Top News

FDA Approves Digital Pill

Nov 14, 2017

The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.

FDA to Recognize Inspections from EU Drug Authorities

Oct 31, 2017

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

UBM Announces BioLive Event

Oct 26, 2017

The new BioLive event, which will be a global hub for biopharmaceutical manufacturing, will launch alongside CPhI Worldwide 2018 in Madrid.

PharmTech eBook Series

 

Biologics and Sterile Manufacturing 2017 eBook
New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.
 
View E-Book

 

Industry News

Novartis, ASCP, and ACS Partner for African Cancer Initiative

Nov 16, 2017

The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.

CPhI Global Pharma Index Shows India’s Reputation Improving

Nov 16, 2017

India was ranked by international pharmaceutical companies as the third most competitive nation globally.

Record Attendance at CPhI Worldwide Reflects Pharma’s Strength

Nov 16, 2017

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

Supplier News

Integrated Analytical Software Solutions for Clinical and Regulatory Processes

MasterControl has added three new cloud-based analytical solutions to its MasterControl Version 11.7 software for clinical managers and regulatory/submissions professionals.

Pall Debuts New Inline Diafiltration Modules for Continuous Bioprocessing

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

Spectrum Chemical and BASF Enter Catalyst Agreement

Spectrum Chemical will provide BASF precious-metal-containing powder catalysts in research quantities for early product development.

Bio/Pharma News

Bayer in $1.5-Billion Deal with Loxo Oncology for Anti-Cancer Drugs

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

Novartis, ASCP, and ACS Partner for African Cancer Initiative

The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.

J&J and Zymeworks in Bispecific Antibody Pact Worth Nearly $1.5 Billion

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

Standards/Regulations

FDA’s Policy on Regenerative Medicine Therapies

Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.

Gottlieb Sends Message About REMS and Market Competition

FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.

FDA Works to Get Pharma Up and Running in Puerto Rico

While most pharma companies are in partial production using generators, few are operating at 100% capacity.

Drug Development

ADC Targets Fail Because of Aggregation Problems

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

Growing Demand for Taste-Masking Technologies

Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.

Awards Recognize Industry Contributions

Industry experts were honored for business, scientific, and social contributions.

Best Practices

Maintaining Thermal Fluid Systems

Preventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.

Treating Halogenated Hydrocarbon Emissions from Pharmaceutical Production

Regenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.

Understanding the Potential of Artificial Intelligence Across the Pharmaceutical Lifecycle

Artificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.

40 Years of PharmTech

PharmTech Reflects on Four Decades of Bio/Pharma Innovation
Pharmaceutical Technology marks 40 years of publishing for the bio/pharma industry reviewing advances and changes in technology, science, regulatory oversight, and patient care.
 
View the special coverage

PharmTech Videos

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PharmTech Talk

FDA Works to Get Pharma Up and Running in Puerto Rico

While most pharma companies are in partial production using generators, few are operating at 100% capacity.

Biosimilars Raise Analytical and Policy Challenges

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

Storm Impact on Drug Supply

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.

PharmTech Europe News

EMA Recommends Ten Drugs for Approval

Two of the medicines recommended for approval are orphan drugs.

Testing Methods for Microbiological Control Addressed at Europe Symposium

EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.

Europe Takes Action to Foster Advanced Therapy Development

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

Peer-Review Research

How to Monitor HPMC Concentration Through Conductivity Measurement

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

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

CPhI Global Pharma Index Shows India’s Reputation Improving

India was ranked by international pharmaceutical companies as the third most competitive nation globally.

Record Attendance at CPhI Worldwide Reflects Pharma’s Strength

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

Awards Recognize Industry Contributions

Industry experts were honored for business, scientific, and social contributions.

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