Alimera Sciences reported that marketing authorization has been granted by the Finnish Medicines Agency in Finland and the Ministry of Health in Luxembourg to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. ILUVIEN is now approved for...
Amgen and its subsidiary Onyx Pharmaceuticals reported the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for Kyprolis for Injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at
Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, today announced the successful completion of the European Mutual Recognition Procedure for AMITIZA for the treatment of chronic idiopathic constipation in select European countries, resulting in a recommendation for marketing authorization. Based on the approval in the United..
HERSHEY, Pa., Rockville, Md. and TOKYO, Jan. 29, 2015/ PRNewswire/ Immunomic Therapeutics, Inc., a company developing next-generation vaccines based on the LAMP-vax platform, and Astellas Pharma Inc. today announced they have entered into an exclusive license agreement for Japan to develop and commercialize JRC2-LAMP-vax, Immunomic Therapeutics'
UK DRUG giant AstraZeneca said yesterday it has struck four research agreements in the hot area of genome editing as it bets on a new "genetic scissors" technology to deliver better and more precise drugs for a range of diseases. The deals will allow AstraZeneca to use its so-called CRISPR technology, which stands for clustered regularly interspace
January 29, 2015 Dendreon Corporation announced today that it has reached an agreement with Valeant Pharmaceuticals International, Inc. pursuant to which, subject to bankruptcy court approval, Valeant will serve as the stalking horse bidder in conjunction with a court-supervised sales process. The Company also announced that it would be ext
The investment in the new Active Pharmaceutical Ingredients plant was first announced in November 2013 during a meeting between Finance Secretary John Swinney and Roger Connor, GSK's president of global manufacturing and supply. GSK's existing Montrose operation, which was seen as being under threat of closure just a few years ago, produces medicin
Jeffrey H. Lawson, M.D., Ph.D., Vice Chair for Research, Professor of Surgery and Pathology at Duke University Medical Center, Director of the Vascular Research Laboratory, Director of Clinical Trials for the Department of Surgery and clinical consultant to Humacyte, is the keynote speaker at the 27th International Symposium on Endovascular Therapy
According to news reporting out of Ramat Gan, Israel, by NewsRx editors, research stated, "Most CADD tools handle non-covalent enzyme inhibitors, despite the growing interest of the pharma industry in covalent inhibitors." Our news journalists report that additional information may be obtained by contacting T. Traube, Bar Ilan University, Dept. of
By a News Reporter-Staff News Editor at Health& Medicine Week Fresh data on Health and Medicine are presented in a new report. According to news originating from Heidelberg, Germany, by NewsRx correspondents, research stated, "The Farnesoid X Receptor was recently validated in clinical studies using the bile acid analogue Obeticholic Acid as an a
Santhera Extends Executive Management and Appoints Chief Commercial Officer Santhera Pharmaceuticals Holding AG/ Santhera Extends Executive Management and Appoints Chief Commercial Officer. Liestal, Switzerland, January 30, 2015- Santhera Pharmaceuticals today announced the strengthening of the leadership team through nomination of senior...
A 2010 survey from The Henry J. Kaiser Family Foundation revealed that between 1999 and 2009, the number of prescriptions dispensed in the US increased by 39%, from 2.8 billion to 3.9 billion. A 2014 survey from the Centers for Disease Control and Prevention revealed 48% of us have used at least one prescription drug in the past 30 days- 5% more th
Ireland- based Actavis Pharmaceuticals has acquired generic drug maker Auden Mckenzie in a deal worth 306 m. Before it announced the Allergan deal in November, the company acquired rival Forest Laboratories for $25 bn in February and infectious disease expert Durata for $675 m in October. Actavis said the acquisition of Auden Mckenzie will make i
Release date- 29012015- HORSHAM, PA- Janssen Biotech, Inc. today announced that the U.S. Food and Drug Administration has approved IMBRUVICA capsules as the first therapy indicated specifically for patients with Waldenstrom's macroglobulinemia, 1 a rare, indolent type of B-cell lymphoma. IMBRUVICA was granted Breakthrough Therapy Designation for WM
The United States Agency for International Development has presented the National Agency for Food and Drug Administration and Control Central Drug Control Laboratory a quality certificate for curbing the deaths caused by fake medicines. USAID's Director in Nigeria, Michael Harvey, presented the International Organization for Standardization...
Novo Nordisk reported the U.S. Food and Drug Administration approval of Norditropin FlexPro 30 mg/3. 0 mL, a prefilled injection pen for patients with growth hormone-related disorders. "Novo Nordisk is committed to advancing growth hormone delivery devices with patients in mind," said Eddie Williams, senior vice president, Biopharmaceuticals, Novo
Octagam 10 percent for the U.S. market can now be manufactured at FDA- licensed facilities in both Stockholm, Sweden and Vienna. "The FDA approval of Octapharma's Vienna manufacturing site for Octagam 10 percent is great news for patients, as it will help facilitate product availability and enhances production flexibility," said Flemming Nielsen,
The Patented Medicine Prices Review Board will hold a public hearing in the matter of the price of the patented medicine Soliris, and Alexion Pharmaceuticals, the pharmaceutical company that holds the patent for Soliris and sells the medicine in Canada. According to a media release, further details on the public hearing and a case management confer
Attorney Wendy R. Fleishman of the law firm Lieff Cabraser Heimann& Bernstein reported that four young men prescribed the antipsychotic medication Risperdal recently filed separate personal injury lawsuits alleging that Risperdal is a defective and dangerous prescription drug. According to a company release, the complaints were brought against...
Dublin- Research and Markets has announced the addition of the "A Product and Pipeline Analysis of the Antibacterial Drugs Market" report to their offering. Drug-resistant bacteria, or superbugs, pose a serious threat to human health. Product and pipeline assessment for recently approved antibacterial drugs, antibacterials under FDA review, as well
Research and Markets has reported the addition of the "4th Annual Pharma Pricing and Reimbursement Forum" conference to its offerings. In a release, Research and Markets noted that report highlights include:. Research and Markets is a source for international market research reports.
Santhera Pharmaceuticals Holding AG/ Santhera Extends Executive Management and Appoints Chief Commercial Officer. Liestal, Switzerland, January 30, 2015- Santhera Pharmaceuticals today announced the strengthening of the leadership team through nomination of senior members of staff to its Executive Management and the appointment of a Chief...
St. Jude Medical reported U.S. Food and Drug Administration approval of the FlexAbility Ablation Catheter, a new ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias. Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute. "As we developed the FlexAbility ablation catheter, we worke
Array Biopharma had its price objective raised by Stifel Nicolaus from $6.00 to $9.00 in a research report released on Monday morning. Analysts at Zacks downgraded shares of Array Biopharma from an outperform rating to a neutral rating and set a $5.20 price target on the stock in a research note on Tuesday, January 6th. Separately, analysts at Jeff
Novo Nordisk declared that the Food and Drug Administration has given green signal to a new 30 mg/3. 0 mL strength of Norditropin FlexPro pen. Norditropin FlexPro is indicated for growth failure in children due to inadequate endogenous GH secretion, children with short stature associated with Noonan or Turner syndrome, children with short stature b