Chiasma, Inc., a U.S. privately–held biopharma company developing octreotide capsules for the orphan condition acromegaly, today announced two new studies presented at the 97th Endocrine Society (ENDO) Annual Meeting in San Diego, Calif. The studies provide additional data from Chiasma’s Phase III trial and new findings on the patient burden of current injection therapies.
“We now have data to help clinicians determine whether octreotide capsules, if approved, are likely to help their patient with acromegaly maintain response,” said Shlomo Melmed, M.D., senior vice president and dean, Cedars–Sinai Medical Center, Los Angeles and global study principal investigator. “Furthermore, the Phase III results show the safety and efficacy of octreotide capsules can be reliably determined within 12 weeks of initiating therapy.”
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7436451-endo-chiasma-clinical-data/
Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a new report, “A Decade of Innovation in Rare Diseases,” to document the significant progress made in the last 10 years in understanding a broad range of rare diseases and translating this knowledge into groundbreaking therapies for a variety of patient populations.
The report illustrates that more than 230 new medicines to treat rare or “orphan” diseases were approved by the U.S. Food and Drug Administration (FDA) in the last decade, and there are currently more than 450 orphan drugs in development.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7350554-phrma-report-innovation-rare-diseases/
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/
Findings from continued clinical studies of investigational chimeric antigen receptor (CAR) therapy, CTL019, demonstrate its potential role in the treatment of certain types of lymphocytic leukemia. In one long-term study of pediatric patients with acute lymphoblastic leukemia (ALL), results showed that 36 of 39 pediatric patients with relapsed/refractory (r/r) ALL, or 92%, experienced complete remissions (CR) with CTL0191.
To view the Multimedia News Release, go to: http://www.multivu.com/players/English/7393851-novartis-new-ctl019-clinic-data-acute-lymphoblastic-leukemia/
Eight out of 10 people will be affected by back pain at some point during their lives, making it the No. 1 cause of disability worldwide and resulting in as much as $200 billion in lost wages and productivity. Many sufferers struggle for years to find relief, but treatment options often only provide short-term relief or, in the case of pain medication, carry serious side effects, including drowsiness, liver damage and potential for addiction. Now, thanks to Hocoma, a leader in the development of robotic and sensor-based medical devices for functional movement therapy, consumers have a new way to improve and sustain low back health in the comfort of their own home.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7370551-hocoma-innovative-medical-device-therapeutic-gaming-technology-valedo-low-back-health/
As the holiday season approaches and people begin planning their decorations, Cyberonics, Inc. is urging them to maintain the momentum of Epilepsy Awareness Month in November by incorporating purple lights into their holiday décor.
To view the Multimedia News Release, go to: http://www.multivu.com/players/English/7378051-cyberonics-launches-mylifeisbright-campaign-healthyandbright-promotion-epilepsy-awareness-month-shine-purple-lights/
Steve Scott became one of the greatest mile runners in American history by taking a strategic approach to his craft. Now 58, Scott is seeking a competitive advantage of a different sort since recently being diagnosed with prostate cancer. Scott publicly revealed his current cancer battle today at the Cougar Challenge, a cross country meet at California State University San Marcos, where he is head coach of the track and field and cross country programs.
To view the Multimedia News Release, go to: http://www.multivu.com/players/English/7350051-scripps-health-steve-scott-reveals-proton-treatments-for-prostate-cancer
Rosecrance, one of the country’s leading teen substance abuse treatment centers, has launched a traveling art exhibit to help parents understand teenagers’ points of view about pressures they encounter and how they are faced with the potential to use, and abuse, substances. Developed by teen patients participating in an art therapy program at Rosecrance’s adolescent campus in Rockford, IL, “In My Shoes” encourages parents to understand their teen’s point of view and actively parent to help teens navigate today’s confusing environment.
To view the Multimedia News Release, go to: http://www.multivu.com/players/English/7348551-rosecrance-s-in-my-shoes-traveling-art-exhibit-parents-teenagers-prevent-substance-abuse/
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/
Inspire Medical Systems, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Inspire Upper Airway Stimulation (UAS) therapy for use in a subset of patients with moderate to severe Obstructive Sleep Apnea (OSA) who are unable to use Continuous Positive Airway Pressure (CPAP). Inspire therapy is a fully implanted neurostimulation device, the first of its kind for sleep apnea, that provides an alternative treatment that is proven, convenient and easy to use.
To view the Multimedia News Release, go to: http://www.multivu.com/mnr/7169651-fda-approves-inspire-upper-airway-stimulation-therapy-sleep-apnea
Eisai Inc. today announced the launch of a new national television advertising campaign for BELVIQ® (lorcaserin HCl) CIV, an FDA-approved prescription therapy for chronic weight management. The advertisement will air on numerous channels including Lifetime, Oxygen and AMC.
The spot illustrates the struggles many people face when they are trying to lose or control their weight. BELVIQ is presented as a targeted approach to weight loss, that, when combined with diet and increased activity, may help some patients lose weight and keep it off.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7161051-eisai-launches-national-television-campaign-belviq-lorcaserin-hcl-civ
High-powered research teams supported by the Crohn's & Colitis Foundation of America (CCFA) are gearing up for an ambitious new goal: developing individualized treatment approaches for patients with Crohn's disease and ulcerative colitis (UC), also known as inflammatory bowel diseases (IBD), through their Genetics and Microbiome Research Initiatives.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/65964-ccfa-genetic-microbiome-discoveries-ibd-crohn-s-disease-ulcerative-colitis