Pharmaceuticals News and Research

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Shire resolves patent infringement lawsuit against Teva relating to INTUNIV tablet

Shire LLC has settled its litigation against Teva Pharmaceuticals USA Inc. ("Teva") in connection with Teva's Abbreviated New Drug Application ("ANDA") for a generic version of Shire's INTUNIV (guanfacince) Extended Release Tablets for the treatment of Attention Deficit Hyperactivity Disorder.

3 Jun 2013

Ohr Pharmaceutical declares 1-for-3 reverse split of its outstanding common stock

Ohr Pharmaceutical, Inc. (OTCQB: OHRP), a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced a 1-for-3 reverse split of the Company's issued and outstanding common stock. The reverse stock split will be effective prior to the stock market opening on Monday, June 3, 2013.

3 Jun 2013

NYSE MKT to continue CorMedix's listing

CorMedix Inc. ("CorMedix") (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, has received a notice from the NYSE MKT that CorMedix made reasonable demonstration of its ability to regain compliance with Section 1003(a)(i) of the NYSE MKT Company Guide ("Company Guide") by October 20, 2013.

1 Jun 2013

New paper analytical devices can screen fake antimalarial drugs

On Wednesday, 5/29/13, the Wall Street Journal published an article titled "Africa's Malaria Battle: Fake Drug Pipeline Undercuts Progress." The piece outlines a counterfeit pharmaceutical problem that is top of mind at Saint Mary's College in Notre Dame, IN. Chemistry Professor Toni Barstis and her undergraduate students at this Catholic, women's, liberal arts college have researched and developed Paper Analytical Devices (PADs) that can screen whether an antimalarial drug is real.

1 Jun 2013

Views held by some GPs: One of the greatest health risks from smoking is nicotine

A survey of GPs (general practitioners) in the UK and Sweden revealed that some hold the view that one of the greatest health risks from smoking is nicotine. This belief likely influences health advice to smokers when considering whether to recommend the use of alternative nicotine products.

1 Jun 2013

RPCI, Jasco Pharmaceuticals partner to advance development of cancer therapy

A new partnership, first of its kind for both organizations, will see Roswell Park Cancer Institute and Jasco Pharmaceuticals, LLC collaborating to advance development of an investigational pharmacological therapy that shows promise for treating both solid-tumor cancers and hematologic malignancies.

1 Jun 2013

Synageva BioPharma presents data on cholesteryl ester storage disease at NLA annual meeting

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare diseases, announced three poster presentations at the National Lipid Association annual meeting held in Las Vegas, Nevada, May 30- June 2, 2013, as well as a Synageva-sponsored satellite symposium held on Friday, May 31, 2013.

1 Jun 2013

Depomed receives complete response letter for SEFELSA NDA

Depomed, Inc., a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration issued a complete response letter to the New Drug Application for SEFELSA, Depomed's investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause.

1 Jun 2013

New avatar system could provide quick and effective therapy for schizophrenia

An avatar system that enables people with schizophrenia to control the voice of their hallucinations is being developed by researchers at UCL with support from the Wellcome Trust.

31 May 2013

GLYX-13 drug induces antidepressant results without street drug side effects

GLYX-13, a molecular cousin to ketamine, induces similar antidepressant results without the street drug side effects, reported a study funded by the National Institute of Mental Health (NIMH) that was published last month in Neuropsychopharmacology.

31 May 2013

Vanda Pharmaceuticals announces submission of tasimelteon NDA to FDA

Vanda Pharmaceuticals Inc. today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for tasimelteon, a circadian regulator.

31 May 2013

University of Strathclyde uses new imaging technique to track nanomedicines' effects on patients

A pioneering imaging technique to track the effects of next-generation nanomedicines on patients has been harnessed by a University of Strathclyde academic.

31 May 2013

Ragweed allergy sublingual immunotherapy: an interview with Dr. Peter Creticos, Johns Hopkins University School of Medicine

Ragweed is a dominant seasonal allergen in North America (~26% of US and North American population is allergic to this noxious weed which pollinates from early August to early October).

31 May 2013

Viewpoints: Obamacare is already working; George W. Bush on 'personal responsibility'; Medicaid expansion and the mentally ill

The Affordable Care Act has been under siege since before it even had a name. Some on the right saw it as government overreach. Some on the left considered it better for insurance companies than for consumers. As many of the law's provisions take effect over the next year, we're hearing from both sides all over again. This time the theme is that the law is too complex. ... Read the discussion (5/29).

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

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

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

Targacept initiates TC-5214 Phase 2b clinical study in patients with OAB

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced the initiation of a Phase 2b clinical study of TC-5214 as a treatment for overactive bladder.

29 May 2013

Pacira Pharmaceuticals reports results of EXPAREL Phase 2/3 clinical trial for TKA

Pacira Pharmaceuticals, Inc. today announced findings from the completed first part of its Phase 2/3 clinical trial assessing the use and administration of EXPAREL (bupivacaine liposome injectable suspension) as a single-dose injection femoral nerve block for total knee arthroplasty surgery.

29 May 2013

Pharmaceuticals News and Research

Shire resolves patent infringement lawsuit against Teva relating to INTUNIV tablet

Ohr Pharmaceutical declares 1-for-3 reverse split of its outstanding common stock

NYSE MKT to continue CorMedix's listing

New paper analytical devices can screen fake antimalarial drugs

Views held by some GPs: One of the greatest health risks from smoking is nicotine

RPCI, Jasco Pharmaceuticals partner to advance development of cancer therapy

Synageva BioPharma presents data on cholesteryl ester storage disease at NLA annual meeting

Depomed receives complete response letter for SEFELSA NDA

New avatar system could provide quick and effective therapy for schizophrenia

GLYX-13 drug induces antidepressant results without street drug side effects

Vanda Pharmaceuticals announces submission of tasimelteon NDA to FDA

University of Strathclyde uses new imaging technique to track nanomedicines' effects on patients

Ragweed allergy sublingual immunotherapy: an interview with Dr. Peter Creticos, Johns Hopkins University School of Medicine

Viewpoints: Obamacare is already working; George W. Bush on 'personal responsibility'; Medicaid expansion and the mentally ill

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

FDA accepts Teva Pharmaceutical's sNDA for COPAXONE

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

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

Targacept initiates TC-5214 Phase 2b clinical study in patients with OAB

Pacira Pharmaceuticals reports results of EXPAREL Phase 2/3 clinical trial for TKA

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