Regulation News: Breaking Regulation News, Comments and Articles. - Page: 3

miRagen Therapeutics Achieves First Milestone in Strategic Alliance with Servier

Servier selects third cardiovascular target triggering the first milestone under the collaboration Servier, a privately-run French research-based pharmaceutical company and a major player in Europe and emerging markets having expertise in the development of treatments for cardiovascular diseases, and miRagen Therapeutics, Inc., a biopharmaceutical comp...

Tufts CSDD Study Finds Adoption of Adaptive Clinical Trial Designs Is Increasing

Report Shows Growing Acceptance by Pharmaceutical Companies and Regulatory Agencies Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces publication of a Tufts Center for the Study of Drug Development (CSDD) report on the adoption and impa...

Johnson & Johnson plans on more than 10 drugs filed by 2017

May 23 (Reuters) - Johnson & Johnson said on Thursday that it plans to submit more than 10 new products for regulatory approval by 2017, including drugs to treat hepatitis C, immune diseases, and schizophrenia as well as vaccines for flu, rabies and...

Verastem to Present at the 2013 ASCO Annual Meeting

Verastem, Inc., (NASDAQ: VSTM) focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced that members of the research and development team will present the clinical design for an ongoing study of VS-6063 and preclinical data on the dual PI3K/mTOR inhibitor VS-5584 at the American Society of Clinical...

VG Energy Enters into a Strategic Alliance with DAK Renewable Research for LipidMax Field Trials

SAN MARINO, Calif., May 23, 2013 /PRNewswire/ -- VG Energy, an agricultural biotech company, announces today a strategic alliance with DAK Renewable Research to conduct field trials using LipidMax to increase the corn oil yield. VG Energy is a majority owned subsidiary of VG Life Sciences, Inc. (OTC Pink: VGLS). VG Energy's exclusively licensed compound LipidMax selectively inhibits certain metab...

Celgene Announces U.S. FDA Grants Priority Review for ABRAXANE sNDA in Advanced Pancreatic Cancer

European Medicines Agency Accepts Regulatory Submission of Type II Variation for ABRAXANE for the Treatment of Advanced Pancreatic Cancer Celgene International Sàrl, a subsidiary of Celgene Corpor...

Edison Investment - Alexza Pharmaceuticals - Stage set for Adasuve

Alexza’s US marketing deal with Teva for Adasuve (orally-inhaled loxapine) enhances the product’s US sales prospects given Teva’s expertise in the psychiatric and hospital markets. Adasuve is a potentially disruptive new product for acute agitation in schizophrenia or bipolar disorder, given its advantages over existing options (injection/oral/buccal). The investment case is sh...

Making the goal of integrated care a reality?

Nicola Walsh Announcing the government’s invitation to local organisations to apply to become pioneers of integration, Norman Lamb MP emphasised how crucial this initiative is. But will the pioneers be given the freedoms and flexibilities to overcome the current challenges they face? And how can we ensure that this initiative promotes th...

Court Rules against BCBSRI for its Overpayment Recoupment and Withholding Claims - ERISAclaim.com Demystifies Landmark Court Order for U. S. Healthcare Claim Denials

On May 22, 2013, federal court rules against BCBSRI for its overpayment recoupment and withholding lawsuit against two healthcare providers: BCBSRI can make no recovery from past payments and can withhold no money from future claims. ERISAclaim.com demystifies the landmark Court order for No. 1 health care claim denials. Hanover Park, IL (PRWEB) May 23, 2013 On May 22, 2013, federal court rules a...

DiaGenic ASA: Annual General Meeting held

Regulatory News: The annual general meeting of DiaGenic ASA (OSE:DIAG) was held on 23 May 2013. All proposals set out in the notice to the general meeting were approved. In accordance with the rec...

Daily Dose Of Fish Oil May Reduce Risk Of Diabetes, Heart Disease

redOrbit Staff & Wire Reports - Your Universe Online The use of fish oil supplements has been linked to a moderate increase in production of a hormone that has in turn been associated with a decreased risk of some forms of diabetes and heart disease, researchers from the Harvard School of Public Health (HSPH) report in a new study. The supplements, which are also known as omega-3 fatty acid...

HealthSouth Announces Plans To Build a Rehabilitation Hospital in Newnan, Georgia

  BIRMINGHAM, Ala., May 23, 2013 /PRNewswire/ -- HealthSouth Corporation (NYSE: HLS) announced today that it plans to build a 50-bed comprehensive inpatient rehabilitation hospital in Newnan, Ga. "We look forward to bringing this new hospital and the much needed comprehensive, inpatient rehabilitation services to the residents of Coweta, Fayette and south Fulton counties," sa...

Vaccine blackjack: IL-21 critical to fight against viral infections

(Medical Xpress)—Scientists at Emory Vaccine Center have shown that an immune regulatory molecule called IL-21 is needed for long-lasting antibody responses in mice against viral infections.

