NESS ZIONA, Israel & FORT LEE, N.J.--(BUSINESS WIRE)--Kamada Ltd. (NASDAQ and TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications and Kedrion S.p.A., the parent company of Kedrion Biopharma Inc., a company focused on plasma-derived proteins used in treating and preventing serious diseases and disorders, today announced the submission of a Biological License Application (BLA) has been filed with the U.S. Food and Drug Administration (FDA) for a post-exposure treatment for rabies, a life-threatening condition. The human anti-rabies immune globulin (IgG) therapy was developed as a collaboration between the two companies.Kamada and Kedrion have a strategic agreement for the clinical development and marketing of the anticipated new IgG rabies treatment in the U.S. Kamada will hold the license for the approved product and Kedrion will exclusively market the therapy in the U.S., subject to receiving marketing approval from the FDA.
The Montreal Heart Institute opens its Cardiovascular Genetics Centre - An important step towards personalized medicine
he Montreal Heart Institute (MHI) continues its pursuit of innovation. Today, it has opened its Cardiovascular Genetics Centre. "We've just made an important step towards personalized medicine. This is the only specialized centre in Quebec with comprehensive expertise in patient monitoring thanks to a combination of clinical investigation and molecular testing for genetic cardiovascular diseases," said Dr. Talajic, Director of the Centre. The MHI's Cardiovascular Genetics Centre was created in order to provide an integrated multidisciplinary clinical assessment for patients and families affected by a genetic cardiovascular disease. "The Centre can provide all the cardiovascular assessments needed for the diagnosis, risk stratification, and development of treatment options," added Dr. Denis Roy, Chief Executive Officer of the MHI.
Cellvizio® Endorsed by the American Society of General Surgeons as Integral to the Care of Patients with Gastroesophageal Reflux Disease (GERD) and Barrett's Esophagus
PRNewswire/ --Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced that the American Society of General Surgeons (ASGS) endorsed Cellvizio® as integral to the comprehensive assessment and therapeutic decisions for the treatment of Barrett's esophagus and Gastroesophageal Reflux Disease (GERD). The Position Statement from the ASGS will be available on the ASGS website.
St. Jude Medical Launches Global Clinical Trial to Evaluate a New Therapy Option for Patients at an Increased Risk of Stroke Due to Atrial Fibrillation
ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the start of the St. Jude Medical AMPLATZER™ Amulet™ IDE trial, which will evaluate the safety and effectiveness of the company’s AMPLATZER™ Amulet™ Left Atrial Appendage Occluder used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). The first implant of the study took place at North Mississippi Medical Center in Tupelo, Mississippi by Dr. Jim Stone.
Orexo completes 1,080 patient REZOLV study and reports on improved treatment of opioid dependent patients
Orexo AB (publ.) announces that the REZOLV retrospective study (Retrospective Evaluation of Zubsolv® Outcomes – A Longitudinal View) has been completed as planned in August. With 1,080 patients, the study is the largest retrospective study completed in the US aimed at optimizing the treatment of opioid dependence. The opioid epidemic in the US continues to increase, and with recent legislative changes in the US that expand access to treatment, the current annual growth of nearly 9 percent of patients treated is expected to accelerate significantly. During the past 3 years, Orexo has identified a substantial lack of real-world clinical outcome data on treatment of opioid dependence with buprenorphine-based treatments such as Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII). REZOLV was undertaken as an opportunity to inform physicians, payers and patients about factors that may positively impact treatment outcomes when using Zubsolv for the treatment of opioid dependence.
FDA Approves BLINCYTO® (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia
PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials.The approval is based on results from the Phase 1/2 '205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of BLINCYTO in pediatric patients with relapsed or refractory B-cell precursor ALL.
Myriad Genetics Completes Acquisition of Assurex Health
Myriad Genetics, Inc. (NASDAQ:MYGN) a global leader in personalized medicine, announced today that it has completed its acquisition of Assurex Health effective August 31, 2016. Assurex Health, which is based in Mason, Ohio, is an informatics-based precision medicine company providing treatment decision support to healthcare providers for mental health patients. "We are exceptionally pleased to close the Assurex Health acquisition as GeneSight® becomes our second largest product, with an outstanding growth trajectory, substantial current market potential, and the opportunity for expanded indications," said Mark C. Capone, president and CEO, Myriad Genetics. "This acquisition is an excellent strategic fit since it leverages our existing preventive care business unit with the addition of a product that has a market potential of billion in this channel. The acquisition has the added strategic benefit of establishing the foundation for our neuroscience business where GeneSight has a market potential of over billion and the ability to leverage this sales channel for future pipeline products." To fund the transaction, Myriad entered into a credit agreement with JP Morgan Chase Bank for an aggregate principal amount of 0 million.
Biogen’s Investigational Alzheimer’s Disease Treatment Aducanumab Granted FDA Fast Track Designation
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Today Biogen (NASDAQ: BIIB) announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA’s Fast Track program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s disease.“By collaborating with regulators through programs like Fast Track, we hope to bring effective treatments to patients and families affected by Alzheimer’s disease as quickly as possible,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen.
Mylan Invalidates Third Teva Copaxone® 40 mg/mL Patent Via U.S. Patent and Trademark Office's Inter Partes Review Proceeding
HERTFORDSHIRE, England and PITTSBURGH, Sept. 1, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Patent and Trademark Office (PTO) has ruled in favor of Mylan in its inter partes review (IPR) proceeding and found all claims of U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd., unpatentable. This is the third patent related to Copaxone® 40 mg/mL to be found unpatentable in the last week.