Category - Developments

Developments

FDA accepts Homology’s IND for Phase 1/2 study of PKU gene therapy

Homology Medicines (NASDAQ:FIXX) received FDA clearance to commence its Phase 1/2 study of HMI-102 in adults with phenylketonuria (PKU), a rare genetic disease affecting metabolism. Individuals with PKU lack the...

April 5, 2019

Developments

Entasis initiates Phase 3 pivotal trial for drug-resistant infections

Entasis Therapeutics (NASDAQ:ETTX) has initiated a Phase 3 pivotal clinical trial to evaluate ETX2514 and sulbactam (ETX2514SUL) for the treatment of carbapenem-resistant A. baumannii infections. A. baumannii causes...

April 5, 2019

Developments

Profound Medical posts positive top line pivotal trial results in prostate cancer with TULSA-PRO

Profound Medical (TSX:PRN; OTCQX:PRFMF) reported positive top line results from the TACT pivotal study designed to support its application to the FDA for 510(k) clearance to market TULSA-PRO in the U.S. The TULSA-PRO...

April 5, 2019

Developments

IntelGenx among few Quebec companies leading cannabis edibles market

An article recently published in La Presse highlighted Montreal’s IntelGenx (OTCQX:IGXT; TSXV:IGX) as one of the few Quebec-based companies at the forefront of the cannabis edibles market. Of some 150 Health Canada...

April 3, 2019

Developments

BriaCell immunotherapy/KEYTRUDA combination increases anti-tumor activity in early trial

BriaCell Therapeutics (TSX-V:BCT) (OTCQB:BCTXF) announced that early Phase 1/2a data suggest its Bria-IMT immunotherapy, combined with the checkpoint inhibitor KEYTRUDA, demonstrated additive or synergistic anti-tumor...

April 3, 2019

Developments

Evogene to develop next generation medical cannabis products

Evogene (NASDAQ, TASE:EVGN) has established a new subsidiary, Canonic, to develop next generation medical cannabis products. Evogene has been evaluating the medical cannabis field for more than a year, including market...

April 3, 2019

Developments

BDO USA acquires of BioProcess Technology Consultants

BDO USA acquired BioProcess Technology Consultants, a provider of chemistry, manufacturing and controls (CMC) consulting services to the global biopharmaceutical industry. The acquisition of BioProcess bolsters BDO’s...

April 3, 2019

Developments

Ziopharm glioblastoma program gets FDA fast track designation

Ziopharm Oncology’s (NASDAQ:ZIOP) controlled IL-12 program received FDA fast track designation for the treatment of recurrent or progressive glioblastoma multiforme (rGBM) in adults. Controlled IL-12 consists of IL-12...

April 3, 2019

Developments

Idera Pharma presents positive Phase 1 data of tilsotolimod for solid tumors

Idera Pharma (NASDAQ:IDRA) presented results of its Phase 1 trial of tilsotolimod as monotherapy in patients with various refractory solid tumors. Tilsotolimod is a toll-like receptor 9 agonist that activates cancer...

April 3, 2019

Developments

ADMA Biologics ASCENIV gets FDA approval

ADMA Biologics’ (NASDAQ:ADMA) ASCENIV has received FDA approval for the treatment of primary humoral immunodeficiency disease (PI) in adults and adolescents. The approval is based on results of a pivotal Phase 3...

April 2, 2019

Category - Developments

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