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

12:21 EDT 31st October 2014 | BioPortfolio

Regulation News - Page: 3RSS

Read the latest Regulation News from around the world, updated every five minutes. Breaking stories from leading news and press agencies, bloggers and experts on Regulation.

Search or Follow Our Regulation - Page: 3 News…

If you are looking for more stories, you may wish to search our extensive news archives for relevant stories: Search for More Regulation - Page: 3 News.

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

Thursday 30th October 2014

Cortendo Announces HealthCap Leads $11M (NOK 73.4M) Private Placement

Company to Evaluate U.S. Financing and Listing Strategy Cortendo AB [ticker: CORT on NOTC-A], a global biopharmaceutical company focused on orphan endocrine disorders, today announced that it has entered into an agreement (“Agreement”) with HealthCap, the Third Swedish National Pensi

Orphan drugs no longer niche

By 2020 orphan drugs are expected to account for 19 per cent of the total share of prescription drug sales in the US, Japan and Europe, excluding generics, reaching $176 billion in annual sales, according to a new report from market intelligence firm...

Chugai licenses ISPRI/OptiMatrix platform from EpiVax for de-risking biologics

PROVIDENCE, R.I., Oct. 30, 2014 /PRNewswire/ -- Chugai Pharmaceutical Co., Ltd. (Chugai), signed an agreement with Rhode Island-based biotechnology company, EpiVax, Inc., to incorporate EpiVax's ISPRI immunogenicity screening and deimmunization technology into Chugai's drug development toolbox. Chugai is widely regarded as one of the most cutting edge biopharmaceutical companies in Japan. Research...

HEMACORD®, the First FDA-Licensed Stem Cell Product, Wins Prix Galien USA "Best Biotechnology Product" Award

NEW YORK, Oct. 30, 2014 /PRNewswire-USNewswire/ -- The New York Blood Center's Milstein National Cord Blood Program (NCBP) is pleased to announce that HEMACORD®, the first FDA-licensed hematopoietic stem cell product, has been awarded the prestigious "Best Biotechnology Product" Award by Prix Galien USA.  The award recognizes "biomedical products that advance the human condition and wh...

Cancer Leaders Call for Congress to Act Quickly in 2015 to Reinvigorate Cancer Innovation in the U.S.

WASHINGTON, Oct. 30, 2014 /PRNewswire-USNewswire/ -- Even before the next Congress is formally elected, a national group of healthcare stakeholders called the Cancer Innovation Coalition (CIC) took the unusual step of going to Capitol Hill to call for early legislative and regulatory action in 2015 that will reinvigorate cancer innovation in the U.S. The reason, according to a panel of lead...

Teva Reports Third Quarter 2014 Results

Revenues of $5.1 billion, in line with the third quarter of 2013. Excluding the impact of the divestment of the U.S. OTC plants and of foreign exchange fluctuations, sales grew organically by 2%. Non-GAAP operating income of $1.5 billion, an increase of 13% from the third quarter of 2013. GAAP operating income of $1.1 billion, up 39%...

Tissue-specific clocks in Arabidopsis show asymmetric coupling

Many organisms rely on a circadian clock system to adapt to daily and seasonal environmental changes. The mammalian circadian clock consists of a central clock in the suprachiasmatic nucleus that has tightly coupled neurons and synchronizes other clo...

Stanford spinout developing surgical site wound care snags $6M

Prescient Surgical, a Bay Area wound care startup that aims to reduce surgical site infection, has raised about $6 million, according to a regulatory filing. The company’s staying pretty vague...

Synergy Pharmaceuticals Inc. Announces Full Exercise of Over-Allotment Option

Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced the full exercise of the over-allotment option granted to the initial purchasers to purchase an additional $25 million aggregate principal amount of 7.50% Convertible Senior Notes due 2019 in connection with its previ...

Cigna Reports Strong Third Quarter 2014 Results, Raises Outlook

Consolidated revenues increased 9% to a total of $8.8 billion in the third quarter Adjusted income from operations1 was $519 million, or $1.95 per share Shareholders’ net income was $534 million, or $2.01 per share Projected adjusted income from operations1,2 for 2014 has increased to $1....

Shredding Paper, Saving Cash: Going Digital with a Cloud-Based eTMF

Clinical Informatics News | Contributed Commentary | Adopting an electronic trial master file for collaborative clinical trials will be increasingly important for maintaining regulatory compliance in a cost-effective and timely manner — but also r...

Grace Century’s Stem Cell Biobank Project Announces Chairman’s Appointment to National Stem Cell Ethics Committee of The Bahamas

Dr. James A. Manganello, Provia Laboratories Chairman of the Board, has been appointed to the National Stem Cell Ethics Committee (NSCEC) of The Bahamas. As a leading international private equity consultancy, Grace Century’s cutting-edge stem cell biobank project, Provia Laboratories, specializes in high quality biobanking (the collection, transport, processing, and cryogenic storage of biologic...

