Headache News and Research

Latest Headache News and Research

Almirall, Forest Labs submit aclidinium bromide NDA to FDA for treatment of COPD

Forest Laboratories, Inc. and Almirall, S.A. announced they have recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aclidinium bromide, a long-acting inhaled antimuscarinic agent developed for the treatment of COPD.

30 Jun 2011

FDA's ODAC recommends withdrawal of Avastin approval for metastatic breast cancer

Genentech, a member of the Roche Group, announced today that, during a U.S. Food and Drug Administration (FDA) hearing, the FDA's Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin in combination with paclitaxel chemotherapy for previously untreated HER2-negative metastatic breast cancer.

30 Jun 2011

Dendreon receives FDA approval for Los Angeles cancer immunotherapy manufacturing facility

Dendreon Corporation today announced that the U.S. Food and Drug Administration approved its Los Angeles cancer immunotherapy manufacturing facility, allowing the company to continue to increase the availability of PROVENGE across the U.S. to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.

30 Jun 2011

Positive results from RISE and RIDE Phase III trials of Genentech's Lucentis for diabetic macular edema

Genentech, a member of the Roche Group, today announced 24-month results from the two pivotal Phase III trials (RISE and RIDE) assessing the efficacy and safety of Lucentis (ranibizumab injection) in people with diabetic macular edema (DME).

29 Jun 2011

Tibotec, Gilead Sciences enter license agreement for new combination product of PREZISTA and cobicistat

Tibotec Pharmaceuticals today announced that it has entered into a license agreement with Gilead Sciences, Inc., for the development and commercialization of a new once-daily single tablet fixed-dose antiretroviral combination product containing Tibotec's protease inhibitor PREZISTA® (darunavir) and Gilead's cobicistat, an investigational pharmacoenhancing or "boosting" agent.

28 Jun 2011

Omeros identifies compounds that interact with orphan GPCRs associated with leukemia

Omeros Corporation today reported that it has identified compounds that interact with orphan G protein-coupled receptors (GPCRs) P2Y8 and OPN4. P2Y8 (also known as P2RY8) is associated with acute lymphoblastic leukemia (ALL), an aggressive cancer of the white blood cells.

27 Jun 2011

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec (imatinib mesylate) was approved in Canada.

27 Jun 2011

New data from JANUMET clinical study on type 2 diabetes presented at ADA 2011

In a new post-hoc analysis based on the American Association of Clinical Endocrinologists (AACE/ACE) diabetes algorithm presented at the American Diabetes Association (ADA) 71st Annual Scientific Sessions, significantly more patients with type 2 diabetes treated with JANUMET-tablets achieved blood sugar goals after 18 weeks compared to metformin as initial therapy.

27 Jun 2011

Positive preliminary findings from ATI's neurostimulation system study on cluster headache

Autonomic Technologies, Inc. (ATI), the developer of a novel miniaturized implantable system for severe headaches, today announced positive preliminary findings from a study evaluating the safety and efficacy of the company's investigational neurostimulation system for the treatment of cluster headache.

27 Jun 2011

EMA CHMP recommends approval of linagliptin for type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of linagliptin, 5 mg, film-coated tablets (to be marketed under the trade name Trajenta® in Europe) for the treatment of adults with type 2 diabetes.

24 Jun 2011

EMA CHMP issues positive opinion for Baxter's IVIG therapy for multifocal motor neuropathy

Baxter International Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for extension of the therapeutic indications of KIOVIG to include a new indication for multifocal motor neuropathy (MMN), a severe, debilitating disorder requiring lifelong treatment.

From Baxter International Inc. 24 Jun 2011

Endo's complete response for new formulation of OPANA ER NDA accepted by the FDA

Endo Pharmaceuticals announced today that it received notification from the U.S. Food and Drug Administration (FDA) that Endo's complete response to the FDA's Jan. 7, 2011 Action Letter relating to Endo's new drug application (NDA) for a new formulation of OPANA ER has been accepted.

24 Jun 2011

MAP to present LEVADEX data on migraine at 15th Congress of IHC

MAP Pharmaceuticals, Inc. today announced that LEVADEX orally inhaled migraine drug will be featured in four poster presentations, including one late-breaker presentation, at the 15th Congress of the International Headache Society (IHC) in Berlin, Germany on June 23-26, 2011.

