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Tafinlar, Mekinist get FDA approval to treat patients with advanced melanoma

The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

30 May 2013

Perrigo receives final approval for generic Sanctura XR

Perrigo Company today announced that it has received final approval for the generic version of Sanctura XR. Perrigo had previously prevailed in litigation at both the district and appellate levels. The product has begun shipping immediately.

29 May 2013

Atopix awarded grant to pursue development of OC459 for atopic dermatitis

Atopix Therapeutics Ltd, a biopharmaceutical company developing a novel class of anti-allergic medicines, has been awarded a £1.7 million grant from the UK Biomedical Catalyst fund to pursue development of OC459 in the treatment of moderate-to-severe atopic dermatitis (a form of eczema).

29 May 2013

EMA grants Sucampo orphan drug designation for unoprostone isopropyl to treat retinitis pigmentosa

Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, today announced that it has received orphan drug designation in the European Union for unoprostone isopropyl for the treatment of retinitis pigmentosa (RP). RP is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity, and there are no drugs or therapeutic procedures currently approved for the treatment of RP today.

29 May 2013

Patented nicotinamide riboside launched by Chromadex

ChromaDex Corporation, an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, animal health, cosmetic and pharmaceutical industries, announced today the launch of NIAGEN, its novel, patented, branded nicotinamide riboside.

29 May 2013

Teh Seng’s generic Lidoderm manufacturing facility in Taiwan successfully completes FDA cGMP audit

TWi Pharmaceuticals, Inc., today announced that Teh Seng Pharmaceutical Mfg. Co., the manufacturing partner for its generic version of Lidoderm (5% lidocaine patch) located in Taiwan, has completed the cGMP audit and pre-approval inspection by US Food and Drug Administration and been granted "acceptable" status under the FDA's regulatory guidelines.

29 May 2013

Standalone labelling service announced by Packaging Coordinators Inc (PCI)

Packaging Coordinators Inc (PCI), formerly AndersonBrecon, a global supplier of pharmaceutical commercial packaging solutions and clinical trials services, today announced a standalone labelling service that can dramatically reduce design and printing turnaround times. The fast response labelling solution has been developed to meet the ever-evolving needs of customers in the industry, providing bespoke, around-the-clock support and ensuring that even projects where labelling requirements change unexpectedly are successfully kept on track.

From Packaging Coordinators Inc. (PCI) 29 May 2013

Research sheds new light on the increasing use of prescription drugs among young people

Young people are increasingly turning to prescription drugs to get high. Research out of the University of Cincinnati sheds new light on what could increase or lower that risk.

29 May 2013

Unique omega-3 supplement improves lung function, reduces airway inflammation in asthmatics

An Indiana University study has found that a unique omega-3 supplement derived from the New Zealand green-lipped mussel significantly improved lung function and reduced airway inflammation in asthmatics who experience exercise-induced bronchoconstriction, also called exercise-induced asthma.

29 May 2013

Bay Pines VA Healthcare System to study effectiveness of 7-Keto compound in PTSD

The Bay Pines VA Healthcare System announced that it will begin a research study related to post-traumatic stress disorder. The study will focus on whether the use of a naturally occurring compound known as 7-Keto assists in the treatment of PTSD.

29 May 2013

UT Southwestern researchers develop new class of drugs for prostate cancer

A new study on prostate cancer describes a novel class of drugs developed by UT Southwestern Medical Center researchers that interrupts critical signaling needed for prostate cancer cells to grow.

29 May 2013

Valeant Pharmaceuticals receives Complete Response Letter from FDA for efinaconazole NDA

Valeant Pharmaceuticals International, Inc. today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for efinaconazole for the treatment of onychomycosis.

