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Prednisolone associated with recurrence of CAP after its withdrawal

Patients hospitalized with mild to moderate community-acquired pneumonia (CAP) should not be routinely prescribed prednisolone, a corticosteroid, as it is associated with a recurrence of symptoms after its withdrawal, according to the first randomized double-blind clinical trial to address the subject.

24 Feb 2010

WuXi PharmaTech's Shanghai c-GMP manufacturing facility receives MPA compliance certificate

WuXi PharmaTech (WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that it received the formal certificate of GMP compliance from the Medical Products Agency (MPA) of Sweden, acting on behalf of the European Medicines Agency (EMEA), for its c-GMP drug product manufacturing and analytical testing facilities located in Shanghai.

24 Feb 2010

Clout of drug industry seen in MD residency programs and in health reform

News outlets report on the pharmaceutical industry's involvement in doctor training and its role in shaping the health care overhauls pending in Congress.

24 Feb 2010

Forest Laboratories' Bystolic tablets for treatment of stable CHF failed to receive FDA approval

Forest Laboratories, Inc. announced today that the U.S. Food and Drug Administration did not approve the additional indication for Bystolic® (nebivolol) tablets as a treatment for stable chronic heart failure (CHF) as requested in the company’s Supplemental New Drug Application (sNDA).

23 Feb 2010

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

Salix Pharmaceuticals, Ltd. today reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).

23 Feb 2010

NASDAQ halts trading of Salix Pharmaceuticals stock, FDA Committee to discuss XIFAXAN NDA

Salix Pharmaceuticals, Ltd. today announced that NASDAQ has halted trading of the Company’s common stock this morning. The Gastrointestinal Drugs Advisory Committee of the FDA is meeting today to discuss the efficacy and safety of the New Drug Application (NDA) for XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy.

23 Feb 2010

Health Canada approves GARDASIL for prevention of genital warts in males

Today, Merck announced that Health Canada has approved GARDASIL(R) (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Recombinant Vaccine) for boys and men nine through 26 years of age for the prevention of infection caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.

23 Feb 2010

NCC, Pfizer provide over 10M units of ReFacto Antihemophilic Factor to underserved hemophilia patients

The National Cancer Coalition (NCC) is pleased to announce its recent collaboration with Pfizer, Inc to provide hemophilia medicines to underserved patients in the developing world. To date, NCC has received more than 10 million international units of ReFacto® Antihemophilic Factor (Recombinant), a therapy used for the treatment and prevention of bleeding in people with hemophilia A, to assist patients who otherwise would have little opportunity for adequate treatment. The value of this donation is more than $13 million, and it will help many hundreds of hemophilia patients around the world.

23 Feb 2010

Gross sales of Acorda Therapeutics' ZANAFLEX CAPSULES and tablets increase 9.1% to $58.3M in 2009

Acorda Therapeutics, Inc. today announced its financial results for the fourth quarter and full year ended December 31, 2009.

23 Feb 2010

ExonHit Therapeutics includes proprietary lead compounds into collaboration with Allergan

ExonHit Therapeutics today announced the inclusion of proprietary lead compounds, which were derived from one of its internal medicinal chemistry programs, into its productive and long-running strategic collaboration with Allergan.

23 Feb 2010

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

23 Feb 2010

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

Obecure Ltd., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., has received notice of allowance from the US Patent Office for its two key patent applications covering methods of use and compositions covering the use of betahistine with olanzapine for the mitigation of the serious weight gain associated as a side effect of the antipsychotic drug.

23 Feb 2010

Study shows CEL-2000 vaccine blocks RA progression in mice

CEL-SCI Corporation and their scientific collaborators announced today that the Company's CEL-2000 vaccine demonstrated that it is able to block the progression of rheumatoid arthritis (RA) in a mouse model.

23 Feb 2010

FDA grants Haemonetics clearance to collect two RBC on Cymbal system

On January 27, 2010 the FDA cleared the Haemonetics 510(k) for its expanded nomogram to collect two Red Blood Cells on the Cymbal® Automated Blood Collection System from female donors who are at least 150 pounds and are 63 inches in height. The Cymbal is a small, portable, battery operated instrument that automates blood collection from volunteer donors, improving process control and helping alleviate blood shortages.

23 Feb 2010

DURECT, Nycomed amend POSIDUR Development and License Agreement

DURECT Corporation announced today that Nycomed and DURECT have amended the Development and License Agreement entered into between the parties in 2006 covering the development and commercialization of POSIDUR™ (also known as SABER™-Bupivacaine or OPTESIA™), an investigational drug for the treatment of post-surgical pain.

23 Feb 2010

Star Scientific seeks FDA marketing approval for Ariva-BDL dissolvable tobacco lozenge

Star Scientific, Inc. announced that on Friday, February 19 the company filed an application with the Food & Drug Administration for approval to market Ariva-BDL™ as a "modified risk" tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009. This submission is the first such application to be filed with the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

23 Feb 2010

Eon Labs to pay $3.5M for resolving False Claims Act allegations concerning Nitroglycerin SR capsules

Eon Labs Inc. has agreed to pay the United States $3.5 million to resolve False Claims Act allegations relating to the company's drug Nitroglycerin Sustained Release (SR) capsules, the Justice Department announced today. Eon Labs is a subsidiary of Sando Inc., which is in turn a subsidiary of Novartis AG.

23 Feb 2010

Watson Laboratories files ANDA for generic Aplenzin ER in treatment of major depressive disorder

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.- Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 174 mg and 348 mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail. Watson's 174 mg and 348 mg strength bupropion hydrobromide tablet products are generic versions of Biovail's Aplenzin™ ER, which is indicated for major depressive disorder.

23 Feb 2010

Senate, FDA reports increasing concerns about controversial diabetes drug

"Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market ... ," The New York Times reports. "The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline."

23 Feb 2010

AAN guideline evaluates drugs’ safety and efficacy for treatment of muscle cramps

A new guideline from the American Academy of Neurology recommends that the drug quinine, although effective, should be avoided for treatment of routine muscle cramps due to uncommon but serious side effects.

23 Feb 2010

Pharmaceutical News

Prednisolone associated with recurrence of CAP after its withdrawal

WuXi PharmaTech's Shanghai c-GMP manufacturing facility receives MPA compliance certificate

Clout of drug industry seen in MD residency programs and in health reform

Forest Laboratories' Bystolic tablets for treatment of stable CHF failed to receive FDA approval

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

NASDAQ halts trading of Salix Pharmaceuticals stock, FDA Committee to discuss XIFAXAN NDA

Health Canada approves GARDASIL for prevention of genital warts in males

NCC, Pfizer provide over 10M units of ReFacto Antihemophilic Factor to underserved hemophilia patients

Gross sales of Acorda Therapeutics' ZANAFLEX CAPSULES and tablets increase 9.1% to $58.3M in 2009

ExonHit Therapeutics includes proprietary lead compounds into collaboration with Allergan

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

Study shows CEL-2000 vaccine blocks RA progression in mice

FDA grants Haemonetics clearance to collect two RBC on Cymbal system

DURECT, Nycomed amend POSIDUR Development and License Agreement

Star Scientific seeks FDA marketing approval for Ariva-BDL dissolvable tobacco lozenge

Eon Labs to pay $3.5M for resolving False Claims Act allegations concerning Nitroglycerin SR capsules

Watson Laboratories files ANDA for generic Aplenzin ER in treatment of major depressive disorder

Senate, FDA reports increasing concerns about controversial diabetes drug

AAN guideline evaluates drugs’ safety and efficacy for treatment of muscle cramps

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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