Regulation News: Breaking Regulation News, Comments and Articles.

Integral Finance and Compliance Control team up to provide Financial, Quality and Compliance advice to Startups, spin-outs and SME’s

Finance Ltd and Compliance Control Ltd are collaborating to offer services and software which cover financial management and compliance control for Startups, Spin-outs and Small to Medium Enterprises (SMEs), in particular in the Life Science, Biotech...

HEALTHCAREfirst to Host Free Webinar for Hospice Agencies About 2013 Proposed Regulatory Changes

Ozark, MO, May 25, 2013 --(PR.com)-- HEALTHCAREfirst, Inc., the leading provider of home health and hospice technologies and services, announced today that it is hosting a free webinar detailing the 2013 proposed rule from CMS for hospice. Presented by Deanna Loftus, Director of Regulatory Compliance for HEALTHCAREfirst, the webinar will review the proposed rule and what it might mean for hospic...

Avoiding Type 2 Diabetes With The Help Of Fish Oil Supplements

Widely-used fish oil supplements modestly increase amounts of a hormone that is associated with lower risk of diabetes and heart disease, according to a study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Met...

Is increased dialogue the answer to the scourge of counterfeit medicines?

Just two decades ago, pharmaceutical companies were self-contained nuclei, creating medicines and devices from raw ingredients and transporting them to the end user, often within local markets. Today, each stage of manufacture for one product is dis...

Indemnity proposals for pharmacists unnecessary

Pharmacy organisations have highlighted the merits of current indemnity arrangements for pharmacists in response to Government proposals that all registered healthcare professionals should have health indemnity or insurance in order to practise....

Pharmacy Voice opposes data inspection plans

Community pharmacy owners are opposing Government proposals to give information commissioner officers power to inspect their handling of confidential data in unannounced visits. Pharmacy Voice branded the idea as "unnecessary", since da...

Engage with Labour’s health policy review, says Reed

Shadow pharmacy minister Jamie Reed has called for pharmacists to engage with the Labour Party’s health and social care policy review. "We want to hear your views, your experiences and your hopes and fears for the NHS," he said at th...

A regulatory circuit that involves HR23B and HDAC6 governs the biological response to HDAC inhibitors

Manatt Practices Rank High in Chambers USA

LOS ANGELES, May 24, 2013 /PRNewswire/ -- Manatt, Phelps & Phillips, LLP, announced today that Chambers USA has named 10 practices and 23 firm lawyers among its 2013 list of leading lawyers for business in the United States. (Logo: http://photos.prnewswire.com/prnh/20130227/LA67358LOGO) Since 1999, Chambers has been identifying the leading lawyers and law firms in the United States through...

California Biomedical Industry Leaders Urge Congress to Take Action on FDA User Fees for FY2014

Across-the-board cuts threaten innovation and patient access to new technologies (LA JOLLA, Calif.) (PRWEB) May 24, 2013 CHI-California Healthcare Institute today submitted a letter to House Appropriators and the California congressional delegation, joined by over 40 biomedical companies, urging them to restore sequestered industry user fees paid to the U.S. Food and Drug Administration in 2013,...

Diabetes And Oncology Might Cushion Eli Lilly's Fall Off A Patent Cliff

ByCory Renauer:Eli Lilly and Company (LLY) is heading straight for a patent cliff. Zyprexa lost patent protection in most major markets in 2011. The antipsychotic's worldwide sales for Q1 2013 fell 49% year on year to $284.8 million from $562.7 in Q1 2012. Evista, which comprised 4.3% of Q1 2013 revenue, will lose U.S. patent protection in March of 2014. Its biggest seller, Cymbalta, which compris...

C-Path, IMI consortia in biomarkers deal

Consortia led by the Critical Path Institute and Europe's Innovative Medicines Initiative (IMI) partnered to develop new biomarkers to predict, diagnose and monitor drug-induced injury to the liver, kidney and vascular system. The Predictive Safety T...