28 May 2013

Research data on AMPYRA Extended Release Tablets to be presented at CMSC and ACTRIMS meeting

Acorda Therapeutics, Inc. will present new research data on AMPYRA (dalfampridine) Extended Release Tablets, 10 mg at the 5th Cooperative Meeting of the Consortium of Multiple Sclerosis Centers and Americas Committee for Treatment and Research in Multiple Sclerosis, being held in Orlando, FL, May 29 - June 1.

28 May 2013

Asfotase alfa gets Breakthrough Therapy designation from FDA for treatment of patients with HPP

Alexion Pharma International Sàrl, a subsidiary of Alexion Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to asfotase alfa for the treatment of patients with hypophosphatasia (HPP) whose first signs or symptoms occurred prior to 18 years of age, including perinatal-, infantile-, and juvenile-onset forms of the disease.

28 May 2013

Frutarom reports increased demand for natural ingredient targeting urinary incontinence in adults

Frutarom Health, Switzerland, reports increased demand for Go-Less, its natural ingredient targeting urinary incontinence in adults.

28 May 2013

Report finds increase in unintentional marijuana ingestions among young children

Following modification of drug enforcement laws for possession of marijuana in Colorado, there was an apparent increase in unintentional marijuana ingestions by young children, according to a report and accompanying editorials published Online First by JAMA Pediatrics, a JAMA Network publication.

28 May 2013

Study reveals that an epilepsy drug shows promise in preventing noise-induced tinnitus

An epilepsy drug shows promise in an animal model at preventing tinnitus from developing after exposure to loud noise, according to a new study by researchers at the University of Pittsburgh School of Medicine.

28 May 2013

New equations could shorten hospitalization for patients with uncontrolled pain, say researchers

For patients with uncontrolled pain from terminal cancer, a new approach to calculating initial dosage may allow a quicker start of spinal analgesia-and less time in the hospital, according to a study in the June issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

28 May 2013

Unintentional ingestions of marijuana-laced foods by children have increased significantly

A new study shows the relaxation of marijuana laws in Colorado has caused a significant spike in the number of young children treated for accidentally eating marijuana-laced cookies, candies, brownies and beverages.

28 May 2013

Omthera to be acquired by AstraZeneca

AstraZeneca today announced that it has entered into a definitive agreement to acquire Omthera Pharmaceuticals, a specialty pharmaceutical company based in Princeton, New Jersey, focused on the development and commercialization of new therapies for abnormal levels of lipids in the blood, referred to as dyslipidemia.

28 May 2013

Pharmaceutical News

Tafinlar, Mekinist get FDA approval to treat patients with advanced melanoma

Perrigo receives final approval for generic Sanctura XR

Atopix awarded grant to pursue development of OC459 for atopic dermatitis

EMA grants Sucampo orphan drug designation for unoprostone isopropyl to treat retinitis pigmentosa

Patented nicotinamide riboside launched by Chromadex

Teh Seng’s generic Lidoderm manufacturing facility in Taiwan successfully completes FDA cGMP audit

Standalone labelling service announced by Packaging Coordinators Inc (PCI)

Research sheds new light on the increasing use of prescription drugs among young people

Unique omega-3 supplement improves lung function, reduces airway inflammation in asthmatics

Bay Pines VA Healthcare System to study effectiveness of 7-Keto compound in PTSD

UT Southwestern researchers develop new class of drugs for prostate cancer

Valeant Pharmaceuticals receives Complete Response Letter from FDA for efinaconazole NDA

Research data on AMPYRA Extended Release Tablets to be presented at CMSC and ACTRIMS meeting

Asfotase alfa gets Breakthrough Therapy designation from FDA for treatment of patients with HPP

Frutarom reports increased demand for natural ingredient targeting urinary incontinence in adults

Report finds increase in unintentional marijuana ingestions among young children

Study reveals that an epilepsy drug shows promise in preventing noise-induced tinnitus

New equations could shorten hospitalization for patients with uncontrolled pain, say researchers

Unintentional ingestions of marijuana-laced foods by children have increased significantly

Omthera to be acquired by AstraZeneca

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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