SUMMARY: The Food and Drug Administration is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs. FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Division of Advisory Committee and Consultant Management, Office of Executive Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bl
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled, "Guidance for
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Requests for Inspection by an Accredited Person und
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Prohibited From Use in Animal Food or Feed. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled, "Substances Prohibited From Use in Animal Food or Feed" has been approved by the Office of Manag
Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Repatha? recommending approval for use in certain patients with high cholesterol. "We are pleased to receive a positive opinion from the CHMP for Repatha as it is an im
The research service provides an analysis of the healthcare market in Asia-Pacific. The regional scope of this research service includes China, India, Japan, Australia, and Association of Southeast Asian Nations. Over 6 million smartphones, wearables, and remote patient monitoring devices will be shipped to APAC in 2015. Asian companies will streng
Astellas Pharma and Medivation recently reported data from the Phase 2 STRIVE trial comparing enzalutamide and bicalutamide in non- metastatic and metastatic prostate cancer patients whose disease progressed despite treatment with a luteinizing hormone- releasing hormone analogue therapy or following surgical castration. The data were presented...
May 22 A second proton center has joined Knoxville's Provision Center for Proton Therapy in a clinical registry to measure the long-term effectiveness of the treatment. Ackerman Cancer Center in Jacksonville, Fla., said it will participate in the registry study, developed and managed by the Center for Biomedical Research in collaboration with the
Bristol-Myers Squibb Company today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that nivolumab, a PD-1 immune checkpoint inhibitor, be granted approval for the treatment of locally advanced or metastatic squamous non-small cell lung cancer after prior.
By a News Reporter-Staff News Editor at Insurance Weekly News Investigators publish new report on Orthopedic Procedures. According to news reporting from Providence, Rhode Island, by VerticalNews journalists, research stated, "Reverse shoulder arthroplasty has been Food and Drug Administration approved in the United States since 2004 but did not
Ackerman Cancer Center has joined the registry study developed and managed by the Center for Biomedical Research in collaboration with the Provision Center for Proton Therapy. "With the PRO 0425 study, we are collecting data that will allow us to compare information across disease sites and treatment modalities and provide a unique window into the
-Granted Qualified Infectious Disease Product and Fast Track Designations for CD101 IV by FDA: On May 11, 2015, Cidara announced that the U.S. Food and Drug Administration designated its lead antifungal product candidate, CD101 IV, as a Qualified Infectious Disease Product with Fast Track status. -Robert Perez and Timothy Franson Appointed to Board
The value of developing a global program to audit and monitor medical device manufacturing for patient safety was recognized at the International Medical Device Regulators Forum inaugural meeting in 2012. That meeting led to the creation of MDSAP. US Food and Drug Administration Health Canada Therapeutics Goods Administration Australia Agncia...
Pharmacyclics, Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending a change to the terms of the marketing authorization for IMBRUVICA in the European Union to indicate the treatment of adult patients with Waldenstrm's macroglobulinemia who have..
Shanghai, May 22, 2015 A consortium consisting of entities affiliated with Shanghai Fosun Pharmaceutical Group, HOPU Investments, China Everbright Limited's healthcare fund, and WuXi PharmaTech announced today that the Consortium has signed a merger agreement pursuant to which the Consortium will acquire Ambrx Inc. The transaction is expected to
Haemonetics is a global healthcare company dedicated to providing innovative blood management solutions to our customers. Economic weakness in Russia has impacted our financial results for fiscal 2015 and we expect that our Russian business performance in fiscal 2016 will be similar to fiscal 2015. While the needs for our products in the Russian...
WASHINGTON, May 22 The Department of Health& Human Services published the following notice in the Federal Register from the Food& Drug Administration:. A Notice by the Food and Drug Administration on 05/22/2015. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRASta
-Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration provided the Company with notification regarding its...
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the Institutional Review Board overseeing the Company's Phase 1 clinical trial of Kevetrin for the treatment of advanced solid tumors being conducted at Harvard...
From May 2012 until his retirement in April 2015, Dr. Shannon was the Chief Medical Officer of GlaxoSmithKline. He formerly held the position of Global Head of Pharma Development at Novartis AG, based in Basel, Switzerland from 2005 until 2008. After joining Sandoz in 1994 as Head of Drug Regulatory Affairs, Dr. Shannon led of the Integration Offic
Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending a change to the terms of the marketing authorisation for IMBRUVICA in the European Union, to indicate the treatment of adult patients with Waldenstrm's macroglobulinemia
Release date- 20052015- New Brunswick, N.J.- At a meeting today with industry analysts, senior leaders from the Janssen Pharmaceutical Companies of Johnson& Johnson will announce plans to file for regulatory approval of more than 10 new products between 2015 and 2019, each with the potential to exceed $1 billion in revenue1, as well as more than 40
The U.S. Food and Drug Administration's recent approval of Zarxio the first biosimilar product approved in the United States points toward growth in the contract manufacturing organization industry, according to Kalorama Information. The FDA believes that biosimilars will provide access to important therapies for patients who need them.
WASHINGTON, May 22 The Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal. A Notice by the Food and Drug Administration on 05/22/2015.
Merck, known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA , the company s anti-PD-1 therapy, for the treatment of advanced melanoma, as both first-line therapy and in previous