Headache News and Research

Latest Headache News and Research

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 Oct 2010

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

ViroPharma Incorporated today announced that it has completed enrollment in its Phase 2 study evaluating subcutaneous delivery of Cinryze™ (C1esterase inhibitor [human]). This multi-center, open-label, multi-dose Phase 2 study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze in adolescent and adult subjects with hereditary angioedema (HAE).

25 Oct 2010

FDA issues complete response letter for ViroPharma's Cinryze

ViroPharma Incorporated today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.

25 Oct 2010

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Cephalon, Inc. today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL (armodafinil) Tablets [C-IV] and PROVIGIL (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA).

25 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

Alexion 2010 third quarter revenue increases from $102.6 to $141.6 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and nine months ended September 30, 2010.

21 Oct 2010

MAP Pharmaceuticals to present nine analyses on LEVADEX for migraine therapy at 2010 EHMTIC congress

MAP Pharmaceuticals, Inc. today announced that the Company will present nine analyses relating to its LEVADEX™ orally inhaled migraine therapy product candidate, including analysis from the FREEDOM-301 Phase 3 trial, at the 2010 European Headache and Migraine Trust International Congress (EHMTIC) in Nice, France.

21 Oct 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

Alexion announces results of eculizumab two open-label Phase 2 studies for aHUS treatment

Alexion Pharmaceuticals, Inc. today announced that its two open-label Phase 2 studies investigating eculizumab (Soliris) as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS) have met the primary and key secondary endpoints with high clinical and statistical significance, in interim analyses.

21 Oct 2010

FDA approves Herceptin with chemotherapy for HER2-positive metastatic cancer

Genentech, a member of the Roche Group today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic (cancer that has spread) cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.

21 Oct 2010

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

Arena Pharmaceuticals, Inc. announced today results from a Phase 1 clinical trial of APD916, a novel drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy with cataplexy.

20 Oct 2010

Reports examine drug company payments to doctors

ProPublica: "Drug companies say the millions of dollars they pay physicians for speaking and consulting justly compensates them for the laudable work of educating their colleagues. But a series of lawsuits brought by former employees of those companies allege the money often was used for illegal purposes — financially rewarding doctors for prescribing their brand-name medications.

20 Oct 2010

Novartis announces six-year data of Reclast injection for postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis.The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

19 Oct 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Botox receives FDA approval for treatment of chronic migraine

The U.S. Food and Drug Administration today approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month.

18 Oct 2010

Biogen, Elan announce clinical utility data of two-step ELISA to detect anti-JCV antibodies

Biogen Idec and Elan Corporation, plc today announced data further supporting the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum.

18 Oct 2010

Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis. The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

18 Oct 2010

FDA approves BOTOX as prophylactic treatment for Chronic Migraine

Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved BOTOX(onabotulinumtoxinA) for the prophylactic (preventive) treatment of headaches in adults with Chronic Migraine.

18 Oct 2010

Headache News and Research

Latest Headache News and Research

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

FDA issues complete response letter for ViroPharma's Cinryze

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Alexion 2010 third quarter revenue increases from $102.6 to $141.6 million

MAP Pharmaceuticals to present nine analyses on LEVADEX for migraine therapy at 2010 EHMTIC congress

FDA issues complete response letter for BYDUREON NDA

Alexion announces results of eculizumab two open-label Phase 2 studies for aHUS treatment

FDA approves Herceptin with chemotherapy for HER2-positive metastatic cancer

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

Reports examine drug company payments to doctors

Novartis announces six-year data of Reclast injection for postmenopausal women with osteoporosis

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Botox receives FDA approval for treatment of chronic migraine

Biogen, Elan announce clinical utility data of two-step ELISA to detect anti-JCV antibodies

Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

FDA approves BOTOX as prophylactic treatment for Chronic Migraine

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Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

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Headache News and Research

Latest Headache News and Research

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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