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LIVALO statin effective than simvastatin in reducing lipid levels

New Phase III data published today in "Current Medical Research and Opinion" highlight that the recommended starting dose of 2 mg of LIVALO (pitavastatin), a novel synthetic statin, was statistically superior to simvastatin at a dose of 20 mg over 12 weeks in reducing low-density lipoprotein cholesterol

22 Oct 2009

FDA grants Response Biomedical a Special 510(k) clearance for the RAMP Influenza A/B Assay

Response Biomedical Corporation announced that the Company has been granted a Special 510(k) U.S. FDA clearance for an update to the Company’s RAMP® Influenza A/B Assay Package Insert to include analytical reactivity information for a strain of the 2009 H1N1 virus cultured from positive respiratory specimens.

22 Oct 2009

Antiviral prescriptions at retail pharmacies increase by 36% in one week

SDI’s Vector One®: National shows that for the week ending Oct. 16, the number of antiviral prescriptions dispensed at retail pharmacies was 36% higher than the prior week.

22 Oct 2009

Amorfix Life Sciences signs sale and distribution agreement with Cedarlane Laboratories

Amorfix Life Sciences, a company focused on treatments and diagnostics for misfolded protein diseases, announced today that it has signed an agreement with Cedarlane Laboratories for the sale and distribution of Amorfix's proprietary antibodies and reagents.

22 Oct 2009

Faster insulin absorption for varying insulin doses and PH20 concentrations demonstrated

Halozyme Therapeutics, Inc. today announced dose response study results that demonstrated faster insulin absorption and increased peak insulin concentrations after co-administration of its recombinant hyaluronidase enzyme (rHuPH20 or PH20) with regular human insulin and with insulin lispro. The enhanced absorption effects were observed at clinically relevant insulin doses across a broad range of PH20 concentrations.

22 Oct 2009

PAREXEL to present key trends in late phase development and Comparative Effectiveness Research

Experts from PAREXEL International Corporation, a leading global biopharmaceutical services provider, will address key trends in late phase development and Comparative Effectiveness Research at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 12th Annual European Congress, to be held from October 24 - 27, 2009 in Paris, France.

From Parexel 22 Oct 2009

FDA extends Acorda Therapeutics' Fampridine-SR PDUFA goal date

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR to January 22, 2010. The original Prescription Drug User Fee Act (PDUFA) date for this priority review application was October 22, 2009.

22 Oct 2009

More infants are being immunized but funding gap leaves millions of children still at risk

Reversing a downward trend, immunization rates are now at their highest ever and vaccine development worldwide is booming, according to a new assessment released today by the World Health Organization (WHO), UNICEF and the World Bank.

22 Oct 2009

“Sid the Science Kid” show to explain the science behind flu vaccinations

Health and Human Services Secretary Kathleen Sebelius, Education Secretary Arne Duncan, and Lisa Henson, CEO of the Jim Henson Company, will join Washington-area school children for a screening of the new “Sid the Science Kid” special episode on the flu at the U.S. Department of Education Auditorium.

22 Oct 2009

Advisory Committee on Immunization Practices supports the permissive use of GARDASIL

Merck & Co., Inc. announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) supports the permissive use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for boys and young men ages 9 to 26, which means that GARDASIL may be given to males ages 9 to 26 to reduce the likelihood of acquiring genital warts at the discretion of the patient's health care provider.

22 Oct 2009

Drug expert to discuss recent policy shift in medical marijuana at 2009 Symposium

The National Association of Boards of Pharmacy(R) (NABP(R)) welcomes Office of National Drug Control Policy drug policy expert Kevin Sebat to speak at its 2009 Symposium. On December 3, 2009, Sebat will discuss the current federal laws regarding marijuana as well as the recent policy shift regarding prosecution of medical marijuana cases in states that have legalized the practice.

22 Oct 2009

Study explores aldosterone antagonist usage among US patients hospitalised with heart failure

A study published today in JAMA (October 21) by Nancy M. Albert and colleagues, exploring aldosterone antagonist usage among US patients hospitalised with heart failure, found that only one-third of patients meeting current US Clinical Practice Guidelines criteria were actually being treated.

22 Oct 2009

Complex issue of CER in biopharmaceutical development explored

In a new report released today, John Doyle, Vice President and Practice Leader for Quintiles Consulting, and an expert on pharmaceutical market access, explores the complex issue of comparative effectiveness research (CER) and its strategic importance in successful and efficient biopharmaceutical development.

