Top News

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

Jul 12, 2018

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Pfizer Announces Restructuring

Jul 11, 2018

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

Takeda Receives US Clearance for $62-Billion Acquisition of Shire

Jul 11, 2018

The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.

Industry News

Drugs Containing Valsartan Recalled

Jul 16, 2018

Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

Jul 12, 2018

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Generics Drive Finished Drug Market Growth in Korea

Jul 12, 2018

CPhI Korea to feature zone for finished dosage formulation drug products.

Supplier News

Otsuka to Acquire Visterra for $430 Million

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.

Catalent Implements Optofluidic Platform for Cell-Line Development

Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.

Teva to Relocate US Headquarters to New Jersey

Teva Pharmaceuticals USA will move its US headquarters to Parsippany-Troy Hills, NJ.

Bio/Pharma News

Moderna Opens Manufacturing Site for mRNA Therapeutics

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

Otsuka to Acquire Visterra for $430 Million

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.

Pfizer Announces Restructuring

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

Drug Development

Application of API-in-Capsule Best Practices to Accelerate Drug Product Development

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

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.

Generics Drive Finished Drug Market Growth in Korea

CPhI Korea to feature zone for finished dosage formulation drug products.

Drug Manufacturing

Moderna Opens Manufacturing Site for mRNA Therapeutics

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

Catalent Implements Optofluidic Platform for Cell-Line Development

Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.

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.

Best Practices

The Power of In Vitro Assays in Immuno-Oncology

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

Modular Facility Design Maximizes Space Flexibly

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.

INTERPHEX to Hold Keynote Series on Aseptic, Sterile, and Biologics Drug Manufacturing

Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.

Standards/Regulations

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.

Collaboration on GMP Inspections Has Been Successful but Challenges Exist

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.

Meeting the EU Serialization Deadline

Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.

Sponsored Videos

PharmTech Talk

Congress and FDA Take Action to Combat Opioid Crisis

Legislators look to widen access to medications for addiction treatment and overdose emergencies.

FDA Seeks to Revive Quality Metrics Initiative

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Congress Presses FDA to Do More to Combat Drug Shortages

Legislators have requested that FDA do more to prevent drug shortages.

PharmTech Europe News

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.

EMA Reviews Product from China Facility

The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

EDQM Annual Report Showcases 2017 Highlights

The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.

PharmTech eBook Series

 

Biologics and Sterile Drug Manufacturing 2018 eBook

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.  

View E-Book

 

Peer-Review Research

Oral Delivery of Macromolecular Drugs

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

A Study of the Effects of Histogram Binning on the Accuracy and Precision of Particle Sizing Measurements

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Sponsored eBooks

 

Strategies for Accelerating Drug and Process Development
This eBook offers several approaches to meet these needs, including how to gauge the level and type of polymorph screening needed to minimize risk and how to implement Quality by Design during process development.

More eBooks

 

CPhI Update

Generics Drive Finished Drug Market Growth in Korea

CPhI Korea to feature zone for finished dosage formulation drug products.

Call for Entries: 2018 CPhI Pharma Awards

Annual awards program recognizes innovation in bio/pharmaceutical drug development and manufacturing.

Cross-Industry Expertise Can Promote Manufacturing Improvements

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

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