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Review of study presented at American Heart Association Scientific Sessions

Adding the cholesterol drug niacin to a statin improved HDL ("good") cholesterol levels and significantly reduced carotid arterial plaque buildup measured with ultrasound within 8 months, with further improvement seen at the end of the study (14 months).

21 Nov 2009

Multi-state electronic tracking program to prevent diversion of common medicines for methamphetamine production

The National Association of Drug Diversion Investigators (NADDI) today announced a new initiative in the war on methamphetamine. The National Precursor Log Exchange (NPLEx) is a multi-state electronic tracking program that enforces purchase limitations on over-the-counter (OTC) medicines containing pseudoephedrine in real-time at the point of sale.

21 Nov 2009

Pennsylvania Department of Health commences H1N1 vaccination to members of priority groups

The Department of Health today began providing free H1N1 flu shots to members of priority groups that did not have previous access to the vaccine.

21 Nov 2009

Carvedilol in combination with ACE inhibitors may benefit cardiac patients

In a new study, researchers report that a class of heart medications called beta-blockers can have a helpful, or harmful, effect on the heart, depending on their molecular activity.

21 Nov 2009

Chemical-based tooth whitening or bleaching agents may be harmful, ADA warns

The American Dental Association (ADA) today asked the U.S. Food and Drug Administration (FDA) to establish appropriate classifications for tooth-whitening chemicals.

21 Nov 2009

Zoladex consumers entitled to treble damages, Court rules

The United States Court of Appeals for the First Circuit upheld an earlier District Court ruling yesterday, approving a settlement in the long-running Average Wholesale Price (AWP) pharmaceutical litigation against AstraZeneca Pharmaceuticals ( AZN).

21 Nov 2009

FDA approves Pfizer's Geodon Capsules for the adjunctive maintenance treatment of bipolar disorder

Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved Geodon® (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.

21 Nov 2009

Employers take action to improve medication adherence

More employers are taking steps to improve their employees' health by making sure they take their medicines as prescribed, a move that could stave off more serious and costly health consequences, according to a new report sponsored by the National Pharmaceutical Council (NPC).

21 Nov 2009

FDA approves sNDA for pediatric autism drug ABILIFY

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

20 Nov 2009

FDA Warning Letter for Deconsal: Cornerstone Therapeutics preparing a response

Cornerstone Therapeutics Inc., a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today reported that it had received a Warning Letter from the Food and Drug Administration ("FDA") alleging that its Deconsal CT chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg) and Deconsal DM chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg, Dextromothorphan HBr 15 mg) are new drugs lacking an approved application and as such should not be introduced into interstate commerce.

20 Nov 2009

Evidence does not connect H1N1 vaccine to patient deaths, WHO says

The deaths of 41 people from six countries who had received the H1N1 (swine flu) vaccine were not directly linked to the vaccine, the WHO said Thursday, the Associated Press/MSNBC reports (11/19).

20 Nov 2009

Antibiotic resistance a growing problem, particularly in southern, eastern Europe

Antibiotic resistance is increasing throughout the world because of excessive use, Agence France-Press reports. The news service writes, "Experts at the 2nd annual European antibiotics awareness day held by the Stockholm-based European Centre for Diseases Prevention and Control (ECDC) said new, hyper-resistant bacteria were emerging, threatening the pillars of global health."

20 Nov 2009

News outlets examine malaria drug resistance, hope for malaria eradication in Africa

Experts at an American Society of Tropical Medicine and Hygiene meeting this week said that resistance to the best available drug to treat malaria "is more widespread in Southeast Asia than previously reported," Science News/Wired Science reports. Researchers have been monitoring drug resistance along the Thailand-Cambodia border where patients taking artemisinin combination therapy - the most potent treatment for malaria - have been clearing the parasite from their bodies more slowly.

20 Nov 2009

"Hotline" report on finasteride for prevention of prostate cancer

In response to a recent New York Times article that questions why currently available medications designed to treat and prevent some cancers are being ignored, ECRI Institute, an independent nonprofit organization, is offering a roadmap to the evidence on Finasteride for Prevention of Prostate Cancer for free download.

20 Nov 2009

Antigenics to withdraw its MAA for Oncophage following CHMP’s negative opinion

Antigenics Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has formally adopted a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) as a treatment in earlier-stage, localized renal cell carcinoma (kidney cancer).

20 Nov 2009

FDA acknowledges Dendreon's amended BLA for PROVENGE as a complete response

Dendreon Corporation today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

20 Nov 2009

Pfizer’s Revatio Injection receives FDA approval

Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

20 Nov 2009

FDA extends Exalgo NDA review by three months

CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months.

20 Nov 2009

Quest Diagnostics reports sharp downward trends in cocaine and methamphetamine use

New data released today by Quest Diagnostics Incorporated, the nation's leading provider of employment-related drug testing services, reveal that drug testing of hair specimens from employees and job applicants in the general U.S. workforce has tracked sharp downward trends in cocaine and methamphetamine use from 2005 to the first half of 2009 that mirror similar drops shown by urine testing.

From Quest Diagnostics 20 Nov 2009

Soligenix receives $9.4M NIAID grant to develop technology for advancing rapidly acting vaccines

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines. Soligenix received a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), to support this work.

20 Nov 2009