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

00:01 EDT 1st October 2014 | BioPortfolio

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Showing "regulation regulatory" News Articles 51 to 75 of 7,200+

Monday 29th September 2014

Chinese Regulations on In-Vitro Diagnostic Reagents Market: Application & Approval 2014 Edition New Study Now Available at adds "Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)" report to its research store. Dallas, Texas (PRWEB) September 30, 2014 China’s regulatory framework for in-vitro diagnostic reagents is undergoing earthshaking changes. The country’s new leaders have r...

API Developers Note Upgrades, Successful Inspections

Added manufacturing capabilities, partnerships, and regulatory milestones mark recent achievements by API developers.

Regeneron and Sanofi Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps

TARRYTOWN, N.Y. and PARIS, Sept. 30, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps (CSwNP) ...

BrainStorm Completes Uplisting to the NASDAQ Capital Market

NEW YORK, NY and PETACH TIKVAH, ISRAEL -- (Marketwired) -- 09/30/14 -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its shares of common stock have been approved for uplisting to the NASDAQ Capital Market, and will commence trading on the NASDAQ Capital Market when trading begins on Septe...

Pfizer And Kyowa Hakko Kirin To Collaborate On Immuno-Oncology Combination Study

Agreement to Combine Kyowa Hakko Kirin’s Anti-CCR4 Antibody Mogamulizumab and Pfizer’s investigational 4-1BB agonist (PF-05082566) in Clinical Study Pfizer Inc. (NYSE:PFE) and Kyowa Hakko Kirin (Tokyo:4151), announced today that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s PF-05082566, an...

LED Medical Diagnostics Showcases New Digital Imaging Products at American Conferences and Trade Shows

BURNABY, BC--(Marketwired - September 30, 2014) - LED Medical Diagnostics Inc. (TSX VENTURE: LMD) (OTCQX: LEDIF) (FRANKFURT: LME) ("LED Medical" or "the Company") has participated in several conferences in the United States in the last few weeks that have raised the Company's profile. These forums have also enabled CEO Dr. David Gane and members of the marketing team to convey information to conf...

IBEX Provides Update on Garvinci Suit

MONTREAL, QUEBEC -- (Marketwired) -- 09/30/14 -- IBEX Technologies Inc. (TSX VENTURE: IBT) today provided an update on the status of its litigation with Garvinci Inc. ("Garvinci") and its owner, Mr. Jean Francois Gareau. BACKGROUND In 2006 and 2007, as part of a later aborted acquisition arrangement, IBEX loaned Garvinci Inc. a total of $1,000,000 with interest at 12%. These loans were persona...

Verisante Technology, Inc. Announces Re-Negotiated Letter of Intent for Equity Stake in Chinese Company

VANCOUVER, BRITISH COLUMBIA -- (Marketwired) -- 09/30/14 -- Verisante Technology, Inc. (TSX VENTURE: VRS)(OTCQX: VRSEF) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today it has renegotiated a Letter of Intent between the Company and strategic partner (the "Partner") in the People's Republic of China, which terms were previously announced on June 25, 2014. U...

Medical News Today: Implanted medical devices cleared by FDA 'lacking information'

A study has found that FDA regulatory processes have led to many implanted medical devices being cleared for market while lacking scientific evidence of their safety or efficacy.

ICH Q12 to Foster Post-Approval Change Management

Expert working group forming to develop Q12 guideline to explore “regulatory commitments” concept and proactive post-approval change management plans. But there will be challenges and the devil, as always, will be in the details.

Industry’s ‘Regulatory Commitments’ Concept Draws FDA’s Interest

An industry team is talking up the potential role of what it’s calling ‘regulatory commitments’ to prospectively manage post-approval changes in a way that’s more consistent worldwide. FDA has responded with interest and is engaged in discuss...

The Post-Approval Challenge of Global Regulatory Complexity

Why industry wants Q12 lifecycle management guideline: 100 regulatory submissions for one post-approval change and other frustrations.

