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Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

Takeda Global Research & Development Center, Inc., (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing their submission of a New Drug Application (NDA) for vortioxetine for the treatment of major depressive disorder (MDD) in adult patients.

13 Dec 2012

New diagnostic assay for screening ALK fusions in non-small cell lung carcinoma

Approximately one in 20 patients with non-small cell lung carcinoma (NSCLC) has chromosomal aberrations targeting the anaplastic lymphoma kinase (ALK) gene. This has considerable implications for treatment because these patients are highly responsive to ALK-specific kinase inhibitors such as crizotinib.

From NanoString Technologies 13 Dec 2012

Viewpoints: Pelosi says higher Medicare age 'doesn't work;' Marketplace's clout could lower seniors' drug costs

In the talks to avert the fiscal cliff, the idea of raising the Medicare age is central to the Republican proposal. There's just one critical problem: It doesn't work. It doesn't have public support. It's unfair. And it doesn't lower health expenditures. Such a proposal is a reflection of the broader Republican plan: an assault on the middle class, seniors -- and our future.

12 Dec 2012

TKI-resistant human leukemia stem cells are the source of genomic instability

An international team of scientists, led by researchers from Temple University School of Medicine, has found that a source of mounting genomic chaos, or instability, common to chronic myeloid leukemia (CML) may lie in a pool of leukemia stem cells that are immune to treatment with potent targeted anticancer drugs.

12 Dec 2012

Review describes current state of lung cancer care

A review in the December issue of the journal Archives of Pathology & Laboratory Medicine by Paul Bunn Jr, MD, University of Colorado Cancer Center investigator and past president of ASCO, IASLC and AACI describes the current state of lung cancer care.

12 Dec 2012

FDA grants Orphan Drug designation to Milo Biotechnology's AAV1-FS344 inhibitor

Milo Biotechnology today announced its AAV1-FS344 has been granted Orphan Drug designation from the FDA's Office of Orphan Products Development for treatment of Becker and Duchenne muscular dystrophy. AAV1-FS344 is a gene therapy-delivered myostatin inhibitor that increases muscle strength.

12 Dec 2012

Drugs that bind to specific serotonin receptors can improve and impair female sexual function

Drugs that bind to specific serotonin receptors in the brain can both improve and impair female sexual function in non-human primates.

12 Dec 2012

Industry sponsored clinical trials present a more favourable picture of reported findings

Studies reporting the results of industry sponsored clinical trials present a more favourable picture of the effects of drugs and medical devices than those reporting on non-industry sponsored trials, according to a new Cochrane systematic review. The researchers call for a rethink of the way that industry bias is handled in medical guidelines and reviews.

12 Dec 2012

New collaborative model for drug discovery can ensure antibiotics are not lost to resistance

Noting "multidrug-resistant organisms are showing up in top-flight hospitals" around the world, Carl Nathan, chair of the department of microbiology and immunology at Weill Cornell Medical College, writes in this New York Times opinion piece, "What makes the rapid loss of antibiotics to drug resistance particularly alarming is that we are failing to make new ones."

12 Dec 2012

Low prices for life-saving products may increase perception of risk among consumers

Consumers assume their risk of getting a serious illness is higher when medications are cheaper because they believe that prices for life-saving products are based on need and not profit, according to a new study in the Journal of Consumer Research.

12 Dec 2012

Blocking myeloid-derived suppressor cells after lymphopenia improves adoptive T-cell therapy

Researchers at the Moffitt Cancer Center have found that delayed tumor growth and enhanced survival of mice bearing melanoma were possible by blocking the reconstitution of myeloid-derived suppressor cells and Tregs (suppressors of anti-tumor activity) after total body irradiation had eliminated them. Blocking myeloid-derived suppressor cells and regulatory T-cell reconstitution improved adoptive T-cell therapy, an immunotherapy designed to suppress tumor activity.

