Posts tagged FDA
FDA committee approves GW Pharma cannabidiol for seizures

The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA unanimously recommended supporting the approval of the NDA from GW Pharmaceuticals (NASDAQ:GWPH) and its U.S. subsidiary Greenwich Biosciences, for the cannabidiol oral solution (CBD), Epidiolex, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two years of age and older.

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Ladenburg ups Novavax PT to $3.50 from $2.50

Ladenburg Thalmann raised its price target for Novavax (NASDAQ:NVAX) to $3.50 from $2.50 after the company presented Phase 1/2 data suggesting its NanoFlu vaccine has the potential to be the most potent product for preventing flu, including the Singapore A strain that is expected to be a dominant strain for the 2019-2020 flu season.

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Profound Medical completes enrollment in TACT pivotal trial

Profound Medical (OTCQX:PRFMF; TSXV:PRN) has completed patient enrollment in the TACT pivotal study designed to further evaluate safety and efficacy of its TULSA-PRO medical device to ablate prostate tissue in patients with localized, organ-confined prostate cancer.

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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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Titan Pharma in talks with Braeburn about future of Probuphine partnership

Titan Pharmaceuticals (NASDAQ:TTNP) is in discussions with Braeburn Pharmaceuticals about their partnership for the development and commercialization of Probuphine, the first six-month maintenance treatment of opioid dependence. 

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CIBC-favored health care stocks for 2018

For 2018, CIBC World Markets is recommending investors hold a basket of healthcare stocks that include a combination of more speculative small and midcap companies with selected large caps.

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Eiger completes enrollment in Phase 2 ULTRA study

Eiger BioPharmaceuticals (NASDAQ:EIGR) completed enrollment of the Phase 2 ULTRA study designed to evaluate the effects of ubenimex in patients with primary and secondary lymphedema of the lower limbs. A total of 54 patients were enrolled across sites in the U.S. and Australia.

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NeuroproteXeon additional Phase 2 data published in JACC

Closely-held NeuroproteXeon announced the publication of a second finding from a randomized, controlled Phase 2 trial of inhaled xenon and oxygen, combined with hypothermia, for out-of-hospital cardiac arrest (OHCA) patients.

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Tetra Bio-Pharma updates Dronabinol XL AdVersa development plans

Tetra Bio-Pharma (TSXV:TBP; OTCQB:TBPMF) is partnering with a major manufacturer of controlled active pharmaceutical ingredients in the U.S. to  manufacture Dronabinol XL AdVersa as part of the company’s plans to submit a 505(b)(2) NDA for the treatment of chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS.

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