Headache News and Research

Latest Headache News and Research

Abbott issues statement in response to FDA's mixed vote for weight loss medication sibutramine

The U.S. Food and Drug Administration today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT and the weight loss medication sibutramine (sold as Meridia® in the United States).

16 Sep 2010

BioCryst reports results from forodesine studies for CTCL and CLL

BioCryst Pharmaceuticals, Inc. announced preliminary top-line results from its multinational, open-label, single-arm trial evaluating 200 mg once-daily oral forodesine in the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), as well as interim results from the Company's exploratory Phase 2 study to investigate the efficacy and safety of 200 mg twice-daily oral forodesine as monotherapy for chronic lymphocytic leukemia (CLL).

15 Sep 2010

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

Repetitive transcranial magnetic stimulation helps to regain motor function in partially paralyzed patients

Stroke patients who were left partially paralysed found that their condition improved after they received a simple and non-invasive method of brain stimulation, according to research in the September issue of the European Journal of Neurology.

14 Sep 2010

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C).

14 Sep 2010

High dose peretinoin reduces recurrence of HCC after surgical resection or ablation in HCV positive patients

Kowa Company, Ltd. announced today that the results of a Phase II/III trial showed that high dose peretinoin (NIK-333) given daily for up to 96 weeks reduced the recurrence of hepatocellular carcinoma (HCC) after surgical resection or ablation in hepatitis C virus (HCV) positive patients when compared to placebo.

13 Sep 2010

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

13 Sep 2010

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.

10 Sep 2010

FDA approves pediatric use of Protopam Chloride

The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride (pralidoxime chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents). The drug is approved to be administered either by intravenous (IV) or intramuscular (IM) injections.

10 Sep 2010

Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

Santarus, Inc., S2 Therapeutics, Inc. and VeroScience LLC today announced that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET (bromocriptine mesylate) tablets in the U.S.

9 Sep 2010

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals, Inc. today announced that all non-asthmatic patients and a subset of asthmatic patients have completed 12 months of treatment in the open-label safety trial of LEVADEX™. In addition, the Company has completed patient treatment in a thorough QT trial, the last trial necessary to support a New Drug Application (NDA) for LEVADEX.

8 Sep 2010

MAP Pharmaceuticals reports results from PD trial that compares effects of LEVADEX, IV DHE

MAP Pharmaceuticals, Inc. today reported results from a pharmacodynamics trial comparing the acute effects on pulmonary artery pressure of LEVADEX, dihydroergotamine mesylate administered intravenously and placebo. In the trial, there was no statistically significant difference between the LEVADEX and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration.

8 Sep 2010

USPTO awards Medicis new patent for SOLODYN Extended Release Tablets

Medicis today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 7,790,705 related to the use of SOLODYN® (minocycline HCI, USP) Extended Release Tablets. The new patent, entitled "Minocycline Oral Dosage Forms for the Treatment of Acne," relates to the use of dosage forms of SOLODYN which provide approximately 1 mg/kg dosing based on the body weight of the person, and expires in 2027.

8 Sep 2010

Phase 3 REALIZE study shows milestone in treatment development for hepatitis C

Vertex Pharmaceuticals Incorporated today announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone.

8 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

Botox maker agrees to pay $600 million for misbranding

The Associated Press: "Allergan Inc., the maker of wrinkle-smoothing Botox, has agreed to pay $600 million to settle a yearslong federal investigation into its marketing of the top-selling, botulin-based drug. The Justice Department and the company said Wednesday in a statement it will plead guilty to one misdemeanor charge of 'misbranding,' in which the company's marketing led physicians to use Botox for unapproved uses. Those included the treatment of headache, pain, spasticity and cerebral palsy in children.

3 Sep 2010

Inhibitex completes INX-189 Phase1a trial for HCV

Inhibitex, Inc., announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting.

2 Sep 2010

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation.

31 Aug 2010

FDA approves additional strengths of SOLODYN for inflammatory lesions treatment

Medicis today announced that the U.S. Food and Drug Administration (FDA) has approved additional strengths of SOLODYN (minocycline HCl, USP) Extended Release Tablets in 55 mg, 80 mg and 105 mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

30 Aug 2010

Headache News and Research

Latest Headache News and Research

Abbott issues statement in response to FDA's mixed vote for weight loss medication sibutramine

BioCryst reports results from forodesine studies for CTCL and CLL

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Repetitive transcranial magnetic stimulation helps to regain motor function in partially paralyzed patients

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

High dose peretinoin reduces recurrence of HCC after surgical resection or ablation in HCV positive patients

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

FDA approves pediatric use of Protopam Chloride

Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals reports results from PD trial that compares effects of LEVADEX, IV DHE

USPTO awards Medicis new patent for SOLODYN Extended Release Tablets

Phase 3 REALIZE study shows milestone in treatment development for hepatitis C

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Botox maker agrees to pay $600 million for misbranding

Inhibitex completes INX-189 Phase1a trial for HCV

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

FDA approves additional strengths of SOLODYN for inflammatory lesions treatment

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

How microRNA is transforming science: From discovery to diagnostics

Advancing benzodiazepine detection

The Surgeon-Scientist Pioneering Regenerative Engineering

Headache News and Research

Latest Headache News and Research

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

How microRNA is transforming science: From discovery to diagnostics

Advancing benzodiazepine detection

The Surgeon-Scientist Pioneering Regenerative Engineering

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