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CREON Delayed-Release Capsules now available in US for patients with EPI

AbbVie announced that a new, higher-dose capsule of CREON (pancrelipase) Delayed-Release Capsules is commercially available in the United States. The U.S. Food and Drug Administration recently approved CREON in a 36,000 lipase-unit dose to treat patients with exocrine pancreatic insufficiency due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions.

31 May 2013

FDA issues complete response letter to Endo's NDA for AVEED injection

Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. announced today that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for Endo's long-acting testosterone undecanoate injection, AVEED, for men diagnosed with hypogonadism.

31 May 2013

FDA accepts Teva Pharmaceutical's sNDA for COPAXONE

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has accepted for review the company's supplemental new drug application for COPAXONE (glatiramer acetate injection) 40mg/ 1mL, a higher concentration dose of COPAXONE that offers a less frequent three times a week dosing regimen administered subcutaneously for patients with relapsing-remitting multiple sclerosis.

31 May 2013

Oncothyreon, Array BioPharma to develop and commercialize ARRY-380 for breast cancer patients

Oncothyreon Inc. and Array BioPharma Inc. today announced that they will collaborate to develop and commercialize ARRY-380, an orally active, reversible and selective small-molecule HER2 inhibitor.

30 May 2013

Researchers examine quality of information given by sales reps when promoting drugs to physicians

Dr. Genevi-ve Durrieu (from the Pharmaco-epidemiology team assessing the use of medication and the risks involved, Unit 1027 "Epidemiology and public health analyses: risks, chronic diseases and handicaps" - Inserm / Universit- Toulouse III - Paul Sabatier) led the French part of this study, the results of which are published in the Journal of General Internal Medicine. Within the framework of this international study, is France proving to be a model student?

30 May 2013

Injectable drugs used in TPN to be imported into US, says FDA

The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition in critical shortage will be imported into the United States and available to patients this week.

30 May 2013

Taking blood thinners before minor procedures safe for stroke patients

Many patients who have experienced strokes or mini strokes take blood thinners such as aspirin or warfarin (Coumadin) to reduce the risk of blood clots that can cause strokes.

30 May 2013

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

Pharmaceutical News

CREON Delayed-Release Capsules now available in US for patients with EPI

FDA issues complete response letter to Endo's NDA for AVEED injection

FDA accepts Teva Pharmaceutical's sNDA for COPAXONE

Oncothyreon, Array BioPharma to develop and commercialize ARRY-380 for breast cancer patients

Researchers examine quality of information given by sales reps when promoting drugs to physicians

Injectable drugs used in TPN to be imported into US, says FDA

Taking blood thinners before minor procedures safe for stroke patients

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

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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