Medical Tidbits, IMS Health Study: Global Market for Cancer Treatments Grows to o $107 Billion in 2015, Fueled by Record Level of Innovation

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PARSIPPANY, N.J.–(BUSINESS WIRE)–More than 20 tumor types are being treated with one or more of the 70 new cancer treatments that have been launched in the past five years, with the sustained surge in innovative therapies driving the global oncology market to $107 billion in 2015. However, many of these drugs are not yet available to patients in most countries, and even when registered they may not be reimbursed under public insurance programs, according to a new study released today by the IMS Institute for Healthcare Informatics.$107 Billion in 2015, Fueled by Record Level of Innovation read more

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its subsidiary in the Philippines HI-Eisai Pharmaceutical Inc., has received approval for a new indication for its in-house discovered anticancer agent Halaven® (eribulin mesylate) for the treatment of soft tissue sarcoma. Halaven is the first and only single agent to demonstrate a statistically significant overall survival (OS) benefit in a Phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma). The Philippines is the second country in Asia in which Halaven has been approved for the soft tissue sarcoma indication following approval in Japan, the United States and Europe. read more


Agreement includes rights to the fixed-dose combination of lesinurad and allopurinol in gout 

AstraZeneca today announced that it has entered into a licensing agreement with Grünenthal GmbH for the exclusive rights to Zurampic (lesinurad) in Europe and Latin America.Zurampic was approved by the European Medicines Agency (EMA) in February 2016, in combination with a xanthine oxidase inhibitor (XOI), for the adjunctive treatment of hyperuricemia (excess of uric acid in the blood) in adult patients with uncontrolled gout. read more

Vitrolife acquiring OCTAX and MTG, jointly holding a world-leading position in laser technology for IVF

OCTAX is the developer and producer of the world-leading OCTAX Laser and Imaging Systems. MTG is the exclusive global distributor of OCTAX and acts as a distributor in Germany, Austria and Switzerland for IVF products from other manufacturers as well. Furthermore, MTG develops and markets a range of their own IVF products globally, primarily within the cryo-preservation, QC and andrology areas. The head office of the companies is located in Bruckberg, Germany and the companies have in total approximately 30 employees. The consolidated net sales for the companies in 2015 amounted toapproximately EUR 8.5 million (6.9). The consolidated operating income before depreciation and amortization (EBITDA) in 2015 amounted to approximately EUR 2.0 million (0.6). The consolidated net sales for the companies during January to March 2016 amounted to approximately EUR 2.7 million (1.8). read more

Elekta’s Leksell Gamma Knife Icon cleared for use in Japan and United States

TOKYO and WASHINGTON, June 1, 2016 – Elekta (EKTA-B.ST) announces that Elekta’s Leksell Gamma Knife® Icon™ has been cleared for clinical use by both the Japanese Ministry of Health, Labour and Welfare and the Nuclear Regulatory Commission in the United States. Icon is the world’s most precise and sophisticated system for radiosurgery treatment of certain brain tumors, vascular malformations and functional disorders. read more

JUVÉDERM VOLBELLA® XC Approved By U.S. FDA For Use In Lips And Perioral Rhytids
JUVÉDERM VOLBELLA® XC found to increase lip fullness and soften the appearance of lines around the mouth through one year. (1,2)*

DUBLIN , June 1, 2016 /PRNewswire/ — Allergan plc , (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration ( FDA ) to market JUVÉDERM VOLBELLA® XC, for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21.1 In clinical trials, JUVÉDERM VOLBELLA® XC was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through one year.1,2*

Stӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication – Reports of Mycobacterium Chimaera Infections

The FDA has received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T. Currently, efforts are underway in the U.S. to determine if the infections in U.S. patients and M. chimaera isolates from samples taken from the 3T are linked with M. chimaera isolates from European patients who were infected and the M. chimaera previously identified at the 3T manufacturer’s production and servicing facility in Germany. read more

European Commission Grants Orphan Drug Designation to ALXN1210 for the Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the European Commission has granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting C5 antibody being evaluated in patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a debilitating, ultra-rare, life-threatening blood disorder in which uncontrolled activation of complement, a component of the immune system, results in hemolysis (destruction of a patient’s red blood cells).

Kiadis Pharma Announces Its Decision to File for Marketing Authorization with the European Medicines Agency (EMA) for ATIR101™ in Blood Cancers

Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces a regulatory strategy update that, based on positive Phase II data, it has taken the decision to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead product ATIR101™ for use in blood cancers to reduce relapse rates, Transplant Related Mortality (TRM) and Graft-versus-Host-Disease (GVHD) in the context of a hematopoietic stem cell transplantation using a haploidentical donor. The Company will now start compiling an MAA document and anticipates submitting the application to EMA in Q1, 2017.

Biogen’s Investigational Alzheimer’s Disease Treatment Aducanumab Accepted into European Medicines Agency’s PRIME Program

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Today Biogen (NASDAQ:BIIB) announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was accepted into the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program. PRIME aims to bring treatments to patients faster by enhancing the EMA’s support for the development of investigational medicines for diseases without available treatment or in need of better treatment options. read more

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