Top News

FDA Forms Drug Shortages Task Force

Jul 19, 2018

FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.

FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

Jul 19, 2018

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

Jul 19, 2018

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Industry News

FDA Forms Drug Shortages Task Force

Jul 19, 2018

FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.

Augmenting Labeling for OTC Drugs

Jul 19, 2018

New FDA guidance suggests ways to supplement labeling, to ensure that patients select and use nonprescription drugs safely.

FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

Jul 19, 2018

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

Supplier News

Hydroxyapatite Chromotography Media Offers Enhanced Biomolecule Purification

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Otsuka to Acquire Visterra for $430 Million

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.

Bio/Pharma News

FDA Issues Warning Letter to Baxter’s Drug Manufacturing Plant Acquired in Claris Buy

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Drug Development

FDA Invites Comment on New Exposure Limits for Cadmium

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

Application of API-in-Capsule Best Practices to Accelerate Drug Product Development

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Drug Manufacturing

Pharmaceuticals in the Environment

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

FDA Issues Warning Letter to Baxter’s Drug Manufacturing Plant Acquired in Claris Buy

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Best Practices

The Power of In Vitro Assays in Immuno-Oncology

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

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.

Standards/Regulations

Pharmaceuticals in the Environment

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

EU and Japan Strengthen Collaboration on GMP Inspection

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Sponsored Videos

PharmTech Talk

Congress and FDA Take Action to Combat Opioid Crisis

Legislators look to widen access to medications for addiction treatment and overdose emergencies.

FDA Seeks to Revive Quality Metrics Initiative

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Congress Presses FDA to Do More to Combat Drug Shortages

Legislators have requested that FDA do more to prevent drug shortages.

PharmTech Europe News

EMA Sees Gaps in Pharma’s Readiness for Brexit

Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.

EMA Reviews Product from China Facility

The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

EDQM Annual Report Showcases 2017 Highlights

The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.

PharmTech eBook Series

 

Biologics and Sterile Drug Manufacturing 2018 eBook

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.  

View E-Book

 

Peer-Review Research

Oral Delivery of Macromolecular Drugs

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

A Study of the Effects of Histogram Binning on the Accuracy and Precision of Particle Sizing Measurements

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

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.

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.

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CPhI Update

Generics Drive Finished Drug Market Growth in Korea

CPhI Korea to feature zone for finished dosage formulation drug products.

Call for Entries: 2018 CPhI Pharma Awards

Annual awards program recognizes innovation in bio/pharmaceutical drug development and manufacturing.

Cross-Industry Expertise Can Promote Manufacturing Improvements

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

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