STAT

NOVEMBER 7, 2023

doctors scale back their use of  opioid painkillers , a new option for hard-to-treat pain is taking root: ketamine, the decades-old surgical drug that is now a  trendy psychedelic therapy. WASHINGTON (AP) — As U.S.

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pharmaphorum

MARCH 14, 2024

Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.

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Pharma Times

JANUARY 24, 2022

Beckley Psytech leads a new project focused on addressing psychiatric and neurological conditions through the use of psychedelic medicines.

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European Pharmaceutical Review

APRIL 13, 2023

Psychedelics are a class of psychoactive substances that produce temporary changes in perception, mood and cognitive processes. 1 Some psychedelics are found in nature, including psilocybin, a naturally occurring molecule found in almost 150 species of mushrooms which turns into psilocin once ingested, causing psychedelic effects.

Biosimilars 114

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 114

pharmaphorum

JANUARY 5, 2024

Beckley Psytech has announced that is has received substantial strategic investment from atai Life Sciences, totalling $50 million, to accelerate the clinical development of short-duration psychedelics.

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Outsourcing Pharma

OCTOBER 20, 2023

Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.

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Compounding 93

Pharmafile

APRIL 25, 2023

read more

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European Pharmaceutical Review

DECEMBER 21, 2022

Psychedelic research, in particular, is gaining momentum. . Regardless, most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use. Up until recently, it took a prohibitive stance toward psychedelic research.

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Compounding Controlled Substances Drug Development 107

Pharmacy Times

MARCH 11, 2024

If clinical trials continue to show that psychedelics offer safe and long-lasting results, then psychedelic-assisted therapy could flourish as a treatment in the mental health space.

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European Pharmaceutical Review

JUNE 28, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a first-of-its-kind trial to run this year to test psychedelic drugs as a treatment for major depressive disorder (MDD). The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy.

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Dosage Drug Development 74

Outsourcing Pharma

NOVEMBER 10, 2023

A partnership between clinical research technology company uMotif and cognitive science company, Cogstate Limited, will see the companies continue existing work that includes a major phase 2 clinical trial of a psychedelic therapeutic.

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Outsourcing Pharma

AUGUST 3, 2021

The Psychae Institute, established by a global team of scientists, will conduct pre-clinical and clinical research around psychedelic medicine development.

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Pharmacy Times

MARCH 27, 2024

Psychedelic medicines such as psilocybin, MDMA, ketamine, and LSD have been shown to have a significant impact on conditions such as major depressive disorder, generalized anxiety disorder, and post-traumatic stress disorder in clinical trials.

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pharmaphorum

MARCH 2, 2022

There is a growing pipeline of psychedelic therapies and an expanding body of science to suggest that they may be able to provide an alternative to existing mental health treatments. The image of psychedelic drugs within medical research is changing. A psychedelic renaissance.

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Compounding Drug Development 102

European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

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Compounding Drug Development 99

pharmaphorum

AUGUST 16, 2021

UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies. Beckley – formerly known as Beckley Canopy Therapeutics – raised £7.4

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Compounding 135

Outsourcing Pharma

JULY 4, 2023

Clerkenwell Health, a specialist clinical research organisation (CRO) focused on supporting clients with the design and delivery of psychedelic-assisted therapy trials, is sponsoring the upcoming Psych Symposium 2023 on Thursday 6 July in London.

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Pharmafile

FEBRUARY 22, 2023

Beckley Psytech, a private, clinical-stage biotech company, announced that the FDA has granted Investigational New Drug (IND) approval for their global multi-site phase 2b study into psychedelic drug BPL-003. BPL-003 is indicated for use in patients with Treatment Resistant Depression (TRD). read more

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Compounding 59

Pharmacy Times

OCTOBER 18, 2023

In the clinical setting, psychedelic medicine has promise as a safe and efficacious treatment for PTSD, TBIs, and other mental health issues.

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pharmaphorum

OCTOBER 2, 2020

Psychedelic therapy company Field Trip Psychedelics has announced that it will soon join the growing list of psychedelic companies going public. . COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. per Class A share. .

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Compounding 118

pharmaphorum

SEPTEMBER 14, 2021

The first patient has received a low dose of Beckley Psytech’s psychedelic medicine psilocybin in a clinical trial for short-lasting unilateral neuralgiform headache attacks (SUNHA), a rare disorder. The UK company says that SUNHA is a debilitating condition that is estimated to affect 40,000 patients in US and Europe.

