Regulatory
National Cancer Control Efforts Should Address the System, Not Its Individual Parts, Says New Report
Current cancer control efforts in the United States typically are fragmented and uncoordinated, but taking a systems approach to establish a U.S. National Cancer Control Plan would address the challenge more holistically, says a new report from the National Academies of Sciences, Engineering, and Medicine.
Polarean Imaging plc, the clinical stage medical-imaging technology company, with a proprietary drug-device combination product for the visualisation of pulmonary function in the magnetic resonance imaging market, announces its audited final results for the year ended 31 December 2018.
In April, the U.S. Food and Drug Administration (FDA) issued a Refuse to File (RTF) letter to Zogenix for its New Drug Application (NDA) for Fintepla (fenfluramine hydrochloride).
Clinical data showed Dupixent reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.
BioTek’s Synergy™ Neo2 Hybrid Multi-Mode Microplate Reader received expanded certification from Cisbio Bioassays for their proprietary HTRF® technology, a TR-FRET assay platform used in the Life Sciences.
The FDA said the companies marketed the herbal extract with unproven claims. Kratom has not been approved by the FDA for any use.
The Management Board of MagForce AG has resolved and successfully completed, with the approval of the Supervisory Board, on basis of the authorization provided for in the Company’s articles of association, an increase of the registerd share capital of the Company from currently EUR 26,463,802.00 to EUR 27,640,274.00 by issuing 1,176,472 new no-par value bearer shares under exclusion of the shareholders’ statutory subscription rights.
Premark Pharma announced the completion of a licensing deal with Novartis Pharma AG, granting Premark exclusive worldwide rights to develop and commercialise PMP2207, an ophthalmic ointment formulation, as a potential treatment for blepharitis.
In a statement, WHO said it was discontinuing two guidelines that have been in place since 2011 and 2012 “in light of new scientific evidence that has emerged since the time of their publication” regarding the dangers of opioid abuse.
The partial clinical hold was lifted after the company revised the study protocol for the trial. The partial clinical hold remains on other multiple myeloma trials involving venetoclax.
PRESS RELEASES