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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

Quest Diagnostics reports use of prescription opiates by American workers has increased by 40%

According to the American Council for Drug Education, more than 70 percent of substance abusers hold a job, which increases their risk of work related injury to them or others. While this statistic includes abuse of both legal and illegal drugs, Quest Diagnostics, a diagnostic testing company, reported the use of prescription opiates by American workers and job applicants has increased by 40% since 2005.

From Quest Diagnostics 22 Oct 2010

New multi-centre trial to treat cold and flu in children

Three Canadian research teams are trying to determine if a novel Canadian medicine approved by Health Canada for adults can help parents deal with the hacking coughs and runny noses their children suffer.

22 Oct 2010

Medivir reports consolidated net sales of SEK 54.7M

Medivir AB , a research-based specialty pharmaceutical company focused on infectious diseases, is publishing its interim report today for the period covering 1 January - 30 September and a business update for the third quarter 2010.

22 Oct 2010

Diamyd Medical to divide operations into two business areas

In her comments in today's year end report, Elisabeth Lindner, President and CEO of Diamyd Medical, states that the company has decided to divide its operations into two business areas beginning with the new 2010/2011 fiscal year; Diabetes and Pain.

22 Oct 2010

Researchers analyze drugs' efficiency on influenza A virus

Beating the flu has always been tough, but it has gotten even more difficult in recent years. Two of the four antiviral drugs used to treat a nasty case of the influenza A virus no longer work.

22 Oct 2010

Paragon Bioservices awarded contract to assist USAMRIID in vaccine development efforts

Paragon Bioservices, a Baltimore-based CMO focused on the contract research, process development and manufacturing of biologics, announced today that it has been awarded a $4.99 million contract to assist the U.S. Army Medical Research Institute for Infectious Diseases in its vaccine development efforts.

22 Oct 2010

Pharmaceutical News

CBER's Laboratory Quality System program receives accreditation

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

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

Neptune launches Onemia medical food

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

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

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

Research finds succimer drug not effective in removing mercury

Vancomycin beneficial for managing patients hospitalized with cellulits

Sinovac Biotech receives Drug Registration Certificate for seasonal influenza vaccine

FDA issues complete response letter for ViroPharma's Cinryze

Arena's NDA receives Complete Response Letter for lorcaserin

FDA approves LO LOESTRIN FE tablets for oral contraception

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Quest Diagnostics reports use of prescription opiates by American workers has increased by 40%

New multi-centre trial to treat cold and flu in children

Medivir reports consolidated net sales of SEK 54.7M

Diamyd Medical to divide operations into two business areas

Researchers analyze drugs' efficiency on influenza A virus

Paragon Bioservices awarded contract to assist USAMRIID in vaccine development efforts

PhD researcher at LifeArc

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