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Showing "regulation regulatory" News Articles 51 to 75 of 7,100+

Friday 29th August 2014

Senesco Closes Enrollment in Its Phase 1b/2a SNS01-T Study

Senesco Technologies, Inc. (“Senesco” or the “Company”) (OTCQB:SNTI) today announced the closing of enrollment in its ongoing Phase 1b/2a open-label, multiple-dose, dose-escalation clinical trial of SNS01-T, a first-in-class modulator of eukaryotic translation initiation factor 5A (eIF5A), in patients with relapsed or refractory multiple myeloma, p...

Team VersaTech and CRGT Win HHS FDA Contract to Support Food Applications Regulatory Management (FARM) System Upgrade

Reston, VA (PRWEB) August 29, 2014 The Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), awarded a five-year, single-award, indefinite delivery, indefinite quan...

The Drug Enforcement Agency (DEA) Just Announced Plans to Regulate All Hydrocodone Combination Drugs as Schedule II Drugs, Parker Waichman LLP Comments

DEA’s announcement comes after a recommendation last year concerning the potent combination drug products. Port Washington, New York (PRWEB) August 29, 2014 Parker Waichman LLP, a national law firm that has long been dedicated to protecting the rights of victims who have been injured by medications reports that the Drug Enforcement Administration (DEA) has announced new regulations for all hydr...

Fitch Affirms Meridian Hospital Company's Bonds at 'BBB+', Outlook Stable

(The following statement was released by the rating agency) LONDON, August 29 (Fitch) Fitch Ratings has affirmed Meridian Hospital Company Plc's (Meridian) GBP91.2m index-linked bonds due 2028 at 'BBB+' with Stable Outlook. The affirmation reflects s...

Drug Makers Willing to Lose India 'Advantage'

Indian drugmakers are fleeing a regulatory morass at home and moving some research and development to Europe and the United States as try to boost margins by producing high-value drugs. Reuters Health Information

The future of biosimilar use and regulation in Latin America

There is a growing uptake of biosimilars in Latin America, but this has not been accompanied by an increase in pharmacovigilance, training or regulation. To address this, an expert panel was put together to discuss the issues involved. The panel’s ...

Amgen submits BLA to FDA for novel cholesterol drug

Amgen has submitted the first Biologics Licence Application (BLA) to the US FDA for a PCSK9 inhibitor.Its drug evolocumab is for the treatment of high cholesterol and is an investigational fully human monoclonal antibody that inhibits proprotein conv...

Value of generics overlooked in one country that needs them most: Greece

A study of physicians’ prescribing patterns and perceptions towards generics in Greece has revealed a clear need for an appropriate regulatory framework and organized generic drug industry in the country.

Pixcelldata Announces New Deal with Dutch Tele-Pathology Specialists eX-Path Ahead of ECP 2014

DUBLIN, August 29, 2014 /PRNewswire/ -- Pixcelldata, the innovative Irish developer of digital pathology management and collaboration software has announced a major new deal with Dutch based eX-Path, global providers of tele-pathology services, founded by renowned pathology expert, Dr. Marius Nap. The announcement was made in advance of the 26th European Congress of Pathology which is taking pla...

iCo Therapeutics Announces Second Quarter 2014 Financial Results

VANCOUVER, Aug. 29, 2014 /PRNewswire/ - iCo Therapeutics ("iCo" or "the Company") (TSX-V: ICO) (OTCQX: ICOTF), today reported financial results for the six months ended June 30, 2014. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS"). Second Quarter 2014 Highlights Announced top-line results related to...

Thursday 28th August 2014

TGen to lead first-in-patient clinical trial studies to test novel drugs for glioblastoma

SIn 2012, The Ben & Catherine Ivy Foundation awarded $10 million in grants for two groundbreaking brain cancer research projects at the Translational Genomics Research Institute. One of those projects has officially received the final regulatory appr...

REFILE-In race for bigger margins, drug makers willing to lose the India "advantage"

MUMBAI, Aug 29 (Reuters) - Indian drugmakers are fleeing a regulatory morass at home and moving some research and development to Europe and the United States as they try to boost margins by producing high-value drugs.

biOasis Closes Non-Brokered Private Placement for $1,609,753.15 Gross Proceeds

VANCOUVER, BRITISH COLUMBIA -- (Marketwired) -- 08/29/14 -- biOasis Technologies Inc. (TSX VENTURE: BTI)(OTCQX: BIOAF) (the "Company") is please to announce it has closed its non-brokered private placement announced on August 8th, 2014. The Company has issued 1,694,447 units (each a "Unit"), including an over allotment of 94,477 Units, at a price of CDN$0.95 per unit, for gross proceeds of CDN$1...

