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EC approves Nivestim for prevention of FN

Hospira announced today that the EC has approved Nivestim™ (filgrastim) for the prevention of FN, the most serious haematological toxicity that occurs as a result of cancer chemotherapy. Nivestim now has marketing authorisation in all EU member states. Nivestim is expected to reduce the cost of neutropenia treatment.

10 Jun 2010

CPL Biologicals completes construction of vaccine facility in Dholka, India

CPL Biologicals (CPLB), a joint venture of Cadila Pharmaceuticals Ltd. and Novavax, Inc., today announced that it has completed construction of its vaccine facility in Dholka, India and will commence equipment and installation validation this month so that the facility conforms to global standards for production of vaccines for human use.

10 Jun 2010

Onset Therapeutics expands sales force by over 50% in 2010

Onset Therapeutics, a specialty pharmaceutical company focused in dermatology, today announced the completion of the Company's latest sales force expansion initiative designed to provide national dermatology coverage to support the success of two recently launched products and the Company's rapidly growing pipeline of products in various stages of development.

10 Jun 2010

PAREXEL experts to present on biopharmaceutical industry issues at 46th DIA

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that several of its experts will present on important industry issues at the Drug Information Association (DIA) 46th Annual Meeting, being held from June 13 – 17, 2010 in Washington, DC.

From Parexel 10 Jun 2010

Periogenix to be introduced at International Symposium for Periodontics & Restorative Dentistry

OroScience plc (Palo Alto, CA), in conjunction with Ace Surgical Supply, Inc. (Brockton, MA), will be exhibiting and introducing Periogenix at the 10th International Symposium for Periodontics & Restorative Dentistry in Boston, Massachusetts from June 10th to 12th, 2010. Sponsored by the International Quintessence Publishing Group, publisher of The International Journal of Periodontics & Restorative Dentistry, and the American Academy of Periodontology, this symposium addresses current trends in periodontal surgery and implant and esthetic dentistry.

10 Jun 2010

Extensive usage of antibiotic linezolid associated with ICU outbreak of LRSA

An outbreak of infection due to linezolid and methicillin-resistant Staphylococcus aureus (LRSA) in 12 intensive care unit patients in Spain was associated with transmission within the hospital and extensive usage of the antibiotic linezolid, often used for the treatment of serious infections, with reductions in linezolid use and infection-control measures associated with resolution of the outbreak, according to a study in the June 9 issue of JAMA.

10 Jun 2010

Human Genome Sciences submits BLA for BENLYSTA to FDA

Human Genome Sciences, Inc. today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval to market BENLYSTA® (belimumab) for the treatment of systemic lupus erythematosus (SLE).

10 Jun 2010

New study finds propofol poses low risk for children undergoing research-driven imaging studies

A new study finds that propofol, a well-known anesthesia medication, has a low occurrence of adverse events for children undergoing research-driven imaging studies. The study, led by a pediatric anesthesiologist now at Children's National Medical Center, showed a low incidence of adverse events and no long term complications when propofol was used to sedate children for imaging studies that require them to be still for long periods of time.

10 Jun 2010

UC emergency medicine assistant professor compares efficacy of two seizure medications to prevent SE

When seizures strike, the most immediate goal for caregivers is to get appropriate medication to the patient as quickly as possible to stop the seizing activity. In a paper published in the June Academic Emergency Medicine, UC emergency medicine assistant professor Jason McMullan, MD, found that the best means of stopping status epilepticus may be with the least direct medication.

10 Jun 2010

MonoSol Rx, APR expand film formulation development collaboration

MonoSol Rx, the developer of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, and APR Applied Pharma Research s.a. ("APR") announced today an expansion of their relationship to identify and develop film formulations of prescription drug products beyond ondansetron and donepezil to include zolmitriptan. Zolmitriptan is currently commercially available for the acute treatment of migraine headache in adults, and facing initial patent expirations in 2012.

10 Jun 2010

Effectiveness of combination band ligation and nadolol for first variceal bleeding not established

A controlled trial conducted by researchers at the E-DA Hospital in Kaohsiung, Taiwan, suggests that a combination of band ligation and nadolol may not be the most effective prophylaxis for first variceal bleeding resulting from cirrhosis. Results of this study appear in the July issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

10 Jun 2010

SGS announces total package testing solution for medical device, pharma product manufacturers

SGS Consumer Testing Services today announced an expansion of its package testing services with a global program to ensure packaging integrity for medical devices and pharmaceutical products. The program – announced at this week's EastPack 2010 conference in New York - offers one-stop testing of product containers, secondary packaging and transit packaging to evaluate the product protection capabilities, durability and environmental sustainability of all package components.

