Industry News
FDA Publishes Guidance on the Effects of Drugs on Blood Pressure
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
Data Integrity Failures Found at China Facility
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
WHO Vaccinates Against Ebola with Merck & Co.'s Experimental Vaccine
World Health Organization’s Ebola ring vaccination uses Merck & Co.’s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.
New “Right-to-Try” Law Challenges FDA Oversight
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
European and Indian Pharmacopoeias Coordinate on Quality Standards
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
FDA Commissioner Puts Branded Companies on Notice
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
China’s Pharma Growth Potential to Drive Attendance at CPhI China
Internationalization and regulatory reform are driving growth and investment China.
Apotex Recalls Product Due to Elevated Levels of Impurities
The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
AuroMedics Pharma Issues Recall Due to Glass Particulates in Vials
The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.
IPEC-Americas Acquires Global Excipient Event
ExcipientFest has been acquired by IPEC and rebranded as Excipient World.
BIA Proposes New Biotech Fund Structure to UK Government
The BioIndustry Association has called on the British government to introduce a new venture capital fund structure that will enable the public to invest in the United Kingdom’s biotech revolution.
Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
CGMP Violations Found at India Facility
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
GlobalData Reports on Barriers Impeding Biosimilar Entry into US Market
Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
Precision Medicines Speed Development and Reduce Healthcare Costs
The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.
FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
GlobalData Reports on Humira Biosimilars Uptake in EU
The data and analytics company reports on the anticipated uptake of Humira (adalimumab) biosimilars in the EU once they are launched in 2018.
Pandemic Fears Stoke Calls for New Vaccines and Global Health Initiatives
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
Data Integrity Failures and Other CGMP Violations Found at China Facility
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
USP Drops Biologics Naming Proposal
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
EMA Updates Flu Vaccine Recommendations
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
EMA and the Netherlands Finalize Seat Agreement
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
CRISPR Shows Promise for Enhancing Gene Therapy
Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.
Possible Cell Therapy Treatment for Alzheimer's Disease
Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.
FDA Seeks to Advance Treatments for Opioid Use Disorder
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
CDER Publishes Drug Safety Report
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
FDA Publishes Q&A on GMPs for APIs
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
Report Gives Update on International API Inspections
A new report gives an overview of the work of the International API Inspection Program.
Premier Pharmacy Labs Recalls Products Due to Sterility Concerns
Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.
Thermo Fisher, University of Pittsburgh Create Center of Excellence
Thermo Fisher Scientific and the University of Pittsburgh have established a new pharmacogenomics center of excellence to support translational research that demonstrates the value of PGx in precision medicine.
