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AMPYRA for MS: Acorda Therapeutics announces wholesale pricing and patient assistance program

Acorda Therapeutics, Inc. today announced the wholesale acquisition cost (WAC) for AMPYRA™ (dalfampridine) Extended Release Tablets will be $1,056 per 30-day supply (60-count pill bottle), an annual cost of $12,850. AMPYRA was approved on January 22, 2010 by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA is expected to be available in March 2010.

3 Feb 2010

Report: California biomedical industry faces unprecedented challenges

The biomedical industry is one of the most recession-resilient sectors in California's hard-hit economy and a critical driver of innovation, job growth and revenue that will help lead the state to economic recovery, according to a report released today by the California Healthcare Institute (CHI) and PricewaterhouseCoopers LLP (PwC).

3 Feb 2010

Maximizing quality in clinical trials is emphasized at community workshop

A community workshop sponsored by SNM's Clinical Trials Network (CTN) officially kicked off on Feb. 1, in Albuquerque, N.M., and presented participants with a series of educational sessions on the use of molecular imaging in clinical trials for investigational therapeutic drugs.

3 Feb 2010

SNM Clinical Trials Network Workshop: Experts to discuss usage of molecular imaging

On Feb. 2, the final day of the second annual SNM Clinical Trials Network Workshop, experts working in various facets of the molecular imaging community met in Albuquerque, N.M., to discuss the nuts and bolts of using imaging in clinical trials and the challenges and opportunities ahead in the regulatory landscape.

3 Feb 2010

New 3D scaffold for stem cell renewal

Medical researchers were shocked to discover that virtually all human embryonic stem cell lines being used in 2005 were contaminated. Animal byproducts used to line Petri dishes had left traces on the human cells. If those cells had been implanted in a human body they likely would have been rejected by the patient's immune system.

3 Feb 2010

SNM's Nanomedicine and Molecular Imaging Summit examines the use of nanoparticles

SNM's Nanomedicine and Molecular Imaging Summit wrapped up today in Albuquerque, N.M., with in-depth discussion-and a high sense of energy looking ahead.

3 Feb 2010

Food and fluid restriction during labour provides no significant benefit

The traditional practice of restricting food and fluids during labour does not provide any benefits, finds a new review co-authored by a Queen's University Associate Professor.

3 Feb 2010

Subject experts address a variety of career topics at ACS Webinar

News media and others interested in the chemical sciences are invited to join the next in a series of American Chemical Society (ACS) Webinars, Your Career Matters! featuring speakers that address a variety of pertinent career topics impacting science and engineering professionals.

3 Feb 2010

Video campaign teaches parents on how to minimize risk from toxic chemicals

Chronic childhood illnesses – asthma, allergies, autism, cancer, obesity and diabetes – are plaguing our nation, and credible scientific evidence links chemical exposure to many of these conditions.

3 Feb 2010

Obama's budget addresses the urgent need for bringing healthy food options to underserved communities

In his FY2011 budget proposal, President Barack Obama addressed the urgent need for bringing healthy food options to underserved communities by calling for more than $400 million in investments in new and expanded supermarkets, farmers markets and other food stores.

3 Feb 2010

BioSpecifics Technologies' XIAFLEX receives FDA approval

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX™, a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord.

3 Feb 2010

Bariatric physician advises consumers to stay away from shelf stable food

Many people do not realize the dangers of shelf stable foods. A shelf stable food is one normally stored in the refrigerator which has been altered so that it can be stored at room temperature for a long shelf life.

3 Feb 2010

Repros Therapeutics receives FDA confirmation for initiating Androxal IND

Repros Therapeutics Inc. today announced that the Company has received verbal confirmation from the Division of Metabolic and Endocrine Drug Products of the Food and Drug Agency that the Company may initiate its Investigational New Drug Application for the study of oral Androxal® in the treatment of hypogonadal men with Type II Diabetes (T2D) with a Phase IIa trial.

3 Feb 2010

Veran Medical Technologies receives two FDA clearances to expand the use of ig4 Navigation platform

Veran Medical Technologies announced today that it has recently received two clearances (K093146 & K093995) from the U.S. Food and Drug Administration (FDA) to expand its indications for use of the ig4 Navigation platform.

3 Feb 2010

U.S. government to reimburse American hospitals that treat airlifted Haitian patients

"The federal government announced on Monday that it would reimburse American hospitals who treat Haitian earthquake victims with life-threatening injuries, making it possible for more hospitals in states outside Florida to consider taking those patients," the New York Times reports.

3 Feb 2010

Obama's FY 2011 budget gives global health funding boost

President Barack Obama's FY 2011 budget request for global health totals $9.6 billion and includes funding for global health activities within the State Department, USAID and HHS, the Wall Street Journal reports

3 Feb 2010

Obama's budget includes a tempered vision of health reform

Democrats' health overhaul efforts are stalled in Congress, but President Obama's 2011 budget offers a "modest" back-up plan, the Associated Press reports. "The budget released Monday contains lots of respectable ideas to squeeze savings, expand coverage and improve quality, but no ambitious change that launches the nation on a path to health care for all."

2 Feb 2010

Lannett Company plans to submit NDA for Morphine Sulfate products to FDA

Lannett Company, Inc. today announced plans to submit its New Drug Application (NDA) for its Morphine Sulfate products to the U.S. Food and Drug Administration (FDA) at the end of the month.

2 Feb 2010

FDA accepts Teva Pharmaceutical Industries' BLA for XM02 G-CSF

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva’s Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

2 Feb 2010

Javelin Pharmaceuticals' NDA for Dyloject Injection accepted for formal review

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has been accepted for formal review.

2 Feb 2010