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ProStrakan acquires US commercial rights to Fareston for treatment of metastatic breast cancer

ProStrakan Group plc announces today that it has acquired exclusive US commercial rights to Fareston (toremifene citrate) for the treatment of metastatic breast cancer in postmenopausal women.

1 Oct 2012

EC approves Sosei’s Seebri Breezhaler to treat COPD

Sosei Group Corporation confirms the information released today by Novartis that the European Commission has approved Seebri Breezhaler (glycopyrronium bromide) 44 mcg delivered dose (equivalent to 50 mcg glycopyrronium measured dose per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

1 Oct 2012

Administering immunotherapy for three years can reduce allergies, asthma in children

When children suffer from dust mite induced allergies and asthma, finding relief can seem impossible. While there isn't a complete cure for childhood respiratory allergies, researchers have found that long term control of allergic asthma can occur after only three years of allergy shots.

1 Oct 2012

Counterfeit drugs for sale: FDA issues warning regarding online pharmacies

The Food and Drug Administration is warning U.S. consumers that the vast majority of Internet pharmacies are fraudulent and likely are selling counterfeit drugs that could harm them.

29 Sep 2012

Atrazine may increase risk of choanal atresia

A common herbicide used in the United States may be linked to an increased risk of a congenital abnormality of the nasal cavity known as choanal atresia, say researchers at Baylor College of Medicine and other Texas institutions.

29 Sep 2012

WHO urges action to stop spread of drug-resistant malaria in Vietnam, Myanmar

"The World Health Organization said Thursday that governments in the Mekong region must act 'urgently' to stop the spread of drug-resistant malaria which has emerged in parts of Vietnam and Myanmar," Agence France-Presse reports.

29 Sep 2012

FDA launches campaign to raise public awareness on prevalence of fraudulent Internet pharmacies

The U.S. Food and Drug Administration today launched a national campaign to raise public awareness about the prevalence of fraudulent Internet pharmacies, which can be dangerous to patient health, and to help consumers make safe purchases.

29 Sep 2012

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