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Elan, Biogen Idec submit applications to FDA and EMA for updation of TYSABRI labels

Today Biogen Idec and Elan Corporation, plc announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI (natalizumab) labels.

16 Jan 2013

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

GE Healthcare today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility.

16 Jan 2013

Janssen receives EC approval for PREZISTA 800mg tablet to treat HIV

Janssen R&D Ireland announced today that the European Commission (EC) has approved a new PREZISTA (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day.

16 Jan 2013

Zimbabwe continues to face medicine shortages, stock-outs, PlusNews reports

"Chronic shortages of generic and antiretroviral drugs, stock-outs, high medication costs, and long distances to clinics are some of the hurdles people face in their quest to access essential medicines in Zimbabwe," PlusNews reports.

16 Jan 2013

FDA approves Santarus’ UCERIS for induction of remission in patients with ulcerative colitis

Santarus, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

16 Jan 2013

CHOP to study antibiotic delivery to children after hospitalization for serious bacterial infection

The Children's Hospital of Philadelphia (CHOP) was awarded nearly $2M in research funding from the Patient-Centered Outcomes Research Institute (PCORI) to study antibiotic delivery to children returning home after hospitalization for a severe bacterial infection.

16 Jan 2013

Experimental vaccine elicits antibodies that can protect against Ebola virus infection

Researchers at the National Institutes of Health (NIH) and Oregon Health & Science University (OHSU) have found that an experimental vaccine elicits antibodies that can protect nonhuman primates from Ebola virus infection.

16 Jan 2013

Patients with Parkinson's develop artistic talents after dopamine-inducing therapy

Parkinson's experts across the world have been reporting a remarkable phenomenon - many patients treated with drugs to increase the activity of dopamine in the brain as a therapy for motor symptoms such as tremors and muscle rigidity are developing new creative talents, including painting, sculpting, writing, and more.

16 Jan 2013

Pfizer’s Quillivant XR now available in the U.S. for treatment of ADHD

Pfizer Inc. today announced that Quillivant XR (methylphenidate hydrochloride) CII for extended-release oral suspension is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD).

16 Jan 2013

Diospyrin inactivates a drug target for tuberculosis in new way

A compound from the South African toothbrush tree inactivates a drug target for tuberculosis in a previously unseen way.

16 Jan 2013

Over-expression of NEK2 in cancer cells significantly enhances drug resistance

Increased NEK2 gene expression linked to increased drug resistance, faster cancer growth, and poorer patient outcome - The finding may improved diagnostic and prognostic tools for cancer care and could lead to improved cancer therapies

16 Jan 2013

Children with chronic medical conditions more likely to use alternative medicine

Children who regularly see specialists for chronic medical conditions are also using complementary medicine at a high rate, demonstrates recently published research from the University of Alberta and the University of Ottawa.

15 Jan 2013

Multidisciplinary team work on proactive approach to flu vaccine design

An internationally recognized expert in viruses, Robert W. Finberg, MD, the Richard M. Haidack Professor of Medicine and chair and professor of medicine at the University of Massachusetts Medical School, is lead investigator on a $12 million project to develop new ways of predicting how the influenza virus changes and evolves in response to anti-viral drugs and the human immune system. This approach has promise for becoming a pivotal tool in creating a more effective vaccine against the virus.

11 Jan 2013

Additional insights into workings of ALVAC vaccine against HIV

Four years ago, a potential HIV vaccine showed promise against the virus that causes AIDS, but it fell short of providing the broad protection necessary to stem the spread of disease.

11 Jan 2013

Fiscal cliff boosts clinical data registries, but cuts some health care payments

CQ HealthBeat reports on a provision of the fiscal cliff law intended to encourage physicians to submit data to registries that could be a tool to promote better quality care. The Medicare NewsGroup analyzes another provision that changes how payments are calculated for end stage renal disease drugs.

11 Jan 2013

UCSF teams to study new ways to reduce childhood mortality and disease in developing nations

Two UCSF teams have received a total of $16 million from the Bill & Melinda Gates Foundation to study new ways to significantly reduce childhood mortality and disease in developing nations.

11 Jan 2013

Melanomas that develop resistance to vemurafenib also become addicted to the drug

Researchers in California and Switzerland have discovered that melanomas that develop resistance to the anti-cancer drug vemurafenib (marketed as Zelboraf), also develop addiction to the drug, an observation that may have important implications for the lives of patients with late-stage disease.

11 Jan 2013

Cholera could be contained in Haiti by vaccinating less than half the population

Cholera could be contained in Haiti by vaccinating less than half the population, University of Florida researchers suggest in a paper to be published Thursday in the journal Scientific Reports.

11 Jan 2013

FDA requires sleep drugs that contain zolpidem to lower recommended doses

The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics.

11 Jan 2013

New guidelines to help fast track radiation oncology drug development

Researchers from the translational research program of the National Cancer Institute and the Radiation Therapy Oncology Therapy Group have developed new guidelines to help fast track the clinical development of targeted cancer drugs in combination with radiation therapy.

11 Jan 2013

Pharmaceutical News

Elan, Biogen Idec submit applications to FDA and EMA for updation of TYSABRI labels

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

Janssen receives EC approval for PREZISTA 800mg tablet to treat HIV

Zimbabwe continues to face medicine shortages, stock-outs, PlusNews reports

FDA approves Santarus’ UCERIS for induction of remission in patients with ulcerative colitis

CHOP to study antibiotic delivery to children after hospitalization for serious bacterial infection

Experimental vaccine elicits antibodies that can protect against Ebola virus infection

Patients with Parkinson's develop artistic talents after dopamine-inducing therapy

Pfizer’s Quillivant XR now available in the U.S. for treatment of ADHD

Diospyrin inactivates a drug target for tuberculosis in new way

Over-expression of NEK2 in cancer cells significantly enhances drug resistance

Children with chronic medical conditions more likely to use alternative medicine

Multidisciplinary team work on proactive approach to flu vaccine design

Additional insights into workings of ALVAC vaccine against HIV

Fiscal cliff boosts clinical data registries, but cuts some health care payments

UCSF teams to study new ways to reduce childhood mortality and disease in developing nations

Melanomas that develop resistance to vemurafenib also become addicted to the drug

Cholera could be contained in Haiti by vaccinating less than half the population

FDA requires sleep drugs that contain zolpidem to lower recommended doses

New guidelines to help fast track radiation oncology drug development

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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