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Evidence does not connect H1N1 vaccine to patient deaths, WHO says

20. November 2009 23:12
The deaths of 41 people from six countries who had received the H1N1 (swine flu) vaccine were not directly linked to the vaccine, the WHO said Thursday, the Associated Press/MSNBC reports (11/19). [More]

Posted in: Disease/Infection News | Healthcare News | Pharmaceutical News

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Pfizer’s Revatio Injection receives FDA approval

20. November 2009 09:18
Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations. [More]

EMEA's CHMP recommends approval of Merck's ELONVA

20. November 2009 08:52
Merck & Co., Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. [More]

Posted in: Drug Trial News | Women's Health News

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FDA issues complete response for Rituxan, a drug for treating chronic lymphocytic leukemia

19. November 2009 03:13
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies’ applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL). [More]

Xeomin receives approval for post-stroke spasticity of upper limb in European countries

19. November 2009 01:42
Today, Merz Pharmaceuticals announced Xeomin®, the first botulinum toxin type A free from complexing proteins has been granted an extension of indication for post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults in various European countries. [More]

Once-a-day dosing clinical study of udenafil for erectile dysfunction completed

19. November 2009 00:44
Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced today that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED). [More]

Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

18. November 2009 10:31
Millennium: The Takeda Oncology Company today announced it has further expanded its protein homeostasis program with the initiation of a Phase I clinical trial for an oral formulation of MLN9708, the Company’s second-generation proteasome inhibitor. An intravenous formulation of MLN9708 entered clinical trials in March. [More]

Clinical Data commences patient enrollment in Stedivaze Phase III trial

18. November 2009 08:13
Clinical Data, Inc. today announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing. The study will evaluate the safety and efficacy of Stedivaze (apadenoson) for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI), a method for detecting defects in the blood supply to the heart. [More]

Positive results from REVIVE, a phase 3 pivotal study of avanafil announced

18. November 2009 07:16
VIVUS, Inc. today announced positive results from REVIVE (TA-301), a phase 3 pivotal study evaluating the safety and efficacy of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED), in 646 patients. [More]

Entellus Medical completes its Series D financing totaling $30MM

17. November 2009 06:53
Entellus Medical, the Minnesota-based developer of novel, less invasive treatments for chronic conditions of sinusitis, has completed its Series D financing totaling $30MM. The Series D round was led by new investor Essex Woodlands Health Ventures and supported by existing investors Split Rock Partners and SV Life Sciences. [More]

Posted in: Business / Finance | Medical Condition News

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Shire publishes new study results on INTUNIV Extended-Release Tablets

17. November 2009 04:21
Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone. [More]

Genentech submits sBLAs to the FDA for Avastin

17. November 2009 03:36
Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that investigated Avastin in combination with docetaxel chemotherapy. [More]

Migraine headaches linked with increased risk of common kind of stroke

16. November 2009 11:16
Pooling results from 21 studies, involving 622,381 men and women, researchers at Johns Hopkins have affirmed that migraine headaches are associated with more than twofold higher chances of the most common kind of stroke: those occurring when blood supply to the brain is suddenly cut off by the buildup of plaque or a blood clot. [More]

Posted in: Medical Condition News

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FDA approves Lysteda for treating menorrhagia

16. November 2009 09:04
Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia. [More]

Posted in: Women's Health News | Pharmaceutical News

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Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

16. November 2009 08:49
Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002). [More]
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