Nearly 10 percent of babies born in the United States are born premature, according to the March of Dimes. The underlying cause of many complications during pregnancy is often a poorly functioning placenta, the organ that nourishes and maintains the fetus.
A new study by an international team of researchers, including Erkki Ruoslahti, Ph.D. , distinguished professor at Sanford Burnham Prebys Medical Discovery Institute’s (SBP) NCI-Designated Cancer Center , and adjunct professor at the Center for Nanomedicine and Department of Molecular, Cellular, and Developmental Biology, UC Santa Barbara, has found a way to selectively deliver drugs to the placenta without harming the fetus. read more
Allergan and Richter Announce Positive Phase III Results for Ulipristal Acetate 5 and 10 mg in the Treatment of Uterine Fibroids
DUBLIN and BUDAPEST, Hungary, May 9, 2016 /PRNewswire/ –Allergan Plc (NYSE: AGN) and Gedeon Richter Plc. today announced positive results from Venus I, one of two pivotal Phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. read more
Nordic Nanovector announces an open Investigational New Drug application for new clinical study of Betalutin® in diffuse large B-cell lymphoma
Clinical development programme expected to start in 2H 2016
Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces that its Investigational New Drug (IND) application for a new Phase 1 clinical study of Betalutin® in a second non-Hodgkin lymphoma (NHL) indication is now open with the US Food & Drug Administration (FDA).
The Company plans to investigate Betalutin® in relapsed diffuse large B-cell lymphoma (DLBCL) patients who are ineligible for stem cell transplant. This represents the most prevalent relapsed DLBCL patient population and the one with the greatest unmet medical need.
The Phase 1 dose-finding study (Lymrit 37-05) has a classical 3+3 dose-escalation design and is expected to enrol up to 24 patients in the US and Europe. The study is designed to identify an optimal dose regimen of Betalutin® in patients pre-dosed with unconjugated “cold” read more
Boston Scientific Announces Positive Long-Term Outcomes For S-ICD System In The EFFORTLESS Study
Late-Breaker Data Presented at HRS Scientific Sessions Is Most Extensive Post-Market Study for S-ICD PRNewswire/ –Boston Scientific (NYSE: BSX) today announced results from the largest post-market registry for the Subcutaneous Implantable Defibrillator (S-ICD) System. Data collected from the EFFORTLESS study were presented as a late-breaking clinical trial at the 37th Annual Scientific Sessions of the Heart Rhythm Society (HRS) in San Francisco, and confirmed long-term safety and efficacy for the only device available to treat sudden cardiac arrest without leads touching the heart and vasculature. read more
Antidepressant use during pregnancy may lengthen umbilical cord
Umbilical cords of children whose mothers used selective serotonin reuptake inhibitors during pregnancy may be longer than umbilical cords of other newborn children, shows a new study from the University of Eastern Finland and Kuopio University Hospital. Selective serotonin reuptake inhibitors, SSRIs, are commonly prescribed antidepressants, and this is the first time their association with umbilical cord length was observed. The findings were published in PLOS ONE. read more
Irvine Scientific is the First Company to Receive FDA 510(k) Clearance on Vitrification Media for Use With Oocytes
SANTA ANA, California–(EON: Enhanced Online News)–Irvine Scientific, a world leader in the development and manufacture of Assisted Reproductive Technologies (ART), today announced the receipt of FDA 510(k) clearance for expanded use of Vit Kit® vitrification media to include human oocytes. The company is the first, and only company to date, to obtain 510(k) clearance of vitrification media for use with oocytes within the US. Irvine Scientific’s Vit Kit-Freeze and Vit Kit-Thaw are now intended for worldwide use with oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos read more
Vivostat Co-Delivery: cutting-edge burn treatment on trial
LONDON–(EON: Enhanced Online News)–Some burns are too difficult or infected to treat using traditional surgery without the patient going through multiple procedures, pain and discomfort or even death.
“The cells are expensive and seeing them run off the wound away from the patient can be heart-breaking.”
The pioneering co-delivery using the patient’s own blood and other substance has been utilised for many years in wound therapy and is being used for the first time with skin cells at the Queen Elizabeth Hospital Birmingham on burns patients. Though it is still in the early stages of assessment, surgeons claim this non-invasive form of surgery may be the only lifeline available to patients suffering from extensive burns.
Epizyme Announces Collaboration with Lymphoma Study Association to Evaluate Combination of Tazemetostat with R-CHOP in Front-line Non-Hodgkin Lymphoma
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that it has entered into a collaboration agreement with the Lymphoma Study Association (LYSA) to investigate the combination of tazemetostat with R-CHOP as a front-line treatment in patients with diffuse large B-cell lymphoma (DLBCL). LYSA is a premier cooperative group in France dedicated to clinical and translational research for lymphoma, and is certified by the French National Cancer Institute. Under the agreement, the phase 1b/2 trial will be jointly conducted with the Lymphoma Academic Research Organisation (LYSARC), the operational arm of LYSA. read more
MGB Biopharma’s Pre-IND Meeting With FDA Provides Clear Guidelines on Further Development of Oral MGB-BP-3, a Truly Novel Antibiotic Targeting Clostridium Difficile Infections
MGB Biopharma, a biopharmaceutical company developing a truly novel class of anti-infectives to address the major global problem of antibiotic resistance, announces that it has held a pre-Investigational New Drug (pre-IND) meeting with the Food and Drug Administration (FDA) to discuss the regulatory strategy for the development programme of MGB-BP-3 in the US. For more information please visit http://www.mgb-biopharma.com.