JAMA

Rosemary Mazanet, M.D., PhD. Joins Columbia Care's Board of Directors

Retrieved on: 
Monday, September 11, 2023
Natural Resources, Alternative Medicine, Other Manufacturing, Health, Specialty, Cannabis, Manufacturing, Retail, Columbia University, University of Southern California, Heart, Database, University, Palliative care, Wharton School of the University of Pennsylvania, Journal of Palliative Medicine, Coronavirus Scientific Advisory Board, General partnership, Human, FSE, National Institutes of Health, Bangladesh Technical Education Board, Dana–Farber Cancer Institute, Harvard Medical School, Tablet, Leonard Davis Institute of Health Economics, Journal, RAND Corporation, Clinical research, Internal medicine, Filgrastim, Knowledge, Hospital, FDA, Dana, NEO, NLRB v. Kentucky River Community Care, Inc., Chair, JAMA, Pharmaceutical industry, Management, Amgen, New York University, Brigham

Dr. Mazanet began advising Columbia Care in 2013 and then joined its Scientific Advisory Board as its Chair in 2015.

Key Points: 
  • Dr. Mazanet began advising Columbia Care in 2013 and then joined its Scientific Advisory Board as its Chair in 2015.
  • Since 2013, she has played an integral role of developing groundbreaking form factors specifically for palliative care, such as pressed tablets.
  • I know she will continue to add significant value as a member of our Board of Directors.
  • Congratulations, Rosemary and thank you," said Nicholas Vita, CEO, Columbia Care.

Good Night, Sleep Tight with affron® Natural Melatonin Booster

Retrieved on: 
Wednesday, September 13, 2023
JAMA, Melatonin, Obesity, Headache, Centers for Disease Control and Prevention timeline, Sleep, National Sleep Foundation, Diabetes, Tryptophan, Agriculture, Enzyme, Kynurenine pathway, Person, Trial of the century, American Medical Association, Plasma, Journal, Dizziness, Espinel, Pineal gland, Vivo, Kynurenine, SLU, Water, Menopause, Relaxation, Somnolence, Dietary supplement, Pharmaceutical industry

MADRID, Sept. 13, 2023 /PRNewswire/ -- Results of a new study demonstrate that the standardized affron® saffron extract boosts the body's endogenous production of melatonin. Melatonin—nicknamed the "sleep hormone"—is naturally produced in the body from the dietary amino acid tryptophan. Among other roles, melatonin helps synchronize the sleep–wake cycle and other circadian rhythms and helps adjust for seasonal changes in sleep timing. It has become one of the most commonly used treatment for sleep disorders.

Key Points: 
  • Among other roles, melatonin helps synchronize the sleep–wake cycle and other circadian rhythms and helps adjust for seasonal changes in sleep timing.
  • In summary, the study shows unequivocally that affron has an effect on sleep quality because it stimulates endogenous melatonin production.
  • Insufficient Sleep is defined by The Sleep Foundation as "curtailed sleep that persists for three months or longer," as well as "poor sleep that occurs because of sleep fragmentation or other disruptions."
  • "Better sleep is as much about good sleep as it is about duration of sleep," explains Espinel.

Together, the All-in-One AI Health Assistant, Improves Care for Aging Americans With Voice-Based Mental Health Detection Feature

Retrieved on: 
Wednesday, August 30, 2023
VoIP, Software, Mobile, Wireless, General Health, Telemedicine, Virtual Medicine, Mental Health, Apps, Applications, Technology, Artificial Intelligence, Health Technology, Practice Management, Health, Clifford Whittingham Beers, Blood pressure, Kaiser, JAMA, Obesity, Depression, Face, Google Play, Anxiety, Ageing, Kaiser Family Foundation, Android, Multimedia, MIT, App Store (iOS/iPadOS), American Medical Association, Journal, DSM-IV codes, Patient, Risk, Frustration, Apple, Conditional sentence, Heart rate, MIT Lincoln Laboratory, JAMA Psychiatry, Caregiver, PharmacoEconomics, Nursing, Mobile phone, Medical device

Together , the leading AI-based health assistant, today unveiled its latest groundbreaking feature: Mental Vitals, an innovative mental health detection tool designed to screen for symptoms of depression and anxiety through voice analysis.

Key Points: 
  • Together , the leading AI-based health assistant, today unveiled its latest groundbreaking feature: Mental Vitals, an innovative mental health detection tool designed to screen for symptoms of depression and anxiety through voice analysis.
  • "Our mission with Together is to unify every aspect of health care, from vitals monitoring to mental health detection, into one intuitive platform," said Dr. Renee Dua, founder and chief product officer of Together.
  • According to a Mental Health America 2023 survey report , 54% of adults with a mental illness did not receive treatment.
  • By combining mental health detection, vital measurement, and routine health management, Together can be uniquely effective as an AI-driven patient-centric care coordination and whole-person health platform.

