Headache News and Research

Latest Headache News and Research

Natazia tablets receive FDA approval for prevention of pregnancy

Bayer HealthCare Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved Natazia (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy.

7 May 2010

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

6 May 2010

Columbia Laboratories reports 34% increase in net revenues from U.S. sales of progesterone products

Columbia Laboratories, Inc. today announced financial results for the three-month period ended March 31, 2010.

6 May 2010

Alexza Pharmaceuticals secures $15M working capital loan from Hercules Technology Growth Capital

Alexza Pharmaceuticals, Inc. announced today that it has executed a $15 million working capital loan agreement with Hercules Technology Growth Capital. The funds available under the loan will be used for capital equipment and working capital purposes. In connection with the loan, Alexza issued Hercules warrants to purchase 376,394 shares of common stock at an exercise price of $2.69 per share, which was the 50-day average daily weighted average trading price at the time the term sheet for the loan was issued by Hercules.

6 May 2010

First Edition: May 5, 2010

Today's health policy news ranges from additional analysis of specific provisions of the health overhaul bill to Capitol Hill action and developments in the insurance market.

5 May 2010

Survey reveals need for educating U.S. women about stroke symptoms

Although more than 425,000 women suffer from stroke each year, 55,000 more than men, a new survey showed that women may be dramatically underestimating their risk of this medical emergency, the third leading cause of death in the United States. Only 27 percent of women who were surveyed could name more than two of the six primary stroke symptoms. Moreover, seven out of 10 women who were surveyed said they are not aware they are more likely than men to have a stroke, and were not at all or only somewhat knowledgeable about risk factors.

5 May 2010

Alexza Pharmaceuticals announces filing of universal shelf registration statement with SEC

Alexza Pharmaceuticals, Inc. announced today that it has filed a universal shelf registration statement with the Securities and Exchange Commission (SEC) that, if declared effective by the SEC, will allow the Company to sell, from time to time, up to $75 million of its common stock, preferred stock, debt securities and/or warrants, either individually or in units, in one or more offerings.

5 May 2010

Roche announces Health Canada approval for ACTEMRA to treat RA

Roche today announced that Health Canada has approved ACTEMRA(TM) (tocilizumab) to treat patients with rheumatoid arthritis (RA), a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications, such as fatigue and anemia.

4 May 2010

Data from Phase IV study of Bystolic tablets in Hispanic patients with hypertension presented at ASH 2010

Forest Laboratories, Inc. today presented data from a Phase IV study evaluating the effects of Bystolic (nebivolol) tablets in Hispanic patients with hypertension at the 2010 annual scientific meeting of the American Society of Hypertension.

4 May 2010

PROVENGE receives FDA approval for treatment of CRPC

Dendreon Corporation today announced that the U.S. Food and Drug Administration has approved PROVENGE (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer.

30 Apr 2010

Provenge cellular immunotherapy for men with advanced prostate cancer receives FDA approval

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

30 Apr 2010

New MDC tool provides alternative choices to user's current prescription drugs

Healthcare reform legislation has enacted changes that will significantly affect the Medicare Part D prescription drug program. The most immediate impact of the reform aims to close the "donut hole", a component of the benefit design in which seniors must pay the full cost for their drugs themselves.

29 Apr 2010

Normal BMI, regular exercise protect against musculoskeletal symptoms

Researchers at the Norwegian University of Science and Technology have found an association between the level of leisure time physical exercise and a future risk of developing fibromyalgia. The research team also identified BMI as an independent risk factor for fibromyalgia. Details of the study appear in the May 2010 issue of Arthritis Care & Research, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology.

29 Apr 2010

Takeda settles with six defendants in generic ACTOS, ACTOplus met patent infringement lawsuit

Takeda Pharmaceutical Company Limited announced today that Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., have completed settlement agreements with six out of eight defendants in patent infringement litigation brought against these parties in response to their Abbreviated New Drug Applications for generic ACTOS® (pioglitazone HCl) and ACTOplus met® (pioglitazone HCl and metformin HCl). Takeda recently concluded litigation with the sixth settling defendant.

28 Apr 2010

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

Salix Pharmaceuticals, Ltd. today announced plans for the Hepatic Encephalopathy Living Program (H.E.L.P.). H.E.L.P. is a first-of-its-kind patient and health care provider support program for the management of hepatic encephalopathy (HE) and will launch on May 24, 2010. The program will provide patients with HE educational materials, co-pay assistance, treatment adherence support and a 24-hour toll-free hotline.

27 Apr 2010

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

ViroPharma Incorporated today announced that it has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze (C1 esterase inhibitor [human)] in 24 adolescents and adult subjects with hereditary angioedema.

27 Apr 2010

First Edition: April 27, 2010

Today's headlines focus on the details of health reform that continue to emerge -- including states' reactions to high risk pools and questions about the sweeping expansion of Medicaid.

27 Apr 2010

Court of Appeals denies McNeil Pediatrics' CONCERTA patent appeal

The Court of Appeals for the Federal Circuit has denied an appeal by McNeil Pediatrics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., to overturn a 2009 decision by the U.S. District Court of Delaware that the patent for CONCERTA (methylphenidate HCl) Extended-Release Tablets CII is invalid and not infringed by Andrx Corporation.

27 Apr 2010

Victoza produces greater reductions in A1C, FPG and body weight than Januvia: Study

Yesterday, The Lancet published online the results of the first study comparing the once-daily human GLP-1 analog, Victoza (liraglutide [rDNA] injection) with a DPP-4 inhibitor, Januvia. The 26-week trial showed that Victoza produced significantly greater reductions in A1C, fasting plasma glucose, and body weight than Januvia, with similar or better overall treatment satisfaction.

24 Apr 2010

Genentech submits sBLA for Herceptin plus chemotherapy for advanced HER2-positive stomach cancer

Genentech, Inc., a wholly owned member of the Roche Group, announced today that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Herceptin® (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer.

23 Apr 2010

Headache News and Research

Latest Headache News and Research

Natazia tablets receive FDA approval for prevention of pregnancy

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Columbia Laboratories reports 34% increase in net revenues from U.S. sales of progesterone products

Alexza Pharmaceuticals secures $15M working capital loan from Hercules Technology Growth Capital

First Edition: May 5, 2010

Survey reveals need for educating U.S. women about stroke symptoms

Alexza Pharmaceuticals announces filing of universal shelf registration statement with SEC

Roche announces Health Canada approval for ACTEMRA to treat RA

Data from Phase IV study of Bystolic tablets in Hispanic patients with hypertension presented at ASH 2010

PROVENGE receives FDA approval for treatment of CRPC

Provenge cellular immunotherapy for men with advanced prostate cancer receives FDA approval

New MDC tool provides alternative choices to user's current prescription drugs

Normal BMI, regular exercise protect against musculoskeletal symptoms

Takeda settles with six defendants in generic ACTOS, ACTOplus met patent infringement lawsuit

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

First Edition: April 27, 2010

Court of Appeals denies McNeil Pediatrics' CONCERTA patent appeal

Victoza produces greater reductions in A1C, FPG and body weight than Januvia: Study

Genentech submits sBLA for Herceptin plus chemotherapy for advanced HER2-positive stomach cancer

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Headache News and Research

Latest Headache News and Research

How microRNA is transforming science: From discovery to diagnostics

Advancing benzodiazepine detection

The Surgeon-Scientist Pioneering Regenerative Engineering

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