Royalty Pharma Reduces Acceptance Condition to 50% Plus One Share

NEW YORK, May 23, 2013 /PRNewswire/ -- Echo Pharma Acquisition Limited ("Royalty Pharma") announced today that it has committed to waive down the Acceptance Threshold from 90 percent to 50 percent of Maximum Elan Shares Affected plus one Elan Share in accordance with the terms of the Revised Offer Document issued today, subject to the conditions summarized below. Under the terms of the Incre...

Advanced Bionics Announces the Commercial Release of the Naída CI Q70 Sound Processor in Europe, Canada and Several Other Countries around the World

-- The World’s Newest, Most Advanced Behind-the-Ear Sound Processor Receives Regulatory Approval for Commercial Release in Europe and Canada -- Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that the new Naída CI Q70* (Naída CI) sound processor

PAREXEL International To Present At Jefferies Healthcare Conference

BOSTON, May 23, 2013 /PRNewswire/ -- PAREXEL International Corporation (NASDAQ: PRXL) announced today that it will be presenting at the Jefferies Healthcare Conference in New York.  James Winschel, Sr. Vice President and Chief Financial Officer, will be making a presentation on PAREXEL and discussing business developments at 1:30 p.m. ET on Monday, June 3, 2013. A live webcast of t...

Volcano Announces Preliminary Results from the ADVISE II Study and Inclusion in the SYNTAX2 Trial During Hot Line Late Breaking Clinical Trial Sessions at EuroPCR 2013

SAN DIEGO and PARIS, May 23, 2013 /PRNewswire/ -- Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced preliminary results from the ADVISE (Adenosine Vasodilator Independent Stenosis Evaluation) II trial during the hot line late bre...

Study: Sleep disturbance may contribute to depression risk by impairing emotion regulation

A new study provides neurobiological evidence for dysfunction in the neural circuitry underlying emotion regulation in people with insomnia, which may have implications for the risk relationship between insomnia and depression.

Innate lymphoid cells regulate CD4+ T-cell responses to intestinal commensal bacteria

Innate lymphoid cells (ILCs) are a recently characterized family of immune cells that have critical roles in cytokine-mediated regulation of intestinal epithelial cell barrier integrity. Alterations in ILC responses are associated with multiple chron...

BioSyent Pharma Submits Two New Drugs to Health Canada for Marketing Approval

TORONTO, ONTARIO -- (Marketwired) -- 05/23/13 -- BioSyent Inc. (TSX VENTURE: RX) ("BioSyent") is pleased to announce that its subsidiary, BioSyent Pharma Inc., has submitted two new drug products to Health Canada seeking marketing approval. These two urgent care drugs are supplied in a patented delivery system that offers technical advantages over existing alternatives and will be used in hospi...

Atossa Genetics to Exhibit Its ForeCYTE Breast Health Test at the 2013 ASCO Annual Meeting

SEATTLE, WA -- (Marketwired) -- 05/23/13 -- Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, will display its ForeCYTE Breast Health Test at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, from May 31 through June 4, 2013. Atossa's exhibit will be located in booth 2019 at McCormick Place. The ForeCYTE Breast Health Test, developed and marketed...

DKSH Inks Agreement to Provide Regulatory Services to Rovithai

DKSH has signed an agreement to provide regulatory services to DSM subsidiary Rovithai in Thailand.

Theravance to Present at Investor Conferences in June 2013

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 05/23/13 -- Theravance, Inc. (NASDAQ: THRX) announced today that Rick E Winningham, Theravance's Chief Executive Officer, is scheduled to present at the following investor conferences in June 2013: Jefferies 2013 Global Healthcare Conference Grand Hyatt, New York City, NY Wednesday, June 5, 2013 10:30 a.m. ET Goldman Sachs 34th Annual Global Healthca...

VentriPoint Announces Closing of Private Placement and Proposed Issuance of Shares for Debt

SEATTLE, WASHINGTON -- (Marketwired) -- 05/23/13 -- Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company") (TSX VENTURE: VPT) (OTCQX: VPTDF) announces that it has completed the first of its two previously announced non-brokered private placements. The Company has issued an aggregate of US$748,000 principal amount of non-convertible secured debentures (the "Non-Unit Debentures") which matu...

College of Pharmacy Partners With TNI BioTech to Develop New Drugs for Africa

WASHINGTON, DC -- (Marketwired) -- 05/23/13 -- Howard University College of Pharmacy has signed a multi-year agreement with TNI BioTech, Inc. (OTCQB: TNIB), a Bethesda, Md., biotech firm that develops immunotherapy drugs to treat patients with chronic diseases, to assist in TNI BioTech's efforts to provide affordable health care and the development of pharmaceutical skills in Africa. The College...