Pharmaceutical

The following issues have been halted by IIROC:

Company: BetterLife Pharma Inc.

CSE Symbol: BETR

All Issues: Yes

Reason: At the request of the Company Pending News

Halt Time (ET): 8:10 AM

IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada .

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) - Halts/Resumptions

View original content: http://www.newswire.ca/en/releases/archive/December2021/22/c0660.html

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BETR:CNX

BetterLife To Participate at the H.C. Wainwright 1st Annual Mental Health Conference

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, today announced that Dr. Ahmad Doroudian, Chief Executive Officer, will participate in a fireside chat at the upcoming H.C. Wainwright 1 st Annual Mental Health Conference being held on June 27 th 2022 in New York City, NY.

The theme of the conference is "Neuropsychiatry, Psychedelics, and Beyond." The fireside chat will focus on the background of BetterLife and what differentiates it in the mental healthcare space.

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BetterLife To Present BETR-001 Preclinical Data at the Upcoming Federation of European Neuroscience Societies Forum

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, today announced that an abstract submitted on the anti-depressant activity of its lead compound 2-bromo-LSD ("BETR-001") was accepted for poster presentation at the upcoming FENS Forum, being held July 9-13 in Paris, France. The study, led by Dr. Vern Lewis, is part of BetterLife's collaboration with the laboratory of Dr. Argel Aguilar-Valles at Carleton University's Department of Neuroscience.

Dr. Lewis will present preclinical data demonstrating the anti-depressant and neural plasticity-promoting properties of BETR-001 from both in vitro and in vivo studies. BETR-001 is a non-hallucinogenic Lysergic Acid Diethylamide ("LSD") derivative molecule.

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BetterLife To Present BETR-001 Preclinical Data at the Upcoming Canadian Association for Neuroscience Conference

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, today announced that an abstract on the preclinical data on anti-depressant activity of its lead compound 2-bromo-LSD ("BETR-001") was accepted for presentation at the upcoming Canadian Association for Neuroscience (CAN) Conference, being held May 12-15 in Toronto, Canada. The study, led by Dr. Vern Lewis, is part of BetterLife's collaboration with the laboratory of Dr. Argel Aguilar-Valles at Carleton University's Department of Neuroscience. This collaboration is also supported by the Mitacs Accelerate program.

At CAN, Dr. Lewis will present preclinical data demonstrating the neural plasticity-promoting and anti-depressant properties of BETR-001 from both in vitro and in vivo studies. The Dr. Lewis' study demonstrated that treatment of rat embryonic cortical neurons with BETR-001 increases the structural complexity of neurons (dendrite growth and complexity) and therefore, provides evidence of neural plasticity activity of BETR-001. In certain measurements of structural plasticity in neurons, BETR-001 performed better than ketamine in this model.

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BetterLife's BETR-001 Demonstrates BETR-001 Anti-depressant Activity in Preclinical Models of Depression

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, is pleased to announce it has obtained additional positive data confirming the anti-depressant activity of its lead compound 2-bromo-LSD ("BETR-001") in preclinical models of depression. The study is part of BetterLife's collaboration with the laboratory of Dr. Argel Aguilar-Valles at Carleton University's (Carleton) Department of Neuroscience.

BETR-001 is a second-generation Lysergic Acid Diethylamide ("LSD") derivative molecule that BetterLife believes will mimic the therapeutic potential of LSD without causing psychedelic effects, such as hallucinations. The current study evaluated the anti-depressant activity of BETR-001 on depressive-like behavior of mice in a forced swim test. The amount of time mice spend immobile (a depression-like behavior) was significantly reduced 24 hours after treatment with single dose of BETR-001 (1.0 mg/kg) compared to the untreated control group. BETR-001 had no effect on the locomotion behavior of mice in this study, suggesting the increased mobility in the forced swim test was due to its anti-depressant activity. "We are very pleased with these preclinical results as they show that BETR-001 efficacy in the forced swim test is consistent with 2-bromo-LSD's 5-HT2A agonist activity, promotion of neural plasticity, and its anti-depressant effect in stress-induced preclinical depression model, as demonstrated in previous studies by BetterLife. The mounting evidence on BETR-001 efficacy in preclinical models of depression leaves little doubt on its therapeutic potential in depression and related disorders," stated BetterLife's Chief Executive Officer, Dr. Ahmad Doroudian.

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BetterLife Obtains In Vivo PK Data for BETR-001 Confirming its Bioavailability in Brain

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of second generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has obtained the first set of positive in vivo pharmacokinetic (PK) data confirming the bioavailability of its lead compound BETR-001 (2-bromo-LSD, formerly TD-0148A) in the brain (target tissue) and plasma of treated mice. BETR-001 is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD). We had previously confirmed the non-hallucinogenic property of BETR-001 in the head-twitch-response (HTR) assay in mice, a model commonly used as a behavioral proxy in rodents for human hallucinogenic effects. A key objective of the current study was to confirm that lack of hallucinogenic property of BETR-001 is not due to its poor bioavailability especially in the target brain tissue.

