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Rexahn Pharmaceuticals Submits Zoraxel Phase IIb Protocol To FDA

March 5, 2010 Health News No Comments

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, announced that it has submitted a Phase IIb protocol to the FDA for ZoraxelTM for the treatment of erectile dysfunction (ED). “The progression of Zoraxel’s clinical program is very encouraging,” said Rexahn Chief Executive Officer, Dr. Chang Ahn. “We believe that the future of ED treatment lies in compounds that act on the central nervous system and effectively modify the condition, rather than targeting end organ erectile function…

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ImmuneRegen BioSciences Submits Homspera(R) For FDA Orphan Drug Product Designation For The Treatment Of Idiopathic Pulmonary Fibrosis

March 5, 2010 Health News No Comments

ImmuneRegen BioSciences Inc.®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS), today announced the submission of an application for Orphan Drug Product Designation for the company’s lead compound, Homspera®, for the application of treating Idiopathic Pulmonary Fibrosis, a deadly pulmonary disease with no FDA-approved treatments. The United States Orphan Drug Act was created in 1983 to provide incentives for companies to develop and market treatments for diseases or conditions affecting fewer than 200,000 people in the United States…

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Cleveland BioLabs Submits Response To Department Of Defense Request For Proposal For Radiation Countermeasure

February 25, 2010 Health News No Comments

Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced that it has submitted a response to the Request for Proposal (RFP) issued by The Department of Defense (DoD) for the advanced development, Food and Drug Administration (FDA) approval/licensure and delivery of Medical Radiation Countermeasure (MRC). In a statement to the press, Michael Fonstein, Ph.D…

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Biodel Submits VIAject(R) New Drug Application To FDA For Treatment Of Diabetes

January 4, 2010 Health News No Comments

Biodel, Inc. (Nasdaq: BIOD) announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes. VIAject® is Biodel’s proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It is Biodel’s most advanced product candidate and has been tested in more than 884 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India…

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Santarus Submits IND For Phase III Clinical Testing Of Rifamycin SV MMX In Travelers’ Diarrhea

January 2, 2010 Health News No Comments

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to begin a Phase III clinical program evaluating rifamycin SV MMX® in patients with travelers’ diarrhea…

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Arena Pharmaceuticals Submits New Drug Application To FDA For Lorcaserin For Weight Management

December 23, 2009 Health News No Comments

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena’s internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin’s clinical development program that includes 18 clinical trials totaling 8,576 patients. William R. Shanahan, M.D…

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Jazz Pharmaceuticals Submits New Drug Application For JZP-6 (sodium Oxybate) For The Treatment Of Fibromyalgia

December 16, 2009 Health News No Comments

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. The submission is based on a comprehensive clinical development program for JZP-6, including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality…

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AMCP Submits Comments On Proposed Medicare Part D Rule

December 11, 2009 Health News No Comments

The Academy has submitted comments on a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would make technical and policy changes to the Medicare Part D drug benefit. CMS’s proposed rule, issued Oct. 22, 2009, clarifies program participation requirements, specifies changes to strengthen beneficiary protections, requires plan offerings to include meaningful differences, updates plan payment rules and processes, and implements new policy areas. AMCP’s Dec. 7, 2009, comment letter addresses eight specific areas of interest to managed care pharmacy…

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Javelin Pharmaceuticals Submits Dyloject™ New Drug Application To FDA For Management Of Acute Moderate-to-Severe Pain In Adults

December 4, 2009 Health News No Comments

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults. If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the United States as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990.

“Our NDA submission for Dyloject is a significant milestone for… Continue reading

SpinalMotion Submits Lumbar Disc PMA

November 30, 2009 Health News No Comments

SpinalMotion, developer of the investigational Kineflex® lumbar and Kineflex/C® cervical disc implants for treating patients with degenerative disc disease (DDD), reported that it has submitted the Pre-Market Approval (PMA) to FDA for the Kineflex lumbar artificial disc. The company also announced that it has secured $27.

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Diabetic Gastroparesis

March 22, 2010

Gastroparesis (delayed stomach emptying) is a digestive problem that’s associated with diabetes. Most often gastroparesis occurs in people with type 1 diabetes; however, it can also occur in those with type 2 diabetes. Most have had diabetes for at least 10 years and have other complications of diabetes. With gastroparesis, the stomach cannot empty itself of food in a normal fashion.

What causes gastroparesis in diabetes?

