Industry News
FDA Releases Guidance on Osteoporosis Treatment
The agency published guidance on the nonclinical evaluation of osteoporosis treatments.
FDA Approves Cholera Vaccine
FDA approved Vaxchora intended for travelers who are at risk for the disease.
CPhI Istanbul Discuss MENA Trends for 2016
At the conference, industry experts discussed regional trends and challenges for the Middle East and North Africa for 2016.
Results Released from Ixekizumab Phase III Trials
In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.
PSUR Repository Becomes Mandatory in EU
Mandatory use of the periodic safety update report repository becomes mandatory on June 13.
US and EU Regulators Seek to Reduce Pharma Inspections
Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.
FDA Finalizes Compounding Guidance
The agency publishes three final guidance documents on drug compounding.
FDA Issues Warning Letter to Taiwan Facility
The agency cited KO DA Pharmaceutical Co. with cGMP violations.
FDA Reiterates Decision to Require Suffixes in Biosimilar Naming
The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.
EMA Encourages Advanced Therapies
The agency published a report on fostering the development of advanced therapy medicinal products.
FDA Approves Dalizumab
FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.
FDA Cites Another Company for Data Integrity Violations
FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.
AAPS Grants Five Graduate Student Fellowships
The AAPS Foundation presented five graduate students each with a $10,000 fellowship for their research in the pharmaceutical sciences.
USGS Study Indicates Pharmaceuticals are Widespread in Small Streams in the Southeast US
The United States Geological Survey study detected one or more pharmaceuticals in 59 streams throughout the Southeast United States.
FDA Issues Warning Letter to API Manufacturer
The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.
CGT and CTM CRC Collaborate on Scaffold Technology Project
Cell and Gene Therapy Catapult and the Australian CRC for Cell Therapy Manufacturing will collaborate on a project to test technology for T-cell stimulation and expansion.
Well Care Compounding Pharmacy Issues Recall
The company recalls products due to sterility concerns.
EMA Publishes Annual Report
The agency detailed its 2015 achievements in an annual report.
NIH to Launch Large-Scale HIV Vaccine Trial
The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen
FDA Issues Biomarker Qualification Guidance
The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.
FDA Warns of Serious Side Effects Associated with Fluoroquinolone Drugs
FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.
Any Chance for “Cures” Legislation This Year?
Biomedical innovation legislation may stall in 2016.
ISSCR Releases Updated Guidelines on Stem Cell Research
The updated guidelines detail best practices for conducting research with human embryonic stem cells.
What’s Behind NIH’s Quality Problems?
Drug manufacturing lapses undermine NIH research programs.
EMA Discusses Drug Prices
The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.
EMA’s SME Initiative Shows Positive Results
The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.
EU Pharma Industry Representatives Pen Letter on Brexit
Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.
Investigational Malaria Vaccine May Protect Healthy Adults for More Than One Year
Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.
FDA Issues Warning Letter to Repackaging Facility
The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.
Report Shows Increase in Capacity in Cell and Gene Therapy Manufacturing in the UK
The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.
