Medical Tibits, Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study Of Romosozumab In Postmenopausal Women With Osteoporosis

breaking medical news, FDA Approvals, clinical research for cancer

THOUSAND OAKS, Calif. and BRUSSELS, Feb. 22, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). These data showed FRAME met the co-primary endpoints by reducing the incidence of new vertebral fracture through months 12 and 24 in postmenopausal women with osteoporosis treated with romosozumab. The study also met the secondary endpoint of reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women with osteoporosis through 12 months. However, the secondary endpoint of reducing the incidence of non-vertebral fractures through months 12 and 24 was not met. read more

All the Latest News in Cancer Research

From genetics and cell biology to the pioneering research on new cancer therapies: “Frontiers in cancer research and therapy” is a two day conference on cancer hosted later this month by Karolinska Institutet.

Reporters are welcome to attend the symposium and interview the speakers.
Conference: Frontiers in cancer research and therapy
When: 25 – 26 February 2016
Where: Nobel Forum, Nobels väg, Karolinska Institutet Campus Solna

30 years or so ago, he demonstrated a link between mutations in the HER2 gene and breast cancer. Dennis Slamon from the University of California Los Angeles, USA, then led the development of trastuzumab (Herceptin), an antibody therapy for HER2 that is now extremely important in the treatment of breast cancer. These days he is involved in the development of CDK inhibitors, drugs that inhibit the cell cycle in tumours. He will be speaking on molecular differences in breast cancer and the significance this has for treatment. read more

ReCor Medical Announces IDE Approval for RADIANCE-HTN Hypertension Clinical Trial

PRNewswire/ — ReCor Medical announced today that it has received FDA IDE approval for the RADIANCE-HTN clinical trial to evaluate the effect of the ReCor Paradise® Renal Denervation System on blood pressure in patients with hypertension. RADIANCE-HTN is a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: those with essential hypertension on two or fewer antihypertensive medications, and those with treatment-resistant hypertension on a minimum of 3 antihypertensive medications. read more

FibCLOT®, Human Fibrinogen from LFB, Obtains First Marketing Authorisations in Europe

For patients with a rare bleeding disorder: The human fibrinogen from LFB has been licensed since 22nd January in Germany and Hungary, and 27th January in Denmark, to treat patients with a congenital fibrinogen deficiency who are at risk of complications during surgery because of their rare genetic bleeding disorder. This congenital fibrinogen deficiency affects several hundred patients in Europe, and specific management is needed to prevent and treat perioperative bleeding in these patients. read more

BioCardia®, Inc. Announces Two Presentations Related to CardiAMP Cell Therapy at Cardiovascular Research Technologies in Washington, DC

CARDIAMP CELL THERAPY FOR POST ACUTE MYOCARDIAL INFARCTION – THE ALSTER HELIX PHASE I STUDY

Dr. Martin W. Bergmann from Hamburg, Germany presented the clinical results of the ALSTER HELIX PHASE I STUDY. ALSTER HELIX was the first study to assess safety and efficacy of the delivery of a bone marrow cell therapy directly into the heart muscle from within the chamber of the heart, between 21 and 45 days after onset of acute myocardial infarction read more

Camurus AB: Braeburn and Camurus Announce Initiation of a Phase 2 Study in Opioid Dependent Patients with Moderate to Severe Chronic Pain

Braeburn Pharmaceuticals and Camurus announced today that the first patients have been dosed with CAM2038, weekly and monthly subcutaneous buprenorphine injections, in a pharmacokinetic study of opioid dependent patients with chronic pain. The primary objective of this Phase 2 study is to assess the steady state pharmacokinetics of buprenorphine after repeated doses in opioid dependent patients with chronic pain, including effects of injection into different subcutaneous sites. This study will also explore the effect of CAM2038 on chronic pain, along with evaluation of safety and tolerability.

BioAgilytix Announces Acquisition of European-Based IPM Biotech to Expand and Enhance the Global Reach and Breadth of Their Best-of-Breed Bioanalytical Capabilities

DURHAM, N.C.–(BUSINESS WIRE)–BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has announced the acquisition of IPM Biotech, a German-based bioanalytical contract research laboratory renowned for its expertise in large molecule bioanalysis, particularly in the area of immunogenicity. The transaction not only expands BioAgilytix’s global footprint, with IPM’s newly planned GLP laboratory facility as its European headquarters, but also brings on board IPM’s rich immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) expertise to complement BioAgilytix’s world-class capabilities in biomarkers, cell-based assays, and immunogenicity & pharmacokinetics. Each company has experienced successful organic growth through a strong commitment to scientific quality, and together will offer this same rigor of science and service to customers across continents, with expanded capabilities to support all phases of large molecule global studies. read more

OBI Pharma Reports Topline Results From OBI-822/821 Randomized Controlled Phase 2/3 Clinical Trial In Patients With Metastatic Breast Cancer

PRNewswire/ — OBI Pharma, Inc., a Taiwan biotech company (TPex: 4174), today announced the topline results of the Phase 2/3 study of OBI-822/821 (formerly OPT822/OPT821), which evaluated the clinical benefit and immunogenicity of the investigational immunotherapy in patients with metastatic breast cancer. Based on the data available to date, the study (Protocol Number OPT-822-001) did not meet the primary efficacy end point of progression-free survival. However, patients who demonstrated an immune response (IgG or IgM) showed highly significant improvement in progression-free survival and the secondary endpoint of overall survival is trending towards statistical significance.  OBI-822/821 was generally well tolerated with no major safety concerns. Full results will be presented at an upcoming international scientific conference read more

Pfizer Receives Expanded FDA Approval For IBRANCE (palbociclib) In HR+, HER2- Metastatic Breast Cancer

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of IBRANCE® (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now IBRANCE also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.1 Pfizer’s supplemental New Drug Application (sNDA) for IBRANCE was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs based on results from the Phase 3 PALOMA-3 trial in pre-, peri- and post-menopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy in the adjuvant or metastatic setting.1 read more

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