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23:18 EST 28th January 2015 | BioPortfolio

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Showing "regulation regulatory" News Articles 51 to 75 of 7,500+

Tuesday 27th January 2015

Immunovaccine Study Demonstrates Early Protection Against Anthrax with Single Dose Experimental Vaccines

HALIFAX, NOVA SCOTIA -- (Marketwired) -- 01/28/15 -- Immunovaccine Inc. ("Immunovaccine") (TSX: IMV), a clinical stage vaccine and immunotherapy company, today announced that three different recombinant protective antigen (rPA) vaccines formulated with its novel DepoVax™ enhancement technology protected animals against a lethal anthrax challenge after a single vaccination. The National Institut...

Hemostemix Names Gerald D. Brennan, Jr. to Board of Directors; Announces Management Title Change

CALGARY, AB -- (Marketwired) -- 01/28/15 -- Hemostemix Inc. (the "Corporation") (TSX VENTURE: HEM) announced today that its board of directors has appointed Gerald ("Jerry") D. Brennan, Jr. to the board effective immediately. Jerry has more than 20 years of executive management experience in the areas of corporate finance, legal, and general administration. He holds a BABS degree from Marquette U...

Research projects contribute to shaping EU regulation to control invasive species

(Helmholtz Centre for Environmental Research - UFZ) A new regulation governing the control of invasive alien species became effective in all EU states on Jan. 1 2015. The European Union hopes that it will actively combat one of the greatest threats t...

Stryker Reports 2014 Results and 2015 Outlook

Kalamazoo, Michigan - January 27, 2015 - Stryker Corporation (NYSE:SYK) reported operating results for the fourth quarter and full year of 2014: Fourth Quarter Highlights              Net sales grew 6.1% to $2.6 billion (8.6% constant currency)               Orthopaedics(1)                                      ...

Nanobiotix Shares Transferred from Compartment C to Compartment B of the Regulated Market of Euronext in Paris

Regulatory News: NANOBIOTIX (Euronext: NANO ISIN: FR0011341205), a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, today announces the transfer o...

Exsurco Achieves ISO 13485 Registration for Medical Device Design & Manufacture

An ISO 13485:2003 Certificate of Registration was awarded to Exsurco Medical. This manufacturer of unique, technologically advanced devices and tools for tissue processing was able to meet the requirements for this international standard for quality management systems for medical device manufacturing showing the company's continued commitment to customers in the tissue processing fields. Birmi...

FDAnews Announces: Drug GMP Report — Drugmakers Win Four-Month Reprieve from Product Tracing Requirement

For over 20 years, drug manufacturers have relied on Drug GMP Report for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation — information drugmakers need to stay in compliance. Each monthly issue brings subscriber the latest on FDA enforcement trends and warning letters, track and trace developments, international regulations and more. Falls Church...

Sandoz moves to dismiss Amgen patent suit

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) filed a motion in the U.S. District Court for the Northern District of California seeking an order to dismiss patent infringement and related claims from Amgen Inc. (NASDAQ:AMGN) related to Sandoz's...

21st Century Cures draft proposes wide reforms

The U.S. House Energy & Commerce Committee released a discussion draft Tuesday of 21st Century Cures legislation that proposes sweeping changes to FDA regulation of drugs, medical devices, clinical research and reimbursement.The draft includes a prov...

Democrats snub 21st Century Cures bill

Nine months after U.S. House Energy & Commerce Committee chairman Rep. Fred Upton (R-Mich.) launched the 21st Century Cures initiative as a bipartisan effort, the committee released a discussion draft Tuesday without support from Democrats. Republica...

Emerging Markets Regulatory Tracker: Australia Issues Release Guidance

Australia’s TGA has issued new guidance for the market release of all types of medicinal products, including drugs and biotech products.

Herbalife Further Strengthens Its Corporate Affairs Team

Global nutrition company Herbalife, (NYSE: HLF) announced today that Marcus Reese joins the company in the newly created role of vice president, state and local government affairs, reporting to Alan Hoffman, executive vice president, global corporate affairs. In this role Reese will be responsible for managing Herbalife’s relations with stat...

Asia, Israel (Teva?) to steer 'golden era' of regenerative meds

Industry is probably headed towards the ''golden era'' in regenerative medicine/stemcell-based therapies, with the segment achieving critical mass, and clarity emerging on regulatory pathways and pivotal data readouts anticipated, finds a report by M...

Misonix, Inc. To Report Second Quarter Fiscal Year 2015 Financial Results On Wednesday, February 4, 2015

FARMINGDALE, N.Y., Jan. 27, 2015 /PRNewswire/ -- Misonix, Inc. (NASDAQ: MSON), an international ultrasonic surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic instruments for spine surgery, neurosurgery and other surgical specialties, announced today that it will report financial results for the second quarter fiscal year 2015 on Wednesday, February 4, ...

