Headache News and Research

Latest Headache News and Research

FDA endorses Covidien's REMS program for EXALGO tablets

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New Drug Application and proposed Risk Evaluation and Mitigation Strategy (REMS) program for EXALGOTM (hydromorphone HCl extended release) tablets, an opioid formulation.

24 Sep 2009

Results of Phase 3 CRYSTAL study of mCRC patients announced

The retrospective CRYSTAL analysis was conducted as a result of an effort to increase the tissue ascertainment rate to determine the K-ras status of patients’ tumors. The analysis included extended patient follow up of nearly 1.5 years and doubled the tissue ascertainment rate from 45% to 89%. These data are an update from the overall survival results from CRYSTAL that were published in the April 2009 issue of the New England Journal of Medicine.

23 Sep 2009

Clinical informatics solution for health care providers and pharmaceutical firms

Humedica, a next-generation health care informatics company, today announced the company’s official launch, along with the previous completion of its $30 million round of venture capital and the roll-out of its ground-breaking clinical analytics platform.

23 Sep 2009

Millennium's sNDA for VELCADE granted priority review by the FDA

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

19 Sep 2009

Results from the BLOSSOM trial announced by Arena Pharmaceuticals

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported today positive, highly significant top-line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trial.

18 Sep 2009

Genentech releases Phase III PRIMA study findings

Genentech, Inc., a wholly-owned member of the Roche Group and Biogen Idec, today announced that a Phase III study (PRIMA) showed that patients with follicular lymphoma who continued receiving Rituxan (rituximab) alone after responding to Rituxan and chemotherapy lived longer without their disease worsening (progression-free survival or PFS) than those who did not continue to receive Rituxan.

17 Sep 2009

Teva announces availability of its Plan B One-Step emergency contraceptive over-the-counter

Teva Women’s Health, Inc. announced today that its Plan B® One-Step (levonorgestrel) tablet, 1.5 mg emergency contraceptive is now available at licensed U.S. retail pharmacies. Approved by the U.S. Food and Drug Administration (FDA) on July 10, Plan B® One-Step can help prevent an unintended pregnancy after unprotected sex or contraceptive failure with just one pill in one dose.

16 Sep 2009

Medtronic informs physicians about the incorrect labeling of current SC catheter

Medtronic, Inc. today announced that the U.S. Food and Drug Administration (FDA) has classified its letters to physicians related to the incompatibility of its Sutureless Connector (SC) intrathecal catheters with the IsoMed constant-flow infusion pumps as a Class I recall.

15 Sep 2009

Phase 1 results of CTP-347 presented

Concert Pharmaceuticals, Inc. announced today the presentation of Phase 1 data on CTP-347, a deuterium-modified analog of paroxetine for the treatment of hot flashes. Concert presented the results during a poster session at the American College of Clinical Pharmacology’s 38th Annual Meeting.

14 Sep 2009

Preliminary results of Phase 2b clinical trial of AZ-104 announced by Alexza Pharmaceuticals

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced preliminary results from its 366 patient Phase 2b clinical trial of AZ-104 (Staccato(R) loxapine) in patients with migraine headache.

14 Sep 2009

Prolifiq's sales communication software for Life Sciences companies

Today at the annual RAPS (Regulatory Affairs Professionals Society) conference in booth #607, Prolifiq announced software that allows Life Sciences companies to comply with an increasingly complex web of regulations governing sales communication. Prolifiq for Life Sciences--designed for medical device, pharmaceutical and biotechnology companies--is used to organize, send and track approved digital content to health care practitioners.

14 Sep 2009

Phase 3 results of TARGET 1 and TARGET 2 clinical trials released

Salix Pharmaceuticals, Ltd. today announced the successful outcome of two Phase 3, randomized, double-blind, placebo-controlled, multicenter trials, TARGET 1 and TARGET 2, designed to evaluate the efficacy and safety of rifaximin 550 mg TID in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS).

14 Sep 2009

Phase III STARTMRK clinical study on ISENTRESS in comparison to efavirenz

ISENTRESS , an integrase inhibitor from Merck & Co., Inc., was studied in comparison to efavirenz in maintaining viral load suppression to undetectable levels (less than 50 copies/mL) and at improving CD4 cell counts in previously untreated (treatment-naïve) HIV-1-infected patients through 96 weeks in a Phase III study called STARTMRK.

14 Sep 2009

Data from Phase III clinical trial of TYSABRI presented at ECTRIMS

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showing the potential of TYSABRI® (natalizumab) to redefine successful multiple sclerosis (MS) therapy.

14 Sep 2009

Results further support the benefits of TYSABRI for multiple sclerosis patients

Biogen Idec and Elan Corporation, plc (NYSE: ELN) today announced six-month results of an ongoing, one-year longitudinal, observational, patient-reported outcomes study showing multiple sclerosis (MS) patients taking TYSABRI- (natalizumab) experienced an improvement in both their physical function and psychological well-being.

14 Sep 2009

Practical tips for parents on H1N1 and seasonal flu infections

With the early onset of flu season coinciding with the start of school this year, concern about the flu, and in particular the H1N1 strain of the flu, is growing among parents. Experts from The Children’s Hospital in Denver, Colo., can offer a pediatric perspective on all types of flu, including H1N1, also known as swine flu.

14 Sep 2009

AVONEX results in fewer injection site reactions, according to a clinical study

Data from an observational phase IV study of 499 patients entitled The Swiss MS Skin Project show that multiple sclerosis (MS) patients taking AVONEX (interferon beta-1a IM) reported significantly fewer injection site reactions (ISRs) compared to patients on Betaferon- (interferon beta-1b), Copaxone- (glatiramer Acetate) or Rebif - (interferon beta-1a).

13 Sep 2009

Cymbalta maintains reduction in pain for patients with chronic low back pain

New data show patients with chronic low back pain on Cymbalta(R) (duloxetine HCl) maintained reductions in pain for 41 weeks. In patients who initially responded to duloxetine, this maintenance of pain reduction was accompanied by further reduction in pain that was statistically significant as measured by the Brief Pain Inventory (BPI) average pain rating.

11 Sep 2009

Phase 3 trial results of LEVADEX orally inhaled migraine therapy to be presented

MAP Pharmaceuticals, Inc. announced today that it will present analysis of data from the efficacy portion of the first Phase 3 trial of its novel LEVADEX orally inhaled migraine therapy, currently in development, at the 14th Congress of the International Headache Society.

11 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009