12 Dec 2012

Drugs for Neglected Diseases receives UNITAID grant for paediatric HIV programme

The Drugs for Neglected Diseases initiative welcomes the announcement by UNITAID to grant up to USD 17.3 million to the organization for its paediatric HIV programme.

12 Dec 2012

AC253 drug appears to restore memory in Alzheimer's brain cells

Medical researchers at the University of Alberta have discovered a drug intended for diabetes appears to restore memory in Alzheimer's brain cells.

11 Dec 2012

Lotus Pharmaceutical submits generic Xenical ANDA with FDA

Lotus Pharmaceutical Company Inc. has confirmed its submission of Abbreviated New Drug Application for Orlistat capsules, a generic version of Xenical, to the US Food and Drug Administration (FDA).

11 Dec 2012

Pfizer's PD0325901 experimental drug blocks untreatable NF1 tumors

Researchers conducting a preclinical study in mice successfully used targeted molecular therapy to block mostly untreatable nerve tumors that develop in people with the genetic disorder Neurofibromatosis 1 (NF1).

11 Dec 2012

Janssen announces U.S. prescribing information update for EDURANT tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies, which evaluated the efficacy and safety of EDURANT for the treatment of human immunodeficiency virus type 1 (HIV-1) in antiretroviral treatment-naive adults.

11 Dec 2012

Vaccines serve as 'engine for economic growth'

Vaccines "save lives by protecting people against disease," but they "also are an engine for economic growth -- far beyond their health benefits," GAVI Alliance CEO Seth Berkley writes in a CNN opinion piece.

11 Dec 2012

Naltrexone may help avoid weight gain among women smokers

A medication being tested to help smokers kick the habit also may help avoid the weight gain that is common after quitting but only in women, according to a study published in the December issue of Biological Psychiatry. This is the first medication shown to reduce weight gain for up to one year in women smokers who quit.

11 Dec 2012

SCOTUS agrees to hear 'pay-for-delay' drug case

The Supreme Court will hear arguments on the legality of drug companies paying their generic-making counterparts to keep generic drugs -- in this case, a testosterone gel -- off the market.

11 Dec 2012

Weill Cornell research team develops new experimental drug therapy to target DLBCL

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin's lymphoma and the seventh most frequently diagnosed cancer. The most chemotherapy resistant form of DLBCL, called activated B-cell - DLBCL (ABC-DLBCL), remains a major therapeutic challenge.

11 Dec 2012

Pharmaceutical News

Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

New diagnostic assay for screening ALK fusions in non-small cell lung carcinoma

Viewpoints: Pelosi says higher Medicare age 'doesn't work;' Marketplace's clout could lower seniors' drug costs

TKI-resistant human leukemia stem cells are the source of genomic instability

Review describes current state of lung cancer care

FDA grants Orphan Drug designation to Milo Biotechnology's AAV1-FS344 inhibitor

Drugs that bind to specific serotonin receptors can improve and impair female sexual function

Industry sponsored clinical trials present a more favourable picture of reported findings

New collaborative model for drug discovery can ensure antibiotics are not lost to resistance

Low prices for life-saving products may increase perception of risk among consumers

Blocking myeloid-derived suppressor cells after lymphopenia improves adoptive T-cell therapy

Drugs for Neglected Diseases receives UNITAID grant for paediatric HIV programme

AC253 drug appears to restore memory in Alzheimer's brain cells

Lotus Pharmaceutical submits generic Xenical ANDA with FDA

Pfizer's PD0325901 experimental drug blocks untreatable NF1 tumors

Janssen announces U.S. prescribing information update for EDURANT tablets

Vaccines serve as 'engine for economic growth'

Naltrexone may help avoid weight gain among women smokers

SCOTUS agrees to hear 'pay-for-delay' drug case

Weill Cornell research team develops new experimental drug therapy to target DLBCL

Exploring the nanoscale: How AFM is transforming cosmetic science

Innovating Texture and Culture in Plant-Based Foods

Advancing brain microphysiological systems (bMPS)

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