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FDA notifies PDUFA action date for Cell Therapeutics' NDA for pixantrone

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has notified CTI that a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 under standard review has been established regarding CTI's NDA for pixantrone as potential treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

5 Sep 2009

Spectrum's ZEVALIN expanded label receives FDA approval for treating non-Hodgkin’s Lymphoma

Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage biotechnology company with a focus in oncology, today announced ZEVALIN® (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received approval from the U.S. Food and Drug Administration (FDA) for an expanded label for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy.

5 Sep 2009

Discovery of two antibodies could move AIDS vaccine development forward

Scientists from Scripps Research Institute on Thursday announced they have discovered and isolated two antibodies "with the ability to neutralize [or block the action of] many strains of the AIDS virus, a discovery that might help create a long-sought vaccine against the deadly disease," Bloomberg reports.

5 Sep 2009

Clinical trial of Cerebroprotein Hydrolysate for Injection completes

Hard to Treat Diseases (the "Company") announced today, that its China based subsidiary Mellow Hope, has just finished (August 2009) the clinical trial of Cerebroprotein Hydrolysate for Injection (Brand name: NUTRIPROTEIN) in India.

5 Sep 2009

Target Clinics in Maryland start selling seasonal flu vaccinations

Target(R) announces that flu vaccinations are now available at all six Target Clinic locations in Maryland. The Centers for Disease Control and Prevention recommends nearly everyone protect themselves against this potentially serious illness.

4 Sep 2009

New protein fragments identified for anthrax vaccine development

Researchers at Albert Einstein College of Medicine of Yeshiva University have identified two small protein fragments that could be developed into an anthrax vaccine that may cause fewer side effects than the current vaccine.

4 Sep 2009

Shire receives FDA approval for INTUNIV extended release tablets

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

4 Sep 2009

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl).

4 Sep 2009

Competition results in wide approval of Rev Vac safety syringe

Revolutions Medical Corporation ("Revolutions Medical" or the "Company") (OTCBB: RMCP), producers of the Rev Vac safety syringe, today confirmed that the opportunities for its Rev Vac safety syringe became even more significant with the August 31 announcement of close competitor Retractable Technologies, Inc. ("Retractable Technologies").

4 Sep 2009

Drive to collect unused prescription drugs starts on October 3

In an effort to keep unused prescription drugs out of the hands of pre-teens and teenagers, DDN executive Joe Otto enlisted the support of Menomonee Falls Police Chief Anna Ruzinski, Community Memorial Hospital, and his company. As a result, Community Memorial Hospital will serve as collection site when Waukesha County kicks off its first drug collection program on October 3.

4 Sep 2009

Filing and review of belatacept's license application accepted by the FDA

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the company’s submission of a biologic license application for belatacept, which is in ongoing phase III development for use in kidney transplantation.

4 Sep 2009

rPA anthrax vaccine and its Valortim anthrax anti-toxin program data presented

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that data from the Company's third generation recombinant protective antigen (rPA) anthrax vaccine program and its Valortim((R)) anthrax anti-toxin program were presented at the Bacillus - ACT 2009 meeting, August 30 - September 3, 2009, organized by the American Society for Microbiology.

4 Sep 2009

Phase III clinical trial results of XIAFLEX published in a journal

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products today announced results of the pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of Dupuytren's disease, was published in today's edition of the New England Journal of Medicine.

4 Sep 2009

FDA review on postmarketing studies for approved drugs and biologics

Makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner, according to a study released today by the U.S. Food and Drug Administration.

4 Sep 2009

FDA approves new xTAG Cystic Fibrosis 39 Kit v2 from Luminex

Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new cystic fibrosis (CF) test: the xTAG® Cystic Fibrosis 39 Kit v2.

From Thermo Fisher Scientific Inc. 4 Sep 2009

Department of Health's guidance on swine flu vaccination leaves local health chiefs confused

Thousands of frontline health workers in England are trapped in a postcode lottery after Department of Health (DH) guidance on swine flu vaccination has left local health chiefs confused over who is eligible for the jab.

4 Sep 2009

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV- (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

4 Sep 2009

Giant Eagle offers generic prescription antibiotics for free at its in-store pharmacies

At a time when many families affected by a difficult economy are struggling with the costs of prescription medications, supermarket retailer Giant Eagle, Inc. is making ten broadly used generic prescription antibiotics in 46 common dosages available for free every day at all of its 210 in-store pharmacies.

4 Sep 2009

Lawsuits filed against Johnson & Johnson, Ortho-McNeil Pharmaceutical and Walgreen

St. Louis-based law firm Carey & Danis LLC announces the filing of four civil lawsuits on behalf of twenty plaintiffs against Johnson & Johnson (NYSE: JNJ) and Ortho-McNeil Pharmaceutical Inc., the makers of the powerful antibiotic Levaquin, as well as the Walgreen Co. (NYSE:WAG), which sells the drug.

4 Sep 2009

Sodium chloride for treating head lice

At just 31 years of age, and with a first grader in tow, single mom Wendy Langley set out to take on the giants in the head lice industry. The reason? She couldn't, as she says, stand putting a popular but potentially toxic head lice treatment that "smelled like bug spray" on her kid's head to kill lice. Plus, she was constantly terrified the runny liquid would seep into her daughter's eyes.

4 Sep 2009