Oramed Patent Allowed in the US for Oral Administration of Proteins

JERUSALEM, September 24, 2015 -- Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the Company's patent for its invention, titled "Methods and Compositions for Oral Administrations of Proteins" has been allowed by the United States Patent and Trademark Office.

Nadav Kidron, CEO of Oramed, stated, "This is an important milestone which paves our entrance into the US diabetes market which is the largest single diabetes market worldwide."

About ORMD-0801 Capsule for Type 2 Diabetes

ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. Orally administered insulin should bring with it enhanced patient compliance. In addition, intestinally absorbed-oral insulin actually mimics insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream.

Published: 24 September 2015
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Concert Pharmaceuticals Announces Results of a Phase 1 Trial That Demonstrates CTP-656 Achieved a Superior Pharmacokinetic Profile to Kalydeco®

Results Presented at the Cystic Fibrosis Trusts UK Conference 2015

LEXINGTON, Mass.-- Concert Pharmaceuticals, Inc. (CNCE) today announced positive data from a Phase 1 single ascending dose clinical trial of CTP-656. CTP-656 is a novel deuterium-modified version of ivacaftor, which is commercially available as a single agent under the name Kalydeco® and as part of a fixed-dose combination therapy called Orkambi®. The clinical results continue to support the development of CTP-656 as a once daily potentiator for the treatment of certain cystic fibrosis genotypes as monotherapy or in combination with other CFTR modulators. CTP-656 demonstrated a superior pharmacokinetic profile compared to Kalydeco, current standard of care. Results of the Phase 1 trial also showed that CTP-656 was well-tolerated and its safety profile was comparable to Kalydeco. The Phase 1 single dose results were presented during the “hot off the press” session at the Cystic Fibrosis Trusts UK Conference 2015 in Manchester, England.

Published: 23 September 2015
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Heron Therapeutics Reports Positive Top-Line Results from Phase 2 Study of HTX-011 in the Management of Post-Operative Pain

-Pain intensity through 24 hours reduced by 69%
-Pain intensity through 72 hours reduced by 40%
-Time to first use of opiate rescue medication increased by 488%
-32% of patients received no opiate rescue through 72 hours compared to 5% for placebo
Conference call and webcast at 8:30 am ET on September 23

REDWOOD CITY, Calif.-- Heron Therapeutics, Inc. (HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, today announced positive, top-line results from its Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. The primary and all key secondary endpoints in the study were met with a high degree of statistical significance.

Published: 23 September 2015
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Can-Fite BioPharma Announces $9 Million Registered Direct Offering

PETACH TIKVA, Israel, Sept. 19, 2015  Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced that it has entered into definitive agreements with institutional investors to receive gross proceeds of $9 million.

 

In connection with the offering, the Company will issue 2,068,966 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $4.35 per ADS in a registered direct offering.  Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one-half of an ADS. The warrants have an exercise price of $5.25 per ADS, shall be exercisable six months following the issuance date and will expire five and one-half years from the issuance date. The closing of the offering is expected to take place on or about September 23, 2015, subject to the satisfaction of customary closing conditions.

Published: 22 September 2015
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AMPIO Receives Special Protocol Assessment (SPA) from the FDA and Commences Second Phase III pivotal trial of Ampion™

ENGLEWOOD, Colo., Sept. 22, 2015  -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced it has commenced the second Phase III Study of Ampion™ to treat pain and inflammation due to osteoarthritis (OA) of the knee. Details of the clinical trial design are available on our website, www.ampiopharma.com and will also be uploaded to Clinicaltrials.gov.

A Special Protocol Assessment (SPA) is a written agreement between the FDA and the sponsor company (Ampio Pharmaceuticals), which defines the clinical trial end points required for approval and significantly reduces the risk of bringing a drug to market.

Published: 22 September 2015
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  1. VBL Therapeutics ( VBLT )
  2. TRACON Pharmaceuticals ( TCON )
  3. Can-Fite BioPharma Ltd ( CANF )
  4. TG Therapeutics Inc ( TGTX )
  5. Xencor Inc ( XNCR )