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Warner Chilcott receives complete response letter from FDA for low dose oral contraceptive

Warner Chilcott plc announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its "low dose" oral contraceptive (also referred to as WC 3016).

27 Jan 2010

Abbott declares quarterly dividend of 40 cents per share

Abbott today announced financial results for the fourth quarter ended Dec. 31, 2009.

27 Jan 2010

GenSpera commences treatment in G-202 Phase I trial for solid tumors

GenSpera, Inc. announced that the first patient was treated in the Phase I clinical study of its cancer chemotherapeutic agent, G-202, at the University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. The trial is also being conducted at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.

27 Jan 2010

US PTO grants new allowances to intellectual property covering Neurologix' GAD based delivery systems

Neurologix, Inc., a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, announced that the U.S. Patent and Trademark Office (US PTO) has expanded the intellectual property protections enabled by a previously issued patent that is central to Neurologix’s Parkinson’s disease program. The new allowances to U.S. Patent Number 765,446, entitled “Glutamic acid decarboxylase (GAD) based delivery systems,” broaden the patent’s coverage beyond Parkinson’s disease to include the use of GAD65 in the treatment of other neurological and related disorders.

27 Jan 2010

MAQUET Cardiovascular initiates study evaluating EVH in CABG compared to open vein harvesting

MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced the initiation of the OPTION (Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques) study. This clinical trial is designed to evaluate the equivalence of Endoscopic Vessel Harvesting (EVH) in Coronary Artery Bypass Graft (CABG) surgery compared with historical data for open vein harvesting. David Moore, M.D., of THE HEART HOSPITAL Baylor Plano is the principal investigator for the OPTION trial.

27 Jan 2010

Update on Cardium Therapeutics' plans for commercial development of Generx

Cardium Therapeutics reported today that its Cardium Biologics division provided an update on plans for the continuing commercial development of Generx™ (alferminogene tadenovec, Ad5FGF-4), a DNA-based angiogenic therapy product candidate for patients with coronary artery disease.

27 Jan 2010

Fibromyalgia drug to earn 38% patient share in the U.S. and 30% patient share in Europe

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a fibromyalgia drug that improves sleep quality more than Pfizer's Lyrica would earn a 38 percent patient share in the U.S. and a 30 percent patient share in Europe due to its efficacy, safety and tolerability, and delivery.

27 Jan 2010

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

27 Jan 2010

Sumavel DosePro and Levadex to earn up to $400M by 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Zogenix/Astellas Pharma/Desitin Pharmaceuticals' needle-free Sumavel DosePro, which launched earlier this month in the United States, and MAP Pharmaceuticals' orally-inhaled Levadex will earn approximately $400 million in combined sales by 2018 in the migraine drug market.

27 Jan 2010

UCSB research: Rapamycin drug, a potential treatment for ADPKD

Research performed at UC Santa Barbara points to the drug rapamycin as a potential treatment for kidney disease. The study builds on past research and shows that studies performed on mice are more likely to translate to humans than previously thought.

27 Jan 2010

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

EpiCept Corporation announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

27 Jan 2010

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

Osiris Therapeutics, Inc. today announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for completing enrollment in a Phase II clinical trial evaluating Prochymal, an adult mesenchymal stem cell (MSC) therapy, as a treatment for patients recently diagnosed with type 1 diabetes. The milestone is the fourth in a series of payments resulting from JDRF’s partnership with Osiris for the development of a therapy for type 1 diabetes.

27 Jan 2010

ERYtech Pharma receives ODD for its GRASPA from FDA

ERYtech Pharma announces that FDA has granted an Orphan Drug Designation (ODD) for GRASPA®, the company’s lead product in Acute Lymphoblastic Leukaemia.

27 Jan 2010

YM BioSciences' nimotuzumab Phase II trials: FDA advises patient enrollment

YM BioSciences Inc., announced that the FDA has advised the Company that it may now enroll patients at US clinical sites into two ongoing randomized, double-blind Phase II trials of its lead product, nimotuzumab. One of the two trials is in non-small-cell lung cancer (NSCLC) patients who are ineligible for curative treatment and being treated palliatively and the other in patients with brain metastases from NSCLC. Current NSCLC palliative treatment and treatment for brain metastases is radiation alone.

27 Jan 2010

Spectrum Pharmaceuticals to submit additional data for FUSILEV sNDA

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it’s supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.

25 Jan 2010

Biogen Idec and Swedish Orphan Biovitrum commence dosing in rFIXFc Phase I/IIa trial for hemophilia B

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies’ long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.

25 Jan 2010

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux® (cetuximab) provided an improvement in overall survival (OS) when added to the standard 1st-line FOLFIRI chemotherapy regimen for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors in the CRYSTAL study.

24 Jan 2010

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients.

24 Jan 2010

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Biovail Corporation today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial is intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.

22 Jan 2010

USPTO issues new patent for Advaxis' intellectual property portfolio

The U.S. Patent and Trademark Office (USPTO) issued today patent 7,635,479, "Compositions and Methods for Enhancing the Immunogenicity of Antigens,” by Dr. Yvonne Paterson, et al, which is assigned to the Trustees of the University of Pennsylvania and licensed to Advaxis, Incorporated (OTCBB: ADXS).

22 Jan 2010

Efficacy News and Research

Warner Chilcott receives complete response letter from FDA for low dose oral contraceptive

Abbott declares quarterly dividend of 40 cents per share

GenSpera commences treatment in G-202 Phase I trial for solid tumors

US PTO grants new allowances to intellectual property covering Neurologix' GAD based delivery systems

MAQUET Cardiovascular initiates study evaluating EVH in CABG compared to open vein harvesting

Update on Cardium Therapeutics' plans for commercial development of Generx

Fibromyalgia drug to earn 38% patient share in the U.S. and 30% patient share in Europe

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Sumavel DosePro and Levadex to earn up to $400M by 2018

UCSB research: Rapamycin drug, a potential treatment for ADPKD

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

ERYtech Pharma receives ODD for its GRASPA from FDA

YM BioSciences' nimotuzumab Phase II trials: FDA advises patient enrollment

Spectrum Pharmaceuticals to submit additional data for FUSILEV sNDA

Biogen Idec and Swedish Orphan Biovitrum commence dosing in rFIXFc Phase I/IIa trial for hemophilia B

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

USPTO issues new patent for Advaxis' intellectual property portfolio

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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