Gastroparesis is caused by damage to the vagus nerve, which regulates the digestive system and makes muscles function. Diabetes is a leading cause of gastroparesis, accounting for about one-third of cases. Damage to the… Continue reading

House Now Taking Crucial Votes On Health Reform

March 22, 2010

News outlets are reporting on the minute-by-minute activity in the House of Representatives.

CNN: “6:28 p.m.: The House votes to move into general debate over the health care legislation. The vote is 224-206. Debate is slated for two hours. The fact that the motion to debate passed is an indication that Democrats have enough votes to pass the legislation itself” (3/21). 

Roll Call: “The rule provides for two hours of debate followed by votes on the Senate health care bill, a Republican motion to recommit, and the reconciliation package of fixes to the Senate bill. Republicans, who have launched… Continue reading

Stupak To Vote ‘Yes’ On Health Bill, Says ‘We’re Well Past 216′ Votes

March 22, 2010

Rep. Bart Stupak, D-Mich., and other anti-abortion Democrats, will support their party’s health bill, presumably giving Democrats the votes to pass the overhaul package.

CNN ”Rep. Bart Stupak, D-Michigan, announces that he, House Speaker Nancy Pelosi and the White House have reached an agreement that protects ‘the sanctity of life in health care reform.’”

Roll Call: “‘I’m pleased to announce we have an agreement,’ Stupak said in a press conference, backed by other holdouts. The announcement came as the White House said President Barack Obama would issue an executive order ensuring no taxpayer funds are used to… Continue reading

Stupak To Vote ‘Yes’ On Health Bill, Democrats Confident of Passage

March 21, 2010

Rep. Bart Stupak, D-Mich., will support the Demcorats’ health bill, presumably giving Democrats the votes to pass the overhaul package. CNN carried Stupak’s news conference live, where he announced that an executive order from President Barack Obama, guaranteeing certain rules about abortion funding, convinced him he could support the bill.

The New York Times: “Dan Pfeiffer, communications director for the president, wrote this in releasing the order: ‘While the legislation as written maintains current law, the executive order provides additional safeguards to ensure that the status quo is upheld and enforced, and that the health care legislation’s restrictions against the public… Continue reading

Showdown On Health Bill Nears, Dems Still Counting Votes

March 21, 2010

The New York Times: “With the stage set for a historic showdown over landmark health legislation in the House, the White House and Democratic Congressional leaders narrowed their hunt for votes to a slim list of lawmakers, including several opponents of abortion who were demanding assurance that no federal money would be used to pay for insurance coverage of the procedure. … Even on Sunday morning, the vote was clearly too close to call. Rep. John Larson, the chairman of the Democratic caucus, told ABC’s ‘This Week’ program that the votes were in hand. ‘We have the votes now… Continue reading

As Showdown On Health Bill Nears, Democrats Still Counting Votes

March 21, 2010

New York Times reports: “With the stage set for a historic showdown over landmark health legislation in the House on Sunday afternoon, the White House and Democratic Congressional leaders narrowed their hunt for votes to a slim list of lawmakers, including several opponents of abortion who were demanding assurance that no federal money would be used to pay for insurance coverage of the procedure. … Even on Sunday morning, the vote was clearly too close to call. Rep. John Larson, the chairman of the Democratic caucus, told ABC’s ‘This Week’ program that the votes were in hand. ‘We have the… Continue reading

As Showdown On Health Bill Nears, Democrats Still Counting Votes

March 21, 2010

New York Times reports: “With the stage set for a historic showdown over landmark health legislation in the House on Sunday afternoon, the White House and Democratic Congressional leaders narrowed their hunt for votes to a slim list of lawmakers, including several opponents of abortion who were demanding assurance that no federal money would be used to pay for insurance coverage of the procedure. … Even on Sunday morning, the vote was clearly too close to call. Rep. John Larson, the chairman of the Democratic caucus, told ABC’s ‘This Week’ program that the votes were in hand. ‘We have the… Continue reading

Improving Public Health Through Early Warning Systems And Marine Drug Discovery

March 21, 2010

On Monday, March 22, NOAA’s Oceans and Human Health Initiative will host two briefings to key House and Senate staffers on NOAA’s efforts to improve understanding and management of the ocean, coasts, and Great Lakes to enhance benefits to human health and reduce public health risks. Panelists from NOAA and academia will highlight partnerships and success stories from across the U.S. on beach, seafood, and drinking water safety; sentinel species and habitats health and insights for human health; and drug discoveries from the sea…

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