Top News

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.

Biopharmaceutical Companies Announce Plans to Develop Zika Vaccine

Feb 02, 2016

Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.

NICE Announces Plans to Back Remicade Biosimilars

Jan 28, 2016

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

Industry News

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.

ISPE Announces Facility of the Year Awards Category Winners for 2016

Feb 02, 2016

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

Biopharmaceutical Companies Announce Plans to Develop Zika Vaccine

Feb 02, 2016

Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.

Supplier News

LabConnect Builds New Biorepository Facility

LabConnect built a biorepository facility in Tennessee.

Onyx Scientific Announces Facility Expansion

Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.

Adents, Siemens Team on Serialization Solution

Siemens and ADENTS develop joint solution for drug serialization challenges.

Bio/Pharma News

ViaCyte Enters Clinical Trials for Type 1 Diabetes Treatment

ViaCyte has entered Phase I/Phase II clinical trials for VC-01, a candidate treatment for the treatment of type 1 diabetes.

Sartorius Group Sales Revenue Jumps 16% in 2015

Sartorius releases financial results for 2015, announcing a 16% increase in group sales revenue.

Merck: Biosimilar Makers Likely to Target New Patients

Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.

Standards/Regulations

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.

FDA’s Quality Office Promotes Modernization

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

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

Expedited Approvals and Orphan Drugs Dominated 2015 Novel New Drugs

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

Bio/Pharma Navigates New Routes to Drug Development

Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?

Nanotechnology  Shows Promise for API Synthesis and Delivery

Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.

USP Supply Chain Safety Videos

Sponsored Videos

 

PharmTech Talk

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.

Negotiating Medicare Part D Prices

Can the feds negotiate Medicare Part D prices?

Improving CMC Review for Breakthrough Therapies

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

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

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.

Identifying Causes Of Delamination

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.

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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