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
EnteroMedics Inc. (NASDAQ: ETRM) today announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC® vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years. The Maestro System is the first new medical device to be approved by the FDA for obesity in over ten years. EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7269351-enteromedics-fda-approval-vbloc-maestro-system-weight-loss-device/
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/
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/
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
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) approval and launch of the Cochlear™ Nucleus® Hybrid Implant System, a revolutionary new hybrid hearing solution that helps people who may hear a little but are still missing a lot, even with their hearing aids. The Nucleus Hybrid System is a unique combination of proven solutions, which allows people to get back what they've been missing by amplifying the low-pitched hearing a person does have while restoring access to the high-pitched hearing they've lost. People who are candidates for the technology no longer have to worry about straining to hear with their hearing aids as the Nucleus Hybrid System will allow them to maximize their hearing in all frequencies.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7150651-cochlear-fda-approval-u-s-launch-cochlear-nucleus-hybrid-implant-system
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
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
The USPSTF today issued a draft recommendation giving its second highest approval rating for CT screening for lung cancer for those at high risk, a move that if approved in final form, will trigger Medicare and insurance coverage and bring about a dramatic drop in the leading cause of cancer deaths.
Today, LCA also launched its Risk Navigator tool – www.AtRiskForLungCancer.org. Additionally, it expanded the hours of its support line – (800) 298-2436 – operating 8 a.m. to 7 p.m. EST. LCA will also launch a national educational advertising campaign in September to encourage the public to know their risk for lung cancer.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/62719-lung-cancer-alliance-uspstf-recommends-ct-screening-for-lung-cancer
In a revolutionary treatment for early-onset scoliosis (EOS), a team of surgeons implanted adjustable growing rods in two children from California. The pioneering surgeries — the first ever in the United States — were performed on May 7th at Rady Children’s Hospital in San Diego. The Food and Drug Administration (FDA) granted Compassionate Use approval to use the MAGEC™ (MAGnetic Expansion Control) System, developed by Ellipse Technologies, Inc., for these two patients.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61604-rady-children-s-hospital-san-diego-ellipse-magec-early-onset-scoliosis-eos
Raptor Pharmaceutical Corp. (“Raptor” or the “Company”) (Nasdaq: RPTP), today announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI™ (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. In a Phase 3 study, PROCYSBI showed consistent cystine depletion over the full 12-hour dosing period. Sustained levels of cysteamine have not historically been achieved in the majority of patients in this population. Studies have shown that sustained cystine depletion in patients may significantly delay disease progression, including kidney dysfunction, dialysis, kidney transplant, organ failure and premature death.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61338-raptor-pharmaceutical-procysbi-fda-approval-nephropathic-cystinosis
Dune Medical Devices, Inc., announced today that its breakthrough intra-operative tissue assessment tool for early-stage breast cancer surgery, the MarginProbe System, has received Premarket Approval (PMA) by the United States Food and Drug Administration. The technology significantly improves surgeons’ ability to intra-operatively identify
