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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

Cutting Edge Information hopes to see ill patients have speedier access to potential cures

The FDA has approved the first set of vaccines aimed at preventing H1N1 infection after an approval process of less than four months. Cutting Edge Information is currently analyzing the lessons learned that may emerge for both the Food and Drug Administration (FDA) and life science firms after this crisis experience.

1 Oct 2009

USPTO allows BioMarin's claims covering the approved administration of sapropterin dihydrochloride with food

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the United States Patent and Trademark Office has allowed claims covering the approved administration of Kuvan® (sapropterin dihydrochloride) with food, based on the discovery that food increases the bioavailability of Kuvan. The company expects that the patent, which expires in 2024, will officially issue later this year.

1 Oct 2009

Drug companies take immediate measures to deliver millions of H1N1 vaccines

Drug companies are sprinting ahead in a race against the clock to deliver millions of doses of vaccine for the H1N1 influenza virus before cooler weather ushers in the 2009-2010 flu season. A two-part cover story in the current issue of Chemical & Engineering News, ACS' weekly newsmagazine, focuses on that topic and efforts to develop antiviral drugs for flu infections.

1 Oct 2009

FDA completes inspection of Hovione's API plant in Loures, Portugal

Hovione's API plant in Loures, Portugal has just successfully passed a pre-approval inspection by FDA

1 Oct 2009

Researchers stress the importance of ensuring quality psychiatric treatment in general practice settings

Fifty-nine percent of all prescriptions filled for psychotropic medications are written by general practitioners, according to a research report published this month in Psychiatric Services.

1 Oct 2009

Medicaid members to receive cover for administration cost of the H1N1 vaccine from WellCare

WellCare Health Plans, Inc. (NYSE: WCG) announced it will cover the full cost of administration of the H1N1 vaccine as a preventative care benefit for Medicare Advantage, Medicare private fee-for-service (PFFS) and Medicaid plan members when it becomes available to the public.

1 Oct 2009

Bristol-Myers announces availability of ERBITUX for metastatic colorectal cancer treatment

Bristol-Myers Squibb Canada is pleased to announce that the Ontario government has made ERBITUX(TM) (cetuximab) available to patients suffering from metastatic colorectal cancer. This decision makes Ontario the second province, after British Columbia, to introduce funding for this important treatment option and represents encouraging news for those patients who rely on provincial drug coverage and stopped responding to standard treatments for metastatic colon cancer.

1 Oct 2009

Pharmaceutical News

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

Cutting Edge Information hopes to see ill patients have speedier access to potential cures

USPTO allows BioMarin's claims covering the approved administration of sapropterin dihydrochloride with food

Drug companies take immediate measures to deliver millions of H1N1 vaccines

FDA completes inspection of Hovione's API plant in Loures, Portugal

Researchers stress the importance of ensuring quality psychiatric treatment in general practice settings

Medicaid members to receive cover for administration cost of the H1N1 vaccine from WellCare

Bristol-Myers announces availability of ERBITUX for metastatic colorectal cancer treatment

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