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Synerx Pharma announces FDA submission of Isosulfan Blue injection ANDA

Synerx Pharma, LLC has announced the submission to the FDA of Isosulfan Blue Injection (generic equivalent to Lymphazurin, Covidien (formerly US Surgical)).

16 Dec 2008

FDA requires stronger warnings on antiepileptic medicines

The U.S. Food and Drug Administration has announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

16 Dec 2008

Natural product from red seaweed brings new antiviral spray

Marinomed Biotechnologie GmbH has been awarded the top prize in the Mercur 2008 innovation awards. This award to Marinomed honours the discovery of antiviral properties in a natural product and the rapid development of the discovery into a nasal spray for treating the common cold.

16 Dec 2008

GlaxoSmithKline statement on FDA advisory committee vote on use of asthma medicines containing long-acting beta agonists

The following is GlaxoSmithKline's statement regarding recommendations of a combined Advisory Committee to the FDA on the use of asthma medicines containing long-acting beta agonists, including GSK's Serevent (salmeterol) and Advair (salmeterol/fluticasone proprionate).

14 Dec 2008

FDA approves Lusedra (fospropofol disodium) injection for monitored anesthesia care sedation

Eisai Corporation of North America today announced that the U.S. Food and Drug Administration (FDA) has approved Lusedra (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

14 Dec 2008

FDA to review Barr Pharmaceutical's BLA for adenovirus type 4 and 7 live oral vaccines

Barr Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral Vaccines Biologics License Application (BLA).

14 Dec 2008

New deodorant promises to slow down the growth of underarm hair

The global giant Unilever which specialises in home, personal care and foods products has promised women a new deodorant which will apparently slow down the growth of underarm hair.

14 Dec 2008

AstraZeneca responds to FDA advisory committees' recommendation on SYMBICORT

On December 11, 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs).

12 Dec 2008

FDA grants compassionate case for use of novel wet age-related macular degeneration treatment

NeoVista, Inc., announced today that the U.S. Food and Drug Administration (FDA) had approved the company's "compassionate case" waiver to utilize its novel wet age-related macular degeneration (AMD) treatment on a patient with an advanced form of the disease who did not meet criteria for inclusion into current NeoVista investigational treatment protocols.

10 Dec 2008

Electronic prescribing can boost drug cost savings

Electronic prescribing (e-prescribing) systems that allow doctors to select lower cost or generic medications can save $845,000 per 100,000 patients per year and possibly more system-wide, according to findings from a new study funded by HHS' Agency for Healthcare Research and Quality.

10 Dec 2008

Save money wih generics

Today, more than ever, consumers can opt for generic equivalents of brand-name medications at substantial cost savings.

10 Dec 2008

New class of anti-inflammatory drugs

In the treatment of pain, inflammation and fever, non-steroid anti-rheumatic drugs (NSAR) such as acetylsalicylic acid - more commonly known as Aspirin - or Ibuprofen have always been popular choices.

10 Dec 2008

Quantros acquires MEDMARX from United States Pharmacopeia

U.S. Pharmacopeia (USP) Convention, an official public standards-setting authority for all prescription and over-the-counter medicines sold in the United States, on December 4, 2008 transferred all rights, ownership and management of the overall MEDMARX reporting program to Quantros.

10 Dec 2008

Experimental drug successfully blocks mutation in bone marrow cancers

Oregon Health & Science University Knight Cancer Institute researchers have found that an experimental drug successfully blocks an enzyme that causes some bone marrow cancers.

10 Dec 2008

Merck Serono's Kuvan receives European marketing authorization

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that the European Commission has granted marketing authorization for Kuvan(R) for the treatment of hyperphenylalaninemia (HPA) in phenylketonuria (PKU) or BH4 deficient patients.

10 Dec 2008

Doctors question FDA suicide alert on anticonvulsant drugs

Medical specialists at the nation's largest professional meeting on epilepsy discussed multiple questions and concerns they have about data presented by the FDA in support of its recent suicide alert on anticonvulsant drugs (AEDs) and the potential effect of the federal agency's analyses on clinical practice and the way AED drug trials are to be conducted in the future.

10 Dec 2008

Kiadis Pharma receives two orphan drug designations for Reviroc

Kiadis Pharma has announced that the U.S. Food and Drug Administration (FDA) has granted its product Reviroc Orphan Drug Designations (ODD) for the treatment of two types of Non-Hodgkin Lymphoma (NHL).

8 Dec 2008

GlaxoSmithKline extends Genelabs offer

GlaxoSmithKline has announced today that it has extended its previously announced tender offer to purchase all of the outstanding shares of common stock of Genelabs Technologies, Inc. for $1.30 in cash per share without interest and less any required withholding taxes, until 12:00 midnight EST on Friday, December 12, 2008, unless the tender offer is further extended.

8 Dec 2008

Electronic prescribing system may encourage physicians to prescribe lower-cost medications

Clinicians using an electronic prescribing system appear more likely to prescribe lower-cost medications, reducing drug spending, according to a report in the December 8/22 issue of Archives of Internal Medicine.

8 Dec 2008

Cytori reports benefit of adipose-derived regenerative cells in spinal disc model

Cytori Therapeutics, Inc. reported preclinical study results, which demonstrate the potential benefit of adipose-derived stem and regenerative cells (ADRCs) for the treatment of damaged intervertebral discs, evidenced by significantly increased disc tissue density and disc-specific extracellular matrix components at 12-months post treatment in a large animal model.

8 Dec 2008