiV Healthcare, HIV, Pharmaceutical industry

ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to further evaluate its use for the prevention of HIV in adults.

Key Points: 
  • ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to further evaluate its use for the prevention of HIV in adults.
  • Future areas of study will include its potential use in combination with other medicines as a complete, ultra long-acting HIV treatment regimen.
  • ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the HIV community.
  • Based on these combined findings, ViiV Healthcare is no longer pursuing CAB 200 SC + rHuPH20 for ultra long-acting dosing.

Akili Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024
Biotechnology, Technology, FDA, Health, Pharmaceutical, Neurology, Mental Health, Health Technology, Medical Devices, Apps, Applications, Software, Therapy, Acquisition, Shionogi, Investment, Marketing, Variable, Quality of life, Growth, Coronavirus, Table, Food, Sale, Prevalence, Frustration, ARPU, GAAP, COVID-19, Welfare, DSM-IV codes, Patient, Policy, Clinical trial, Net, ADHD, Workforce, Ageing, Prescription, Pharmaceutical industry

Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today reported its financial results for the quarter and full year ended December 31, 2023, and provided an update on business progress.

Key Points: 
  • Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today reported its financial results for the quarter and full year ended December 31, 2023, and provided an update on business progress.
  • Revenues: Total revenues for the fourth quarter of 2023 were $749 thousand compared to $702 thousand for the third quarter of 2023, driven by the continued growth of EndeavorOTC in the adult ADHD market in the fourth quarter.
  • Net Loss: GAAP net loss was $11.1 million for the fourth quarter of 2023, compared to a GAAP net loss of $15.9 million for the third quarter of 2023.
  • Non-GAAP net loss was $10.8 million for the fourth quarter of 2023, compared to a non-GAAP net loss of $13.9 million for the third quarter of 2023.

PureTech Founded Entity Akili Announces Positive Results from Shionogi’s Phase 3 Clinical Trial of Localized Version of Akili’s EndeavorRx ® for Pediatric ADHD Patients in Japan

Retrieved on: 
Tuesday, February 27, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Shionogi, Ministry, PRTC, Marketing, FDA, Food, Safety, Welfare, Patient, ADHD, Ageing, Pharmaceutical industry

"We are pleased by this additional validation of Akili’s EndeavorRx,” said Eric Elenko, Ph.D., Chief Innovation Officer at PureTech.

Key Points: 
  • "We are pleased by this additional validation of Akili’s EndeavorRx,” said Eric Elenko, Ph.D., Chief Innovation Officer at PureTech.
  • “The latest Japanese clinical trial of our patented, clinically proven technology is an important milestone for many reasons,” said Dr. Scott Kollins, Chief Medical Officer at Akili.
  • The trial aimed to evaluate the efficacy and safety of SDT-001 in 164 pediatric ADHD patients aged 6 to 17 who received conventional treatments such as environmental adjustments and psychosocial therapies.
  • Furthermore, symptom improvements were sustained even after two cycles of SDT-001 use, with no safety concerns noted.

Akili Announces Positive Results from Shionogi’s Phase 3 Clinical Trial of Localized Version of Akili’s EndeavorRx® for Pediatric ADHD Patients in Japan

Retrieved on: 
Monday, February 26, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Shionogi, Ministry, Marketing, FDA, Food, Safety, Welfare, Patient, ADHD, Ageing, Pharmaceutical industry

“The latest Japanese clinical trial of our patented, clinically proven technology is an important milestone for many reasons,” said Dr. Scott Kollins, Chief Medical Officer at Akili.

Key Points: 
  • “The latest Japanese clinical trial of our patented, clinically proven technology is an important milestone for many reasons,” said Dr. Scott Kollins, Chief Medical Officer at Akili.
  • “It not only further validates the efficacy and safety of EndeavorRx, it also moves us and our international partner SHIONOGI a step closer to making the product available in Japan.
  • The trial aimed to evaluate the efficacy and safety of SDT-001 in 164 pediatric ADHD patients aged 6 to 17 who received conventional treatments such as environmental adjustments and psychosocial therapies.
  • Furthermore, symptom improvements were sustained even after two cycles of SDT-001 use, with no safety concerns noted.

