Industry News
EMA Reviews Products from Pharmaceutics International
The agency is following up on a February 2016 inspection of the facility that found GMP violations.
Next Steps Uncertain for the UK Pharma Industry Post Brexit Vote
In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.
FDA Provides Quality Metrics Technical Conformance Guide
The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.
China Approves Drug Marketing Authorization Holder Pilot Plan
China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.
Study: HIV-1 Neutralizing Antibodies in Infants May Impact Vaccine Development
Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.
Pharmacopeias Continue Harmonization Program
The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.
Clinical Supply Facility Warned by FDA
The agency cited the company for sterile manufacturing violations.
CPhI Accepting Applications for 2016 Pharma Awards
The annual CPhI Pharma Awards honor companies and individuals driving the pharmaceutical industry forward through innovation, new approaches, technologies, and strategies.
EMA and FDA Collaborate on Patient Engagement
The two agencies have set up a working group on involving patients in drug development.
MedPAC Recommends Changes to Medicare Drug Coverage
Pressure is mounting to reduce costs and spending on prescription drugs.
Study: Patients Who Have Reactive Responses to Infliximab Should Not Switch to Biosimilar Versions
A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.
FDA Issues Warning Letter to Austin Biotechnology Inc.
The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.
Compounding Pharmacy Warned for Sterile Manufacturing Violations
FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.
FDA Issues Warning Letter to Drug Compounder
The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.
Compounding Pharmacy Gets Warning Letter
FDA cited a Las Vegas compounding pharmacy for sterility violations.
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.
