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WHO H1N1 vaccine shipments headed to more developing countries

The WHO on Friday announced "it had delivered the first doses of H1N1 [swine flu] vaccine to Cuba, and a dozen countries in Africa would receive millions of doses in coming weeks," Reuters reports.

23 Mar 2010

FDA approves APP Pharmaceuticals' Indomethacin for Injection

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Indomethacin for Injection. Indomethacin is therapeutically equivalent to the reference-listed drug INDOCIN® I.V., by Lundbeck, Inc.

23 Mar 2010

FDA's ODAC voted to review T315I mutation prior to approval of OMAPRO

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 7-1 that a validated test to identify the T315I mutation should be reviewed by the FDA prior to approval of OMAPRO™ (omacetaxine mepesuccinate).

23 Mar 2010

LPI's ANDA for Eszopiclone tablets receives tentative approval from USFDA

Lupin Pharmaceuticals, Inc. announced today that it has received tentative approval for the Company's Abbreviated New Drug Application for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration.

23 Mar 2010

GSK notifies regulatory authorities of the presence of PCV-1 in Rotarix vaccine

GlaxoSmithKline today confirmed that it has notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine, Rotarix™. PCV-1 does not multiply in humans and is not known to cause illness in humans.

23 Mar 2010

Legacy Biotechnologies, Phillips Sales and Marketing reach agreement to distribute Reme-Flu remedy

Nuvilex, Inc., announces today that Legacy Biotechnologies, Inc., its joint venture partner in Reme-Flu™ homeopathic flu remedy, has reached an agreement with Phillips Sales and Marketing to begin the national sales and marketing campaign for retail distribution of Reme-Flu™.

22 Mar 2010

Galderma Laboratories' Differin Lotion receives FDA approval

Galderma Laboratories, L.P. today announced the U.S. Food and Drug Administration approval of Differin® (adapalene) Lotion, 0.1%, the first-ever lotion formulation of the well-tolerated retinoid adapalene, for the treatment of acne. Differin Lotion, 0.1% will be available by prescription in April 2010.

22 Mar 2010

Rexahn Pharmaceuticals forms Parkinson’s Disease SAB to develop strategy for Serdaxin

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced the formation of its Parkinson’s Disease Scientific Advisory Board (SAB), featuring some of the leading medical researchers in neurology.

22 Mar 2010

Decision Resources forecasts multiple myeloma drug market to more than double from $2.1B in 2008 to $5.3B in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the multiple myeloma drug market will more than double from $2.1 billion in 2008 to $5.3 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

22 Mar 2010

PharmAthene to provide update on contract modification suspension

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that in addition to its year end results, it will provide an update on the contract modification suspension it received on Friday, March 19, 2010.

22 Mar 2010

BEMA Granisetron development program: BDSI announces positive meeting with FDA

BioDelivery Sciences International, Inc. announced the positive outcome of a meeting with the FDA on the development program for BEMA Granisetron, the company’s potential treatment for the prevention of nausea and vomiting associated with cancer therapy. FDA concurred with BDSI’s plans to pursue a development program based on clinical pharmacokinetic data for a 505(b)(2) New Drug Application.

22 Mar 2010

Acorda Therapeutics submits applications to extend patent protection for AMPYRA to USPTO

Acorda Therapeutics, Inc. today announced that the Company has submitted applications to extend patent protection for AMPYRA™ (dalfampridine) Extended Release Tablets, 10 mg to the United States Patent and Trademark Office.

22 Mar 2010

Dow Jones reports on side effects of Labopharm's once-daily version of Trazodone, stock falls by 5%

After Canadian specialty pharmaceutical company Labopharm received FDA approval for its once-daily version of antidepressant Trazodone, Dow Jones Newswires reported that it will be difficult to convince prescribers to switch from less expensive generic versions. Dow Jones found that when compared, the side effects of Labopharm's drug fare no better than the generic versions that dominate the market.

22 Mar 2010

Aston University scientists receive grants to develop new forms of drug delivery

Before you swallow a tablet, or put it into a glass of water to dissolve, do you ever stop and think about how it actually works in your body and how quickly and effectively it can deliver the drug to where it is needed?

22 Mar 2010

Study: Older adults with chronic illness often struggle to manage several prescribed drugs at a time

People with chronic illness often struggle to manage several prescribed drugs at a time. It's overwhelming when the vials, bottles and inhalers bulge from your medicine cabinet and you're confused about which drug is which, or when to take what.

20 Mar 2010

Bleach solution effective in reducing hospital-acquired infections

Clostridium difficile (C. difficile) is the one of the leading pathogens causing hospital-acquired infection in the United States. It may cause diarrhea, colitis, sepsis and lead to prolonged hospitalization and death.

20 Mar 2010

Effective defense against HIV: Acne drug minocycline

Johns Hopkins scientists have found that a safe and inexpensive antibiotic in use since the 1970s for treating acne effectively targets infected immune cells in which HIV, the virus that causes AIDS, lies dormant and prevents them from reactivating and replicating.

20 Mar 2010

High dose of Zocor could lead to muscle injury, warns FDA

The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg.

20 Mar 2010

Drug company fights for patent extension

The New York Times: The drug maker Medicines Company that makes the blood thinner called Angiomax, missed the application deadline to extend its patent back in 2000 by a day or two, depending on how you count.

20 Mar 2010

Divisions within pro-life groups on overhaul ease opposition

A previously steadfast coalition opposed to abortion - which feared that the health overhaul could divert federal money to support the procedure - is beginning to crack, The Christian Science Monitor reports. "Increasingly, abortion foes - including high-profile Catholic organizations and members of Congress - are saying that while the language aimed at preventing use of federal funds for abortion is not perfect, the bill is still worth passing as a first step."

19 Mar 2010

Pharmaceutical News

WHO H1N1 vaccine shipments headed to more developing countries

FDA approves APP Pharmaceuticals' Indomethacin for Injection

FDA's ODAC voted to review T315I mutation prior to approval of OMAPRO

LPI's ANDA for Eszopiclone tablets receives tentative approval from USFDA

GSK notifies regulatory authorities of the presence of PCV-1 in Rotarix vaccine

Legacy Biotechnologies, Phillips Sales and Marketing reach agreement to distribute Reme-Flu remedy

Galderma Laboratories' Differin Lotion receives FDA approval

Rexahn Pharmaceuticals forms Parkinson’s Disease SAB to develop strategy for Serdaxin

Decision Resources forecasts multiple myeloma drug market to more than double from $2.1B in 2008 to $5.3B in 2018

PharmAthene to provide update on contract modification suspension

BEMA Granisetron development program: BDSI announces positive meeting with FDA

Acorda Therapeutics submits applications to extend patent protection for AMPYRA to USPTO

Dow Jones reports on side effects of Labopharm's once-daily version of Trazodone, stock falls by 5%

Aston University scientists receive grants to develop new forms of drug delivery

Study: Older adults with chronic illness often struggle to manage several prescribed drugs at a time

Bleach solution effective in reducing hospital-acquired infections

Effective defense against HIV: Acne drug minocycline

High dose of Zocor could lead to muscle injury, warns FDA

Drug company fights for patent extension

Divisions within pro-life groups on overhaul ease opposition

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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