Connect with us

/home/grassnews/public_html/wp-content/themes/zox-news/parts/post-single.php on line 153
">
Warning: Undefined array key 0 in /home/grassnews/public_html/wp-content/themes/zox-news/parts/post-single.php on line 153

Warning: Attempt to read property "cat_name" on null in /home/grassnews/public_html/wp-content/themes/zox-news/parts/post-single.php on line 153

Pear Therapeutics to Present Data on reSET®, for the Treatment of Substance Use Disorder, and Pear-004, for the Treatment of Schizophrenia, at American Psychiatric Association Annual Meeting

Published

on

Reading Time: 2 minutes

BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/APAAM19?src=hash” target=”_blank”gt;#APAAM19lt;/agt;–Pear
Therapeutics
, Inc., the leader in prescription digital therapeutics
(PDTs), today announced poster and oral presentations for the American
Psychiatric Association Annual Meeting May 18-22 in San Francisco. The
presentations will include clinical trial data for reSET, for the
treatment of Substance Use Disorder, and Pear-004, for the treatment of
Schizophrenia.

“Prescription digital therapeutics are a novel treatment class in
healthcare that represent a shift in how we treat serious disease,
delivering efficacy for enhanced outcomes as part of standard of care
while simultaneously empowering people to access care as they need it,”
said Yuri Maricich, M.D., M.B.A., Chief Medical Officer at Pear
Therapeutics. “While prescription digital therapeutics deliver
scientific mechanisms of action and undergo rigorous testing via
randomized clinical trials and review by regulatory bodies such as the
FDA, there is a need to educate healthcare providers and patients on the
difference between PDTs and unregulated health and wellness apps.”

Dr. Maricich will deliver a podium presentation titled, “Prescription
Digital Therapeutics: A New Addition to Standard of Care
,” on
Monday, May 20 at 12:00 p.m. PT. The session will include presentations
and a panel discussion featuring:

John Santopietro, M.D., DFAPA, Senior Vice President, Hartford
HealthCare; Physician–In–Chief, Behavioral Health Network; Assistant
Clinical Professor of Psychiatry, Yale School of Medicine; Assistant
Professor of Psychiatry, University of Connecticut School of Medicine
Tim
Campellone, Ph.D.,
Clinical Director, Multiple Sclerosis, Pear
Therapeutics
Frances Thorndike, Ph.D., Global Clinical Lead,
Insomnia, Pear Therapeutics
Ken Weingardt, Ph.D., Clinical
Director, Schizophrenia, Pear Therapeutics

In addition, Pear will present two scientific posters:

Early Prediction of High-Risk Patients Is an Opportunity for Early
Intervention
(poster number P6-010) will be
featured Monday, May 20 from 2:00 – 4:00 p.m. PT. The poster highlights
data demonstrating the ability to predict with 70% accuracy whether
people are likely to complete treatment with reSET based on engagement
data from the first week of treatment, providing the potential to better
identify and treat high-risk patients.

Agile Development of Pear-004, a Prescription Digital Therapeutic
for Patients With Schizophrenia
(poster number P7-029) will be
featured Tuesday, May 21 from 10:00 a.m. to 12:00 p.m. PT. The poster
highlights the iterative nature of PDT development, often involving
extensive clinician and patient feedback, and multiple product
iterations to enhance engagement, dosing, and efficacy. Pear-004 is
currently in a phase
2 proof-of-concept study
in collaboration with Novartis.

Pear Therapeutics is a privately held, prescription digital therapeutics
company developing clinically validated, FDA-authorized software
applications to treat serious disease.

About Pear Therapeutics
Pear Therapeutics is the
leader in prescription digital therapeutics. We aim to redefine medicine
by discovering, developing, and delivering clinically validated
software-based therapeutics to provide better outcomes for patients,
smarter engagement and tracking tools for clinicians, and cost-effective
solutions for payers. Pear has a pipeline of products and product
candidates across therapeutic areas, including severe psychiatric and
neurological conditions. Our lead product, reSET®, treats
Substance Use Disorder and was the first prescription digital
therapeutic to receive marketing authorization from the FDA to treat
disease. Pear’s second product, reSET-O®, for the treatment
of Opioid Use Disorder, received marketing authorization from the FDA in
December 2018. For more information, visit us at www.peartherapeutics.com.