10 Jun 2010

Ontario Pharmacists' Association disappointed with government's regulatory changes

The Ontario Pharmacists' Association today expressed concerns and disappointment with the Ontario government's announcement that it is moving ahead with regulatory changes that will significantly reduce support to Ontario pharmacists and their patients.

10 Jun 2010

Study: ChEI improves driving skills in patients with mild AD

A promising study from Rhode Island Hospital demonstrated that cholinesterase inhibitors, a type of medication often prescribed for Alzheimer's disease, improved some cognitive skills in patients with mild AD - skills that are necessary for driving. Findings from the study showed that after being treated with a ChEI, AD patients improved in some computerized tests of executive function and visual attention, including a simulated driving task.

10 Jun 2010

NICE decides not to recommend lapatinib for women with advanced breast cancer

The National Institute for Health and Clinical Excellence has decided not to recommend the oral drug lapatinib (Tyverb) for women with advanced breast cancer, except for use in clinical trials.

10 Jun 2010

FDA approves Roxane Laboratories' Valacyclovir Hydrochloride Tablets ANDA

Roxane Laboratories, Inc. announced today the Abbreviated New Drug Application (ANDA) approval of Valacyclovir Hydrochloride Tablets 500mg and

10 Jun 2010

Intellect Neurosciences receives Notice of Allowance from Israeli patent office for OXIGON drug candidate

Intellect Neurosciences, Inc announced it has received a Notice of Allowance from the Israeli Patent and Trademark Office for a new patent related to the Company's clinical-stage drug candidate OX1 (OXIGON), which has disease-modifying potential for Alzheimer's and other neurodegenerative disorders.

9 Jun 2010

NWBT announces release of new detailed report by Pharmaceuticals and Biotech Analyst

Northwest Biotherapeutics, Inc., developer of the DCVax personalized cancer vaccine, today announced the release of a new detailed report by Pharmaceuticals and Biotech Analyst Dr. Navid Malik of the London-based Matrix Group.

9 Jun 2010

Some commonly used drugs cause bone loss: New research

New research helps to explain why some commonly used drugs come with a serious downside: They up your odds of breaking a bone. The drugs in question, glucocorticoids (e.g. cortisone and prednisone) and the insulin sensitizer rosiglitazone work through entirely different mechanisms as therapies for inflammatory diseases and diabetes respectively, and two studies in the June issue of Cell Metabolism now show that they lead to bone loss in different ways too.

9 Jun 2010

Impax reaches agreement with Endo and Penwest to settle pending litigation for OPANA ER

Impax Laboratories, Inc. today announced that it has reached agreement with Endo Pharmaceuticals and Penwest Pharmaceuticals to settle pending U.S. litigation with regard to the production and sale of generic formulations of OPANA ER (oxymorphone hydrochloride) Extended Release tablets.

9 Jun 2010

Pharmaceutical News

EC approves Nivestim for prevention of FN

CPL Biologicals completes construction of vaccine facility in Dholka, India

Onset Therapeutics expands sales force by over 50% in 2010

PAREXEL experts to present on biopharmaceutical industry issues at 46th DIA

Periogenix to be introduced at International Symposium for Periodontics & Restorative Dentistry

Extensive usage of antibiotic linezolid associated with ICU outbreak of LRSA

Human Genome Sciences submits BLA for BENLYSTA to FDA

New study finds propofol poses low risk for children undergoing research-driven imaging studies

UC emergency medicine assistant professor compares efficacy of two seizure medications to prevent SE

MonoSol Rx, APR expand film formulation development collaboration

Effectiveness of combination band ligation and nadolol for first variceal bleeding not established

SGS announces total package testing solution for medical device, pharma product manufacturers

Ontario Pharmacists' Association disappointed with government's regulatory changes

Study: ChEI improves driving skills in patients with mild AD

NICE decides not to recommend lapatinib for women with advanced breast cancer

FDA approves Roxane Laboratories' Valacyclovir Hydrochloride Tablets ANDA

Intellect Neurosciences receives Notice of Allowance from Israeli patent office for OXIGON drug candidate

NWBT announces release of new detailed report by Pharmaceuticals and Biotech Analyst

Some commonly used drugs cause bone loss: New research

Impax reaches agreement with Endo and Penwest to settle pending litigation for OPANA ER

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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