22 Oct 2009

Update from Karo Bio for the period January-September

In an update of the project portfolio, Karo Bio announced, among other things, that the company, in accordance with earlier communicated plans, has submitted an IND application for eprotirome to the American Food and Drug Administration (FDA); that a candidate drug has been nominated within the ER-beta program; and that the company has decided not to initiate further in-house development of KB3305 for the treatment of type 2 diabetes.

22 Oct 2009

ISTA Pharmaceuticals' presentations on Phase 3 clinical results of Bepreve

ISTA Pharmaceuticals, Inc. today announced poster presentations of results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies in allergic conjunctivitis. The studies demonstrated Bepreve was safe and well-tolerated when given twice daily for six weeks in a healthy pediatric population as young as three years of age.

22 Oct 2009

Cephalon announces receipt of a Paragraph IV Certification Notice Letter regarding ANDA

Cephalon, Inc. (Nasdaq: CEPH) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of the 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths of NUVIGIL® (armodafinil) Tablets [C-IV].

22 Oct 2009

Alacer launches new Emergen-C, a vitamin drink to boost immune systems

Emergen-C Immune+(TM) is a new formula providing a fun, healthy and convenient way to get a concentrated boost of immune-strengthening nutrients. The new Emergen-C Immune+ is comprised of the original Emergen-C(®)( )formula, containing 1,000 milligrams of vitamin C, plus a proprietary immune complex with beta glucans, a healthy dose of zinc and a host of other nutrients - all working together to help support the body's natural immune function.

22 Oct 2009

Study results of PTH1-34 oral parathyroid hormone presented

Emisphere Technologies, Inc. today announced study results demonstrating that a single dose of the novel oral parathyroid hormone PTH1-34, which utilizes Emisphere’s proprietary Eligen® Drug Delivery Technology and absorption-enhancer carrier molecule 5-CNAC, achieved potentially therapeutically relevant exposure and safety profiles to those of the currently available injectable formulation in healthy postmenopausal women.

22 Oct 2009

Study compares effects of clin-BPO 2.5% and clin-BPO 5% on epidermal functions

Dermatologists agree that topical fixed-combination products containing clindamycin (clin) and benzoyl peroxide (BPO) are effective in the treatment of acne. However, products containing BPO concentrations at 5% or higher may limit use due to associated dryness and irritation in some patients.

22 Oct 2009

GlaxoSmithKline's CERVARIX recommended by CDC for protection against cervical cancer

GlaxoSmithKline announced today that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommended that CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] be given to girls and young women to protect against cervical pre-cancers and cervical cancer caused by oncogenic HPV 16 and 18.

22 Oct 2009

Pharmaceutical News

LIVALO statin effective than simvastatin in reducing lipid levels

FDA grants Response Biomedical a Special 510(k) clearance for the RAMP Influenza A/B Assay

Antiviral prescriptions at retail pharmacies increase by 36% in one week

Amorfix Life Sciences signs sale and distribution agreement with Cedarlane Laboratories

Faster insulin absorption for varying insulin doses and PH20 concentrations demonstrated

PAREXEL to present key trends in late phase development and Comparative Effectiveness Research

FDA extends Acorda Therapeutics' Fampridine-SR PDUFA goal date

More infants are being immunized but funding gap leaves millions of children still at risk

“Sid the Science Kid” show to explain the science behind flu vaccinations

Advisory Committee on Immunization Practices supports the permissive use of GARDASIL

Drug expert to discuss recent policy shift in medical marijuana at 2009 Symposium

Study explores aldosterone antagonist usage among US patients hospitalised with heart failure

Complex issue of CER in biopharmaceutical development explored

Update from Karo Bio for the period January-September

ISTA Pharmaceuticals' presentations on Phase 3 clinical results of Bepreve

Cephalon announces receipt of a Paragraph IV Certification Notice Letter regarding ANDA

Alacer launches new Emergen-C, a vitamin drink to boost immune systems

Study results of PTH1-34 oral parathyroid hormone presented

Study compares effects of clin-BPO 2.5% and clin-BPO 5% on epidermal functions

GlaxoSmithKline's CERVARIX recommended by CDC for protection against cervical cancer

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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