Posts tagged FDA
FDA advisory vote on TLANDO not a knockout for Lipocine

Although Lipocine (NASDAQ:LPCN) is disappointed by a FDA advisory committee vote against the benefit/risk profile of TLANDO, its oral testosterone replacement therapy (TRT), the company believes there is still a path forward for TLANDO.

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Chi-Med transforming into fully integrated pharma

After 17 years of blistering growth in China, Hutchison China Meditech (Chi-Med) (AIM, NASDAQ:HCM) is taking center stage as a global drug innovator, with a fully integrated pipeline approaching regulatory approvals, a prolific discovery engine and an established commercial organization.

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Soricimed planning to initiate Phase 1b/2a solid tumor trial in Q2

Closely-held Soricimed Biopharma expects to initiate in the second quarter of 2018 a Phase 1b/2a clinical trial with its SOR-C13 drug candidate in patients with prostate cancer, including men who have failed first line treatment, as well as patients with advanced pancreatic and ovarian cancers.

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American CryoStem pioneering adipose tissue stem cell technologies

American CryoStem (OTC:CRYO) has developed platform technologies dedicated to the collection, processing, bio-banking, culturing and differentiation of adipose tissue and adipose derived stem cells (ADSCs) for current or future use in regenerative medicine.

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CKD patients opt to stay on Dimerix drug after trial

Forty-five per cent of patients in Dimerix’s (ASX:DXB) successful Phase 2a trial in chronic kidney disease (CKD), on advice from their physician, applied for and were granted access to remain on DMX-200 under Australia’s Special Access Scheme, which allows participants continued access to a therapy after they complete a clinical study.

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Appili readies antibiotic bridging study

Closely-held Appili Therapeutics plans to begin late in the current quarter a Phase 1 bridging, or bioequivalence, study of its lead anti-infective, ATI-1501, a reformulated, taste-masked liquid suspension of metronidazole, targeting anaerobic bacterial infections, including Clostridium difficile.

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Tetra Bio-Pharma sets active cannabis clinical programs

Tetra Bio-Pharma (OTCQB:TBPMF; CSE:TBP) has an aggressive clinical trial program set to begin in the final quarter this year and first quarter of 2018 to prove the efficacy and safety of at least three therapeutic cannabis products.

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Medicure to leverage sales model to new products

Medicure (TSXV:MPH) intends to leverage its unique sales and marketing model, which has fueled the growth of its Aggrastat IV platelet inhibitor, as it brings new generic products into its cardiovascular portfolio.

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Microbix in talks with investors for Kinlytic relaunch

Following a meeting with the FDA last month, Microbix Biosystems (TSX:MBX) is entertaining expressions of interest from potential partners to license or acquire its anti-clotting urokinase drug, which has been rebranded as Kinlytic, and also provide funding for its re-launch in the U.S. market.

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Titan’s next ProNeura-based implant dovetails with PD awareness month

After receiving FDA approval last year for its Probuphine implant as a maintenance treatment for opioid addiction, Titan Pharmaceuticals (NASDAQ:TTNP) is employing its ProNeura drug delivery technology to develop an implant to treat Parkinson’s disease.

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Checkpoint targeting registration studies by end of 2018

Checkpoint Therapeutics (OTCQX:CKPT) is taking an “aggressive path forward” with its clinical programs and expects to be in registration studies at the end of 2018 with its lead targeted anti-cancer agent, CK-101, and lead immuno-oncology (IO) agent, CK-301.

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Histogenics to complete Phase 3 enrollment in Q2

Histogenics (NASDAQ:HSGX) expects to complete enrollment by the end of the second quarter this year in a Phase 3 clinical trial of its NeoCart biologic cell therapy and tissue engineering solution for knee cartilage regeneration.

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Arch moving to regulatory stage this year

Arch Therapeutics (OTCQB:ARTH) has multiple regulatory filings planned in the U.S. and Europe this year for its AC5 Topical Hemostatic Device as the biopharma company shifts to regulatory-stage footing ahead of commercialization.

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Jaguar, Napo merger set for transformative growth

The proposed merger of Jaguar Animal Health (NASDAQ:JAGX) and closely-held Napo Pharmaceuticals is expected to create a combined company with prescription product revenue, potential line extensions and an expanded pipeline.

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IntelGenx sees 2017 milestones as transformational

IntelGenx (OTCQX:IGXT; TSX-V:IGX) has multiple milestones on tap this year with its oral film drug delivery platform, VersaFilm, as it continues building strategic partnerships in the pharmaceutical industry.

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BioTime leading advances in regenerative medicine

BioTime (NYSE MKT, TASE:BTX) has multiple data milestones scheduled this year in its two lead regenerative medicine programs: OpRegen in dry AMD and Renevia in facial aesthetics.

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In conversation with Mohit Trikha

As chief scientific officer, EVP and head of closely held Triphase Accelerator, Mohit Trikha has parlayed a successful 20-year track record in oncology drug development into a home run, selling Triphase’s first asset, a proteasome inhibitor known as marizomib, to Celgene (NASDAQ:CELG). Prior to joining Triphase, Dr. Trikha was associate VP of clinical development at Ambit Biosciences; director of BioOncology and early development at Genentech; and assistant director of oncology research at J&J’s Centocor. 

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Athersys poised to launch pivotal stroke study next summer

After receiving a Special Protocol Assessment (SPA) from the FDA at the end of September, Athersys (NASDAQ:ATHX) hopes to launch a pivotal trial next summer administering its intravenous MultiStem cell therapy in patients following an ischemic stroke.

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