ERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that it is embarking on a strategic enterprise-wide corporate identity program to build a global brand. This is the manifestation of the journey Teva embarked on two years ago, to differentiate itself based on the unique characteristics of the Company’s business model and create a new breed of healthcare company. read more
Bone Therapeutics Presents ALLOB® Pre-Clinical and Early Clinical Efficacy Data in Spinal Fusion at the ‘Clinical Applications of Stem Cells’ Conference
BONE THERAPEUTICS (Brussels:BOTHE) (Paris:BOTHE) (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, today announces that it has presented pre-clinical and positive early clinical efficacy data of its ALLOB® Phase IIA spinal fusion trial. These preliminary data, presented at the Clinical Applications of Stem Cells Conference, 24-25 February 2016 in Singapore, show spinal fusion on CT scans and absence of intervertebral motion on dynamic x-rays.
FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate ReprThe FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order.
On November 12, 2015, in accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics (Consent Decree), FDA ordered Custom Ultrasonics to recall, at its expense, all of its Automated Endoscope Reprocessors (AERs). On November 24, 2015, Custom Ultrasonics submitted a recall strategy to the FDA, which the Agency found inadequate. Custom Ultrasonics has to date made no additional proposals to FDA to recall its AERs.
Recipharm to acquire Mitim Srl for SEK 640 million adding scale and niche technology in injectable beta lactams
Recipharm AB today announces that it has entered into an agreement to acquire Italian CDMO, Mitim Srl adding scale and capabilities to the group. Mitim is currently owned by a private Italian family and is specialised in the filling of injectable beta lactam products. It is located in Brescia close to Recipharm’s existing operations in Northern Italy. The transaction will complete tomorrow, 24th February 2016. read more
Gilead Announces Results From First Study to Evaluate Switching to F/TAF-Based Regimens from Truvada® (F/TDF)-Based Regimens
Gilead Sciences, Inc. (NASDAQ:GILD) today announced 48-week results from a Phase 3 study (Study 1089) evaluating the safety and efficacy of switching virologically suppressed HIV-1 infected adult patients from regimens containing emtricitabine and tenofovir disoproxil fumarate (F/TDF) (Truvada®) to regimens containing the investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF). At Week 48, the F/TAF-based regimens were found to be statistically non-inferior to the F/TDF-based regimens, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. The study also demonstrated statistically significant improvements in renal and bone laboratory parameters among patients receiving F/TAF-based regimens. The data were presented in an oral session (Session O-2) at the 2016 Conference on Retroviruses and Opportunistic Infections
Provectus Biopharmaceuticals Announces Data on PV-10 and Co-Inhibitory Blockade to Be Presented at American Association for Cancer Research Annual Meeting 2016
KNOXVILLE, Tenn.–(BUSINESS WIRE)–Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or “The Company”), today announced that data on intralesional PV-10 and co-inhibitory blockade in a melanoma model will be presented at the American Association for Cancer Research’s (“AACR”) Annual Meeting 2016 on Wednesday, April 20, 2016, from 8 am to 12 Noon Central Standard Time.
Carillon Mitral Contour System Associated with Significant Improvement of Functional Mitral Regurgitation
(BUSINESS WIRE)–A single-center study recently published in the Journal of Invasive Cardiology noted that treatment with Cardiac Dimensions’ Carillon® Mitral Contour System® resulted in significant improvement of functional (secondary) mitral regurgitation (FMR), a condition that can increase the symptoms of heart failure. read more
Asterias Biotherapeutics Announces Successful End-of-Phase 2 Meeting with FDA for AST-VAC1
PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE:AST) today announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, its investigational therapy targeting acute myeloid leukemia (AML).
During the meeting, the FDA indicated general agreement with Asterias’ proposed development plan for registration of AST-VAC1 through a single Phase 3 trial to support an accelerated development pathway and Biologics License Application (BLA) filing. In this study, Asterias will assess the impact of AST-VAC1 compared to placebo on the duration of relapse-free-survival as the primary endpoint, and on overall survival as the secondary endpoint in patients who have achieved complete remission using standard therapies. The proposed trial will include AML patients 60 years and older, along with younger individuals who are at high risk for relapse and are not candidates for allogeneic bone marrow transplantation. Pending positive results, this trial could be the basis for accelerated approval of AST-VAC1. Asterias currently plans to submit a request for a Special Protocol Assessment (SPA) to the FDA to confirm the primary endpoint and other design elements of this pivotal Phase 3 trial. read more
Migraine, Tension Headaches and Irritable Bowel Syndrome Linked?
PRNewswire-USNewswire/ — Migraine and tension-type headaches may share genetic links with irritable bowel syndrome (IBS), according to a preliminary study released today that will be presented at the American Academy of Neurology’s 68th Annual Meeting in Vancouver, Canada, April 15 to 21, 2016.
Irritable bowel syndrome is the most common gastrointestinal disorder worldwide and affects up to 45 million people in the United States. Many people remain undiagnosed and the exact cause of the chronic condition is not known. Common symptoms include abdominal pain or cramping, a bloated feeling, gas and diarrhea or constipation. read more