Vital Diagnostics, Inc. - Product Pipeline Analysis, 2014 Update

Recently added to the BioPortfolio report store, Vital Diagnostics, Inc. - Product Pipeline Analysis, 2014 Update is a new report from justpharmareports published on 2014-10-16. This 19-page report is available in PDF from $750. Summary Vital Diagnostics, Inc. (Vital Diagnostics) is a medical device company. The company manufactures and distributes clinical chemistry systems, hematology analyzer...

Misonix, Inc. To Report First Quarter Fiscal Year 2015 Financial Results On Thursday, November 6, 2014

FARMINGDALE, N.Y., Oct. 30, 2014 /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 first quarter fiscal year 2015 on Thursday, November ...

Neurocrine Biosciences Receives Breakthrough Therapy Designation for NBI-98854 in Tardive Dyskinesia

SAN DIEGO, Oct. 30, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its Vesicular Monoamine Transporter 2 inhibitor, NBI-98854, in tardive dyskinesia.  A breakthrough therapy designation is granted for a drug that is intended to treat a serious or life-threat...

WHEATON® Highlights Unique Products at AAPS 2014 Providing Purpose-Built Solutions for the Pharmaceutical Industry

MILLVILLE, N.J., Oct. 30, 2014 /PRNewswire/ -- WHEATON® today highlighted several product lines designed to address specific needs of pharmaceutical industry customers that will be featured at the 2014 AAPS Annual Meeting. They include WHEATON's High Recovery Vials, which are uniquely designed to reduce waste and enable easy retrieval of high value liquids without the need to overfill. The co...

Medivir and county councils conclude agreement on Olysio®-based treatment for hepatitis C

Regulatory News: Medivir AB (STO:MVIR-B) announces that the company has entered into an agreement with Swedish county councils regarding the treatment of hepatitis C with Olysio® (simeprevir). The Dental and Pharmaceutical Benefits Agency (TLV) has concluded that treatment with Olysio® (simeprevir) is beneficial from a health eco...

Medivir and county councils conclude agreement on Olysio-based treatment for hepatitis C

Regulatory News: Medivir AB (STO:MVIR-B) announces that the company has entered into an agreement with Swedish county councils regarding the treatment of hepatitis C with Olysio® (simeprevir). The...

EnteroMedics Names Brad Hancock Chief Commercial Officer

ST. PAUL, Minn., Oct. 30, 2014 /PRNewswire/ -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Brad Hancock will join the Company as Chief Commercial Officer effective November 17, 2014. Mr. Hancock has more than 30 years of experience in the medica...

HeartWare International Reports $68.6 Million In Third Quarter 2014 Revenue; 25% Increase From Third Quarter 2013

FRAMINGHAM, Mass., Oct. 30, 2014 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $68.6 million for the third quarter ended September 30, 2014, a 25% increase compared to $54.8 million in revenue for the same p...

Omidria™ Granted Pass-Through Reimbursement Status from CMS

SEATTLE, Oct. 30, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) announced today that it has received transitional pass-through status for its lead product Omidria™ (phenylephrine and ketorolac injection) 1%/0.3% from the Center for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program. Approved earlier this year by the U.S. Food and Drug Ad...

FDAnews Introductory Offer for On-demand Webinar Training Pass Subscription

Gain instant access to industry experts and FDA staff anytime and anywhere without ever leaving the office with FDAnews’ Webinar Training Pass. Subscribers get instant on-demand access to FDAnews’ ever growing collection of webinars and access to all live webinars for the life of the subscription. Falls Church, VA (PRWEB) October 30, 2014 FDAnews Webinar Training Pass http://www.fdanews.com/T...

Over Four Dozen Retailers Join Continental National Bank’s $40K for 40 Years Fundraiser in Benefit of Amigos For Kids

South Florida’s Leader in Community Banking Spearheads Fundraising Effort in Support of Local Children and Families in Need Miami, FL (PRWEB) October 30, 2014 Continental National Bank, South Florida’s leader in Community Banking, is celebrating 40 years of outstanding service by leading over four dozen retailers in raising funds in benefit of Amigos For Kids. All proceeds raised through the ...

Health Canada approves first near-patient DNA test for personalized medicine

Spartan Bioscience’s rapid genetic test detects CYP2C19 mutations that impact the effectiveness of widely-used drugs such as Plavix®, Inderal®, Celexa®, and Losec® Ottawa, Ontario (PRWEB) October 30, 2014 Spartan Bioscience announced today that Health Canada has approved the Spartan RX CYP2C19 System. It detects CYP2C19 genetic mutations in less than 60 minutes from a non-in...

Minimizing Exposure to Medical Malpractice Litigation: Physician-Patient Alliance for Health & Safety to Present at Medical Professional Liability Conference

The Physician-Patient Alliance for Health & Safety announced that it will be presenting at the American Conference Institute’s Medical Professional Liability conference on October 31, 2014 on steps hospitals can take to implement preventative measures to minimize their exposure to medical malpractice litigation. Chicago, IL (PRWEB) October 30, 2014 The Physician-Patient Alliance for Health ...


Search BioPortfolio:
Loading
Advertisement
Advertisement

News Quicklinks