Contacts

Media and Investors:
Amanda Galgay
[email protected]


Warning: Undefined array key 0 in /home/grassnews/public_html/wp-content/themes/zox-news/parts/post-single.php on line 493

Warning: Attempt to read property "cat_ID" on null in /home/grassnews/public_html/wp-content/themes/zox-news/parts/post-single.php on line 493

Cannabis

Cannabis Capsule Global Analysis Report 2024: Market to Reach $79.2 Billion in 2028 – Forecast to 2033 Featuring GW Pharmaceuticals, Trulieve Cannabis, Green Thumb Industries, Tilray, Columbia Care

Published

on

Continue Reading

Innocan

Innocan Pharma Initiates FDA Approval Process for Liposome Injection Therapy for Chronic Pain

Published

on

innocan-pharma-initiates-fda-approval-process-for-liposome-injection-therapy-for-chronic-pain

With its submission of a Pre-IND Meeting Request Letter, Innocan initiates the regulatory process with the U.S. Food and Drug Administration (FDA) for the approval of its prolonged CBD release technology for human use

HERZLIYA, Israel and CALGARY, AB, April 22, 2024 /PRNewswire/ — Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) (“Innocan” or the “Company”), is pleased to announce that is has reached a key milestone: the Company submitted its letter of application for a Pre-IND meeting, the first phase in the FDA approval process in the United States for Innocan’s Liposome-Cannabidiol (LPT-CBD) injectable treatment of chronic pain.

With the global market for pain therapeutics widely expected to exceed US$100 billion by 2032[1], LPT therapy which requires only one single monthly subcutaneous injection, is positioned as a highly attractive alternative to opioid-based approaches. Opioids have and continue to take a significant human toll in recent years, with more than three-quarters of drug overdose deaths in the United States involving opioids, according to the United States Center for Disease Control and Prevention[2].

Innocan’s therapy has shown consistent efficacy in multiple pre-clinical trials in recent years of it’s LPT-CBD injectable treatment through prolonged and controlled release of CBD in animals with chronic pain conditions. Innocan’s Pre-IND Meeting Request Letter to the FDA is a key milestone and important first step in seeking approval of its LPT-CBD therapy for use in humans. At the Pre-IND meeting, the objective will be to obtain guidance from the FDA on the preclinical and clinical development plan, enabling the initiation of an Investigational New Drug (IND) program in the United States.

Iris Bincovich, CEO of Innocan, commented: “We are extremely excited to embark on this next stage in the development of LPT-CBD injectables, this is a major Milestone for Innocan Pharma. We have invested significant effort and many thousands of person-hours in its research and development, accumulating a wealth of preclinical data that will serve as the foundation for our participation in the FDA process. This is a key milestone for Innocan and marks our first step towards the FDA’s recognition of our technology. We see significant potential for our therapy, with an addressable market for pain management therapeutics expected to exceed US $100 billion by 2032, and we look forward to tapping that.

Dr. Joseph Pergolizzi, Innocan’s FDA Advisory Board Member, added:

“We have worked hard to catalogue the data collected as part of our animal LPT therapy testing program and prepare it for the FDA. We look forward to working under FDA guidance, with the goal of completing the review process as quickly and efficiently as possible. We believe that Innocan’s unique treatment method, if and when it should become FDA-approved has the potential of being a highly valuable non-opioid addition in the medical arsenal of the management of chronic pain.”

About Innocan

Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies based on advanced cannabinoids science, to treat various conditions to improve patients’ quality of life. This segment involves two drug delivery technologies: (i) LPT CBD- loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for: Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment, Innocan has established a joint venture by the name of BI Sky Global Ltd. that focuses on advanced targeted online sales. https://innocanpharma.com/

For further information, please contact:

For Innocan Pharma Corporation:
Iris Bincovich, CEO

+1-516-210-4025

+972-54-3012842

+442037699377
[email protected]

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Cautionary note regarding forward-looking information

Certain information set forth in this news release, including, without limitation, information regarding research and development, collaborations, the filing of potential applications with the FDA and other regulatory authorities, the potential achievement of future regulatory milestones, the potential for treatment of conditions and other therapeutic effects resulting from research activities and/or the Company’s products, requisite regulatory approvals and the timing for market entry, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan’s control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of requisite production and distribution arrangements.

Forward-looking information is subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: general global and local (national) economic, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import / export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner) and availability in each market of product inputs and finished products. The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release concerning the timing of launch of product distribution. A comprehensive discussion of other risks that impact Innocan can also be found in Innocan’s public reports and filings which are available under Innocan’s profile at www.sedar.com.

Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.

[1] https://www.gminsights.com/industry-analysis/pain-management-drugs-market

[2] https://www.cdc.gov/opioids/data/index.html

Logo – https://mma.prnewswire.com/media/2046271/3968398/Innocan_Pharma_Corporation_Logo.jpg

Cision View original content:https://www.prnewswire.co.uk/news-releases/innocan-pharma-initiates-fda-approval-process-for-liposome-injection-therapy-for-chronic-pain-302122779.html

Continue Reading

Curaleaf

Curaleaf Completes Acquisition of Northern Green Canada

Published

on

curaleaf-completes-acquisition-of-northern-green-canada

Bolsters Company’s Advantage in Several Key Emerging Markets, including Australia, New Zealand, Germany, Poland and the United Kingdom

NEW YORK, April 22, 2024 /PRNewswire/ — Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) (“Curaleaf” or the “Company”), a leading international provider of consumer cannabis products, announced today the closing of its acquisition of Northern Green Canada (“NGC”), a vertically integrated Canadian licensed cannabis producer focused primarily on expanding in the international market through its EU-GMP certification. The accretive acquisition amplifies the Company’s strategic advantage in established European markets including Germany, Poland and the United Kingdom and provides a foothold in the emerging markets of Australia and New Zealand.

