Pharmaceuticals News and Research

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pSivida announces resubmission of ILUVIEN NDA to FDA for chronic diabetic macular edema

pSivida Corp., a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration with respect to ILUVIEN for chronic diabetic macular edema.

2 Apr 2013

Study links mutated histone protein to rare brain stem cancer in children

Most cancer treatments are blunt. In an attempt to eradicate tumors, oncologists often turn to radiation or chemotherapy, which can damage healthy tissue along with the cancerous growths.

2 Apr 2013

BioCryst Pharmaceuticals receives preliminary comment letter from FDA on peramivir

BioCryst Pharmaceuticals, Inc. announced that it received a preliminary comment letter from the U.S. Food & Drug Administration that outlines a pathway by which BioCryst could file a New Drug Application seeking regulatory approval of intravenous (i.v.) peramivir.

1 Apr 2013

FDA approves Teva's Quartette tablets for prevention of pregnancy

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy.

30 Mar 2013

Medivir seeks FDA approval for simeprevir

Medivir AB today announced that a new drug application has been filed with the U.S. Food and Drug Administration seeking approval for simeprevir.

30 Mar 2013

Inflammation and epigenetics: an interview with Dr Belkina and Dr Denis, Boston University School of Medicine

Inflammation can be thought of as taking two major forms: acute or chronic. Acute inflammation, which can be painful, usually arises quickly and resolves quickly. It accompanies bacterial infections, traumatic injury and is useful to fight infections and promote healing.

28 Mar 2013

Chromatrap chromatin immunoprecipitation (ChIP) assay range added to Porvair Sciences’ portfolio of products for epigenetics

Porvair Sciences has announced the addition of the novel Chromatrap chromatin immunoprecipitation (ChIP) assay range to its portfolio of products for epigenetics.

From Chromatrap® - Porvair Sciences Ltd 28 Mar 2013

CureVac begins CV9104 Phase 2b clinical trial in patients with castration-resistant prostate cancer

CureVac GmbH, a clinical stage biopharmaceutical company that has pioneered the development of a new class of therapies and vaccines based on messenger RNA, today announced that it has initiated a double-blind, randomized Phase 2b clinical trial of its RNActive cancer vaccine, CV9104, for the treatment of patients with castration-resistant prostate cancer.

28 Mar 2013

Navidea commences enrollment in NAV4694 Phase 2b study to detect erebral β-amyloid plaque

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that enrollment has commenced in its Phase 2b, open-label, safety and efficacy positron emission tomography imaging study of [18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with Mild Cognitive Impairment.

28 Mar 2013

Royal Holloway University supports Muscular Dystrophy Campaign

Royal Holloway University, is today giving money generated by its research into Duchenne muscular dystrophy to the Muscular Dystrophy Campaign.

27 Mar 2013

POZEN announces submission of NDA for marketing approval of PA32540/PA8140

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for the marketing approval of PA32540/PA8140.

27 Mar 2013

FDA clears Soligenix's IND application for SGX942 for treatment of oral mucositis

Soligenix, Inc., a clinical stage biopharmaceutical company, announced today that the Food and Drug Administration has completed its review and cleared the Investigational New Drug application for SGX942 for the treatment of oral mucositis resulting from radiation and/or chemotherapy treatment in head and neck cancer patients.

27 Mar 2013

Lightlake to present Phase II clinical trial results of opioid antagonist nasal spray at APA Annual Meeting

Lightlake Therapeutics Inc., an early stage biopharmaceutical company developing addiction treatments, announced today that a scientific abstract based on results of the Company's Phase II clinical trial of its opioid antagonist nasal spray treatment for patients with Binge Eating Disorder has been accepted for presentation at the American Psychiatric Association Annual Meeting taking place in San Francisco, California, May 18-22, 2013.

27 Mar 2013

Pharmaceuticals News and Research

pSivida announces resubmission of ILUVIEN NDA to FDA for chronic diabetic macular edema

Study links mutated histone protein to rare brain stem cancer in children

BioCryst Pharmaceuticals receives preliminary comment letter from FDA on peramivir

FDA approves Teva's Quartette tablets for prevention of pregnancy

Medivir seeks FDA approval for simeprevir

Inflammation and epigenetics: an interview with Dr Belkina and Dr Denis, Boston University School of Medicine

Chromatrap chromatin immunoprecipitation (ChIP) assay range added to Porvair Sciences’ portfolio of products for epigenetics

CureVac begins CV9104 Phase 2b clinical trial in patients with castration-resistant prostate cancer

Navidea commences enrollment in NAV4694 Phase 2b study to detect erebral β-amyloid plaque

Royal Holloway University supports Muscular Dystrophy Campaign

POZEN announces submission of NDA for marketing approval of PA32540/PA8140

FDA clears Soligenix's IND application for SGX942 for treatment of oral mucositis

Lightlake to present Phase II clinical trial results of opioid antagonist nasal spray at APA Annual Meeting

New data reveals impact of opioid-related adverse events on length, cost of hospitalization after surgery

Oncodesign signs agreement with Sanofi to identify kinase inhibitors involved in tissue protection and repair

Biological markers for triple-negative breast cancer (TNBC): an interview with Alexandre Templier, CEO of Quinten

CHOP researchers moving closer to personalized medicine for children with cancer

Genalyte's Maverick Detection System gets CE mark in Europe for research use

Lundbeck, Otsuka reach agreement to develop and commercialize Lu AE58054

Clinigen announces acquisition of Cardioxane from Novartis

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