Posts tagged Health Canada
IntelGenx initiates Phase 2a Montelukast VersaFilm trial in AD

IntelGenx (OTCQX:IGXT; TSXV:IGX) has initiated the Phase 2a proof-of- concept clinical trial with its Montelukast VersaFilm in Alzheimer’s disease patients, following clearance by Health Canada. 

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IntelGenx seeks Health Canada approval for montelukast VersaFilm trial

IntelGenx (OTCQX:IGXT; TSXV:IGX) submitted a clinical trial application to Health Canada for approval to initiate a Phase 2a proof-of-concept study with montelukast in mild-to-moderate Alzheimer's disease (AD). 

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Echelon starts Theralase at speculative buy

Echelon Wealth Partners initiated coverage of Theralase Technologies (TSXV:TLT) with a “speculative buy” rating and one-year price target of 90 cents. The stock closed at 47 cents on Sept. 1.

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Knight NDS for Probuphine in Canada accepted for review

Knight Therapeutics’ (TSX:GUD) New Drug Submission (NDS) for Probuphine, a subdermal implant of buprenorphine for the treatment of opioid drug dependence, has been accepted for review by Health Canada.

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Tetra readies Phase 3 pain relief trial of medical cannabis

Tetra Bio-Pharma (CSE:TBP; OTCQB:TBPMF) and subsidiary, PhytoPain Pharma, have submitted a report on the safety and pharmacokinetics of its PPP001 smokeable cannabis product to Health Canada.

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IntelGenx, Tetra to develop Dronabinol XL tablet

IntelGenx (OTCQX:IGXT; TSXV:IGX) and Tetra Bio-Pharma (CSE:TBP; OTC:GRPOF) signed a definitive agreement to develop and commercialize a drug product containing the cannabinoid, Dronabinol, for the management of anorexia and cancer chemotherapy-related pain.

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IntelGenx, Tetra in development term sheet

IntelGenx (TSX-V:IGX; OTCQX:IGXT) and Tetra Bio-Pharma (CSE:TBP; OTC: GRPOF) announced the signing of a binding term sheet for the development and commercialization of a drug product containing dronabinol.

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Valeant to commercialize Contrave in Canada

Valeant Canada, a subsidiary of Valeant Pharmaceuticals International (NYSE, TSX: VRX), will commercialize Orexigen Therapeutics’ (NASDAQ:OREX) Contrave (naltrexone HCl / bupropion HCl extended release) in Canada.

Under the accord, Valeant will be responsible for obtaining Canadian regulatory approval and for all commercialization activity and expenses. Orexigen will supply Contrave tablets to Valeant Canada or its affiliates for an agreed transfer price and certain potential regulatory and sales milestone payments. Orexigen expects Valeant to file with Health Canada for regulatory approval by January 2017.

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BioSyent signs distribution pact for two CV products

BioSyent (TSX-V:RX; OTC:BIOYF) has signed an exclusive distribution agreement with a European partner for two new products in the cardiovascular therapeutic area for the Canadian market.

The products have been approved in Europe and in certain other markets around the world and will be launched in Canada if approval is granted by Health Canada. BioSyent intends to submit the dossier seeking marketing approval of the products to Health Canada in 2016.

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