Industry News
Experts Reveal Ebola Vaccine Status and Potential
Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.
Zika Vaccine Clinical Trial Begins
The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.
First Generic Version of EpiPen Gets Approval
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
FDA Grants Support Research in Modernizing Pharmaceutical Manufacturing
FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.
Repeat Quality Deviations Found at India Facility
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
Opioids and Animals
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
FDA Issues Warning Letter to Canadian API Manufacturer
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
North Americans Pegged as Least Informed on Pharma GDPR, GlobalData Reports
Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.
ARM Releases Second-Quarter Report on Regenerative Medicines Sector
The Alliance for Regenerative Medicine’s (ARM) report highlights major trends and metrics from the 2018 second quarter in the regenerative medicines sector.
Ebola Vaccinations Begin in Response to Congo’s Last Outbreak
Ebola vaccinations by the World Health Organization began in North Kivu, Democratic Republic of the Congo, one week after the country’s latest outbreak.
EMA Scales Back Activities to Prepare for Brexit
The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.
Avalon GloboCare Partners with Weill Cornell Medical College for CAR-T Production Technologies
Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.
Boehringer Ingelheim Licenses Global Rights to Cystic Fibrosis Gene Therapy
Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.
AuroMedics Pharma Issues Voluntary Recall Due to Glass and Silicone Particulates
AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.
Diabetes Drugs Shown to Help Macrophages Control Inflammation
Researchers at the University of Pennsylvania found that diabetes drugs called thiazolidinediones can promote the metabolism of glutamine to help control disease-causing inflammation.
EMA Recommends Sixteen Medicines for Approval
The recommended drugs include two orphan medicines and three biosimilars.
A-Alpha Bio Wins NSF Grant for Cancer Drug Development
The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.
Gottlieb Reshapes FDA to Elevate Centers
Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.
FDA Opens Door to Importing Drugs
Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.
FDA Takes Actions to Secure Safety of Compounded Drugs
The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.
FDA Invites Comment on New Exposure Limits for Cadmium
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
FDA Sends Warning Letter to California OTC Manufacturer
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays
In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.
FDA Forms Drug Shortages Task Force
FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
Drugs Containing Valsartan Recalled
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
Generics Drive Finished Drug Market Growth in Korea
CPhI Korea to feature zone for finished dosage formulation drug products.
FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Call for Entries: 2018 CPhI Pharma Awards
Annual awards program recognizes innovation in bio/pharmaceutical drug development and manufacturing.
New Program Aims to Improve Patient Medication Adherence
Progressive Care’s DischargeRX program works with hospitals and patients to help improve patient medication adherence and minimize medication-related hospital readmissions.
EMA Sees Gaps in Pharma’s Readiness for Brexit
Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.
