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ALL initiative three-year clinical observational study results published

A program that bundled two generic, low-cost drugs - a cholesterol-lowering statin and a blood pressure-lowering drug - and gave daily doses to 68,560 people with diabetes or heart disease for two years is estimated to have prevented 1,271 heart attacks and strokes in the first year following the study period, according to a Kaiser Permanente study published online in the American Journal of Managed Care.

3 Oct 2009

New study underscores lack of appropriate government action to ensure safety of vaccines

A new study in the leading scientific journal NeuroToxicology lends further credence to parents and scientists concerned about an increasingly aggressive childhood vaccine schedule and toxic vaccine components.

2 Oct 2009

Array BioPharma to present poster on ARRY-403 glucokinase activator

Array BioPharma Inc. today announced that a poster on ARRY-403, a novel, oral, glucokinase activator (GKA), will be presented at the European Association for the Study of Diabetes annual meeting, on October 2, 2009, in Vienna, Austria.

2 Oct 2009

Molecular mechanisms of BN108 and timosaponin AIII described in a journal

Bionovo, Inc. today announced the publication in the peer-reviewed, open-access journal Public Library of Science One (PLoS ONE) of a paper describing the molecular mechanisms underlying the selective cytotoxic activity of its drug candidate BN108 and its active compound, timosaponin AIII.

2 Oct 2009

sNDA for Clonicel submitted to the FDA

Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

2 Oct 2009

Clinical study results demonstrate the efficacy of AFRESA inhalation powder

AFRESA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, showed no significant changes in pulmonary function and sustained glycemic control in adult patients with type 2 diabetes over four years of continuous treatment, according to data presented today at the 45th Annual Meeting of the European Association for the Study of Diabetes.

2 Oct 2009

Change in Heparin manufacturing - expected to decrease the potency

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

1 Oct 2009

Actavis' clients launch generic Atorvastatin in Spain

Actavis Group, the international generic pharmaceuticals company, today announced that its third-party sales division, Medis, has delivered 30 million tablets of Atorvastatin to its clients in Spain. This is the first generic version of the blockbuster molecule to reach the Spanish market.

1 Oct 2009

Mayo study reveals infliximab reduces the need for colectomy

A new study led by Mayo Clinic researchers has found that ulcerative colitis patients had a 41 percent reduction in colectomy after a year when treated with infliximab, according to a study published in the October 2009 issue of Gastroenterology.

1 Oct 2009

HRA Pharma launches its new generation emergency contraceptive in Europe

HRA Pharma (http://www.hra-pharma.com), a privately-held, European pharmaceutical company that designs products, devices and supporting services in reproductive health and endocrinology, announced today that ellaOne(R) (ulipristal acetate, 30mg), its new generation emergency contraceptive, has been launched in France, Germany and the United Kingdom via local HRA teams. HRA Pharma will progressively launch ellaOne in all European countries over the coming months.

1 Oct 2009

GSK allowed access to DiscoveRx' PathHunter ß-Arrestin parental cell lines and reagents

DiscoveRx Corp. announced today the signing of a global agreement with GSK, a leading pharmaceutical company, to provide access to its PathHunter™ ß-Arrestin parental cell lines, clones and associated reagents for use in GSK’s internal GPCR Screening and Profiling efforts.

1 Oct 2009

Advaxis announces Phase I trial results of its ADXS11-001 therapeutic cancer vaccine

The Phase I trial of ADXS11-001, the lead vaccine candidate of Advaxis, Inc. (OTCBB: ADXS), the company that pioneered the live, attenuated Listeria monocytogenes (Lm) vaccine, has shown thirty-six (36) month survival in three (3) of the thirteen (13) evaluable patients treated with Advaxis’ therapeutic cancer vaccine, indicating the possibility of persistent immune protection.

1 Oct 2009

First prescription foam formulation of benzoyl peroxide available

Onset Therapeutics, a specialty pharmaceutical company focused on dermatology, announced today the commercial availability of BenzEFoam (benzoyl peroxide) 5.3% Emollient Foam, the first prescription foam formulation of benzoyl peroxide.

1 Oct 2009

Health Canada approves VIBATIV for treating complicated skin and skin structure infections

Astellas Pharma Canada, Inc. announced today that Health Canada has approved VIBATIV(TM) (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

1 Oct 2009

Addrenex submits a sNDA to the FDA for Clonicel

Sciele Pharma, Inc., a Shionogi company, and Addrenex Pharmaceuticals today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

1 Oct 2009

Diamyd Medical signs agreement with Inclinix to conduct global Phase III program

Diamyd Medical announces today that the company has signed an agreement with Inclinix Inc., North Carolina, for accelerated recruitment of children and adolescents recently diagnosed with type 1 diabetes in the US Phase III study of the diabetes vaccine Diamyd(R).

1 Oct 2009

Scientific Advisory Board to provide guidance to support the development of FST-100

Foresight Biotherapeutics announced today the formation of its scientific advisory board to provide guidance to the company for the development of it’s lead product FST-100, a novel formulation of dexamethasone that includes povidone-iodine. Foresight’s Scientific Advisory Board is comprised of leaders in the field of Ophthalmology.

1 Oct 2009

CVS Caremark to offer vouchers worth $3 million for free seasonal flu shots

With the unemployment rate currently at the highest in over two decades, CVS Caremark today announced it has begun to provide 100,000 free seasonal flu shots to the unemployed as part of its efforts to help keep Americans healthy this flu season. The initiative kicks off today at The Work Place, a member of the Massachusetts Career One-Stop Initiative in Boston.

1 Oct 2009

FDA releases first draft guidance on Risk Evaluation and Mitigation Strategies for select drugs

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

1 Oct 2009

Study aims to discover effective antibiotics to fight against hard-to-treat microbes

Scientists are reporting discovery of a much sought after crack in the armor of a common microbe that infects the stomachs of one-sixth of the world's population, causing stomach ulcers and other diseases. They identified a group of substances that block a key chemical pathway that the bacteria need for survival.

1 Oct 2009

Pharmaceutical News

ALL initiative three-year clinical observational study results published

New study underscores lack of appropriate government action to ensure safety of vaccines

Array BioPharma to present poster on ARRY-403 glucokinase activator

Molecular mechanisms of BN108 and timosaponin AIII described in a journal

sNDA for Clonicel submitted to the FDA

Clinical study results demonstrate the efficacy of AFRESA inhalation powder

Change in Heparin manufacturing - expected to decrease the potency

Actavis' clients launch generic Atorvastatin in Spain

Mayo study reveals infliximab reduces the need for colectomy

HRA Pharma launches its new generation emergency contraceptive in Europe

GSK allowed access to DiscoveRx' PathHunter ß-Arrestin parental cell lines and reagents

Advaxis announces Phase I trial results of its ADXS11-001 therapeutic cancer vaccine

First prescription foam formulation of benzoyl peroxide available

Health Canada approves VIBATIV for treating complicated skin and skin structure infections

Addrenex submits a sNDA to the FDA for Clonicel

Diamyd Medical signs agreement with Inclinix to conduct global Phase III program

Scientific Advisory Board to provide guidance to support the development of FST-100

CVS Caremark to offer vouchers worth $3 million for free seasonal flu shots

FDA releases first draft guidance on Risk Evaluation and Mitigation Strategies for select drugs

Study aims to discover effective antibiotics to fight against hard-to-treat microbes

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

Reducing polypharmacy through innovative drug formulation technologies

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