Top News

Novartis Acquires AveXis for $8.7 Billion

May 16, 2018

The acquisition is expected to strengthen Novartis’ gene therapy pipeline.

Lilly to Acquire ARMO BioSciences for $1.6 Billion

May 15, 2018

Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.

Takeda to Acquire Shire for $62 Billion

May 09, 2018

Takeda expands its global and therapy base with announced acquisition of Shire.

Industry News

European and Indian Pharmacopoeias Coordinate on Quality Standards

May 17, 2018

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

FDA Commissioner Puts Branded Companies on Notice

May 17, 2018

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

IPEC-Americas Acquires Global Excipient Event

May 16, 2018

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.

Supplier News

Parker Bioscience Expands UK Facilities

Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.

Catalent to Develop Biosimilars for Valerius Biopharma

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

GE Increases Cell Culture Media Production Capacity

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

Bio/Pharma News

Novartis Acquires AveXis for $8.7 Billion

The acquisition is expected to strengthen Novartis’ gene therapy pipeline.

FDA Approves Pfizer’s Epoetin Alfa Biosimilar

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

Lilly to Acquire ARMO BioSciences for $1.6 Billion

Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.

Drug Development

FDA Commissioner Puts Branded Companies on Notice

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

IPEC-Americas Acquires Global Excipient Event

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.

Catalent to Develop Biosimilars for Valerius Biopharma

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Drug Manufacturing

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.

GE Increases Cell Culture Media Production Capacity

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

Addressing Continuous Manufacturing’s Growing Pains

As more continuous processes move toward commercialization, users and equipment vendors are working to speed changeovers and address other needs.

Best Practices

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.

Managing Pharmaceutical Recalls with Automation

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

Standards/Regulations

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.

Precision Medicines Speed Development and Reduce Healthcare Costs

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

Sponsored Videos

PharmTech Talk

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.

Precision Medicines Speed Development and Reduce Healthcare Costs

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

FDA Moves to Overhaul New Drug Review Process

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

PharmTech Europe News

European and Indian Pharmacopoeias Coordinate on Quality Standards

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

BIA Proposes New Biotech Fund Structure to UK Government

The BioIndustry Association has called on the British government to introduce a new venture capital fund structure that will enable the public to invest in the United Kingdom’s biotech revolution.

EMA Updates Flu Vaccine Recommendations

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

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

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.

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.

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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