European Medicines Agency - European Union Examiner

The European Medicines Agency has released a revision of the guideline addressing the clinical and nonclinical issues related to similar biological products biosimilars containing biotechnologyderived proteins as the active...

Roche announced that the European Medicines Agency has approved RoACTEMRA to treat children with polyarticular juvenile idiopathic arthritis (PJIA), a rare, chronic and debilitating form of childhood arthritis. The medicine can... All similar articles: 55 »

recently submitted a type-II variation to the European Medicines Agency (EMA) for Rienso (ferumoxytol). We note that AMAG’s sole marketed product Feraheme (US trade name of Rienso) is already available in the EU under the trade...

NEW YORK, June 10, 2013 /PRNewswire/ -- Editor Note: For more information about this release, please scroll to bottom. Today, Wall Street Reports announced new research reports highlighting St. Jude Medical, Inc. (NYSE: STJ),...

Dyax Corp. (NASDAQ: DYAX) is a biopharmaceutical company. The company recently announced that Marc D Kozin (who sits on the board) bought 10,000 shares of Dyax Corp. at $2.48 per share price. In addition, Dyax is looking to...

Available evidence suggesting potential harm from the drugs in industry studies has not been published, an investigation by the IBMJ/I and Channel 4 Dispatches has found. Some independent studies challenge the conclusions of... All similar articles: 104 »

BRINGING a new medicine to market in Africa requires 54 separate applications to each country on the continent, a time-intensive process that could be costing lives. African leaders are now trying to move toward a regional and...

File this under ‘try and try again.’ A US Congressman has, once again, introduced legislation that would require study results to be reported to ClinicalTrials.gov - the federal repository - regardless of whether the outcome is...

www.dementiatoday.com%% Brain atrophy plagues affect more than just people with neurodegenerative disorders. Even seemingly healthy individuals lose brain matter over time. Can doctors and researchers separate brain changes due...

CORK, Ireland (June 6, 2013) -- Janssen R&D Ireland (Janssen) today announced primary efficacy and safety results from four Japanese Phase 3 clinical studies demonstrating that the use of the investigational NS3/4A protease...

SEATTLE, June 11, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced the upcoming presentation of data highlighting PIXUVRI® (pixantrone), the first approved treatment in the European...

Maandag 10 juni 2013 | UCB ] Brussels (Belgium), June 10th 2013 - 0700 CEST - UCB, a global biopharmaceutical company with a focus on immunology treatment and research, is proud to sponsor new data for its immunology portfolio...

Jun 10 2013, 11:21 by: Theodore Cohen | about: DVAX , includes: GSK Before the opening bell this morning, Dynavax reported feedback from the company's meeting with the FDA. This followed the receipt of a complete response... All similar articles: 104 »

By LAURA JOHANNES The Ache: Nine million adults in the U.S. have osteoporosis, a disease that makes bones prone to breakage, according to the National Osteoporosis Foundation. Another 48 million people have low bone mass that...

Commission Charges Whittier Trust and Fund Manager in Insider Trading Investigation into Expert Networks The Securities and Exchange Commission (Commission) today charged a South Pasadena, Calif.-based wealth management company... All similar articles: 56 »

See the rest of the story here . Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fly's real-time, streaming news feed keeps individual investors, professional...

NEW YORK, June 10, 2013 /PRNewswire/ -- Today, Wall Street Reports announced new research reports highlighting Medivation, Inc. (NASDAQ: MDVN), ACADIA Pharmaceuticals, Inc. (NASDAQ: ACAD), Santarus, Inc. (NASDAQ: SNTS), Seattle...

Pharmaceuticals , Inc. (ARNA), Rigel Pharmaceuticals , Inc. (RIGL): This Week in Biotech By The Motley Fool in News See All With the SPDR S&P Biotech Index up 38% over the trailing-12-month period, it's evident that investment...

Will the FDA Safety and Innovation Act that was passed last year to reauthorize user fees paid by industry cause an unwanted side effect? The 2012 law loosened conflict-of-interest restrictions on agency advisory panels and a...

The European Medicines Agency (EMA) and EUnetHTA, the European network for Health Technology Assessment (HTA), met to review the progress of their cooperation in London on 14 May 2013. This was the sixth meeting since the start...

Simon O'Neill, Diabetes UK director of health intelligence, said: "The European Medicines Agency is currently investigating findings from an independent study that has suggested there may be a link between use of GLP-1 and...

ROCHE: EU Approves Child Arthritis Drug Roactemra4-traders (press release)Recommend: 0. ZURICH -- Roche Holding AG (ROG.VX) Monday said the European Medicines Agency has approved RoACTEMRA to treat children with polyarticular...

Evaluating risk requires a balance of quantitative assessment and regulatory review. But often in the European Union, there is a “misuse” of the precautionary principle to appease national of political interests, says Ragnar...

ZURICH, June 10 (Reuters) - Swiss pharmaceuticals company Roche Holding AG said on Monday the European Medicines Agency has approved its rheumatoid arthritis drug RoActemra to treat children aged two or older suffering from a... All similar articles: 374 »

By Kristin Jones Gilead Sciences Inc. (GILD) said its experimental oral hepatitis C treatment, sofosbuvir, has received priority-review status from the U.S. Food and Drug Administration. The FDA grants the priority review...

Seattle Genetics' experimental cancer drug showed promise in treating two rare types of blood cancer, but the design and size of clinical trials limited conclusions, U.S. drug reviewers said. Food and Drug Administration staff...

New forms of diabetes drugs, known as GLP-1-based drugs, and promoted as "the new darlings of diabetes treatment" make the pharmaceutical industry billions. But are they associated with an increased risk of cancer and do we...

ZURICH, June 10 (Reuters) - Swiss stocks were expected to inch higher on Monday, while European markets were seen edging lower after Chinese data suggested that growth in the world's second largest economy was losing momentum....