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FDA grants Fast Track designation to Akashi Therapeutics' HT-100 for treatment of DMD

Akashi Therapeutics, Inc., announced today that the U.S. Food and Drug Administration has granted Fast Track designation to the company's most advanced product candidate, HT-100 (delayed-release halofuginone), an orally available, small molecule drug candidate intended to reduce fibrosis and inflammation and promote healthy muscle regeneration in boys with DMD.

3 Jul 2014

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

UCB, a global biopharmaceutical leader, and Dermira, Inc., a privately held US-based dermatology company, announced today that they have entered into an exclusive licensing agreement for the development and future commercialization of Cimzia (certolizumab pegol) in dermatology.

3 Jul 2014

Combination of cognitive behavioral therapy and medication reduces relapse in depressed youths

Cognitive behavioral therapy in addition to medication improves the long-term success of treatment for children and adolescents suffering from depression, a new UT Southwestern Medical Center study indicates.

3 Jul 2014

Antibiotic therapy: A potential game-changer for hemodialysis treatment

An antibiotic therapy known to reduce catheter-related bloodstream infections in hemodialysis patients has been shown for the first time to reduce mortality, according to a Henry Ford Health System study.

3 Jul 2014

Testosterone therapy does not increase men's risk for heart attack, shows UTMB study

Testosterone prescriptions for older men in the United States have increased more than three-fold over the past decade. Recent studies linking testosterone use with increased risk of heart attack and stroke have caused widespread concern among patients and their families.

2 Jul 2014

Ralphs Pharmacies continue to offer Tdap vaccinations for whooping cough in Southern California

As the number of pertussis cases, also known as whooping cough, reaches epidemic proportions in California, Ralphs Pharmacies continue to offer Tdap (tetanus, diphtheria, pertussis) vaccinations at its 85 in-store pharmacies throughout Southern California.

2 Jul 2014

Galderma's trifarotene molecule gets FDA Orphan Drug Designation for treatment of congenital ichthyosis

Galderma announces that the U.S. FDA granted Orphan Drug Designation status for the company's trifarotene molecule for the treatment of congenital ichthyosis. Based on this decision, Galderma plans to implement a clinical development plan, reinforcing its commitment to exploring new treatment options for rare diseases, as well as meeting the needs of all patients with skin diseases over the course of their lives.

2 Jul 2014

Isis Pharmaceuticals gets $1 million from GSK to discover and develop drugs for HBV

Isis Pharmaceuticals, Inc. announced today that it has earned a $1 million payment from GlaxoSmithKline related to the advancement of its program to develop antisense drugs to treat hepatitis B virus (HBV).

2 Jul 2014

New ebook provides essential insights into Pharma compliance

In an era of increasing regulatory scrutiny and changing social environment there are increasing complex demands for compliance teams related to globalisation, information privacy and security, HCP interactions and external reporting requirements.

2 Jul 2014

Ipsen seeks marketing authorization from FDA for Somatuline Depot 120mg injection

Ipsen Biopharmaceuticals, Inc., the U.S. affiliate of Ipsen today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

2 Jul 2014

Drug everolimus fails to improve overall survival in advanced liver cancer patients

Despite strong preclinical data, the drug everolimus failed to improve overall survival in patients with advanced liver cancer, compared to placebo, according to a study in the July 2 issue of JAMA.

2 Jul 2014

Ipsen submits Supplemental New Drug Application to FDA for Somatuline Depot 120mg injection

Ipsen today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

1 Jul 2014

Research finding may accelerate development of treatments for PTSD

Scientists at Yerkes National Primate Research Center, Emory University have identified a drug that appears to make memories of fearsome events less durable in mice.

1 Jul 2014

FSC Laboratories acquires exclusive marketing rights for Aciphex Sprinkle in the U.S.

FSC Therapeutics, LLC, today announced that the Company has entered into a transaction with Eisai Inc. to acquire exclusive U.S. marketing rights for AcipHex® Sprinkle™ (rabeprazole sodium), Delayed-Release Capsules, 5 mg and 10 mg, for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.

30 Jun 2014

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has approved LemtradaTM (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

30 Jun 2014

Helsinn Group grants GEN Ilaç anamorelin rights for Turkey

Helsinn Group, the company focused on building quality cancer care, today announces that rights to anamorelin, its innovative ghrelin receptor agonist, have been granted in Turkey to GEN Ilaç.

30 Jun 2014

Study identifies effective market research approaches to understand payer needs, decision-making

The Affordable Care Act has been the catalyst for dramatic change in US healthcare. The power structures that influence this $2.8 trillion economic sector are shifting, but one thing is crystal clear: A large percentage of the pharmaceutical sector's top-line revenues flow from payers.

28 Jun 2014

American Academy of Ophthalmology does not recommend marijuana for glaucoma treatment

The American Academy of Ophthalmology – the world's largest association of eye physicians and surgeons – is reminding the public that it does not recommend marijuana or other cannabis products for the treatment of glaucoma.

28 Jun 2014

Psychostimulant increases risk of cardiovascular events in children with ADHD

Psychostimulant use to treat children and adolescents with attention-deficit/hyperactivity disorder (ADHD) is increasing worldwide, and the evaluation of the cardiovascular safety of stimulant medication used in treatment has been a recent topic of concern.

28 Jun 2014

Researchers identify two classes of anti-depressants that reduce symptoms of depression

Depression is common in cancer, up to half of all patients facing the disease experience depressive symptoms, ranging from mild to severe. When depression co-exists with cancer, patients may be at an increased risk of death from cancer and from suicide.

28 Jun 2014

Pharmaceutical News

FDA grants Fast Track designation to Akashi Therapeutics' HT-100 for treatment of DMD

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

Combination of cognitive behavioral therapy and medication reduces relapse in depressed youths

Antibiotic therapy: A potential game-changer for hemodialysis treatment

Testosterone therapy does not increase men's risk for heart attack, shows UTMB study

Ralphs Pharmacies continue to offer Tdap vaccinations for whooping cough in Southern California

Galderma's trifarotene molecule gets FDA Orphan Drug Designation for treatment of congenital ichthyosis

Isis Pharmaceuticals gets $1 million from GSK to discover and develop drugs for HBV

New ebook provides essential insights into Pharma compliance

Ipsen seeks marketing authorization from FDA for Somatuline Depot 120mg injection

Drug everolimus fails to improve overall survival in advanced liver cancer patients

Ipsen submits Supplemental New Drug Application to FDA for Somatuline Depot 120mg injection

Research finding may accelerate development of treatments for PTSD

FSC Laboratories acquires exclusive marketing rights for Aciphex Sprinkle in the U.S.

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

Helsinn Group grants GEN Ilaç anamorelin rights for Turkey

Study identifies effective market research approaches to understand payer needs, decision-making

American Academy of Ophthalmology does not recommend marijuana for glaucoma treatment

Psychostimulant increases risk of cardiovascular events in children with ADHD

Researchers identify two classes of anti-depressants that reduce symptoms of depression

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