Top News

Sanofi to Divest European Generics Business in Deal Worth $2.4 Billion

Apr 19, 2018

Global investment firm Advent to acquire and invest in Sanofi’s European generics business, Zentiva, to boost its position in European market.

Merck KGaA to Sell Consumer Health Biz to Procter & Gamble for $4.2 Billion

Apr 19, 2018

The transaction is part of Merck KGaA’s strategy to actively shape its product portfolio and focus on innovation-driven business.

Sanofi to Invest Roughly $430 Million in Canadian Vaccine Facility

Apr 12, 2018

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

Industry News

Possible Cell Therapy Treatment for Alzheimer's Disease

Apr 24, 2018

Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.

CRISPR Shows Promise for Enhancing Gene Therapy

Apr 24, 2018

Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.

EMA and the Netherlands Finalize Seat Agreement

Apr 24, 2018

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

Supplier News

Catalent to Invest in New Drug Development Center of Excellence

The company will add a new $5-million drug development center of excellence at its facility and headquarters in Somerset, NJ.

AMRI Wins NIH Contract Renewal for Neurotherapeutics

The contract renewal allows AMRI to continue to provide medicinal chemistry and ADME services for advancing drug discovery programs in neurotherapeutics.

Sanofi Buys Berkeley Lights’ Cell Line Platform

The new platform is expected to speed up cell line development.

Bio/Pharma News

LNC Therapeutics Appoints New CEO and Advances Microbiome-Based Drug R&D

LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.

FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

J&J, BMS Team Up on Cardiovascular Therapies

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

Drug Development

Catalent to Invest in New Drug Development Center of Excellence

The company will add a new $5-million drug development center of excellence at its facility and headquarters in Somerset, NJ.

AMRI Wins NIH Contract Renewal for Neurotherapeutics

The contract renewal allows AMRI to continue to provide medicinal chemistry and ADME services for advancing drug discovery programs in neurotherapeutics.

LNC Therapeutics Appoints New CEO and Advances Microbiome-Based Drug R&D

LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.

Drug Manufacturing

Sanofi Buys Berkeley Lights’ Cell Line Platform

The new platform is expected to speed up cell line development.

MilliporeSigma Launches New Single-Use Technologies at INTERPHEX 2018 and Wins Best Tech Award

The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.

New Equipment and Software Meet Needs for Fill/Finish, Serialization, and Data Traceability

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization.

Best Practices

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

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

Managing Pharmaceutical Recalls with Automation

How warehouse execution systems can help in case of a drug recall.

Complying with Good Engineering Practices for Mechanical Integrity of Process Equipment

Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.

Standards/Regulations

EMA and the Netherlands Finalize Seat Agreement

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

CDER Publishes Drug Safety Report

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

FDA Seeks to Advance Treatments for Opioid Use Disorder

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.

Sponsored Videos

PharmTech Talk

Budget Bill Boosts Funding for Biomedical Research and FDA Programs

Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.

FDA's Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

FDA Gets Boost from Trump Budget

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

PharmTech Europe News

EMA and the Netherlands Finalize Seat Agreement

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

European Pharmacopoeia Commission Sets Quality Requirements for Live Biotherapeutic Products

The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.

Glass Technology Services to Hold Pharmaceutical Glassware Workshop in June 2018

This workshop, to be held in Sheffield, United Kingdom, on June 7, 2018, will provide an introduction to the use of glass as primary pharmaceutical packaging.

PharmTech eBook Series

 

Vaccines Development and Manufacturing 2017 eBook

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.  

View E-Book

 

Peer-Review Research

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.

A New Method for Risk Assessment of Pharmaceutical Excipients

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.

Establishing Correlation Between Aerosol and Surface Microbial Populations

The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

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

Detecting Potential Formulation Roadblocks in Early Drug Development

Pharmaceutical Technology will host a panel discussion focused on early drug development on April 24, 2018 at CPhI North America.

Halo Pharma Simplifies Topical Drug Product Development and Manufacturing

The contract development and manufacturing organization will discuss its capabilities in topical drug products at CPhI North America, taking place April 24–26, 2018 in Philadelphia, PA.

Serialization Expert Rick Seibert Presents at CPhI North America 2018

Serialization technology and implementation expert Rick Seibert will present an insight briefing on recent serialization challenges at CPhI North America in Philadelphia, PA.

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