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106m infants worldwide received vaccines last year, coverage gaps remain, report says

A joint report by the WHO, UNICEF and the World Bank on worldwide vaccination efforts released Wednesday found "a record 106 million infants were vaccinated last year against life-threatening diseases, but nearly a fifth of the world's babies still are not protected fully," the Associated Press reports.

22 Oct 2009

EMEA informs Antigenics on a negative opinion for Oncophage MAA

Antigenics Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), has verbally informed the Company at an oral meeting to anticipate a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) in early-stage, localized renal cell carcinoma (kidney cancer).

21 Oct 2009

Lux Biosciences to present on LX211 at 2009 AAO annual conference

Lux Biosciences, Inc., a privately held biotechnology company focused on the development and commercialization of therapies for serious ophthalmic diseases, today announced that the company’s experimental drug LX211 (LUVENIQ; oral voclosporin) will be featured in several presentations at the 2009 American Academy of Ophthalmology annual conference and American Uveitis Society meeting being held October 24-26 in San Francisco.

21 Oct 2009

Swine flu vaccines arrive at health departments, hospitals and community vaccinator facilities

The Swine Flu (H1N1)Vaccine is starting to arrive at health departments, hospitals, and community vaccinator facilities.

21 Oct 2009

Novavax, Xcellerex enter into collaboration to accelerate the development of Novavax's 2009 H1N1 vaccine

Novavax, Inc. and Xcellerex, Inc. have entered into a strategic collaboration to accelerate the development of Novavax's vaccine manufacturing process to commercial scale and begin immediate production of Novavax's novel 2009 H1N1 influenza vaccine for potential commercial sale.

21 Oct 2009

FDA grants Fast Track designation for MacuSight's Perceiva

MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today announced that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for Perceiva, the company's proprietary ocular sirolimus product, for the treatment of diabetic macular edema (DME).

21 Oct 2009

Shire to file a Biologics License Application for REPLAGAL with the FDA

Shire plc, the global specialty biopharmaceutical company, announces plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease, by the end of the year.

21 Oct 2009

King Pharmaceuticals receives FDA complete response letter for CorVue NDA

King Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for CorVue™ (binodenoson) for injection.

21 Oct 2009

Purdue Pharma supports government prescription drug monitoring programs, grants NASCSA $200,000

The National Association of State Controlled Substances Authorities (NASCSA) announced receipt of a $200,000 grant from Purdue Pharma L.P. today at the organization's 25th annual conference in San Diego. The grant is part of Purdue Pharma's ongoing efforts to support the operation, expansion and awareness of appropriately-designed state prescription drug monitoring programs, which can be an effective tool to address prescription drug abuse and diversion.

21 Oct 2009

Study of aldosterone antagonist usage among patients hospitalised with heart failure published

A study published today in JAMA (October 21) by Nancy M. Albert and colleagues, exploring aldosterone antagonist usage among US patients hospitalised with heart failure, found that only one-third of patients meeting current US Clinical Practice Guidelines criteria were actually being treated.

21 Oct 2009

Interim report from Medivir

Medivir designated another candidate drug (CD), MIV-711 in its osteoporosis portfolio, thus enhancing its commercial opportunities.

21 Oct 2009

Oxygen Biotherapeutics announces its expanded product development plan

Oxygen Biotherapeutics, Inc. announced its expanded product development plan.

21 Oct 2009

APP Pharmaceuticals to launch Chlorothiazide Sodium for Injection

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Chlorothiazide Sodium for Injection, USP. APP expects to launch Chlorothiazide Sodium for Injection, USP in the fourth quarter of 2009.

21 Oct 2009

Palmerolide A: Real hope for cancer treatment

A targeted chemotherapy for the treatment of skin cancer is one step closer, after a team of University of Alberta researchers successfully synthesized a natural substance that shows exceptional potential to specifically treat this often fatal disease.

