Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved IMBRUVICA™ (ibrutinib) capsules, a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor. This new approach to treating blood cancers works by blocking BTK, a protein that helps certain cancer cells live and grow.1 IMBRUVICA is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/72762540-janssen-ec-approval-imbruvica-mcl-cll/
Moncler S.p.A. announces that today it has obtained approval from CONSOB for the Prospectus for the Initial Public Offering issued for the purpose of the admission of the Company’s ordinary shares to trading on the Mercato Telematico Azionario organized and managed by Borsa Italiana S.p.A..
To view the Multimedia News Release, go to http://www.multivu.com/mnr/64154-Eurazeo-Moncler-IPO-clearance
Abbott announced today the U.S. Food and Drug Administration approval and launch of the iDesign Advanced WaveScan Studio System. The system acts as the "brain" of the LASIK procedure, generating a high-definition scan that measures and maps irregularities of the eye that may impact vision. From these measurements, the iDesign System creates an accurate and personalized LASIK treatment plan based on the unique "blueprint" of each person’s eyes.
The iDesign System captures more than 1,200 micro readings of the eye, as well as identifying the shape of the cornea, its curvature, how light passes through the eye and pupil diameter under different lighting conditions – all in one, three-second scan that can be used to precisely correct vision.
The development of the sensor technology within the iDesign System was the result of an earlier discovery by Abbott scientists, which NASA used to accurately measure and shape the mirrors in the James Webb Space Telescope to ensure it will transmit high resolution images of deep space back to earth. The telescope is scheduled to launch in 2018.
To view the Multimedia News Release, please go to http://www.multivu.com/players/English/7571951-abbott-idesign-system-3-d-eye-map/
In recent years there has been a shift in the understanding of cancer. Immunotherapy with vaccines has been emerging as the most promising direction towards a decisive improvement of treatment outcomes.
The Dendritic Cell Vaccine has received FDA approval for prostate cancer and trials are now under way for a variety of other cancers. These vaccines are usually administered on their own.
To view Multimedia News Release, go to http://www.multivu.com/mnr/64654-issels-integrative-immunotherapy-for-standard-therapy-resistant-cancers
Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved the Tecnis Symfony® Intraocular Lenses for the treatment of cataracts. The first in a new category of intraocular lenses (IOLs), the Tecnis Symfony lenses are the only lenses in the United States that provide a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia by helping people focus on near objects. The FDA approval includes a version of the lens for people with astigmatism, the Tecnis Symfony Toric IOL.
Cataracts are a common condition, with almost 4 million cataract surgeries performed each year, and that number is expected to increase.1 By age 80, more than half of all Americans either have a cataract or have had cataract surgery.2 However, cataracts do not just impact seniors. In 2016 it is estimated that nearly one in four cataract surgeries will be performed on people younger than 65.1 Many people who have cataracts experience other problems with their vision, such as presbyopia and astigmatism, which the Symfony lenses also address. Presbyopia, which affects most people over age 40, means people have lost the ability to focus on objects up close and often require glasses to perform near visual tasks. Astigmatism is when the cornea is misshapen, which causes blurry or distorted vision.
To view the multimedia release go to:
http://www.multivu.com/players/English/7870151-abbott-intraocular-lenses/
Following FDA approval of the AspireSR® generator for the VNS Therapy® system in June 2015, more than a thousand patients with drug-resistant epilepsy across the United States have received this new treatment option. Many of these patients are experiencing benefits which have positively impacted their lives – and are sharing their stories during Epilepsy Awareness Month with the hope of encouraging others to seek new treatments for drug-resistant epilepsy. Numerous hospitals nationwide have begun providing the AspireSR device to patients with drug-resistant epilepsy – a condition that affects as many as one-third of people with epilepsy, causing them to have seizures in spite of treatment with antiepileptic medications.
The VNS Therapy system is a minimally invasive option in which a medical device is placed under the skin in the upper chest area during an outpatient procedure. The device sends mild electrical pulses through the vagus nerve to areas of the brain known to be associated with seizures. The new AspireSR generator takes the VNS Therapy technology a step further – detecting relative heart-rate increases that are often associated with seizures in people with epilepsy and providing responsive stimulation in an attempt to stop and shorten seizures and improve recovery.
To view the multimedia release go to:
http://www.multivu.com/players/English/7651751-livanova-aspiresr-treatment/
Novartis announced today that the US Food and Drug Administration (FDA) has approved Jadenu™ (deferasirox) tablets, a new oral formulation of Exjade® (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7440151-novartis-jadenu-fda-approval/
Abbott announced today that the U.S. Food and Drug Administration has approved the company’s Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States.
Absorb is the only fully dissolving stent approved for the treatment of coronary artery disease, which affects 15 million people in the United States and remains a leading cause of death worldwide, despite decades of therapeutic advances. While stents are traditionally made of metal, Abbott’s Absorb stent is made of a naturally dissolving material, similar to dissolving sutures. Absorb disappears completely in approximately three years, after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment. By contrast, metal stents are permanent implants that restrict vessel motion for the life of the person treated.
To view the multimedia release go to:
http://www.multivu.com/players/English/7826651-abbott-fda-approval-stent/
Exact Sciences Corp. (NASDAQ: EXAS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company’s noninvasive, stool DNA colorectal cancer screening test. Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients. Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy–to–use screening test they can do in the privacy of their own home.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7092251-fda-approve-s-exact-sciences-cologuard-screening-test-colorectal-cancer/
At the heart of Ketel One Vodka lies one family’s unwavering passion for crafting the world’s finest spirits. Inspired by over 325 years of distilling expertise, the Nolet family brings old-world pot still craft and modern distilling techniques together in one flawless process. From Joannes to Jacobus to Carolus Sr., creator of Ketel One Vodka, to Carolus Jr. and Bob Nolet today, each of the 11 generations of Nolet family distillers is tasked with upholding a legacy of distilling excellence. Some may consider the Nolets a little obsessive, but those individuals just don’t understand. Everything must be done with meticulous attention to detail, because the family name is riding on every bottle of Ketel One Vodka.
“We take our work very seriously, not ourselves,” said Carl Nolet Jr., 11th Generation Nolet Family Distillery. “The stories we tell are all true and based on family events, beliefs and the pressure of upholding 11 generations of legacy for generations to come.”
To view the multimedia release go to:
http://www.multivu.com/players/English/7975151-ketel-one-vodka
Today, Novo Nordisk announced new phase 3 interim data from its guardianTM2 trial for its recombinant coagulation factor VIII (rFVIII) product NovoEight® (turoctocog alfa), the first new rFVIII molecule in over a decade, which shows that it provides long-term reduction from bleeding in people with haemophilia A when used as a preventative treatment.1 The results were presented at the World Federation of Haemophilia (WFH) World Congress and support findings from other studies within the guardianTM clinical programme that found NovoEight® demonstrated good efficacy in preventing and treating bleeds without inhibitor development in previously treated patients.
To view the Multimedia News Release, go to: http://www.multivu.com/mnr/71400529-novoeight-reduction-of-bleeding-haemophilia-a
An injury ends Laura Nelson’s career as a surgeon. Now, as Vice President of a pharmaceutical company, Laura works to finalize the approval of a groundbreaking new drug. But her efforts are being thwarted by a malicious FDA employee who will stop at nothing to prevent the approval, and Laura is standing directly in his path. Find out more about the author here- http://patriciagussin.com/ and check out the book here http://oceanviewpub.com/after-the-fall/. After the Fall by Patricia Gussin. Thriller
