Top News

Celltrion’s Biosimilar to Remicade Likely to be Approved for All Indications

Feb 09, 2016

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

Pfizer Announces Organizational Changes for Pending Allergan Merger

Feb 09, 2016

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

Valeant and Turing Called Out on Drug Pricing

Feb 04, 2016

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.

Industry News

GRAM Completes Fourth FDA Inspection

Feb 11, 2016

GRAM completed a fourth FDA inspection of its parenteral manufacturing facility with no Form 483 observation issues.

MPI Reasearch Invests in Upgrades and Department Expansions

Feb 11, 2016

MPI Research plans to renovate more than 55,000 square feet of facility space as part of the company’s plan to invest in upgrades and department expansion.

Metrohm USA Announces 2016 Young Chemist Award Winner

Feb 10, 2016

Metrohm USA awards the 2016 Young Chemist Award to PhD candidate developing wearable sensors that can non-invasively monitor physiologically relevant chemicals.

Supplier News

GRAM Completes Fourth FDA Inspection

GRAM completed a fourth FDA inspection of its parenteral manufacturing facility with no Form 483 observation issues.

MPI Reasearch Invests in Upgrades and Department Expansions

MPI Research plans to renovate more than 55,000 square feet of facility space as part of the company’s plan to invest in upgrades and department expansion.

Metrohm USA Announces 2016 Young Chemist Award Winner

Metrohm USA awards the 2016 Young Chemist Award to PhD candidate developing wearable sensors that can non-invasively monitor physiologically relevant chemicals.

Bio/Pharma News

FDA Staff Backs Remicade Biosimilar

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Danish Companies and University Collaborate on MRSA Vaccine

Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.

Immunomedics Receives Breakthrough Therapy Designation for Breast Cancer Antibody-Drug Conjugate

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

Standards/Regulations

Little to Like in Obama’s Last Budget

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

Europe Implements Measures to Prevent Falsified Medicines

The agency prepares a plan to implement new packaging safety features.

FDA Staff Backs Remicade Biosimilar

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Drug Development

What Does the Future Hold for the Animal Rule? Examining FDAs Final Guidance

The author reviews FDA's final Animal Rule guidance.

The Impact of SEND on the Pharmaceutical Industry

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.

Excessive Synaptic Pruning Identified as Root of Disease in Schizophrenia

The body’s over-editing of synaptic interactions is recognized as a probable cause of schizophrenia in a landmark study.

Editor's Picks

Litigation and Manufacturing Hurdles Block US Biosimilars Market Success

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

Market Access Outlook for Canada

The author provides an overview of the key aspects of the current Canadian pharmaceutical market.

Mapping a Career Path Forward in Bio/Pharma

Bio/pharma employee dissatisfaction with pay and progress may direct some to new career pathways.

Current Issue

Error Assessment of Drug Concentration in Multicomponent Pharmaceutical Mixtures

A novel method, based on differential calculus, was used to calculate the maximum potential error associated with the drug concentration in pharmaceutical mixtures composed of an infinite number of ingredients measured on an infinite number of balances with different sensitivities. The method was further applied to calculate the ingredients’ least allowable quantities. This approach ensures that the pharmaceutical formulation is prepared within a given maximum permissible error in drug dose.

Exploring New Connections in the Lab of Tomorrow

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Assessing Antibody-Dependent Cell-Mediated Cytotoxicity

The reporter bioassay, used to evaluate ADCC activity of therapeutic antibodies, complements the classical ADCC assay.

USP Supply Chain Safety Videos

Sponsored Videos

 

PharmTech Talk

Vaccines Prove Effective and Cost-Effective

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

Little to Like in Obama’s Last Budget

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

Valeant and Turing Called Out on Drug Pricing

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.

PharmTech Europe News

Bio/Pharma’s 2016 Agenda in Europe

Regulatory, corporate restructuring, and manufacturing issues will challenge bio/pharma to meet the needs and expectations of patients around the world.

Facing Crucial Career Choices

Intellectual challenge, job security, and opportunity for advancement contribute to employee happiness, but the ultimate prize may be a satisfactory salary for bio/pharma employees in Europe.

KTN Launches UK Medicines Manufacturing Landscape Portal

The portal is an interactive tool that pulls together the innovation landscape, company base, and manufacturing sites for the entire medicines sector in the UK.

Peer-Review Research

Error Assessment of Drug Concentration in Multicomponent Pharmaceutical Mixtures

A novel method, based on differential calculus, was used to calculate the maximum potential error associated with the drug concentration in pharmaceutical mixtures composed of an infinite number of ingredients measured on an infinite number of balances with different sensitivities. The method was further applied to calculate the ingredients’ least allowable quantities. This approach ensures that the pharmaceutical formulation is prepared within a given maximum permissible error in drug dose.

Cleaning Limits—Why the 10-ppm Criterion should be Abandoned

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

Achieving Balance in Sterile Product Manufacturing

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.

PharmTech eBooks

 

Drug Development Application Handbook
A compilation of technical articles from the magazine's archives and application notes, technical information, and educational materials from the handbook's sponsors.  View eBook

 

More eBooks
Bioprocessing and Sterile Manufacturing eBook 
Solid Dosage and Excipients
Analytical and Bioanalytical Testing

 

CPhI Update

CPhI and P-MEC India Slated for Dec. 1–3

CPhI and P-MEC India 2015 features exhibits and educational sessions for the Indian pharma industry.

Industry Suppliers Honored for Innovative Advances

The CPhI Pharma Awards celebrate innovations in the pharma industry.

Beyond the Horizon: CPhI Releases the Final Part of its 2015 Market Report

This year, in the final installation of CPhI's annual report on the industry, experts took on topics ranging from innovation to market access and the impact of mega trade pacts.

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