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CMS assigns J-code for Pharmaxis ARIDOL Bronchial Challenge Test Kit

Pharmaxis, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a product-specific billing code, or J-code, for ARIDOL (mannitol inhalation powder) Bronchial Challenge Test Kit.

4 Jan 2012

Lundbeck announces availability of ONFI Tablets in the U.S.

Lundbeck announced today that ONFI Tablets are now available for prescribing in the United States. The FDA recently approved ONFI for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older.

4 Jan 2012

FDA approves CSL Behring's Berinert for treatment of HAE attacks

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder.

4 Jan 2012

Neogen develops new Reveal Q+ test for deoxynivalenol

Neogen Corporation has developed a new test for deoxynivalenol (DON) that combines the speed and simplicity of a lateral flow test with the fully quantitative precision of a more demanding testing method.

4 Jan 2012

CMS assigns J-code for Eisai's Halaven Injection to treat breast cancer

Eisai Inc. announced today that the Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Halaven (eribulin mesylate) Injection.

4 Jan 2012

Regeneron, Genentech enter non-exclusive license and partial settlement agreement for EYLEA

Regeneron Pharmaceuticals, Inc. today announced that the Company has entered into a non-exclusive license and partial settlement agreement with Genentech, Inc., a member of the Roche Group relating to U.S. ophthalmic sales of EYLEA (aflibercept) Injection.

3 Jan 2012

Lundbeck invests in Ossianix to focus on biotherapeutics for CNS disorders

Ossianix, Inc. today announced a strategic investment by H. Lundbeck A/S in the form of a Convertible Promissory Note. The proceeds from Lundbeck's investment is expected to allow Ossianix to generate biopharmaceuticals for the treatment of nervous system disorders by utilizing Ossianix's proprietary single domain antibody platform modeled on the shark vNAR structure.

3 Jan 2012

FDA sets Feb. 9 for ODAC meeting to review CTI's resubmitted pixantrone NDA

Cell Therapeutics, Inc. (CTI) announced today that on February 9, 2012 the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review CTI's resubmitted New Drug Application (NDA) for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy.

3 Jan 2012

Marijuana ingredients appear to affect regional brain function during salience processing

Different ingredients in marijuana appear to affect regions of the brain differently during brain processing functions involving responses to certain visual stimuli and tasks, according to a report in the January issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

3 Jan 2012

Tamiflu resistant flu on the rise: Study

According to World Health Organization researchers there is a rise in Australia in the number of seasonal influenza cases resistant to Tamiflu, the most commonly used antiviral drug. The rise in such cases involving the pandemic 2009 A (H1N1) flu strain, also known as swine flu, took place during Australia's most recent winter: May through August of 2011.

2 Jan 2012

Pfizer’s Prevenar 13 gets US approval for adults

Health authorities of United States have approved the expansion of Pfizer Inc's Prevnar vaccine for use in adults 50 and older to fight pneumonia, meningitis and other diseases cause by pneumococcus bacteria. The vaccine, which had been approved for children in the United States, is already one of Pfizer's biggest brands and an expanded population of adults could generate more than $1.5 billion in annual sales.

2 Jan 2012

FDA notes shortage of ADHD medicines

According to the U.S. Food and Drug Administration (FDA) drugs to treat attention deficit hyperactivity disorder (ADHD) are in such short supply that hundreds of patients complain daily to the agency that they are unable to find a pharmacy with enough pills to fill their prescriptions.

2 Jan 2012

Similar sounding drug names should come with warnings

There have been mix ups and medication errors with similar sounding names of drugs - eye drops called Durezol and salicylic acid-containing wart remedy Duresal for example.

1 Jan 2012

FDA approves Prevnar 13 pneumococcal conjugate vaccine for adults 50 and older

Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

31 Dec 2011

HimalayaUSA recalls two batches of Organique by Himalaya Nourishing Night Cream

HimalayaUSA announced today it is conducting a voluntary recall of Organique by Himalaya Nourishing Night Cream with batch #S691001 and batch #S691002 effective immediately.

31 Dec 2011

ProStrakan announces FDA approval for Transmucosal Immediate Release Fentanyl REMS Access program

ProStrakan, Inc., a subsidiary of Kyowa Hakko Kirin Co. Ltd., and an international specialty pharmaceutical company, today announces that the U.S. Food and Drug Administration has approved the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program.

31 Dec 2011

ARCA biopharma extends pharmacogenetic intellectual property protection around bucindolol

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office has issued a patent on methods for treating patients with bucindolol based on genetic targeting and focused on a specific genotype - homozygous wildtype for Deletion 322-325 in the alpha-2C adrenergic receptor.

31 Dec 2011

FDA approves Pfizer's Prevnar 13 pneumococcal conjugate vaccine as a single dose for adults

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the Company's pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults.

31 Dec 2011

Patented ribose for food, beverage and supplement applications

Since 2008, the sales of ribose as an energy supplement increased by over 85%. This in conjunction with $9 billion sales of functional energy drinks in 2011 suggests that demand has never been higher for ingredients with a wide array of applications in functional food and beverage industries. Enter Bioenergy Ribose – the Superior Energy Ingredient.

31 Dec 2011

No Cronobacter detected in Mead Johnson products

Mead Johnson Nutrition was notified today by the United States Food & Drug Administration and the Centers for Disease Control that health inspectors have completed their testing on all formula samples collected from the company. These tests confirmed that the Mead Johnson products were safe, and no presence of Cronobacter was detected.

31 Dec 2011