Alleo Labs Announces Publication on the Use of Artificial Intelligence in Neuroscience Drug Discovery and Development

Retrieved on: 
Wednesday, February 7, 2024
SAN, Shionogi, Bristol Myers Squibb, Neurodegenerative disease, Alzheimer's disease, Therapy, Machine learning, DSM-IV codes, Artificial intelligence, DOI, Journal, Merck, Bangladesh Technical Education Board, Medicine, Disease, Pharmaceutical industry

The research review explores the increasing use of artificial intelligence (A.I.)

Key Points: 
  • The research review explores the increasing use of artificial intelligence (A.I.)
  • in developing new drugs for age-related conditions such as Alzheimer's Disease, Parkinson’s Disease, and other chronic neurodegenerative disorders.
  • approaches and available patient data, the publication serves as a drug hunter’s roadmap for applying machine learning to different stages of neuroscience drug discovery.
  • and the invaluable capabilities the technology adds to our drug discovery programs in precision neuroscience.”
    The peer reviewed article is an open access publication that can be found at https://doi.org/10.3390/ph17020158.

ViiV Healthcare announces new packaging option now available in the U.S. for Dovato (dolutegravir/lamivudine)

Retrieved on: 
Tuesday, February 6, 2024
AIDS, Consumer, Health, Pharmaceutical, LGBTQ+, Subtypes of HIV, HIV, Pfizer, Shionogi, ViiV Healthcare, ARV, GSK

The sheets allow people living with HIV to view the number of pills left and track their doses.

Key Points: 
  • The sheets allow people living with HIV to view the number of pills left and track their doses.
  • The FDA approved the Dovato blister pack on November 3, 2023.
  • ViiV Healthcare plans to offer the Dovato blister pack in some European markets in 2024.
  • ViiV Healthcare will continue to offer Dovato in the 30-count pill bottle.

Academic Report by Pixie Dust Technologies, Inc. Showcases Applicability of Gamma Wave Sound

Retrieved on: 
Friday, February 2, 2024
Shionogi, Nara Medical University, Research, Hertz, Oscillation, Television, News, Acoustics, Brain, Dementia, University, National University Corporation, Mobile phone

The study utilized audio from television news and music programs, separating voices from background.

Key Points: 
  • The study utilized audio from television news and music programs, separating voices from background.
  • The background sound was amplitude-modulated at 40 Hz - a novel technique patented in Japan by the Company that is designed to synchronize gamma waves in the brain without compromising speech clarity.
  • "This study's findings are significant in confirming that Gamma Wave Sound can synchronize brain waves in both young and older individuals," commented Chief Research Officer of the Company, Takayuki Hoshi.
  • "We aim to further our research on Gamma Wave Sound and contribute to dementia prevention strategies."

“Defy Dementia with Sound.” Pixie Dust Technologies, Shionogi and Shionogi Healthcare create Gamma Wave Sound to boost everyday cognitive care.

Retrieved on: 
Wednesday, December 20, 2023
Other Health, Seniors, Audio, Video, Other Technology, Research, TV and Radio, Software, Mental Health, Music, Medical Devices, Consumer, Science, Technology, Entertainment, Online, Health, Apps, Applications, Health Technology, Patient, Sound, Quality of life, Dementia, Multimedia, White matter, Patent, Brain, Atrophy, Shionogi, Medical imaging

The Dementia Care Project by Gamma Wave Sound is an initiative designed to help people care for their cognitive function through auditory stimulation.

Key Points: 
  • The Dementia Care Project by Gamma Wave Sound is an initiative designed to help people care for their cognitive function through auditory stimulation.
  • Turning gamma waves technology into a readily available audio experience presents new possibilities in providing cognitive stimulation for dementia.
  • Six major companies across industries in Japan have come together to form the alliance to boost dementia care as part of the Dementia Care Project by Gamma Wave Sound.
  • Furthermore, music artists who support the initiative have released the Gamma Wave Sound edit of their tracks, accelerating the efforts to deliver Gamma Wave Sound through entertainment.