The key PK data points from this mouse study conducted at Nucro-Technics (Scarborough, ON, Canada) include:

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Pfizer Announces Submission of New Drug Application to the U.S. FDA for PAXLOVID

  • Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk for progression to severe illness from COVID-19; consistent with current emergency use authorization
  • Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalizations or death from any cause; no deaths were observed in patients treated with PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) through Week 24, compared to 15 deaths observed with placebo
  • 50-60% of the U.S. population is estimated to have at least one risk factor for progressing to severe COVID-19 illness
  • Available safety data generally consistent in more than 3,500 PAXLOVID-treated participants across EPIC clinical development program

Pfizer Inc . (NYSE: PFE) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19. PAXLOVID is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The submission provides the longer-term follow-up data necessary for acceptance and potential approval.

According to the U.S. Centers for Disease Control and Prevention (CDC), 50-60% of the U.S. population is estimated to have one or more risk factors for progressing to severe COVID-19 illness. 1 These risk factors include any of the following: being aged 65 and older, obesity, diabetes, hypertension, smoking, physical inactivity, chronic kidney or liver disease, and immunocompromised conditions such as cancer, among others. 2

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Pfizer and BioNTech Announce New Agreement with U.S. Government to Provide Additional Doses of COVID-19 Vaccine

  • 105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the U.S. Food and Drug Administration (FDA). The doses are planned to be delivered as soon as late summer 2022 and continue into the fourth quarter of this year.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220629005833/en/

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Merck Announces the Launch of the Merck Digital Sciences Studio to Help Healthcare Startups Quickly Bring their Innovations to Market

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the launch of the Merck Digital Sciences Studio (MDSS) to enable the generation of innovative technologies for drug discovery and development. MDSS will support early-stage biomedical startups with direct investment, access to powerful Azure Cloud computing and opportunities to pilot their technologies in collaboration with discovery and clinical scientists at Merck. Starting today, Merck welcomes applications for 12 spots for the first MDSS cohort. Startups developing artificial intelligence (AI) and machine learning (ML) applications will be prioritized.

"The biopharmaceutical industry has only just started to harness the tremendous opportunity presented by emerging technological developments in AI, and ML," said Fiona Marshall, senior vice president, Discovery, Preclinical and Translational Medicine at Merck Research Laboratories. "The MDSS will provide a collaborative and entrepreneurial setting where scientists have access to the tools and expertise to fuel important innovations that advance drug discovery and development."

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Merck to Hold Second-Quarter 2022 Sales and Earnings Conference Call July 28

Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its second-quarter 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. ET on Thursday, July 28. During the call, company executives will provide an overview of Merck's performance for the quarter and outlook.

Investors, journalists and the general public may access a live audio webcast of the call via this weblink . A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com .

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Roivant and Pfizer Unveil Priovant Therapeutics and Ongoing Registrational Studies for Oral Brepocitinib in Dermatomyositis and Lupus

  • Brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1; in all five placebo-controlled studies completed to date, oral brepocitinib generated statistically significant and clinically meaningful results
  • Priovant is developing brepocitinib in severe autoimmune diseases with few approved therapies and where dual inhibition of TYK2 and JAK1 may provide greater efficacy than inhibiting either alone
  • A single registrational Phase 3 trial evaluating oral brepocitinib in dermatomyositis ( VALOR ) was initiated earlier this quarter
  • An ongoing Phase 2b study in systemic lupus erythematosus (SLE), designed to serve as one of two registrational studies, is expected to generate top-line results in 2H 2023

Roivant Sciences and Pfizer today announced the unveiling of Priovant Therapeutics, dedicated to developing and commercializing novel therapies for autoimmune diseases with the greatest morbidity and mortality. Priovant was established in September 2021 through a transaction between Roivant (Nasdaq: ROIV) and Pfizer (NYSE: PFE), in which Pfizer licensed oral and topical brepocitinib's global development rights and US and Japan commercial rights to Priovant. Pfizer holds a 25% equity ownership interest in Priovant.

Brepocitinib is a potential first-in-class dual inhibitor of TYK2 and JAK1, a novel mechanism of action expected to potentially provide greater efficacy in multiple highly inflammatory autoimmune diseases, as compared to agents that inhibit either TYK2 or JAK1 alone. Priovant is developing oral brepocitinib as a franchise across multiple orphan and specialty autoimmune diseases with few approved therapies, high morbidity and mortality, and pathobiologies for which both TYK2 and JAK1 inhibition are expected to contribute to efficacy. Oral brepocitinib is being evaluated in two ongoing registrational programs. Priovant recently initiated a single registrational Phase 3 study in dermatomyositis ( VALOR ). A large, global Phase 2b study in SLE, designed to serve as one of two registrational studies, is close to fully enrolled with data anticipated in 2H 2023.

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LYNPARZA® Receives Positive Opinion From EU CHMP as Adjuvant Treatment for Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA for the adjuvant treatment of patients with germline BRCA -mutated (g BRCA m), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.

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