AstraZeneca urges re-examination of unintended consequences of Inflation Reduction Act on American cancer and rare disease patients

Retrieved on: 
Friday, August 25, 2023
Other Health, Research, General Health, Professional Services, Pharmaceutical, Oncology, Healthcare Reform, Science, Legal, Congressional News, Views, Health, Public Policy, Government, Orphan Drug Act of 1983, Eculizumab, REMS, Central nervous system, Drug development, Vaccination, Prostate cancer, GMG, Infection, Attenuated vaccine, Fever, JAMA, Cancer, Light, Neuromyelitis optica spectrum disorder, Breast, Medicine, NMOSD, IRA, AstraZeneca, Rash, American Medical Association, Neisseria meningitidis, Vomiting, Inflation, ODA, Low-probability-of-intercept radar, Meningococcal vaccine, Patient, Risk, Autoimmune disease, PNH, Immune system, Nausea, Confusion, Inflation Reduction Act of 2022, Rare, Headache, Patient safety, Death, Disease, Pharmaceutical industry, Vaccine

To help protect access to medicines for cancer and rare disease patients, AstraZeneca today has filed a legal challenge to critical aspects of the drug price negotiation provisions of the Inflation Reduction Act (IRA).

Key Points: 
  • To help protect access to medicines for cancer and rare disease patients, AstraZeneca today has filed a legal challenge to critical aspects of the drug price negotiation provisions of the Inflation Reduction Act (IRA).
  • Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Rare disease and cancer patients depend upon high-risk, low-probability drug development that takes many years to develop and aims for cure.
  • One example is LYNPARZA® (olaparib), a small-molecule cancer medicine approved in 2014 in the US for a small group of late-line ovarian cancer patients.
  • Additional trials added small groups of breast and pancreatic cancer patients, with the most recent indication in prostate cancer approved just this year – nine years later.

JAMA Neurology Publishes Phase 3 Study Results Comparing IPX203 to Immediate-Release Carbidopa/Levodopa for Parkinson’s Disease

Retrieved on: 
Thursday, August 24, 2023
Research, Neurology, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, IR, University, PD, Symantec Endpoint Protection, Disease, Anxiety, LD, CI, Urinary tract infection, Parkinson, Trial of the century, Medication, Amneal Pharmaceuticals, Back pain, Dizziness, Patient, Manuscript, Parkinson's disease, Nausea, Dyskinesia, CRL, FDA, JAMA Neurology, NYSE, Treatment, Safety, JAMA, Pharmaceutical industry

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that JAMA Neurology has published results from the RISE-PD clinical study assessing the efficacy and safety of IPX203 versus optimized immediate-release carbidopa/levodopa (IR CD/LD) for the treatment of Parkinson’s disease (PD).

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that JAMA Neurology has published results from the RISE-PD clinical study assessing the efficacy and safety of IPX203 versus optimized immediate-release carbidopa/levodopa (IR CD/LD) for the treatment of Parkinson’s disease (PD).
  • “Good On” time is defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia.
  • The manuscript titled, “IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease,” was published online on August 14, 2023.
  • Additionally, “Good On” time per dose increased by 1.55 hours with IPX203 compared with immediate-release carbidopa-levodopa (95% CI, 1.37-1.73).

Achieve Life Sciences Reports Financial Results for Second Quarter 2023 and Provides Corporate Update

Retrieved on: 
Monday, August 14, 2023
Cytisine, U.S.–Canada Team Tournament (Go), Smoker, International, Nicotine, First Citizens Bank of South Carolina, American Medical Association, SVB, Webcast, JAMA, FDA, Smoking, Safety, Pharmaceutical industry, Security (finance)

SEATTLE and VANCOUVER, British Columbia, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced second quarter 2023 financial results and provided an update on the cytisinicline development program.

Key Points: 
  • The positive Phase 3 ORCA-2 trial results for cytisinicline as a treatment for smoking cessation were published in JAMA.
  • Achieve announced positive topline results from a second Phase 3 ORCA-3 trial, which confirmed the safety and efficacy of 3mg cytisinicline dosed three times daily versus placebo in 792 adult U.S. smokers.
  • Statistically significant results from the Phase 2 ORCA-V1 trial were also reported in the second quarter of 2023.
  • To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts .

Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones

Retrieved on: 
Monday, August 14, 2023
Retina, Injection, Bevacizumab, Partnership, PIER, Anti-VEGF, PHSA, GlobalData, Special Protection Area, DME, Pharmacy, Marketing, AMD, AmerisourceBergen, Safety, Calendar, Clinical trial, Advanced Therapy Medicinal Product, Diabetic retinopathy, Intraocular pressure, Acquisition, Alliance Healthcare, Standard of care, Patient, Physician, Fujifilm Diosynth Biotechnologies, PDUFA, MAA, FDA, CHMP, Therapy, BLA, BRVO, JAMA, Syringe, Pharmaceutical industry, Medical device, EU

By meeting strict FDA requirements for an ophthalmic approved formulation of bevacizumab, we believe we can enhance the standard of care.