Astellas submits Japan application for enzalutamide

Astellas Pharma Inc. (Tokyo:4503) and Medivation Inc. (NASDAQ:MDVN) said the pharma submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for enzalutamide to treat prostate cancer. FDA approved the oral androgen r...

Merck Halts Preladenant Development In Parkinson’s Following Phase III Failures

Company says it will not pursue regulatory filings for the adenosine-2a receptor antagonist because studies in moderate-to-severe and early-stage disease failed to show sufficient evidence of efficacy.

French firms face tough new rules on links to doctors

When it comes to clamping down on ties between the pharmaceutical industry and stakeholders such as healthcare professionals, the French regulatory authorities certainly mean business. A decree implementing the provisions of the regulatory.....

PIPELINE WATCH – two failures, two filings and two approvals

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.

Building Medical Affairs Capabilities to Ensure Organizational Success across Key Operational Areas

CHAPEL HILL, N.C., May 24, 2013 /PRNewswire/ -- Regulatory and marketplace changes have pushed Medical Affairs to the forefront of many organizations' priority list. Forward-thinking companies across the biopharmaceutical and medical device sectors understand a strong Medical Affairs function is essential to meeting current challenges in clinical development, market education, and regulatory...

Comment on Compounded Drug Crisis Spotlights Regulatory Confusion by Asons

medical negligence such as this is unforgivable. I dread to think about the people that have suffered because of the substandard care received by the so-called medical professionals!

Peruvian guidelines for ‘biosimilar biologic’ products

The regulatory body for approval of medicines in Peru is the Ministerio de Salud (Ministry of Public Health; MINSA).

Galapagos and AbbVie extend collaboration to include Crohn’s disease

Galapagos NV and AbbVie have agreed to extend their GLPG0634 clinical development collaboration to include Crohn’s disease. Galapagos will fund and complete a Phase 2 programme in the disease designed to facilitate rapid progression into Phase 3. U...

United Therapeutics: A Growth Stock With Good Products And A Promising Pipeline

By StockRiters:United Therapeutics (UTHR) is a biopharmaceutical company which develops and markets products for patients suffering from pulmonary arterial hypertension (PAH) and other vascular diseases. Currently, the company has three commercially successful products and a series of potential product candidates in the pipeline. However, United's profitability depends on the clinical trial outcom...

Arena Pharmaceuticals to Present at Two Upcoming Investor Conferences

SAN DIEGO, May 24, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the company is scheduled to present a corporate overview at the following investor conferences: Deutsche Bank Securities 38th Annual Health Care ConferencePresentation: May 30, 2013, at 12:00 p.m. Eastern Time (9:00 a.m. Pacific Time) at The Westin Boston Waterfront Hotel in Boston, Massa...

Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements

NEW YORK, May 24, 2013 /PRNewswire/ -- In accordance with Rule 17.1 and Rule 2.9 of the Irish Takeover Rules and Rule 14e-1 of the United States Exchange Act, Echo Pharma Acquisition Limited ("Royalty Pharma") today announced acceptance levels its original offer for Elan Corporation (NYSE: ELN). Background On 2 May 2013, Echo Pharma Acquisition Limited ("Royalty Pharma") made an offer for the en...

Korean case marks more quality woes for J&J

Janssen (Johnson & Johnson) appears confident of resolving the quality control shortcomings that led to the recall of a product in South Korea, but regulatory authorities in the country are nevertheless pushing ahead with legal action.....

R-Squared Releases Complimentary Webinar Series on Aggregate Spend

The 3-part series “A Systemized Approach to Aggregate Spend and the Sunshine Act" focuses on core challenge of aggregate spend including (1) Finding & Categorizing Spend, (2) Harmonizing Data to Enable Efficiency in Reporting, and (3) Reporting & Leveraging Data. Princeton, NJ (PRWEB) May 24, 2013 R-Squared Services & Solutions, Inc. (R-Squared), a leading developer of complian...