Posts tagged IND
BiondVax, NIAID in Phase 2 trial of universal flu vaccine

BiondVax Pharmaceuticals (NASDAQ, TASE:BVXV) signed a clinical trial agreement for a Phase 2 clinical trial with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

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Titan Pharma implant IND cleared for Parkinson’s study

The FDA has cleared an IND application by Titan Pharmaceuticals (NASDAQ:TTNP) for its ropinirole implant intended to treat the signs and symptoms of Parkinson's disease.

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Ladenburg starts Checkpoint Therapeutics at buy

Ladenburg Thalmann initiated coverage of Checkpoint Therapeutics (OTCQX:CKPT) with a “buy” rating and $20 price target. The stock closed at $13 on March 21.

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Oramed GLP-1 analog found safe in study

Oramed Pharmaceuticals (NASDAQ:ORMP) has successfully concluded a Phase 1b study of ORMD-0901, its oral GLP-1 analog, in Type 2 diabetes patients.

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Popular Science picks Titan’s Probuphine for “Best of What’s New” award

Titan Pharmaceuticals’ (NASDAQ: TTNP) Probuphine implant has been recognized as one of the "12 Most Important Innovations of the Year" in the health category in Popular Science's annual Best of What's New issue.

Probuphine, a subdermal implant developed using Titan's proprietary ProNeura technology, was approved by the FDA in May, becoming the first commercially available long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.

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FDA accepts Revive’s IND for Phase 2 bucillamine study

The FDA has accepted an IND from Revive Therapeutics (OTCQB:RVVTF; TSX-V:RVV) for a Phase 2 clinical study of bucillamine for the treatment of cystinuria.

"This marks another significant milestone for Revive and we look forward to initiating this Phase 2 study shortly," Fabio Chianelli, president, said in a statement.

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Can-Fite reports preclinical data in erectile dysfunction

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has reported new findings for its drug candidate, CF602, showing statistically significant full recovery from erectile dysfunction after one single dose treatment in a preclinical diabetic model.

Can-Fite plans to file an IND application with the FDA for CF602 in the fourth quarter this year and plans to initiate a Phase 1 trial following IND approval.

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Oramed gets Indian patent for oral administration of proteins

Oramed Pharmaceuticals’ (NASDAQ:ORMP) patent for its invention, titled “Methods and Compositions for Oral Administrations of Proteins” has been granted by the Indian Patent Office.

Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule, ORMD-0801. Having completed multiple Phase 2a trials, a Phase 2b trial in patients with Type 2 diabetes is ongoing under an IND with the FDA. In addition Oramed is developing an oral GLP-1 analog capsule, ORMD-0901.

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Titan Pharma receives FDA feedback on Parkinson’s implant

The FDA has provided written feedback to Titan Pharmaceuticals (NASDAQ:TTNP) on the initial development plan for its proprietary ropinirole hydrochloride implant for Parkinson’s disease.

Based on the FDA’s feedback on the development plan submitted in December 2015, Titan is proceeding with the required non-clinical studies to support a potential IND submission in the fourth quarter of 2016, followed by an initial pharmacokinetic and proof-of-concept clinical study. Titan is pursuing a 505(b)(2) registration pathway for the implant.

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Can-Fite receives patent notice for sexual dysfunction drug

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent titled, “A3 Adenosine Receptor Allosteric Modulators”.

The composition of matter patent protects the use of Can-Fite’s proprietary A3 Adenosine Receptor (A3AR) modulator, including the preparation of its pharmaceutical compositions and its use in patients across all therapeutic indications.

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Can-Fite unveils clinical milestones for 2016

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has announced its anticipated clinical milestones for 2016.

“We are very encouraged by the clinical and preclinical data from each of our drugs to date, which indicate their efficacy across six major indications,” CEO, Dr. Pnina Fishman, said in a statement.

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