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Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis.

19 Oct 2009

Vaccinations and preventative hygiene routines can help protect families from H1N1

According to the Centers for Disease Control and Prevention (CDC), 37 states in the U.S. now report widespread influenza activity - and nearly all influenza cases reported to the health authority are 2009 H1N1, also known as swine flu. However, with the release of a 2009 H1N1 vaccine this week, parents have a new preventative tool to help keep their families safe from illness.

19 Oct 2009

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Quotient Biodiagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its biologics license application (BLA) for the first 15 monoclonal antibodies in its proprietary line of transfusion diagnostics. These products are for use by blood donor centers, reference laboratories, and hospitals to type and screen blood.

19 Oct 2009

Viriom picks ChemDiv's Russian subsidiary for development of innovative HIV compounds

ChemDiv, Inc. of San Diego has proudly announced that its wholly owned subsidiary Chemical Diversity Research Institute (CDRI ) of Moscow, Russia, has been chosen by Viriom Ltd. ( Viriom) of Moscow, Russia as a service partner in developing innovative HIV compounds. The program includes pre-clinical and clinical studies, which are expected to begin in 2010.

19 Oct 2009

Talecris Biotherapeutics' PROLASTIN-C receives FDA approval

Talecris Biotherapeutics (Nasdaq: TLCR) today received approval from the U.S. Food and Drug Administration for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology.

19 Oct 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

Human Genome Sciences completes Phase 3 development program, earns $75 million from Novartis

Human Genome Sciences, Inc. today announced that it has earned a $75 million milestone payment from Novartis, related to successful completion of the Phase 3 development program and the decision to submit applications seeking regulatory approval to market ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C.

19 Oct 2009

IAVI and Ragon Institute sign MOU to devise new vaccine strategies for AIDS

The International AIDS Vaccine Initiative (IAVI) announced today that it has signed a memorandum of understanding with the Ragon Institute to accelerate the development of new and promising AIDS vaccine candidates for testing.

19 Oct 2009

Lubricin injections can reduce cartilage degeneration

Medical researchers will report findings today (Oct. 19) that demonstrate that injecting the protein lubricin into knee joints can dramatically reduce cartilage degeneration.

19 Oct 2009

Preclinical data of carfilzomib and PR-957 inhibitors to be presented at 2009 ACR/ARHP meeting

Proteolix, Inc. today announced that data from preclinical studies of carfilzomib and PR-957 will be presented at the 2009 ACR/ARHP Annual Scientific Meeting on October 16 - 21 in Philadelphia, PA.

19 Oct 2009

Majority of girls and young women well aware of HPV vaccine's benefits and limitations

Contrary to concerns that the human papillomavirus vaccine might promote promiscuity, a national survey of girls and young women found that the majority of respondents did not believe the HPV vaccine protected them against other sexually transmitted infections.

19 Oct 2009

NCCN Clinical Practice Guidelines in Oncology updated to include pralatrexate drug

NCCN has added pralatrexate (Folotyn(TM), Allos Therapeutics, Inc.) to the NCCN Guidelines for Non-Hodgkin's Lymphomas as one of the options for second-line therapy for relapsed or refractory peripheral T-cell lymphoma.

19 Oct 2009

Parents are concerned about the overuse of prescription medications with their children: Survey

A new nationwide survey released today reveals that just 12 percent of parents with children under the age of 18 have spoken to their child's doctor about complementary and integrative approaches to medicine, yet nearly 90 percent say they want to know more.

19 Oct 2009

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC® (febuxostat) treatment.

19 Oct 2009

Research study on cowpox virus

In the annals of medicine, Edward Jenner's 1796 vaccination of a young boy against smallpox, using fluid from cowpox blisters, remains a landmark case. In a new study, Kathryn Sykes, a researcher at Arizona State University's Biodesign Institute and her colleagues have taken a fresh look at cowpox.

19 Oct 2009

Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

19 Oct 2009

FDA approves continuation of the fourth 6-month open label extension of PRX-03140

The FDA has approved a Physician-Sponsored IND and continuation of the fourth 6-month open label extension of PRX-03140, a novel 5HT4 partial agonist for the potential treatment of Alzheimer's Disease. The patient was enrolled initially in a two week Phase 2a study in August 2007 where she received 100 mg per day of PRX-03140 in combination with her normal daily dose of Aricept(10 mg).

19 Oct 2009

Antibiotic resistance to be undesirable consequence of antibiotic abuse is inaccurate, reveals report

The perception that antibiotic resistance is primarily the undesirable consequence of antibiotic abuse or misuse is a view that is simplistic and inaccurate, according to a recent report by the American Academy of Microbiology. The reasons behind the spread of resistance are much more complex, including appropriate antibiotic use, lack of proper sanitation and hygiene, and even the environment.

19 Oct 2009

Government closely monitors swine flu vaccine

The government is closely monitoring the safety of the new H1N1 swine flu vaccine amid people's concerns.

19 Oct 2009

Novel HIV drug to be studied in cell cultures and patients

A $6 million, five-year federal grant to The Children's Hospital of Philadelphia Research Institute will enable researchers to investigate a novel approach in treating HIV infection---a unique class of drugs focused on developing therapies for psychological and neurological effects in AIDS.

19 Oct 2009

Pharmaceutical News

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Vaccinations and preventative hygiene routines can help protect families from H1N1

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Viriom picks ChemDiv's Russian subsidiary for development of innovative HIV compounds

Talecris Biotherapeutics' PROLASTIN-C receives FDA approval

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

Human Genome Sciences completes Phase 3 development program, earns $75 million from Novartis

IAVI and Ragon Institute sign MOU to devise new vaccine strategies for AIDS

Lubricin injections can reduce cartilage degeneration

Preclinical data of carfilzomib and PR-957 inhibitors to be presented at 2009 ACR/ARHP meeting

Majority of girls and young women well aware of HPV vaccine's benefits and limitations

NCCN Clinical Practice Guidelines in Oncology updated to include pralatrexate drug

Parents are concerned about the overuse of prescription medications with their children: Survey

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

Research study on cowpox virus

Rituxan's sBLA receives a Complete Response from the FDA

FDA approves continuation of the fourth 6-month open label extension of PRX-03140

Antibiotic resistance to be undesirable consequence of antibiotic abuse is inaccurate, reveals report

Government closely monitors swine flu vaccine

Novel HIV drug to be studied in cell cultures and patients

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