21 Oct 2009

Interim study analysis comparing MENOPUR with rFSH in GnRH Antagonist IVF cycles

Ferring Pharmaceuticals presented an interim study analysis indicating that MENOPUR® (menotropins for injection, USP) is effective in in vitro fertilization (IVF) cycles using a gonadotropin-releasing hormone (GnRH) antagonist. The results were presented in a poster at the 65th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Atlanta, October 17-21, 2009.

21 Oct 2009

D2 Pharma Consulting develops "REMS Challenges and Real World Solutions" White Paper

D2 Pharma Consulting LLC (D2) is a best-in-class national consulting company that works with pharmaceutical and biotech manufacturers on the implementation of REMS compliant distribution programs, in addition to other commercialization activities. D2 structures REMS distribution programs on behalf of their clients that leverage supply chain efficiencies while complying with FDA mandates.

21 Oct 2009

Drug abuse expert Dr. Drew Pinsky and the Five Moms join in fight against OTC cough medicine abuse

Dr. Drew Pinsky, a nationally renowned drug abuse expert, and the Five Moms, five exceptional women dedicated to spreading the word about the dangers of cough medicine abuse, are speaking out to educate parents and congressional staff on Capitol Hill about the issue of over-the-counter (OTC) cough medicine abuse among teens and how to prevent it through education.

21 Oct 2009

NIH grant for Lpath to advance clinical development of its antibody therapeutics

The National Cancer Institute's Small Business Innovation Research (SBIR) Program has awarded Lpath (OTCBB: LPTN), the category leader in lipidomics-based therapeutics, two Phase 1 grants totaling $0.3 million. This follows a series of other SBIR grants awarded to Lpath totaling $6.9 million, including a $3.0 million Phase 2 bridge grant from the NCI awarded this past June.

21 Oct 2009

No significant differences in pregnancy outcomes with different progesterone formulations

A retrospective analysis, conducted at a large infertility clinic between January 2003 and December 2008, demonstrated that there were no significant differences in pregnancy outcomes with three different progesterone formulations for women aged 35 to 40 undergoing in vitro fertilization-embryo transfer (IVF-ET) procedures. These data were presented at the American Society for Reproductive Medicine (ASRM) annual meeting in Atlanta.

21 Oct 2009

Research shows exon-skipping drug may prove effective for treating Duchenne muscular dystrophy

An exon skipping PPMO has demonstrated dramatic effects in the prevention and treatment of severely affected, dystrophin and utrophin-deficient mice, preventing severe deterioration of the treated animals and extending their lifespan.

21 Oct 2009

Pharmaceutical News

106m infants worldwide received vaccines last year, coverage gaps remain, report says

EMEA informs Antigenics on a negative opinion for Oncophage MAA

Lux Biosciences to present on LX211 at 2009 AAO annual conference

Swine flu vaccines arrive at health departments, hospitals and community vaccinator facilities

Novavax, Xcellerex enter into collaboration to accelerate the development of Novavax's 2009 H1N1 vaccine

FDA grants Fast Track designation for MacuSight's Perceiva

Shire to file a Biologics License Application for REPLAGAL with the FDA

King Pharmaceuticals receives FDA complete response letter for CorVue NDA

Purdue Pharma supports government prescription drug monitoring programs, grants NASCSA $200,000

Study of aldosterone antagonist usage among patients hospitalised with heart failure published

Interim report from Medivir

Oxygen Biotherapeutics announces its expanded product development plan

APP Pharmaceuticals to launch Chlorothiazide Sodium for Injection

Palmerolide A: Real hope for cancer treatment

Interim study analysis comparing MENOPUR with rFSH in GnRH Antagonist IVF cycles

D2 Pharma Consulting develops "REMS Challenges and Real World Solutions" White Paper

Drug abuse expert Dr. Drew Pinsky and the Five Moms join in fight against OTC cough medicine abuse

NIH grant for Lpath to advance clinical development of its antibody therapeutics

No significant differences in pregnancy outcomes with different progesterone formulations

Research shows exon-skipping drug may prove effective for treating Duchenne muscular dystrophy

How does norepinephrine influence anxiety-related behaviours?

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

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