Top News

Roche to Acquire Foundation Medicine for $2.4 Billion

Jun 20, 2018

The acquisition is expected to strengthen Roche’s personalized healthcare strategy.

Sanofi Completes $4.8-Billion Ablynx Acquisition

Jun 20, 2018

The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.

Bayer Completes Monsanto Acquisition for $63 Billion

Jun 13, 2018

Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.

Industry News

US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting

Jun 22, 2018

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

FDA Publishes User Fee Guidance

Jun 22, 2018

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

ISPE Forms Foundation to Support the Pharma Industry

Jun 22, 2018

The International Society for Pharmaceutical Engineering (ISPE) launched its philanthropic division, the ISPE Foundation, to support industry demands.

Supplier News

CellGenix Completes First Step of Facility Expansion for Cell-Culture Reagents

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

Canada OKs Samsung BioLogics’ mAb Drug Substance Plant

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

CFDA Approves Drug Developed with CDMO Support

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.

Bio/Pharma News

Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

FDA Approves Generic Suboxone Sublingual Film for Opioid Dependence Treatment

The approval is intended to increase patient access to treatment for opioid addiction.

Roche to Acquire Foundation Medicine for $2.4 Billion

The acquisition is expected to strengthen Roche’s personalized healthcare strategy.

Drug Development

Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

CFDA Approves Drug Developed with CDMO Support

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.

Juniper Pharma Services Expands Laboratory Facilities

The extension provides four additional process development laboratories at its Nottingham site to improve output and efficiency in drug development and clinical trial manufacturing operations.

Drug Manufacturing

CellGenix Completes First Step of Facility Expansion for Cell-Culture Reagents

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

Canada OKs Samsung BioLogics’ mAb Drug Substance Plant

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

A New PAT for wet granulation

Optimal PAT for wet granulation monitoring has significant potential to improve the efficiency of tableting operations. This whitepaper showcases the value of dynamic powder testing and a complementary new in-line PAT for real-time granulation monitoring. Together these technologies deliver efficient endpoint detection and continuous process measurement.

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

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.

CGMP Violations Found at India Facility

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

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.

Sponsored Videos

PharmTech Talk

Congress Presses FDA to Do More to Combat Drug Shortages

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

Global Standard for Managing Post-Approval Changes Moves Forward

Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.

FDA Launches Overhaul of New Drug Review Program

The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.

PharmTech Europe News

US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

New Innovation Center in Scotland Aims to Revolutionize Medicines Manufacturing

The new industry-led Medicines Manufacturing Innovation Center (MMIC) will offer a unique service to develop and implement novel manufacturing techniques.

New Research Hub Tackles Access to Vaccines

The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.

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

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.

Evaluating the Impact of Sterilization on Gel Formulations

Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.

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

Domestic Pharma Industry Drives Machinery Demands at P-MEC China

Intelligent manufacturing and environmental policies are key trends at P-MEC 2018.

CPhI and P-MEC India 2018 Move to Indian Capital

The India Expo Mart in Delhi will host CPhI and P-MEC India with expected attendance of 50,000.

China’s Pharma Growth Potential to Drive Attendance at CPhI China

Internationalization and regulatory reform are driving growth and investment China.

lorem ipsum