Key Points: 
  • By meeting strict FDA requirements for an ophthalmic approved formulation of bevacizumab, we believe we can enhance the standard of care.
  • This represents approximately 3.5 million injections of off-label, repackaged bevacizumab each year in the United States alone.
  • Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.
  • In August 2022, Outlook Therapeutics submitted a PHSA 351(a) BLA for ONS-5010 as an original biologic application.

Genelux Corporation Reports Second Quarter 2023 Financial Results and Provides General Business Updates

Retrieved on: 
Monday, August 14, 2023
IPO, Senior, Investment, Head, JAMA, Clinical trial, Drug, Article, MS, American Medical Association, Journal, Russell, Patient, Patent, Regulatory affairs, Research, Pharmaceutical Development and Technology, Safety, D, Pharmaceutical industry, Genelux Corporation, Q2, NSCLC, Quality, MD

WESTLAKE VILLAGE, Calif., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the second quarter of 2023 and provided general business updates.

Key Points: 
  • - $51 Million raised after closing of two private placements in Q2, totaling $65 million raised in the first half of 2023 -
    WESTLAKE VILLAGE, Calif., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the second quarter of 2023 and provided general business updates.
  • R&D Expenses: Research and development expenses were $2.9 million for the second quarter of 2023, as compared to $1.8 million for the second quarter of 2022.
  • G&A Expenses: General and administrative expenses were $2.5 million for the second quarter of 2023, as compared to $1.0 million for the second quarter of 2022.
  • Net Loss: Net loss was $5.8 million for the second quarter of 2023, as compared to a net loss of $2.8 million for the second quarter of 2022.

Food and Drug Administration Approves First Postpartum Depression Pill, Research Led by Northwell Health’s Feinstein Institutes

Retrieved on: 
Monday, August 7, 2023
Women, Biotechnology, Pharmaceutical, Health, FDA, Mental Health, Consumer, Clinical Trials, GABA, PPD, Medicine, JAMA, NAS, Feinstein Institutes for Medical Research, Neurochemistry, Woman, Multimedia, Research, Northwell Health, The American Journal of Psychiatry, Bangladesh Technical Education Board, American Medical Association, American Journal, Behavioural sciences, Journal, Patient, Zuranolone, Grammatical mood, Psychiatry, Credit, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NIH, Medical research, Food, Safety, Allopregnanolone, Pharmaceutical industry, MD

View the full release here: https://www.businesswire.com/news/home/20230807136425/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230807136425/en/
    The national clinical trials for zuranolone were led by the Feinstein Institutes for Medical Research at Northwell Health.
  • “After years of dedicated research and collaboration with other scientists, women living with postpartum depression have a new, at-home, 14-day treatment option that has the potential to alleviate their symptoms,” said Dr. Deligiannidis.
  • Deligiannidis is a leader in clinical trials for postpartum depression, a condition that affects millions,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes, Karches Family Distinguished Chair in Medical Research.
  • “The FDA approval stemming from her work will make available new therapeutic options that are clearly needed.”
    The Feinstein Institutes and Dr. Deligiannidis lead in researching new methods to diagnose and treat perinatal depression.

Tampa General Hospital and Signallamp Collaborate on New Remote Chronic Care Management Program

Retrieved on: 
Thursday, August 3, 2023
Blood pressure, Stel, JAMA, Partnership, Wi-Fi, Thermometer, Heart, Innovation, American Medical Association, Chronic obstructive pulmonary disease, Journal, Patient, Physician, Risk, TGH, Tampa General Hospital, Health, Caregiver, Software, Nursing, Hospital, Medical device

TAMPA, Fla., Aug. 3, 2023 /PRNewswire/ -- Patients with serious illnesses continue to receive care without leaving home, thanks to a partnership between Tampa General Hospital (TGH) and Signallamp Health Inc., a leading chronic care management company based in Pennsylvania.

Key Points: 
  • TAMPA, Fla., Aug. 3, 2023 /PRNewswire/ -- Patients with serious illnesses continue to receive care without leaving home, thanks to a partnership between Tampa General Hospital (TGH) and Signallamp Health Inc., a leading chronic care management company based in Pennsylvania.
  • Remote patient management is a growing trend in health care that allows caregivers to receive important health information about patients via remote, wearable devices.
  • Tampa General first partnered with Signallamp in 2021 for chronic care management.
  • "Remote patient monitoring solutions are a real game changer in providing at-home care for patients with chronic conditions."