Pharmaceutical News

RSS

Shire receives Paragraph IV Notice Letter from Zydus over filing of ANDA for generic LIALDA

Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter today from Zydus Pharmaceuticals USA, Inc. advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Shire's 1.2g mesalamine delayed release tablets, LIALDA(R).

29 May 2010

FDA may seek criminal penalties against J & J for faulty recall of children's Tylenol, other medicines

The Wall Street Journal: "The Food and Drug Administration said it is weighing whether to seek criminal penalties against the Johnson & Johnson unit that made children's Tylenol and other over-the-counter kids' medicines recalled last month. Joshua Sharfstein, the FDA's principal deputy commissioner, told lawmakers at a hearing Thursday that J&J's McNeil Consumer Healthcare unit had a 'pattern of noncompliance' with good manufacturing practices.

29 May 2010

Today's Opinions: Never-events, Medicare 'propaganda' and drug copays

According to the Labor Department, overall inflation has averaged about 2.5 percent annually, and prescription drug prices have gone up about 3.6 percent each year, over that time frame. Co-pays, though, have increased four times faster than inflation (Peter J. Pitts, 5/28).

29 May 2010

Previous recommendations on H1N1 pandemic influenza vaccine still stand: SAGE

Previous recommendations on who should be vaccinated with the H1N1 pandemic influenza vaccine still stand according to the World WHO's Strategic Advisory Group of Experts on Immunization, the principal advisory group to WHO for development of policy related to vaccines and immunization.

28 May 2010

Study shows infants fed Enfamil LIPIL experience improved immune outcomes

Results of a new study released this week in the June 2010 issue of The Journal of Pediatrics show that infants fed Enfamil LIPIL containing DHA and ARA during the first year of life experienced improved immune outcomes, including improved respiratory health, versus infants fed the same formulation without these beneficial lipids - and this health benefit was shown for the first three years of life.

28 May 2010

Advanced Life Sciences expands partnership with U.S. Government to assess Restanza against STI's

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced the expansion of its collaboration with the U.S. Government to include the evaluation of Restanza's activity against sexually transmitted infections (STI's), such as gonorrhea.

28 May 2010

Researchers see plectasin as promising lead compound for new antibiotics

An active compound from fungi and lower animals may well be suitable as an effective weapon against dangerous bacteria. We're talking about plectasin, a small protein molecule that can even destroy highly resistant bacteria . Researchers at the Universities of Bonn, Utrecht, Aalborg and of the Danish company Novozymes AS have shed light on how the substance does this.

28 May 2010

Wall Street Journal examines GSK's open-source development for drug discovery plan

The Wall Street Journal examines GlaxoSmithKline's plan to share its database of compounds that could treat tropical diseases. The initiative will test how well "open-source principles work for developing new drugs," the newspaper reports.

28 May 2010

New treatment benefits patients with advanced liver disease due to HCV infection: Researchers

Researchers at the UCLA Medical Center found that antiviral therapy during compensated cirrhosis, when compared with all other strategies, is the most cost-effective approach to treating patients with advanced liver disease due to hepatitis C infection. Full details appear in the June issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

28 May 2010

Amgen announces European approval of Prolia

Amgen Inc. today announced that the European Commission (EC) has granted marketing authorization for Prolia® (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

28 May 2010

MSF report warns of effects of international donor 'backtracking' in global fight against HIV/AIDS

"Backtracking by international donors in funding for HIV/AIDS may undermine years of progress and is already putting lives at risk," according to a report released Thursday by Medecins Sans Frontieres, Reuters reports (Kelland, 5/27).

28 May 2010

Researchers study safety and immunogenicity of two H1N1 vaccines in UK children

The first head to head study of the two H1N1 vaccines used in the UK during the recent pandemic finds that the adjuvanted split virus vaccine induced higher immune response rates in young children, but was associated with more reactions than the whole virus vaccine.