Genome-wide analysis of noncoding regulatory mutations in cancer

William Lee and colleagues present a systematic analysis of noncoding somatic mutations in 863 tumor samples representing over 20 cancer types. They identify new mutation hotspots as well as genes with frequent mutations in their promoter regions, in...

EMA validates Opdivo MAA

Bristol-Myers Squibb Co. (NYSE:BMY) said EMA validated an MAA for Opdivo nivolumab to treat non-small cell lung cancer (NSCLC). The pharma said the application is the "first completed regulatory submission" for a PD-1 inhibitor in that tumor type.Opd...

Emerging Markets Regulatory Tracker: Australia (Vol. 4 No. 61)

Australia’s TGA has launched a new internet-based system for consumer reporting of drug and vaccine adverse reactions.

Breaking Exhibitor News from Major Trade Shows Available Online at

As the recognized global leader in event news release distribution, Business Wire hosts dedicated Online Media Centers for hundreds of events worldwide at The following is a listing of direct links to Business Wire Online Media

Regulation of osteoclastogenesis through Tim-3: possible involvement of the Tim-3/galectin-9 system in the modulation of inflammatory bone destruction

Advanzeon Solutions, Inc.'s Wholly-Owned Subsidiary Pharmacy Value Management Solutions, Inc. Signs Marketing Agreement With Jeff Liva & Co.

TAMPA, Fla., Sept. 29, 2014 /PRNewswire/ -- Advanzeon Solutions, Inc. (OTC:BB: CHCR), ("Advanzeon" or the "Company"), which provides behavioral health, wellness, pharmacy management services and sleep apnea programs, to employers, Taft-Hartley health and welfare funds, managed care companies throughout the U.S. today announced that its wholly-owned subsidiary, Pharmacy Value Management Soluti...

Colder Weather is Forcing Mice Indoors

— Rodents Pose Serious Health and Property Risks — With cooler weather setting early this fall, protecting your property from rodent infestation needs to be top of mind for every homeowner or building manager. A recent survey from the National Pest Management Association (NPMA) found nearly half of all infestation

Aerocrine AB and Microsoft collaborate to test secure, cloud-based remote medical device monitoring.

Regulatory News: Aerocrine AB (STO:AERO-B), the innovator of NIOX® brand medical devices announces today a collaboration with Microsoft. Aerocrine’s devices are used by physicians to measure Fractional exhaled Nitric Oxide (FeNO), a biomarker for allergic, airway inflammation which is linked with Asthma. The collaboration will utilize Microsoft...

PIPELINE WATCH – Six approvals, three launches and two filings

This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.

Demand for Oncology-Specific NGS Testing is Growing Fast: New Resource Shows Laboratories How to Seize this Important New Opportunity

Clinical Next-Gen Tumor Sequencing from G2 Intelligence tells laboratories everything they need to know about implementing and optimizing next-gen tumor sequencing in the value-driven oncology market. G2 Intelligence — a 30+ year leader in research, reporting, and analysis on the business of the diagnostic laboratory industry — announces the releas...

India set for new study on spurious drugs

India continues to move towards improved regulatory oversight in the pharmaceutical segment. It has now initiated steps for a new study on spurious drugs and plans an expansion in the number of adverse drug reactions (ADR) monitoring centres in the.....

OPKO Health Supports National Prostate Cancer Council Legislation

OPKO Health, Inc. (NYSE: OPK) is pleased to lend its support to the legislation introduced in the United States Senate on September 16, 2014 by Senators Jeff Sessions (R-AL) and Barbara Boxer (D-CA) legislating the formation of the National Prostate Cancer Council (NPCC). The Boxer-Sessions legislation directs formation of the NPCC to develop and implement...

Queensland Government responds in support of review of Gene Technology Act

The Queensland Government’s response to the recommendations of the review of the operation of the Gene Technology Act 2001 (Qld) has been released. The government said its response to the review recommendations was prepared in consultation with relevant departments “who generally support the findings of the review”. “Departments recognise that there is room to improve Aus...

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