Integrating NGC’s international operation will equip Curaleaf with a secure and consistent high quality, non-irradiated, indoor EU-GMP flower supply, essential to maintaining its leading positions in Germany, the United Kingdom and Poland.

“We are thrilled to welcome NGC formally to the Curaleaf family of global brands,” said Boris Jordan, Founder and Executive Chairman of Curaleaf. “This is an incredibly important deal for our international expansion strategy, as we’ll be able to bolster our supply of high quality EU-GMP certified flower immediately to key European markets as well as enter the fast-growing markets of Australia and New Zealand.”

The global cannabis market is projected to generate $55 billion in sales by 2027. Emerging markets beyond the United States and Canada, including Germany, Australia and New Zealand are expected to contribute $6.3 billion of the $55 billion projection.

Terms of the acquisition of NGC include an initial payment at closing of the Company’s Subordinate Voting Shares valued at approximately US $16 million, subject to a typical post-closing adjustment. An earnout may also be paid in 2025 based upon 2024 performance of NGC’s operations, up to 50% of which will be cash and the rest paid in additional Subordinate Voting Shares. The issuance of Subordinate Voting Shares in connection with the acquisition of NGC has been conditionally approved by the Toronto Stock Exchange, subject to fulfilling customary listing conditions.

About Curaleaf Holdings
Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) (“Curaleaf”) is a leading international provider of consumer products in cannabis with a mission to enhance lives by cultivating, sharing and celebrating the power of the plant. As a high-growth cannabis company known for quality, expertise and reliability, the Company and its brands, including Curaleaf, Select, Grassroots, JAMS, Find and Zero Proof provide industry-leading service, product selection and accessibility across the medical and adult use markets. Curaleaf International is the largest vertically integrated cannabis company in Europe with a unique supply and distribution network throughout the European market, bringing together pioneering science and research with cutting-edge cultivation, extraction and production. Curaleaf is listed on the Toronto Stock Exchange under the symbol CURA and trades on the OTCQX market under the symbol CURLF. For more information, please visit https://ir.curaleaf.com.

Forward Looking Statements
This media advisory contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward–looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, “expects” or, “proposed”, “is expected”, “intends”, “anticipates”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. More particularly and without limitation, this news release contains forward-looking statements and information concerning the expected benefits of the acquisition of NGC, and the Company’s planned expansion on internal markets, the Company’s anticipated strategic advantages in European markets and emerging markets, the integration of NGC’s internal operations, the anticipated global cannabis market, and the listing of shares issuable in connection with the acquisition on the Toronto Stock Exchange. Such forward-looking statements and information reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company with respect to the matters described in this new release, including the Company’s ability to successfully realize the expected benefits of the acquisition, and the Company’s ability to fulfil the listing conditions imposed by the Toronto Stock Exchange. Forward-looking statements involve risks and uncertainties, which are based on current expectations as of the date of this release and subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including the failure to realize the expected benefits of the acquisition, or the Company’s failure to fulfil the listing conditions imposed by the Toronto Stock Exchange. Additional information about these assumptions and risks and uncertainties is contained under “Risk Factors and Uncertainties” in the Company’s latest annual information form filed on March 6, 2024, which is available under the Company’s SEDAR profile at http://www.sedar.com, and in other filings that the Company has made and may make with applicable securities authorities in the future. Forward-looking statements contained herein are made only as to the date of this press release and we undertake no obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. The Toronto Stock Exchange has not reviewed, approved or disapproved the content of this news release.

INVESTOR CONTACT
Curaleaf Holdings, Inc.
Camilo Lyon, Chief Investment Officer
[email protected]

MEDIA CONTACT
Curaleaf Holdings, Inc.
Tracy Brady, SVP Corporate Communications
[email protected]

View original content:https://www.prnewswire.co.uk/news-releases/curaleaf-completes-acquisition-of-northern-green-canada-302123010.html

Continue Reading

Trending on Grassnews

GrassNews.net: Your premier portal for the latest developments in the cannabis industry. We provide timely news, insightful analysis, and in-depth features on everything from legislation changes and business trends, to scientific research and lifestyle topics. Stay informed and navigate the rapidly evolving cannabis landscape with GrassNews.net..

Contact us: [email protected]

Editorial / PR Submissions

Copyright © 2007 - 2024 Hipther Agency. Registered in Romania under Proshirt SRL, Company number: 2134306, EU VAT ID: RO21343605. Office address: Blvd. 1 Decembrie 1918 nr.5, Targu Mures, Romania