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European Commission grants orphan drug designation to SGX301 for treatment of CTCL

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that the European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation to synthetic hypericin (the active pharmaceutical ingredient in SGX301) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare disease and a class of non-Hodgkin's lymphoma, a type of cancer of the white blood cells that are an integral part of the immune system.

4 Aug 2015

Oasmia announces topline results from head-to-head comparison study of Paclical and Abraxane

Oasmia Pharmaceutical AB, developer of a new generation of drugs within human and veterinary oncology, announced today the topline findings from a head-to-head comparison study of its lead human cancer product candidate Paclical and Celgene's Abraxane, which show similar pharmacokinetic (PK) profiles of the two products. The study was conducted in women with metastatic breast cancer.

4 Aug 2015

Cipher receives Acceptance Review Notification from FDA for 510(k) submission for Dermadexin

Cipher Pharmaceuticals Inc. today announced that it has received an Acceptance Review Notification for its 510(k) submission for Dermadexin to the U.S. Food & Drug Administration.

4 Aug 2015

Benefits and risks of taking antidepressant medications during pregnancy

Treating maternal psychiatric disorder with commonly used antidepressants is associated with a lower risk of certain pregnancy complications including preterm birth and delivery by Caesarean section, according to researchers at Columbia University's Mailman School of Public Health, Columbia University Medical Center, and the New York State Psychiatric Institute. However, the medications -- selective serotonin reuptake inhibitors, or SSRIs -- resulted in an increased risk of neonatal problems.

4 Aug 2015

People with chronic insomnia may be able to get relief from half of standard sleeping pills

The roughly nine million Americans who rely on prescription sleeping pills to treat chronic insomnia may be able to get relief from as little as half of the drugs, and may even be helped by taking placebos in the treatment plan, according to new research published today in the journal Sleep Medicine by researchers from the Perelman School of Medicine at the University of Pennsylvania.

4 Aug 2015

Penn Medicine devises new approach to develop vaccines against lethal diseases

Researchers at the Perelman School of Medicine at the University of Pennsylvania have devised an entirely new approach to vaccines - creating immunity without vaccination.

4 Aug 2015

Combining chemotherapy and birinapant effective against high-grade serous ovarian cancer

High-grade serous ovarian cancer often responds well to the chemotherapy drug carboplatin, but why it so frequently comes back after treatment has been a medical mystery.

4 Aug 2015

Omeros receives EC approval to market Omidria in EU and other European countries

Omeros Corporation today announced that the European Commission (EC) has granted marketing authorization for Omidria (phenylephrine and ketorolac injection) 1% / 0.3% in the European Union (EU) for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

3 Aug 2015

Isis Pharmaceuticals, AstraZeneca to develop antisense therapies for cardiovascular, metabolic, renal diseases

AstraZeneca and Isis Pharmaceuticals, Inc. today announced a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases.

3 Aug 2015

Anti-dementia drugs could result in harmful weight loss, say researchers

Medications commonly used to treat dementia could result in harmful weight loss, according to UC San Francisco researchers, and clinicians need to account for this risk when prescribing these drugs to older adults, they said.

3 Aug 2015

Common gout medications may offer protection from alcohol-induced liver disease, inflammation

New research in mice shows that two commonly used gout medications, which target uric acid and adenosine triphosphate, may offer protection from alcohol-induced liver disease and inflammation.

3 Aug 2015

Research shows specific routes of administration can predict risk of drug addiction

Abstinence is the best way to avoid drug addiction. But in many societies, drug use is the norm, not the exception, especially by youth.

3 Aug 2015

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours.

31 Jul 2015

Eisai, Halozyme partner to evaluate eribulin and PEGPH20 in HER2-negative metastatic breast cancer

Eisai Inc. announced today that its parent company Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Halozyme Therapeutics, Inc. (Headquarters: San Diego, California, President and CEO: Dr. Helen Torley) have signed a clinical collaboration agreement to evaluate Eisai's agent eribulin mesylate (brand name: Halaven, "eribulin") in combination with Halozyme's investigational drug PEGPH20 (PEGylated recombinant human hyaluronidase) in first line HER2-negative metastatic breast cancer.

