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The Latest Breaking News from Health Canada

Important Biotech Catalysts For September 13, 2022 - End Of The Day Summary

Akero Therapeutics (NASDAQ:AKRO) revealed topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), the study met its primary endpoint for both the 50mg and 28mg EFX dose groups. Akero Therapeutics shares…

Benzinga

Canadian advocates pledge to continue selling pure drugs amid overdose crisis

Over the last six years, the vast majority of overdose deaths in British Columbia have been driven by impurities in street drugs

The Guardian - US

Magic Mushrooms Producer Optimi Keeps Betting On The FDA-approval Of Psychedelics

Optimi Health (OTCQX: OPTHF) has released an operational update on its planned year of commercialization, including the launch of psychedelics catalog.

Benzinga

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First International Psilocybin Supply Agreement For Optimi Health: Here Are The Details

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a Canadian-based company licensed by Health Canada to produce and supply natural psilocybin and other psychedelic substances, announced that it has entered into its first international psi

Benzinga

Recap Of Tuesday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck's (NYSE:MRK) lead asset MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). Merck shares traded in a range of $89.72 to $90.97 on day volume of 5.2…

Benzinga

Recap Of Thursday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has accepted the Menarini Group and Radius Health’s (NASDAQ:RDUS), New Drug Application (NDA) for elacestrant for patients with ER+/HER2- advanced or metastatic breast cancer. The agency has granted Priority Review designation and assigned a target action date of February 17, 2023. Radius Health…

Benzinga

Recap of Monday's Biotech Catalysts - End Of the Day Summary

Kodiak Sciences Inc. (NASDAQ:KOD) announced positive topline results its BEACON Phase 3 study of tarcocimab tedromer (KSI-301; tarcocimab) in patients with macular edema due to retinal vein occlusion. Kodiak shares traded in a range of $10.02 to $11.79 on a day volume of 4.05 million shares, closed regular trading session…

Benzinga

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Canada-Based Project Solace Aims To Provide Access And Data On Medical Psilocybin

TheraPsil, a Canadian coalition for psilocybin therapy legalization, together with the U.K. independent foundation Drug Science, has launched Project Solace.

Benzinga

Recap of Wednesday's Biotech Catalysts - End of The Day Summary

Benzinga

Avant Brands Reports Record Recreational Cannabis Sales For Q2 2022 Of $3.1M

Avant Brands Inc. (OTCQX: AVTBF) (TSX:AVNT) (FRA:1BU0) released its financial results for the quarter ended May 31, 2022, revealing record recreational cannabis sales of $3.1 million, compared to $2.5 in previous quarter, an increase of $600,000 or 23%.

Benzinga

Gateshead's Shield Therapeutics awaits Canadian regulatory approval for iron deficiency drug

The pharmaceutical firm says Health Canada will screen its Accrufer lead product, with an outcome expected next year

Birmingham Post

Canada: 100+ Healthcare Professionals Protest Psilocybin Access Ban For Psychedelics-Assisted Therapy Training

A judicial review request was submitted to the federal court by more than 100 doctors, psychologists, clinical counselors, social workers and nurses across Canada challenging the country’s health minister’s decision to reject the professionals' application to use restricted psychoactive drugs for training in psilocybin-assisted therapy

Benzinga

$150M is not enough: Canada’s proposed Purdue Pharma settlement for opioid damages is paltry and won’t prevent future crises

On June 29, Canadian federal and provincial governments reached a proposed $150-million settlement with Purdue Pharma Canada, makers of OxyContin, an opioid-based pain medication. The settlement is intended to recover the health-care costs related to the damaging effects from the sale and marketing of OxyContin.

The Conversation

Psychedelics Company Nabs Health Canada Construction Permit, Find Out How They Got It

Canadian life sciences company Nirvana Life Sciences Inc. (CSE: NIRV), focused on research & development of non-addictive pain management and relapse prevention products for pain and addictions, has been granted approval to build its R&D facility in Vancouver by Canada’s governmental department of Health.

Benzinga

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Benzinga

The Daily Biotech Pulse: Eli Lilly Modifies COVID-19 Treatment Pact, Oyster Point Outlines Restructuring Plan, Icosavax Posts Interim RSV Vaccine Data

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

SIGA Technologies Announces $13M Worth Order For Its Monkeypox Treatment

SIGA Technologies Inc (NASDAQ:SIGA) has announced approximately $13 million in procurement orders for oral TPOXX (tecovirimat) The order includes $11 million for initial procaurement from two new international jurisdictions and an approximate $2 million order from a country in the Asia Pacific region with an established contract for oral TPOXX. "We expect a…

Benzinga

Nextleaf To Launch THC-O As An Excise Tax-Free Alternative To Delta-9-THC

Nextleaf Solutions Ltd.

The Guardian - US

MDMA trials under review in Canada over alleged abuse of study participants

Health Canada confirms reviews into trials following complaint of ‘alleged investigator misconduct’

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Benzinga

Canadian Special Access Program Further Authorizes Novel Psychedelic Drugs For Emergency Treatments

For those unaware, Canada provides a legal way for patients presenting unresolved mental health issues to receive psychedelic-assisted treatment.

Benzinga

Canada Approves Amylyx's ALS Drug; FDA To Consider Approval In September

The Canadian government has given its approval to AMX0035, a new drug from Cambridge, Massachusetts-based Amylyx Pharmaceuticals Inc.

Benzinga

Tetra Bio-Pharma Opens New Subsidiary In Australia And Provides Regulatory Update

Tetra Bio-Pharma Inc. (TSX:TBP) (OTCQB: TBPMF) (FRA:JAM1) launched new wholly owned subsidiary 'Tetra Bio-Pharma Australia Pty Ltd', an Australian-based research company focused on the execution of clinical trials in Australia.

Benzinga

Numinus' Ongoing Collaboration With Health Canada Spurs Mindspace Clinic Approval In Quebec

A longstanding commitment of Numinus Wellness Inc. (OTC: NUMIF) to collaborate with Health Canada to help shape protocols for the Special Access Program appears to be paying dividends.

Benzinga

EDSA: Enrollment of Phase 2b Trial of EB01 to Complete in 4Q22…

By David Bautz, PhD NASDAQ:EDSA READ THE FULL EDSA RESEARCH REPORT

Benzinga

Isracann Biosciences' Subsidiary Praesidio Health Submits NPNs To Health Canada

Praesidio Health, a wholly-owned subsidiary of Isracann Biosciences Inc. (OTCPK:ISCNF) (CSE:IPOT) (XFRA:A2PT0E), has completed the natural product number (NPN) submissions to Health Canada for its first formulations.

Benzinga

Numinus Granted Canada's Special Access Program For Magic Mushrooms To Treat Life-Threatening Conditions

Numinus Wellness Inc (OTCQB: NUMIF) has been approved to use psilocybin-assisted therapy through Health Canada’s Special Access Program (SAP), marking the first instance in which Numinus will provide this treatment outside of a clinical trial.

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