Industry News
Industry Stresses Importance of Tackling Vaccine Hesitancy
ABPI has issued a statement of support in response to the United Kingdom’s Prime Minister’s recent order of urgent action to boost the numbers of children receiving vaccinations.
Biosimilar Teriparatide Launches Across Europe
A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.
Data Integrity Violations Found at China Facility
FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.
Olympus to Present Light Microscopy Award
Olympus will launch its first Global Image of the Year Life Science Light Microscopy Award to recognize life science imaging.
Boehringer Ingelheim and MD Anderson Partner on Virtual Center for Cancer Therapies
The partnership aims to establish a virtual R&D center to advance the development of new cancer therapies.
India Facility Receives Warning Letter
FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
European Commission Extends Use of Dupixent to Include Adolescents
The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.
Industry Responds to UK Government Immigration Rules Proposals
Industry has responded favorably to the recent announcement from the UK's PM that immigration rules should be developed to ensure scientific talent is attracted to the country.
FDA Wants Companies to Update Drug Listing Information
The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.
New Jersey Facility Receives FDA Warning Letter
Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.
Considerations in Demonstrating Interchangeability with a Reference Biologic Product
Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.
South Korea’s Biotech Industry Projected to $23.2 Billion by 2022, According to Industry Report
South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.
FDA Publishes Guidance on Rare Pediatric Disease Priority Review
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
FDA Gives Guidance on Developing Treatments for Fabry Disease
The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
FDA Assessing Data Accuracy in Zolgensma Approval
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
Monitoring and Control of Inline Dilution Processes
Successful process intensification with inline dilution requires effective monitoring and control.
Drug Importing Back on Center Stage
FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.
NIIMBL and FDA Partner in Biopharmaceutical Manufacturing
NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.
Bayer Recalls Product Due to Mislabeling
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
Iontas, Teva Enter New Antibody Optimization Agreement
Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
ISA Announces Founding Members of Global Cybersecurity Alliance
Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.
Catalent Biologics Announces Long-Term Strategic Agreement to Develop Zolgensma
Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
FDA Releases Guidance on Electronic Submissions
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
USP to Provide Free Access to Quality Standards for AACP Students
The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.
Connecticut Manufacturer Gets FDA Warning Letter
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
US and Europe Reach Mutual Recognition Agreement Goal on Inspections
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
FDA Releases Draft Guidance on Population Pharmacokinetic Analysis
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
FDA Finalizes REMS Guidance
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
FDA Releases Draft Guidance on Using the Inactive Ingredient Database
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
Guidance on the Harmonization of Compendial Standards Published
FDA released draft guidance on using the USP pending monograph process in the drug application process.
