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Sermo report highlights physician opinions about investigational oral antiplatelet treatment for ACS

Sermo, the world's largest online community for physicians, today announced a free Sermo Report titled, "FDA Committee Recommends Approval for Ticagrelor." The report covers physician opinions about the introduction of an investigational oral antiplatelet treatment for acute coronary syndrome.

26 Aug 2010

FDA accepts Sanofi Pasteur's Menactra vaccine sBLA for active immunization of infants and toddlers

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135.

26 Aug 2010

Momenta Pharmaceuticals provides update on generic Lovenox litigation

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that on August 25, 2010, the United States District Court for the District of Columbia denied sanofi-aventis U.S. LLC's request for a preliminary injunction directing the FDA to suspend and withdraw its approval of the Abbreviated New Drug Application (ANDA) filed by the Company's collaboration partner, Sandoz, for enoxaparin sodium injection USP, a generic version of Lovenox®. The decision is subject to appeal.

26 Aug 2010

Affordable Care Act that mandates free preventative services goes into effect in September

Starting in September, President Obama's Affordable Care Act will go into effect. The act mandates free preventative services such as cholesterol or breast cancer screenings and tetanus shots. But the question is, will doctors and patients take advantage of these new preventative services? "Unfortunately, thanks to our American healthcare system, we have been programmed to focus on treatment and not prevention," said Dr. David Samadi, a urologic oncologist specializing in prostate cancer treatment and robotic surgery, who is also the Chief of Robotics and Minimally Invasive Surgery at The Mount Sinai Medical Center in New York City.

26 Aug 2010

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. announced confirmation by the U.S. Food and Drug Administration (FDA) that its proposed Phase II protocol for CH-4051 in rheumatoid arthritis has been approved by the agency.

26 Aug 2010

FDA notification confirms acyclovir Lauriad for oro-facial herpes labialis

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, today announces that the US Food and Drug Administration (FDA) considers the positive results of the pivotal phase III study with acyclovir Lauriad acceptable to submit a 505(b)(2) New Drug Application of the product in the United States.

26 Aug 2010

Giant Eagle installs RxSafe 1800 pharmacy workflow automation system

RxSafe, LLC, the leader in automated high density robotic storage and retrieval systems for pharmacies, has recently installed an RxSafe 1800™ system at a Pittsburgh, Pennsylvania area supermarket for Giant Eagle, Inc., a leading regional multi-format food retailer.

26 Aug 2010

PCMA reports increase in retail prices of popular brand-name drugs

The Pharmaceutical Care Management Association (PCMA) issued the following statement on a new AARP report that examined retail prices of brand-name drugs and found that the 217 products most used by seniors increased by an average of 8.3 percent during 2009, while over the last five years retail prices for the most popular brand-name drugs increased 41.5 percent:

26 Aug 2010

Transparency needed in administration of drug benefits by pharmacy benefit managers

According to a new AARP report, the average retail price of the most popular brand-name drugs increased by 8.3 percent in 2009 and by 41.5 percent over the past five years – rates well in excess of inflation as measured by the Consumer Price Index. At the same time, major pharmacy benefit managers (PBMs) like CVS Caremark, Express Scripts, Inc. and Medco Health Solutions, Inc., hired by employers and other health plan sponsors to negotiate lower prices from drug manufacturers, experienced record profits, in some cases increasing five-fold over the past decade.

26 Aug 2010

Henry Ford Health System introduces 'Pill Timer' for medication management

A leader in healthcare, Henry Ford Health System will introduce at its hospitals and pharmacies "The Pill Timer," representing a "breakthrough" designed to improve treatment outcomes and reduce adverse drug events often resulting in costly hospital admissions due to poor medication management by patients.

26 Aug 2010

Treating metastatic melanoma tumors with specific genetic signature shows promising results

Use of an experimental targeted drug to treat metastatic melanoma tumors with a specific genetic signature was successful in more than 80 percent of patients in a phase 1 clinical trial.

