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Savient to evaluate strategic alternatives for KRYSTEXXA drug

Savient Pharmaceuticals, Inc. announced that its previously announced process to identify, following the approval of KRYSTEXXA by the U.S. Food and Drug Administration (FDA), a strategic transaction for the sale of the Company did not result in a sale of the Company at this time. The board of directors will continue to evaluate strategic alternatives available to the Company to maximize value.

26 Oct 2010

AAHP highlights safety of homeopathic children's medicines

The American Association of Homeopathic Pharmacists (AAHP), representing the major manufacturers and distributors of homeopathic drugs, highlights the safety of homeopathic children's medicines in response to the recall of Hyland's Teething Tablets. The AAHP supports the efforts to protect the safety of children by both the Standard Homeopathic Company and the U.S. Food and Drug Administration (FDA).

26 Oct 2010

PhRMA representatives meet with officials in India to discuss compulsory licensing

During a visit with government officials, industry leaders and NGOs in India last week, representatives from Pharmaceutical Research and Manufacturers of America (PhRMA), a U.S. lobbying group that represents the country's pharmaceutical industry and biotechnology companies, addressed "the Indian government's proposal to allow local drugmakers to make low-cost version of patented drugs so that they can be made available to patients," the Economic Times reports.

26 Oct 2010

Aspirin reduces risk of death from prostate cancer

Men with prostate cancer who take anticoagulants like aspirin in addition to radiation therapy or surgery may be able to cut their risk of dying of the disease by more than half, according to a large study presented on November 3, 2010, at the 52nd Annual Meeting of the American Society for Radiation Oncology (ASTRO) in San Diego. The study involved more than 5,000 men with localized cancer whose disease had not spread beyond the prostate gland.

26 Oct 2010

Dietary intake of PUFAs associated with decreased prevalence of periodontitis

Periodontitis, a common inflammatory disease in which gum tissue separates from teeth, leads to accumulation of bacteria and potential bone and tooth loss. Although traditional treatments concentrate on the bacterial infection, more recent strategies target the inflammatory response.

26 Oct 2010

Baxter announces launch of GLASSIA in the U.S.

Baxter International Inc. today announced the commercial launch of GLASSIATM [Alpha1-Proteinase Inhibitor (Human)] in the United States. GLASSIATM is the first available ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) and is indicated as a chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1 antitrypsin (AAT), an under-diagnosed hereditary condition characterized by a low level of alpha-1 protein in the blood.

From Baxter International Inc. 26 Oct 2010

CBER's Laboratory Quality System program receives accreditation

The U.S. Food and Drug Administration today announced that the American Association for Laboratory Accreditation has accredited the Laboratory Quality System program in the Center for Biologics and Evaluation Research (CBER) under ISO/IEC 17025 in the fields of biological and chemical testing.

26 Oct 2010

S.A.N.E. Vax requests temporary suspension of Gardasil sales as cervical cancer preventive

In a letter addressed to Dr. Margaret Hamburg, the FDA commissioner, Ms. Norma Erickson, president of S.A.N.E. Vax, Inc. stated her research team has revealed the fact that in November 2001 the VRBPAC (Vaccines and Related Biological Products Advisory Committee) mistakenly allowed the vaccine manufacturer to use "CIN 2/3, AIS, or cervical cancer; i.e. CIN 2/3 or worse by histology- with virology to determine the associated HPV type- as the primary endpoint in the evaluation of a vaccine to prevent cervical cancer."

25 Oct 2010

Immune Network enters letter of intent to acquire Immunitor oral vaccine technology

Immune Network Ltd. advises that a clinical trial of V5 Immunitor oral vaccine was published earlier this month demonstrating an unexpected powerful effect against tuberculosis, including multi-drug-resistant tuberculosis (MDR-TB) and tuberculosis that is complicated by co-infection with HIV and hepatitis C (HCV).

25 Oct 2010

Neptune launches Onemia medical food

Neptune Technologies & Bioressources Inc. enters the pharmaceutical market with the launch of Onemia™, the first medical food of Neptune's subsidiary Acasti Pharma Inc.. Only two years since its foundation, Acasti has completed the development and launch of "Onemia™" on October 21, 2010 at the Cardiometabolic Health Congress meeting in Boston.

25 Oct 2010

Essentialis, FDA enter agreement on SPA for DCCR Phase 3 efficacy study in patients with high triglycerides

Essentialis, Inc. announced today that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 efficacy study required for product registration for its product candidate, Diazoxide Choline Controlled Release Tablet (DCCR), for the treatment of patients with very high triglycerides.

25 Oct 2010

FDA warns about risk of Hyland's Teething Tablets to children

The U.S. Food and Drug Administration today is warning consumers that Hyland's Teething Tablets may pose a risk to children. The FDA recommends that consumers not use this product and dispose of any in their possession. The manufacturer is issuing a recall of this product.

25 Oct 2010

Beijing CDC selects Sinovac as first priority supplier of seasonal influenza vaccine

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has been selected by the Beijing Centers for Disease Control and Prevention (Beijing CDC) as one of the five manufacturers to supply seasonal influenza vaccine to the citizens of Beijing.

25 Oct 2010

Research finds succimer drug not effective in removing mercury

Succimer, a drug used for treating lead poisoning, does not effectively remove mercury from the body, according to research supported by the National Institutes of Health. Some families have turned to succimer as an alternative therapy for treating autism.

25 Oct 2010

Vancomycin beneficial for managing patients hospitalized with cellulits

Patients admitted to the hospital for the common bacterial skin infection cellulitis should be treated as a first line of defense with the potent antibiotic drug vancomycin rather than other antibiotics such as penicillin, according to a Henry Ford Hospital study.

25 Oct 2010

Sinovac Biotech receives Drug Registration Certificate for seasonal influenza vaccine

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that Sinovac Biotech (Hong Kong) Ltd., its wholly owned subsidiary company in Hong Kong, has received the Certificate of Drug/Product Registration from the Hong Kong Department of Health for its seasonal influenza vaccine Anflu.

25 Oct 2010

FDA issues complete response letter for ViroPharma's Cinryze

ViroPharma Incorporated today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.

25 Oct 2010

Arena's NDA receives Complete Response Letter for lorcaserin

Arena Pharmaceuticals, Inc. and Eisai Inc. announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Arena's New Drug Application (NDA) for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese

25 Oct 2010

FDA approves LO LOESTRIN FE tablets for oral contraception

Warner Chilcott plc (Nasdaq: WCRX) today announced that the United States Food and Drug Administration (FDA) has approved LO LOESTRIN FE (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) for the prevention of pregnancy.

25 Oct 2010

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Cephalon, Inc. today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL (armodafinil) Tablets [C-IV] and PROVIGIL (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA).

25 Oct 2010