23 Jun 2011

St. Jude Medical announces results of Genesis neurostimulator trial on chronic migraine

St. Jude Medical, Inc., a global medical device company, today announced study results on the safety and efficacy of peripheral nerve stimulation (PNS) of the occipital nerve for the management of pain and disability associated with chronic migraine, a debilitating condition that affects millions worldwide.

23 Jun 2011

EC grants marketing authorization to BYDUREON for treatment of type 2 diabetes

Eli Lilly and Company, together with Amylin Pharmaceuticals, Inc. and Alkermes, Inc., announced today that the European Commission has granted marketing authorization to BYDUREON.

21 Jun 2011

New anti-abuse formulation of painkiller Oxycodone

It has come to health officials’ attention nationwide that there is a serious rise of abuse of painkillers, especially opioids. Federal officials recently stepped up plans to monitor frequent prescribers and users.

21 Jun 2011

Amylin to present data on investigational diabetes drug candidates at ADA annual meeting

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its two first-in-class diabetes drugs, BYETTA injection and SYMLIN injection, and its investigational diabetes drug candidates BYDUREON and exenatide once monthly at the 71st Scientific Sessions of the American Diabetes Association (ADA) being held in San Diego, CA from June 24 to June 28.

21 Jun 2011

Acura, Pfizer receive FDA approval for OXECTA Tablets to manage severe pain

Pfizer Inc. and Acura Pharmaceuticals Inc. announce the marketing approval from the U.S. Food and Drug Administration (FDA) of OXECTATM Tablets CII.

20 Jun 2011

GTx commences Capesaris Phase IIb trial in advanced prostate cancer

GTx, Inc., announced today that it initiated a Phase IIb clinical trial evaluating Capesaris, a selective estrogen receptor alpha agonist, compared to Lupron Depot for first line treatment of advanced prostate cancer.

20 Jun 2011

Alexion begins eculizumab clinical trial in Shiga-toxin producing E. coli hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. and Alexion Pharma International Sàrl (APIS), announced today that the Paul-Ehrlich-Institut, Germany's healthcare regulatory body for biological products, has authorized initiation of an open-label clinical trial to investigate eculizumab as a treatment for patients with Shiga-toxin producing E. coli hemolytic uremic syndrome, which has resulted from infections by Enterohemorrhagic Escherichia coli in an unusually wide outbreak in Germany that began in May.

20 Jun 2011

Headache News and Research

Latest Headache News and Research

Almirall, Forest Labs submit aclidinium bromide NDA to FDA for treatment of COPD

FDA's ODAC recommends withdrawal of Avastin approval for metastatic breast cancer

Dendreon receives FDA approval for Los Angeles cancer immunotherapy manufacturing facility

Positive results from RISE and RIDE Phase III trials of Genentech's Lucentis for diabetic macular edema

Tibotec, Gilead Sciences enter license agreement for new combination product of PREZISTA and cobicistat

Omeros identifies compounds that interact with orphan GPCRs associated with leukemia

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

New data from JANUMET clinical study on type 2 diabetes presented at ADA 2011

Positive preliminary findings from ATI's neurostimulation system study on cluster headache

EMA CHMP recommends approval of linagliptin for type 2 diabetes

EMA CHMP issues positive opinion for Baxter's IVIG therapy for multifocal motor neuropathy

Endo's complete response for new formulation of OPANA ER NDA accepted by the FDA

MAP to present LEVADEX data on migraine at 15th Congress of IHC

St. Jude Medical announces results of Genesis neurostimulator trial on chronic migraine

EC grants marketing authorization to BYDUREON for treatment of type 2 diabetes

New anti-abuse formulation of painkiller Oxycodone

Amylin to present data on investigational diabetes drug candidates at ADA annual meeting

Acura, Pfizer receive FDA approval for OXECTA Tablets to manage severe pain

GTx commences Capesaris Phase IIb trial in advanced prostate cancer

Alexion begins eculizumab clinical trial in Shiga-toxin producing E. coli hemolytic uremic syndrome

CellVoyant's AI-Powered Vision for the Future of Cell Therapy

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Headache News and Research

Latest Headache News and Research

CellVoyant's AI-Powered Vision for the Future of Cell Therapy

Scalable, Smart, and Accessible: The Future of Lab Automation

Healthy Beginnings, Hopeful Futures: A Conversation with WHO’s Dr. Allotey

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