U.S. Supreme Court Grants Shire Petition

LEXINGTON, Massachusetts, January 27, 2015 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the U.S. Supreme Court granted Shire's petition in the Shire v. Watson patent case regarding LIALDA® (mesalamine, 1.2 gram). The granting of this petition by the Supreme Court vacates the decision of the U.S. Court of Appeals for the Federal Circuit with respect to the clai...

Anthem Blue Cross and Blue Shield Applauds Federal Regulatory Approval of Healthy Indiana Plan 2.0 for Hoosiers

Anthem Blue Cross and Blue Shield announced its support for the Centers for Medicare & Medicaid Services (CMS) approval, and the efforts of Governor Pence to bring affordable health care to more Hoosiers through the new Healthy Indiana Plan (HIP) 2.0. Beginning February 1, Hoosiers adults between the ages of 19-64, with incomes up to 138 percent of the...

Amgen's 2014 Revenues Increased 7 Percent To $20.1 Billion And Adjusted Earnings Per Share (EPS) Increased 14 Percent To $8.70

THOUSAND OAKS, Calif., Jan. 27, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2014. Key results include: For the fourth quarter, total revenues increased 6 percent to $5,331 million, with product sales growing at 8 percent.  Adjusted EPS grew 19 percent to $2.16. For the full year, total revenues increased 7 percent to $2...

TeamHealth Holdings, Inc Announces Fourth Quarter and Full Fiscal Year 2014 Earnings Release Date and Conference Call

KNOXVILLE, Tenn., Jan. 27, 2015 /PRNewswire/ -- TeamHealth Holdings, Inc. ("TeamHealth") (NYSE: TMH), one of the largest suppliers of outsourced healthcare professional staffing and administrative services to hospitals and other healthcare providers in the United States, today announced that the Company will release its fourth quarter and full fiscal year 2014 results after the market close on Tue...

Medicure announces shares for debt settlements

WINNIPEG, Jan. 27, 2015 /PRNewswire/ - Medicure Inc. (the "Company") (TSXV:MPH, OTC:MCUJF.US) announces today that the Company, subject to all necessary regulatory approvals, has entered into shares for debt agreements with certain members of the Board of Directors and a consultant, pursuant to which the Company will issue 108,206 of its common shares at a deemed price of $1.44 per common share to...

New Study Reports No Risk of Lung Cancer from Today’s New-Technology Diesel Engines

The non-profit Health Effects Institute (HEI) today released the results of a comprehensive scientific study that examined the health effects of emissions from new-technology diesel engines. The multi-year study, known as the Advanced Collaborative Emissions Study or ACES, found no evidence of carcinogenic lung tumors or pre-cancerous changes in lung tissu...

SynteractHCR’s Senior Leadership to Participate in International and Domestic Clinical Trials Conferences

SynteractHCR, a full-service, international contract research organization (CRO), will participate in two biopharmaceutical and life science conferences in early February: the European CRO Federation’s

Wolters Kluwer Health Publishes Guide for Achieving Compliance with USP <797> Guidelines for Pharmaceutical Compounding

Wolters Kluwer Health, a leading global provider of information for healthcare professionals and students, announced today the release of a complementary guide designed to help healthcare organizations stay compliant with U.S. Pharmacopeia Chapter <797> Pharmaceutical Compounding - Sterile Preparations (USP 797). A Step-by-Step Guide to a USP ...

Polymicro Technologies™ MediSpec™ Waveguide Features Aiming Beam Technology

Laser power delivery system integrates aiming beam alignment for safer and faster treatment Molex Incorporated, a leading global manufacturer of electronic solutions, announces the

Pharmatech Announces Key Hires and New Structure to Support Growth Initiative

Bikash Chatterjee Named President and Chief Scientific Officer Pharmatech Associates has appointed Bikash Chatterjee to the position of President and Chief Scientific Officer (CSO). Mr. Chatterjee served as the company’s Chief Technology Officer where he established the Pharmatech Ecosystem™ as the company’s design for its four distinct co...

CIO Review Names Title21 Health Solutions in Top 20 Most Promising Biotech Technologies

Title21 Health Solutions™ was selected by CIO Review as a Top 20 Most Promising Biotech Technology Solution Provider for its annual list published in January, 2015. Pleasanton, CA (PRWEB) January 27, 2015 Title21 Health Solutions™ (http://www.Title21Health.com), an innovative Bay Area tech firm providing integrated electronic solutions for Health Sciences, announced today it was honored by CI...


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