Medical Tidbits, FDA proposes ban on most powdered medical gloves

biotech news

Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling. read more

FDA approves new treatment for inhalation anthrax

On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. read more

 Increased travel burden associated with decreased likelihood of receiving radiation therapy to treat rectal cancer

Increased travel distance to a cancer treatment facility negatively impacts the likelihood that patients with stage II/III rectal cancer will receive radiation therapy (RT) to treat their disease, according to a study analyzing 26,845 patient records from the National Cancer Data Base (NCDB) that was published in the March 2016 issue of International Journal of Radiation Oncology • Biology • Physics (Red Journal), the official scientific journal of the American Society for Radiation Oncology (ASTRO). While travel burden was associated with receipt of RT, physician availability related to the geographic concentration of radiation oncologists was not. read more

Moberg Pharma AB (OMX: MOB) today announced a decision to initiate development of BUPI through phase III. The decision follows an evaluation of the complete data set from the recent phase II study for BUPI.

BUPI is a patent pending lozenge formulation of bupivacaine for pain management in oral mucositis in cancer patients. Following positive phase II results, the board has approved a de-risked strategy to continue development through phase III, including one phase III trial to be conducted in Europe co-funded by a grant from Eurostars. A second phase III study will be conducted in India and financed by Moberg’s partner Cadila Pharmaceuticals read more

Hospira Issues a Voluntary Recall for One Lot of Sodium Bicarbonate Injection, USP Due to the Presence of a Particulate

LAKE FOREST, Ill. – Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint. read more

A1M Pharma finalizes drug candidate for treating pre-eclampsia and files for substance patent

A1M Pharma has developed a new drug candidate for treating pre-eclampsia based on a modified version of the natural protein alpha-1-microglobulin (A1M). Applications for substance patents have been filed in major geographical markets, significantly strengthening A1M Pharma’s intellectual property portfolio.

A1M Pharma is developing a treatment and diagnostics for pre-eclampsia as well as a therapy for acute kidney injury based on the endogenous protein alpha-1-microglobulin (A1M). A1M occurs naturally in the body, and is an important component of the protective mechanism against the harmful effects of oxidative stress. read more

Daiichi Sankyo and ArQule Announce Continuation of METIV-HCC Phase 3 Study of Tivantinib in Second-Line Hepatocellular Carcinoma

PRNewswire/ — ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo today announced that the independent data monitoring committee (DMC) of the METIV-HCC study conducted the planned interim assessment and it was determined the trial will continue to its final analysis.

METIV-HCC is a biomarker-selected, double-blind, placebo-controlled, pivotal phase 3 study evaluating tivantinib (2:1) versus best supportive care in previously systemically-treated patients with MET-high, inoperable HCC, with overall survival as the primary endpoint. For more information http://www.daiichi-sankyo.eu
ProMetic confirms PBI-4050’s positive effects on novel biomarkers in patients suffering from metabolic syndrome and Type 2 diabetes

ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the Corporation”) announced today that the preliminary analysis of new pro-inflammatory biomarkers in blood and urine samples from the patients in the on-going, open label, Phase 2, metabolic syndrome and Type 2 diabetes clinical trial provides additional evidence of PBI-4050’s pharmacological and clinical activity in humans. read more

PharmaVentures Advises 3Legs Resources on its Acquisition of the Immuno-Oncology Company SalvaRx Who Announced its Admission for Trading on AIM Today  

PharmaVentures is pleased to announce that it acted as an independent technical and commercial expert adviser to 3Legs on its Reverse Takeover of SalvaRx. 3Legs Resources is an investment company that focuses on life sciences and related technologies.

SalvaRx is an immuno-oncology company developing novel therapeutics that stimulate the immune system to fight cancer. SalvaRx also owns over 60% of iOx Therapeutics, which is developing anti-cancer treatments based on invariant natural killer T-cells and is poised to undertake the first Phase I/II human trials.

Amgen To Present Repatha® (Evolocumab) Data At ACC.16  

PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that it will present 19 abstracts related to its cardiovascular portfolio, including new detailed data  evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins, at the American College of Cardiology’s 65th Annual Scientific Session (ACC.16) in Chicago, April 2-4, 2016. Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.1 read more

Janssen Announces the Initiation of Two Studies Evaluating Daratumumab (DARZALEX®) and Atezolizumab in Multiple Myeloma and Solid Tumor

PRNewswire/ — Janssen Research & Development, LLC announced today it has entered into a clinical trial collaboration agreement with Genentech, a member of the Roche Group, to initiate two studies to determine the safety and tolerability of daratumumab (DARZALEX®), the first CD38-directed monoclonal antibody (mAb), in combination with atezolizumab, an investigational mAb designed to bind with a protein called programmed cell death-ligand 1 (PD-L1). These studies will assess the potential of the combination therapy in multiple myeloma and in solid tumor. Atezolizumab is currently in development by Roche. Janssen licensed daratumumab from Genmab A/S and is responsible for development and marketing. read more

NIRTRAKS Study of a Novel Coronary Stent Enrolls Its First Patient

Medinol is pleased to announce the enrollment of their first patient in the U.S. NIRTRAKS Study. NIRTRAKS is a post marketing, non-randomized study of the NIRxcell™ Stent System in patients with coronary artery disease indicated for PCI.  The study objective is to collect and analyze additional information about the safety and effectiveness of the NIRxcell stent in the treatment of de novo lesions in native coronary arteries in the U.S. population. The data will be collected from 131 patients with a primary endpoint of target vessel failure (TVF) at 3 years.  Dr. Manesh Patel, Duke University Hospital, is the national PI for the study with a total of eight sites participating across the U.S.  “We are pleased with the start of the NIRTRAKS study, allowing us to gather further data on this unique and highly innovative technology.  While we have been utilizing the NIRxcell commercially for the last nine months, we are excited to further understand the clinical application this new design has for our patients,” said Dr. Patel, Duke University Hospital.

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