CAMBRIDGE, Mass. & CAMBRIDGE, England–(BUSINESS WIRE)–Biogen (NASDAQ:BIIB) has joined the Centre for Therapeutic Target Validation (CTTV), the pioneering public-private collaboration to improve the success rate for discovering new medicines. Originally formed by GSK, the Wellcome Trust Sanger Institute and the European Bioinformatics Institute (EMBL-EBI), the CTTV fosters deep, ongoing interactions between academic and industry members for the purpose of developing open, transformative approaches to selecting and validating novel targets in drug development. read more
U.S. FDA Accepts For Review Otsuka and Lundbeck’s sNDA Filing for Labeling Update of REXULTI® (brexpiprazole) for Maintenance Treatment of Schizophrenia
- The safety and efficacy of REXULTI (brexpiprazole) as maintenance treatment in adults with schizophrenia aged 18 to 65 years was demonstrated in a 52-week randomized withdrawal trial.
- The anticipated date for the FDA to complete its review of the proposed expanded labeling is September 23, 2016. REXULTI was approved by the U.S. FDA in July 2015 as a treatment for adults with schizophrenia and as an adjunctive treatment for adults with major depressive disorder.
- There are approximately 2.4 million adults in the U.S. with schizophrenia and around 75% of patients experience relapses where their symptoms come back or, in some cases, worsen. read more
Sarepta Therapeutics Receives Notification of PDUFA Extension for Eteplirsen
PDUFA goal date extended by standard extension period of three months to May 26, 2016
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Feb. 8, 2016– Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for eteplirsen has been extended to May 26, 2016. The rescheduled date for the Peripheral and Central Nervous System Advisory Committee meeting has not yet been determined. read more
Boston Scientific Announces Medicare Will Cover WATCHMAN™ Left Atrial Appendage Closure Device
CMS will cover percutaneous LAAC therapy for Medicare beneficiaries consistent with the FDA label when specific conditions are met
MARLBOROUGH, Mass., Feb. 8, 2016 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced the Centers for Medicare and Medicaid Services (CMS) will cover percutaneous left atrial appendage closure (LAAC) therapy under specific criteria, as outlined in the agency’s final National Coverage Determination (NCD). This decision, effective immediately, provides consistent and uniform access to the WATCHMAN™ LAAC Device as a non-pharmacological treatment option for stroke risk reduction for appropriate Medicare beneficiaries.
“We are very pleased CMS has established national coverage for this life-changing therapy for Medicare beneficiaries who have a reason to seek an alternative to long-term anticoagulation,” said Mike Mahoney, president and chief executive officer, Boston Scientific. “The final decision reflects more than a decade of robust clinical evidence and will facilitate additional data collection via a prospective national registry.”
ADC Therapeutics Doses First Patient in Phase I Trial of ADCT-301 Trial in Acute Myeloid Leukemia
LAUSANNE, Switzerland & LONDON & MURRAY HILL,N.J.–(BUSINESS WIRE)–ADC Therapeutics SA (ADCT), the oncology drug development company, announces that the first patient has been dosed in a Phase I trial to evaluate its lead antibody drug conjugate (ADC) ADCT-301 in Acute Myeloid Leukemia (AML). read more
ICON selected by Genomics England to support the largest genome sequencing project of its kind for cancer and rare diseases
DUBLIN–(BUSINESS WIRE)–ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been selected by Genomics England as data management partner for the 100,000 Genomes Project. read more
Immunovia AB: Immunovia announces collaboration with Mount Sinai Health System to validate early detection blood test for pancreatic cancer
LUND, Sweden & NEW YORK–(BUSINESS WIRE)–Immunovia AB is pleased to announce that Mount Sinai Health System will be one of the first sites participating in a prospective clinical study for the early diagnosis of pancreatic cancer. Designed to validate Immunovia´s blood test, IMMray™ PanCan-d, the study will run for three years across sites in both the US and Europe, starting second half of 2016.For more information, visit http://www.mountsinai
ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of the company’s OPTIS™ Mobile System in Japan and Europe. The diagnostic system is designed to couple state-of-the-art optical coherence tomography (OCT) and angiography co-registration with fractional flow reserve (FFR) technology into one portable system for hospitals with multiple catheterization labs read more
PDS Biotechnology Signs Agreement with National Cancer Institute to form Phase II clinical collaboration for novel cancer immunotherapies based on PDS’ Versamune® platform technology
PRNewswire/ — PDS Biotechnology (PDS), a clinical-stage biopharmaceutical company focused on developing a pipeline of simpler, safer and more effective cancer immunotherapies based on its novel Versamune® platform, today announced that the Company has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), an Institute of the U.S. National Institutes of Health. Under the CRADA, PDS and NCI aim to co-develop several immunotherapies through Phase II clinical trials to be initiated in 2016 and 2017, utilizing combinations of Versamune® with NCI- and PDS-sourced tumor-related proteins or their fragments recognized by the immune system (antigens) in prostate, breast, and HPV-related cancers. read more