31 Jul 2015

Takeda completes post-marketing commitment and data submission for pioglitazone containing medicines

Takeda Pharmaceutical Company Limited today announced the completion of the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large (n= 112,674), multi-database retrospective matched cohort study, conducted in four European countries, for pioglitazone containing medicines, including ACTOS with up to 10 years of follow-up.

31 Jul 2015

Tissue Regenix strengthens position in post-acute wound care market with Medicare coverage for Dermapure

Tissue Regenix Group, the regenerative medical devices company, announces that it has further strengthened its position within the post-acute wound care market as Tissue Regenix Wound Care Inc. has received further approval for DermaPure under Medicare administrator, First Coast Service Options Inc. whose jurisdiction includes Florida, Puerto Rico and the US Virgin Islands.

30 Jul 2015

Roche submits cobas EGFR v2 test PMA to FDA as companion diagnostic test for AZD9291

Roche today announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval (PMA) to the U.S. Food and Drug Administration, as a companion diagnostic test for AZD9291, an AstraZeneca investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation.

30 Jul 2015

Study sheds light on certain antagonist drugs that block physiological responses

Members of the Consolidated Research Group of Molecular Neurobiology of the Department of Biochemistry and Molecular Biology of the University of Barcelona (UB), affiliated with the Centre for Networked Biomedical Research on Neurodegenerative Diseases (CIBERNED), have published a study in the journal Proceedings of the National Academy of Sciences (PNAS) about the formation of G protein-coupled receptors (GPCRs) which allows understanding the unexpected behaviour of some antagonists that block physiological responses.

30 Jul 2015

Commonly prescribed drug also lowers blood pressure when combined with diuretic

With the growth of electronic medical records, research utilizing data from a large number of patients, known as big data studies, can provide important information which may be unattainable via clinical trials which tend to be costly, time-consuming and involve fewer patients.

30 Jul 2015

ACP supports for eliminating non-medical vaccination exemptions

Support for eliminating existing exemptions, except for medical reasons, from immunization laws was among the policy recommendations adopted last weekend at the summer meeting of the Board of Regents of the American College of Physicians.

30 Jul 2015

Pharmaceutical News

European Commission grants orphan drug designation to SGX301 for treatment of CTCL

Oasmia announces topline results from head-to-head comparison study of Paclical and Abraxane

Cipher receives Acceptance Review Notification from FDA for 510(k) submission for Dermadexin

Benefits and risks of taking antidepressant medications during pregnancy

People with chronic insomnia may be able to get relief from half of standard sleeping pills

Penn Medicine devises new approach to develop vaccines against lethal diseases

Combining chemotherapy and birinapant effective against high-grade serous ovarian cancer

Omeros receives EC approval to market Omidria in EU and other European countries

Isis Pharmaceuticals, AstraZeneca to develop antisense therapies for cardiovascular, metabolic, renal diseases

Anti-dementia drugs could result in harmful weight loss, say researchers

Common gout medications may offer protection from alcohol-induced liver disease, inflammation

Research shows specific routes of administration can predict risk of drug addiction

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Eisai, Halozyme partner to evaluate eribulin and PEGPH20 in HER2-negative metastatic breast cancer

Takeda completes post-marketing commitment and data submission for pioglitazone containing medicines

Tissue Regenix strengthens position in post-acute wound care market with Medicare coverage for Dermapure

Roche submits cobas EGFR v2 test PMA to FDA as companion diagnostic test for AZD9291

Study sheds light on certain antagonist drugs that block physiological responses

Commonly prescribed drug also lowers blood pressure when combined with diuretic

ACP supports for eliminating non-medical vaccination exemptions

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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