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pharmaphorum

DECEMBER 17, 2020

In the last few years, biopharma companies focusing on psychedelic medicines have been springing up like mushrooms – magic or otherwise – and venture capital money is starting to follow. In September, Compass became the first psychedelic medicine company to float on the Nasdaq, raising $127 million , and is now trading at a market cap of $1.98

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Pharmacy Times

JANUARY 13, 2023

Jordan Sloshower, MD, MSc, explains his experience working in several clinical trials investigating psilocybin-assisted therapy.

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pharmaphorum

NOVEMBER 3, 2021

Psychedelic medicines specialist Beckley Psytech has enticed a senior figure in Janssen’s neuroscience division to take on the role of its chief medical officer as it ushers its first drugs through clinical trials. The post Psychedelics startup Beckley attracts Janssen neuroscience VP appeared first on. Dr Frank Wiegand.

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pharmaphorum

FEBRUARY 19, 2021

Psychedelic medicine biotech MindMed is to acquire digital medicine and therapeutics startup HealthMode for around $32.2 With the acquisition MindMed gains access to HealthMode’s intellectual property, platforms for clinical drug trials, and its entire 24-strong digital medicine team.

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Drug Development 116

Pharmacy Times

MAY 19, 2023

Rick Strassman, MD, a clinical researcher, author, and expert in psychedelic medicines, sat down to discuss pharmacists' role in adverse event management.

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Pharmacy Management 49

pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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Compounding 134

pharmaphorum

MAY 7, 2021

Small Pharma is following the trend for development of psychedelic medicines, a field where research has been suppressed for years because of legal restrictions on use of these compounds in many countries. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

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Compounding 92

pharmaphorum

JANUARY 6, 2022

Despite the growing interest in developing medicines based on psychedelic compounds, big pharma has seemed a bit wary of getting involved, leaving the task to small start-ups. MSRD has agreed to provide financial and operational support to the development of two families of Mindset’s psychedelic compounds through phase 1a /1b testing.

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Compounding 64

The Guardian - Pharmaceutical Industry

JANUARY 23, 2023

Clinics and scientists around the world aim to turn a profit from a powerful Gabonese plant – but it’s an ethical and legal wild west Lynn Smith was lying in a bed on the third floor of a beachfront house, unable to move her body from the neck down. Then the visuals started.

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pharmaphorum

APRIL 16, 2021

Researchers at Imperial College London’s Centre for Psychedelic Research also say that psilocybin may have a stronger effect and was more likely to help patients achieve remission from depression, although they stress the study was small and more research is needed.

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European Pharmaceutical Review

DECEMBER 21, 2022

There is growing interest in the use of psychedelic-assisted therapy for treatment of mental health conditions. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial. mRNA therapeutics: a limitless revolution in medicine.

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Vaccines 77

Pharmafile

FEBRUARY 21, 2023

Published date: 21/02/2023 Summary: ● This is the first time the FDA has given IND approval for a Phase IIb study of a short-acting psychedelic like 5-MeO-DMT (Mebufotenin). The study will take place across 40 investigator sites in 7 different countries, with study results expected in 2024. . ●

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Compounding 40

FDA Law Blog: Biosimilars

APRIL 10, 2023

1393 introduced in the Senate and the House, would facilitate removing barriers to research and compassionate use for schedule I controlled substances including the psychedelics psilocybin and 3,4-methylenedioxymethamphetamine (“MDMA”). Last month bipartisan legislation, S.

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Controlled Substances 59

European Pharmaceutical Review

NOVEMBER 4, 2022

Participants stayed in specialised rooms designed to provide a non-clinical, calming atmosphere. The therapy’s psychedelic effects lasted between six and eight hours. Further clinical trial results. The investigation interviewed patients on day two, and weeks one, three, six, nine, and 12 of the trial.

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Definitive Healthcare

FEBRUARY 23, 2024

Resource Type E-Books & How-To Guides Blog How-To Guide Healthcare Insight Medical claims 101: What you need to know How to sell effectively to healthcare facilities and executives using the right… Hospital payor mix by state Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pauseOnHover":false,"pauseOnDotsHover":false,"autoplay":false,"rows":0},"sm":{"slidesToShow":2,

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Drug Pricing Hospitals Drug Development 52

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. These drugs can be approved based on a surrogate endpoint, but the applicant provides an undertaking to subsequently perform confirmatory clinical studies.

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Drug Development 76