26 Aug 2010

Prescription drug abuse soars despite state monitoring programs

Stateline: Over the past 10 years, "prescription drug abuse has soared to new levels. A recent White House study found a 400 percent increase in abuse from 1998 to 2008.

26 Aug 2010

Europe's pharma sector faces increasing challenges

The Wall Street Journal: "After a healthy second quarter, Europe's pharmaceutical sector may find itself in trouble in the months ahead as companies face patent expiries, tougher regulation and burdensome health care reforms.

26 Aug 2010

Biogen to publish data on two-step assay for anti-JC virus antibody detection

Biogen Idec and Elan Corporation, plc today announced data has been published in the Annals of Neurology on an investigational, two-step assay to detect anti-JC virus (JCV) antibodies in human serum and plasma

26 Aug 2010

FDA approves brand name VELETRI for Actelion's epoprostenol for injection therapy

Actelion Pharmaceuticals US, Inc., today announced that the U.S. Food and Drug Administration has approved the brand name VELETRI® for the company's epoprostenol for injection therapy. VELETRI has been commercially available since April 2010 as Epoprostenol for Injection for the treatment of moderate to severe pulmonary arterial hypertension (PAH) and PAH associated with the scleroderma spectrum of disease. Actelion plans to release VELETRI-labeled product by early fourth quarter of 2010.

26 Aug 2010

New syndicated report highlights medical management of noninfectious uveitis

BioTrends Research Group, Inc. is pleased to announce the publication of a new syndicated report, TreatmentTrends: Noninfectious Uveitis. This report, based on feedback gathered in an on-line survey completed by 72 retinal specialists in June/July 2010, addresses the medical management of noninfectious uveitis (anterior, intermediate, posterior and panuveitis) and referral/co-management patterns between retinal specialists and other specialties.

25 Aug 2010

Somaxon Pharmaceuticals, Procter & Gamble to co-promote Silenor

Somaxon Pharmaceuticals, Inc. today announced that Somaxon and Procter & Gamble have entered into a co-promotion agreement for Silenor (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.

25 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Perrigo obtains FDA clearance to manufacture infant formula products

Perrigo Company announced it received FDA clearance on August 23, 2010 to manufacture infant formula liquid concentrate and ready-to-use products through its partner Kerry Proteins and Nutritionals located in Sainte Claire, Quebec.

25 Aug 2010

Shire receives FDA ruling on Pentasa Citizen's Petition

Shire plc, the global specialty biopharmaceutical company, announces that its subsidiary Shire Pharmaceuticals Inc. received a ruling from the FDA on its Citizen's Petition relating to Pentasa.

25 Aug 2010

Pharmaceutical News

Sermo report highlights physician opinions about investigational oral antiplatelet treatment for ACS

FDA accepts Sanofi Pasteur's Menactra vaccine sBLA for active immunization of infants and toddlers

Momenta Pharmaceuticals provides update on generic Lovenox litigation

Affordable Care Act that mandates free preventative services goes into effect in September

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

FDA notification confirms acyclovir Lauriad for oro-facial herpes labialis

Giant Eagle installs RxSafe 1800 pharmacy workflow automation system

PCMA reports increase in retail prices of popular brand-name drugs

Transparency needed in administration of drug benefits by pharmacy benefit managers

Henry Ford Health System introduces 'Pill Timer' for medication management

Treating metastatic melanoma tumors with specific genetic signature shows promising results

Prescription drug abuse soars despite state monitoring programs

Europe's pharma sector faces increasing challenges

Biogen to publish data on two-step assay for anti-JC virus antibody detection

FDA approves brand name VELETRI for Actelion's epoprostenol for injection therapy

New syndicated report highlights medical management of noninfectious uveitis

Somaxon Pharmaceuticals, Procter & Gamble to co-promote Silenor

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Perrigo obtains FDA clearance to manufacture infant formula products

Shire receives FDA ruling on Pentasa Citizen's Petition

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PhD researcher at LifeArc

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