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Aeterna Zentaris' partner Keryx receives FDA orphan-drug designation for perifosine in neuroblastoma

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, Inc., has been granted orphan-drug designation by the U.S. Food and Drug Administration for perifosine, Aeterna Zentaris' novel, potentially first-in-class, oral Akt inhibitor, for the treatment of neuroblastoma.

15 Jul 2010

Neptune first-quarter 2010 revenue up by 45% to $4,162,000

Neptune Technologies & Bioressources Inc. today reports its consolidated financial results for the three-month period ended May 31, 2010, appoints IR firm and updates on options and warrants.

14 Jul 2010

NCPDP pleased with HHS' adoption of SCRIPT Standard to achieve Meaningful Use

The National Council for Prescription Drug Programs (NCPDP) today acknowledges and applauds the U.S. Health and Human Services Department (HHS) on its Final Rules announcement on "meaningful use" of an Electronic Health Record (EHR), including the adoption of NCPDP SCRIPT Standard for the secure, electronic transmission of prescriptions and prescription-related information.

14 Jul 2010

Medicaid stalemate, pay-for-delay ban among health care items under debate

"Several states are preparing to make deep cuts to Medicaid as a federal stalemate over funding for the poor drags on—even as states face mandates to expand the program under the new health-care law." Efforts to extend provisions of the stimulus programs that provided extra federal money to state Medicaid programs remain in limbo; the enhanced funding is set to expire at the end of the year.

14 Jul 2010

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

Protalix BioTherapeutics, Inc. announced today that the French regulatory authority has granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists.

13 Jul 2010

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

A new study, published in the July issue of Advances in Therapy, revealed that a novel saw palmetto extract, SPET-085, is as effective as finasteride, the standard prescription drug therapy, in blocking the critical enzyme that leads to benign prostatic hyperplasia.

13 Jul 2010

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

Biodel Inc. today reported results of preclinical tests which demonstrated the potential of the company's glucose-regulated or "smart" basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared the use of BIOD620 to Lantus® (insulin glargine).

13 Jul 2010

Obesity crisis in the spotlight as FDA reviews weight loss drugs

The Washington Post explores the obesity epidemic by reporting from Manchester, Ky., which has an obesity rate as high as 52 percent in a nation where the obesity rate is 24 percent. "The residents of this town of 2,100 — 95 miles southeast of Lexington and deep in the Appalachian foothills — indeed appear to celebrate the joys of community closeness.

13 Jul 2010

Stanford University, OHSU receive grants to study VIAject for treating patients with diabetes

Biodel Inc. announced today the award of two research grants by the Juvenile Diabetes Research Foundation to Stanford University and Oregon Health & Science University to evaluate the use of VIAject (ultra-rapid-acting injectable human insulin) in the treatment of diabetes.

12 Jul 2010

FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Protalix BioTherapeutics, Inc., announced today that the Company's New Drug Application (NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard review time of ten months, assigning a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.

12 Jul 2010

Glaxo’s diabetes pill Avandia under FDA scrutiny again

GlaxoSmithKline (GSK) is under Food and Drug Administration (FDA) scrutiny again. This is for its diabetes pill Avandia which is under review for the second time in three years.

11 Jul 2010

CVS Caremark awarded gold medal for Best Customer Service, silver medal for Best Community Spirit

CVS Caremark's Pharmacy Benefit Management Customer Care team was awarded a gold medal for Best Customer Service (America's region) and a silver medal for Best Community Spirit by ContactCenterWorld.com at the organization's Top Ranking Performers Awards Conference in Orlando. The awards recognize the best in the contact center industry.

9 Jul 2010

Second round of checks to close Medicare doughnut hole sent out

"The Obama administration is sending $250 checks to more than 300,000 older Americans who paid higher drug costs in the Medicare coverage gap known as the 'doughnut hole,' officials announced Thursday. The one-time, tax-free checks are the first tangible benefit of the health care package that became law this year."

9 Jul 2010

IBC offers more personalized online information about PHR to its members

Independence Blue Cross now offers its members more personalized online information about their health – as the amazon.com experience is to the savvy shopper, the ibxpress.com experience is to the smart health care consumer. Personal health information began to flow into members' electronic health records this month – available through ibxpress.com, the company's member website.

9 Jul 2010

State AIDS programs struggle as joblessness increases demand

Growing joblessness and shrinking state and federal budgets have exacerbated the financial burden on the government that provides prescription drug treatment to people with HIV/AIDS. "Now, many people with HIV are losing jobs, along with insurance, or discovering that they are infected at a time when the AIDS Drug Assistance Program — ADAP — they depend on is being overwhelmed by demands being made on it.

9 Jul 2010

Fibrocell Science completes enrollment in azficel-T histology study

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today the completion of enrollment of and first treatment visits for participants in its histology study (IT-H-001) of azficel-T. An autologous cell therapy, azficel-T is currently under review by the U.S. Food and Drug Administration for the treatment of moderate to severe nasolabial fold wrinkles.

8 Jul 2010

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, in collaboration with APR Applied Pharma Research s.a. of Switzerland and Labtec GmbH of Germany, today announced that its partner, Strativa Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for Zuplenz® oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

8 Jul 2010

Crooks defraud health care system with fake insurance plans and phony Medicare, Medicaid claims

"Massive unemployment and a changing health care system is creating a breeding ground for con artists." Fake health insurance is one of the "fastest growing scams." Advertisements for such products are "stapled to neighborhood telephone polls, flyers left on your car or maybe you'll get a phone call from someone who's selling health insurance at extremely low rates, as low as $29.99 a month in some cases, says Jim Quiggle of the Coalition Against Insurance Fraud. The sad truth is that often these bogus policies pay little or nothing on claims, leaving consumers with exorbitant medical bills" (Haley, 7/6).

8 Jul 2010

Winston submits NDA for CIVANEX to U.S. FDA

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its civamide (zucapsaicin) 0.075% cream, CIVANEX®, for the treatment of signs and symptoms of osteoarthritis of the knee.

7 Jul 2010

Changes in Medicare Part B therapy rates likely to reduce Kindred Healthcare's revenues by $11M per year

Kindred Healthcare, Inc. today provided its estimate of the revenue effect of proposed rate changes to Medicare Part B therapy services included in the proposed Medicare Physician Fee Schedule rule. The proposed rule was released by the Centers for Medicare and Medicaid Services ("CMS") on June 25. The proposed rule is subject to a 60-day public comment period and is scheduled to become effective January 1, 2011.

7 Jul 2010