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FDA approves Stiefel’s Sorilux Foam sNDA to treat for scalp psoriasis

Stiefel, a GSK company, today announced that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) Foam, 0.005%. The sNDA expands the indication for Sorilux Foam to include the topical treatment of plaque psoriasis of the scalp in patients aged 18 years and older.

29 Sep 2012

Rapamycin can alleviate frontotemporal lobar degeneration

A southern Taiwan-based National Cheng Kung University (NCKU) research team has discovered that rapamycin, a drug as a autophagy activator is a possible treatment to alleviating frontotemporal lobar degeneration (FTLD), one of the mainly causes of dementia, and so far no medication can be used.

29 Sep 2012

AVEO submits tivozanib NDA with FDA for treatment of advanced renal cell carcinoma

AVEO Oncology and Astellas Pharma Inc. today announced that AVEO has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC).

29 Sep 2012

FDA approves Abbott’s HUMIRA to treat ulcerative colitis

Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved HUMIRA (adalimumab) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough.

29 Sep 2012

A.P. Pharma resubmits APF530 NDA with FDA for prevention of CINV

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, APF530, for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).

29 Sep 2012

Abbott receives FDA approval for Humira to treat ulcerative colitis

The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.

29 Sep 2012

U.S. Pharmacopeial announces winners of 2012-13 Global Fellowship awards

Since the program's inception more than thirty years ago, USP has invested nearly $4 million in over 200 fellowship awards.

28 Sep 2012

EC approves Janssen’s DACOGEN for treatment of de novo acute myeloid leukaemia

Janssen-Cilag International NV announced today that the European Commission has approved the marketing authorisation for DACOGEN(decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

28 Sep 2012

Lessons on the journey to commercialisation

One of the Asia Pacific region’s best known biotech leaders, Dr Greg Collier, says successful commercialisation of a new drug or therapy takes, “discipline, a strong set of nerves and a stroke of luck.”

28 Sep 2012

Inhibiting TRPV4 protects against diet-induced obesity, inflammation and insulin resistance

Ember Therapeutics, Inc., a company harnessing breakthroughs in brown fat biology and insulin sensitization to revolutionize the treatment of metabolic disease, today announced the publication of key preclinical data demonstrating that inhibition of the Transient Receptor Potential Vanilloid (TRPV) family of ion channels - specifically TRPV4 - resulted in activation of brown/beige fat and protection from diet-induced obesity, inflammation and insulin resistance. Ember holds an exclusive option to license these TRPV4 findings and technology.

28 Sep 2012

UNMCC to investigate R-ketorolac use against ovarian cancer cells

Most drugs take ten years-and frequently, more-to go from concept to FDA approval. One way to reduce this time investment is to look for already-approved drugs that could be put to new uses. And that's just what Angela Wandinger-Ness, PhD, UNM Professor of Pathology, and Laurie Hudson, PhD, UNM Professor of Pharmaceutical Sciences, have done.

28 Sep 2012

Efavirenz drug may play a key role in brain damage

The way the body metabolizes a commonly prescribed anti-retroviral drug that is used long term by patients infected with HIV may contribute to cognitive impairment by damaging nerve cells, a new Johns Hopkins research suggests.

28 Sep 2012

Incarcerated patients with chronic HCV likely to achieve sustained viral response

Incarcerated patients with chronic hepatitis C virus (HCV) infection are just as likely to respond to treatment for the disease as patients in the community, according to findings published in the October issue of Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases.

28 Sep 2012

Japanese MHLW approves Sosei’s Seebri inhalation capsules to treat COPD

Sosei Group Corporation confirms the information released today by Novartis that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Seebri (glycopyrronium bromide) Inhalation Capsules 50 mcg administered through the Breezhaler device, as a once-daily, long-term, inhaled maintenance bronchodilator treatment for the relief of various symptoms due to airway obstructive disease in chronic obstructive pulmonary disease.

28 Sep 2012

Teva concludes Asset Transfer Agreement with NeuroSearch

Teva Pharmaceutical Industries Ltd announced today that it has concluded an Asset Transfer Agreement with NeuroSearch A/S of Denmark to purchase all rights, assets and obligations relating to Huntexil (pridopidine / ACR16), a drug candidate being developed for the symptomatic treatment of hand movement, balance and gait disturbances in Huntington disease (HD).

28 Sep 2012

Study explores effects of immunotherapy on malignant gliomas

In what could be a breakthrough in the treatment of deadly brain tumors, a team of researchers from Barrow Neurological Institute and Arizona State University has discovered that the immune system reacts differently to different types of brain tissue, shedding light on why cancerous brain tumors are so difficult to treat.

28 Sep 2012

Cherry intake reduces risk of gout attacks

A new study found that patients with gout who consumed cherries over a two-day period showed a 35% lower risk of gout attacks compared to those who did not eat the fruit.

28 Sep 2012

ARIAD Pharmaceuticals completes rolling submission of ponatinib NDA with FDA

ARIAD Pharmaceuticals, Inc. today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. Food and Drug Administration (FDA).

28 Sep 2012

Janssen introduces new online scientific resource for U.S. healthcare professionals

Janssen Scientific Affairs, LLC today announced the launch of JanssenMD, a new online scientific resource for U.S. healthcare professionals seeking instant access to current information about Janssen products marketed in the U.S. The web-based application is designed for use on desktops, tablets, and smartphones and can be accessed at www.janssenMD.com.

28 Sep 2012

Bayer HealthCare receives FDA approval for Stivarga to treat colorectal cancer

The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).

28 Sep 2012