SAN DIEGO–(EON: Enhanced Online News)–ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. In 2014, the FDA designated NUPLAZID as a Breakthrough Therapy for this condition. read more
Corsens Medical Ltd., Announces Filing of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Corsens Cardiac Monitor
The Cardiac Monitor is intended to detect heart contractility parameters required for continuous heart function monitoring TEL AVIV, Israel–(EON: Enhanced Online News)–Corsens Medical Ltd., today announced that it has successfully completed filing of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Corsens Cardiac Monitor1,2. read more
BioInvent, Oncurious NV and NMTRC Initiating Phase I/IIa Study with TB-403 for the Treatment of Medulloblastoma
BioInvent International (BINV) today announce it has initiated a Phase I/IIa study that will evaluate the safety and tolerability, and explore the preliminary efficacy, of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children. More information is available at www.bioinvent.com.
WASHINGTON – U.S. Secretary of Labor Thomas E. Perez today issued the following statement on Workers’ Memorial Day:
“Every day, millions of Americans leave their homes and report to jobs that provide for their families, strengthen our communities and grow our economy. Too many of them – on average, 13 workers a day – don’t make it back at the end of their shift. On Workers’ Memorial Day, we honor our fallen workers, and we renew our commitment to unwavering vigilance on workplace safety.
“Over the last half century, we have made great strides on occupational safety and health, most recently with the completion of a groundbreaking standard to improve protections for millions of workers exposed to respirable silica dust, which can cause death and disabling lung diseases. But, notwithstanding significant progress, more than 4,500 workers still die from preventable workplace incidents every year, with 50,000 more succumbing to work-related illnesses.
“A nation built on the dignity of work must provide safe working conditions for its people. For everything they do to drive American prosperity, for all their heroic efforts to pull us out of the worst economic crisis in generations, our workers deserve nothing less than rigorous adherence to essential safety standards.
“Ensuring that everyone can make it home safely after a hard day’s work – that no one has to give their life to make a living – is our unfinished business.”
Allergan Receives CHMP Positive Opinion For ENZEPI® (Pancrelipase) For Patients With Exocrine Pancreatic Insufficiency (EPI)
/PRNewswire/ –Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for the Marketing Authorisation of ENZEPI® (pancrelipase) in the European Union. 1 ENZEPI® is a pancreatic enzyme replacement therapy (PERT) for patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).2 ENZEPI® is specifically formulated to meet 100 percent of the label-claimed lipase enzyme activity, in line with the CHMP guidelines.3,4read more
European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for Treatment of HIV
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg; R/F/TAF), an investigational single tablet regimen for the treatment of HIV-1 infection in adults and adolescents (ages 12 years and older with body weight at least 35 kg) without known mutations associated with resistance to the NNRTI class, tenofovir or emtricitabine, and with a viral load less than 100,000 copies per mL read more
Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis
CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. ZINBRYTA is also currently under regulatory review in the United States, Switzerland, Canada and Australia.
New Data Presented at ESTRO 35 Show Positive Cosmesis and Favorable Late Side Effects After Accelerated Partial Breast Irradiation (APBI) with Multicatheter Interstitial Brachytherapy
Phase III trial further reinforces treatment as a valid alternative to whole breast irradiation in patients with early breast cancer
Clinical equivalence of partial breast irradiation (PBI) and whole breast irradiation (WBI) has been demonstrated in two key phase III randomized trials: the Groupe Européen de Curiethérapie European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) trial administering PBI in five days with multicatheter interstitial brachytherapy (published in the Lancet), and the IMPORT-Low trial administering PBI in three weeks with IMRT (presented at the 10th European Breast Cancer Conference). for more information Website: http://www.elekta.com.
GenVec Provides Update on Hearing Loss Clinical Program Data Safety Monitoring Board Recommends Trial Continue
PRNewswire/ — GenVec, Inc. (NASDAQ: GNVC), a clinical-stage gene delivery company, announced today that it was notified by its collaborator Novartis that the Data Safety Monitoring Board (DSMB) for the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss has recommended that the trial continue, subject to approval by the U.S. Food and Drug Administration (FDA). This recommendation was based on a review of safety and efficacy data from the nine patients currently enrolled in the study. Novartis is developing CGF166, GenVec’s lead product candidate for hearing loss, under a Research Collaboration and License Agreement with GenVec. As previously disclosed, on January 8, 2016, GenVec was notified by Novartis that enrollment was paused in the clinical study for CGF166 in accordance with criteria in the trial protocol.