Top News

FDA Issues Quality Metrics Draft Guidance Document for Comment

Jul 28, 2015

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

FDA Approves Praluent, the First PCSK9 Inhibitor in the US

Jul 27, 2015

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

Teva Withdraws Mylan Offer, Agrees to Acquire Allergan’s Generics Business

Jul 27, 2015

The deal to acquire Allergan’s generic-drug business is valued at $40.5 billion.

Industry News

EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs

Jul 27, 2015

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

Drug Compounder Recalls Sterile Products

Jul 27, 2015

Moses Lake Professional Pharmacy issues recall due to lack of sterility assurance.

FDA Issues Guidance on Analytics and Method Validation

Jul 24, 2015

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

Supplier News

TxCell Assigns Manufacture of Lead Product Ovasave to MaSTherCell

The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.

Capsugel Expands Capabilities at its Edinburgh Facility

Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity.

SafeBridge Updates Potent API and Drug Manufacturer Status

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

Bio/Pharma News

arGEN-X Partners with University of Bern to Develop Combination Cancer Therapies

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

FDA Approves Praluent, the First PCSK9 Inhibitor in the US

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

Teva Withdraws Mylan Offer, Agrees to Acquire Allergan’s Generics Business

The deal to acquire Allergan’s generic-drug business is valued at $40.5 billion.

Standards/Regulations

FDA Quality Metrics Offer Regulatory “Carrots” for Manufacturers

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.

FDA Issues Quality Metrics Draft Guidance Document for Comment

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

CPhI 2015 Update

2015 CPhI Pharma Awards

The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development.

CPhI Adds Expert Panel Members

Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.

USP Stresses Pharmacopeial Standards at CPhI China

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

Drug Manufacturing

TxCell Assigns Manufacture of Lead Product Ovasave to MaSTherCell

The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.

Capsugel Expands Capabilities at its Edinburgh Facility

Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity.

Eisai Transfers North Carolina Facility to Biogen

Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.

Drug Development

arGEN-X Partners with University of Bern to Develop Combination Cancer Therapies

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

GSK’s Malaria Vaccine Gets Positive Opinion from EMA

EMA gives GSK’s malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.

Current Issue

Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug Delivery

Delivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.

Multimode Microplate Reader Expands Versatility

Thermo Scientific’s multimode microplate reader, the Varioskan LUX, is designed with intuitive software to allow for automatic and versatile functionality when performing microplate assays.

LED Light Source Maximizes Convenience

Anton Paar’s MCP polarimeters are now designed with a new LED light source and optional integrated air pump to clean and dry sample cells.

USP Supply Chain Safety Videos

PharmTech Talk

FDA Quality Metrics Offer Regulatory “Carrots” for Manufacturers

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.

Are IPRs Impacting the Pharmaceutical Industry?

As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.

Disposable Systems Valuable in Responding to Emergencies and Epidemics

Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.

PharmTech Europe

25th Anniversary Issue

Experts review bio/pharma industry growth and future prospects as Pharmaceutical Technology Europe marks its 25th anniversary.

 

 

 

PharmTech Europe Archives

 

Peer-Review Research

Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug Delivery

Delivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.

Using a Dual-Drug Resinate Complex for Taste Masking

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

Evaluating Disinfectant Efficacy of a Silver-Based Disinfectant

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

Editor's Picks

What’s In a Name? For Biosimilars, A Lot

Will biosimilars share a compendial identity like generic drugs do?

Designing Clean Zones

Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.

Aging Facilities: Aseptic Manufacturing Faces the Future

Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.

PharmTech eBooks

 

Bioprocessing and Sterile Manufacturing eBook
The editors examine novel sterile and bioprocessing technologies including single-use systems, aging systems, cleanrooms, and lyophilization.  View eBook

 

More eBooks
Solid Dosage and Excipients
Analytical and Bioanalytical Testing