Stellar Biotechnologies Reports on Unusual Trading Activity

PORT HUENEME, CA -- (Marketwired) -- 08/29/14 -- Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH) reports that, in view of the unusual market trading activity in the Company's stock, the Investment Industry Regulatory Organization of Canada (IIROC) has contacted the Company in accordance with its usual market surveillance practice. While the Company o...

Rx&D pleased with RCC progress

OTTAWA, ONTARIO -- (Marketwired) -- 08/29/14 -- Following the release today of the Canada-United States Regulatory Cooperation Council (RCC) Joint Forward Plan, Russell Williams, President, Canada's Research-Based Pharmaceutical Companies (Rx&D) issued the following statement: "Canada's Research-Based Pharmaceutical Companies (Rx&D) is pleased with the Regulatory Cooperation Council's pr...

Agility Health Announces Cessation of Negotiations Regarding Acquisition Opportunity

GRAND RAPIDS, MI--(Marketwired - August 29, 2014) - Agility Health, Inc. (TSX VENTURE: AHI) ("Agility Health" or the "Company"), a leading provider of physical rehabilitation and software services that benefit patients, healthcare providers and employers announces that it has ceased negotiations regarding the acquisition opportunity press released July 21, 2014. The Company believes the decision ...

Radient Technologies Inc. Releases First Quarter Results

Radient Technologies Inc. (TSX-V:RTI) (the “Corporation”) announced today that it has released its financial results for the first quarter of its fiscal year ended March 31, 2015. The unaudited financial statements, Management’s Discussion and Analysis, and the CEO & CFO certifications for the three month period ended June 30, 2014 are available ...

In race for bigger margins, drug makers willing to lose the India "advantage"

MUMBAI, Aug 29 (Reuters) - Indian drugmakers are fleeing a regulatory morass at home and moving some research and development to Europe and the United States as try to boost margins by producing high-value drugs.

Onxeo Strengthens Beleodaq Patent Protection in the U.S. Until 2027

Regulatory News: OnxeoSA (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen ONXEO), an innovative company specialized in the development of drugs for orphan oncology diseases,...

Onxeo Strengthens Beleodaq® Patent Protection in the U.S. Until 2027

Regulatory News: Onxeo SA (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen - ONXEO), an innovative company specialized in the development of drugs for orphan oncology diseases, today announced that the U.S. Patent Office will grant a new patent for Beleodaq® (Belinostat U.S. commercial name) on September 16th 2014. ...

Amgen submits evolocumab BLA

Amgen Inc. (NASDAQ:AMGN) submitted a BLA to FDA for evolocumab (AMG 145), a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9), to treat high cholesterol. The application -- the first in the U.S. for a PCSK9 program -- includes d...

GSK/NIAID Ebola vaccine gets grant for trials

The Wellcome Trust, the Medical Research Council and the U.K.'s Department for International Development provided a L2.8 million ($4.6 million) grant to fund trials of an Ebola vaccine candidate from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and NIH's ...

California Hospitals Get Boost in Race Against Federal Healthcare Deadline

Public health reporting requirements satisfied with California-certified MEDHOST YourCareLink California hospitals struggling to meet the federal government’s public health reporting requirements, in advance of a looming deadline, have finally caught a break. The California Department of Health’s decision to authorize healthcare IT firm MEDHOST

Pfizer and Protalix BioTherapeutics Announce FDA Approval of Pediatric Indication for ELELYSO™ (taliglucerase alfa) for Injection, for Intravenous Use for the Treatment of Type 1 Gaucher Disease

Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX, TASE:PLX) announced today that the U.S. Food and Drug Administration (FDA) approved ELELYSO™ (taliglucerase alfa) for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed...

American Telemedicine Association Issues Clinical Guidelines for Telepathology

The American Telemedicine Association (ATA) has released a new set of practice guidelines addressing clinical applications for telepathology. "Clinical Guidelines for Telepathology" provides recommendations on specific applications, practices, benefits, limitations, and regulatory issues that may arise in the practice of telepathology. Washington, DC (PRWEB) August 28, 2014 The American...


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