28 May 2010

CDP-choline may block skull and brain damage that result from alcohol consumption early in pregnancy

The dietary supplement CDP-choline, sold as a brain-boosting agent and under study for stroke and traumatic brain injury, may block skull and brain damage that can result from alcohol consumption early in pregnancy, Medical College of Georgia researchers report.

28 May 2010

ART associated with reduced risk of HIV transmission to sexual partners, study shows

Research published in the Lancet online Thursday "provides the strongest evidence to date" that antiretroviral therapy might also be used to prevent transmission of HIV, Agence France-Presse reports. The observational study found that treating HIV-positive patients with ART reduced the risk of HIV transmission to their sexual partners by 92 percent (5/26).

28 May 2010

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings the number of countries to 28 (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.

28 May 2010

PCA-Rx represents next generation of chelation technology for ASD patients

According to the Center for Disease Control, autism has risen to an epidemic rate of 1 in 100 in the U.S., up from 1 in 150 in 2007. While controversy looms regarding its cause, many parents of autistic children believe a correlation exists with toxin accumulation. To give autism spectrum disorder sufferers a natural alternative to chelation therapy, Maxam Nutraceutics has introduced PCA-Rx.

28 May 2010

Uroplasty reports strong sales growth for Macroplastique in fourth-quarter 2010

Uroplasty, Inc., a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today reported financial results for the fourth fiscal quarter and full year ended March 31, 2010. The results were highlighted by continued strong U.S. sales growth for Macroplastique and a reduction in operating and net loss compared to the prior year.

28 May 2010

NICE denies availability of Sorafenib liver cancer drug on NHS

Sorafenib (brand name Nexavar) will not be made available on the NHS for people with advanced hepatocellular carcinoma, the most common form of primary liver cancer.

28 May 2010

Corvalen M introduced for treatment of fibromyalgia symptoms

Fibromyalgia affects as many as one in 50 Americans, 90 percent of whom are women. Yet, despite its nearly epidemic status, patients still often rely on pharmaceutical options solely for treatment. That's why Bioenergy Life Science, Inc. has introduced Corvalen M, a natural treatment option for fibromyalgia symptoms.

28 May 2010

Welch Allyn climbs to #35 rank in "The Best Companies to Work For" in Mexico list

For the second consecutive year, The Gestion de Negocios named Welch Allyn, a leading global manufacturer of frontline medical products and solutions, to its list of "The Best Companies to Work For" in Mexico, the country's most comprehensive study of workplace culture. This year's ranking represented a leap of 42 spots, as the company moved from #77 in 2009 to #35 this year—a significant accomplishment for the Welch Allyn de Mexico factory that has only been in operation since 2006.

27 May 2010

Pharmaceutical News

Shire receives Paragraph IV Notice Letter from Zydus over filing of ANDA for generic LIALDA

FDA may seek criminal penalties against J & J for faulty recall of children's Tylenol, other medicines

Today's Opinions: Never-events, Medicare 'propaganda' and drug copays

Previous recommendations on H1N1 pandemic influenza vaccine still stand: SAGE

Study shows infants fed Enfamil LIPIL experience improved immune outcomes

Advanced Life Sciences expands partnership with U.S. Government to assess Restanza against STI's

Researchers see plectasin as promising lead compound for new antibiotics

Wall Street Journal examines GSK's open-source development for drug discovery plan

New treatment benefits patients with advanced liver disease due to HCV infection: Researchers

Amgen announces European approval of Prolia

MSF report warns of effects of international donor 'backtracking' in global fight against HIV/AIDS

Researchers study safety and immunogenicity of two H1N1 vaccines in UK children

CDP-choline may block skull and brain damage that result from alcohol consumption early in pregnancy

ART associated with reduced risk of HIV transmission to sexual partners, study shows

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

PCA-Rx represents next generation of chelation technology for ASD patients

Uroplasty reports strong sales growth for Macroplastique in fourth-quarter 2010

NICE denies availability of Sorafenib liver cancer drug on NHS

Corvalen M introduced for treatment of fibromyalgia symptoms

Welch Allyn climbs to #35 rank in "The Best Companies to Work For" in Mexico list

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

Latest News