Top News

Charles River Laboratories Acquires MPI Research

Feb 13, 2018

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

Trump Blasts Drug Prices, Sidesteps Health Reform

Feb 01, 2018

The President described US drug costs as unfair and stated that prices will come down.

Sanofi to Acquire Ablynx in $4.8-Billion Deal

Jan 30, 2018

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.

Industry News

Hospira Recalls Labetalol Hydrochloride Due to Cracked Vials

Feb 23, 2018

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

FDA Publishes Q&A Document on ICH Q11

Feb 23, 2018

The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.

Smithfield Bioscience, University of Virginia Partner for Regenerative Medicine Research

Feb 22, 2018

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

Supplier News

Samsung BioLogics Gets $148-Million Contract for New Manufacturing Plant

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

Smithfield Bioscience, University of Virginia Partner for Regenerative Medicine Research

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

AMRI to Expand Container Closure Integrity Testing Services into EU

The company aims to add the additional analytical services in the European Union throughout 2018.

Bio/Pharma News

AbbVie, Voyager Partner for New Alzheimer's Therapies

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.

Vertex Receives FDA Approval for Continuously Manufactured Drug Product

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

Ferring to Invest in New Biotech Center

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Drug Development

BIO Publishes Report on Pain Meds

A new report states that more research and clinical development must be done in the treatment of pain and addiction.

V ClinBio Acquires Cellix to Gain Patented Drug Delivery Technology

The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.

J&J and Theravance in $1-Billion Deal for Inflammatory Bowel Disease

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.

Drug Manufacturing

Samsung BioLogics Gets $148-Million Contract for New Manufacturing Plant

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

Avid Bioservices to Commercially Manufacture Enzyme Replacement Therapy

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

Jefferson and NIBRT Partner on New Biomanufacturing Training Center

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.

Best Practices

Considerations for Relocating a Pharmaceutical Facility

An architect's evaluation early in a pharmaceutical facility relocation and design process can help identify potential problems.

Best Weighing Practices in the Pharmaceutical Industry

Understanding what affects a measurement and implementing appropriate procedures will aid weighing accuracy.

Maintaining Thermal Fluid Systems

Preventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.

Standards/Regulations

FDA Publishes Q&A Document on ICH Q11

The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.

FDA Issues Guidance on Bioresearch Monitoring Content for NDAs and BLAs

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

FDA Approves New Treatment for Prostate Cancer

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

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

 

Sponsored Videos

PharmTech Talk

FDA Gets Boost from Trump Budget

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

Gottlieb Encourages Biosimilars and Safer Opioid Packaging

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

Pharma Looks to Change the Healthcare Cost Conversation

New programs and initiatives by industry examine rising healthcare costs.

PharmTech Europe News

GSK's Influenza Vaccine Gets EU Nod for Expanded Indication

Fluarix Tetra has been approved for use in children aged six months and above.

ADC Bio to Develop New Bioconjugation Process

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

Cobra Biologics, Symbiosis Awarded Innovate UK Grant

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

Peer-Review Research

Establishing Correlation Between Aerosol and Surface Microbial Populations

The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

Removing Subjectivity from the Assessment of Critical Process Parameters and Their Impact

A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements‚ÄĒPart II: By-Time-Point and Multivariate Control Chart

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

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

Viewpoint: 2018 a Critical Year for Maturation of European Bio Supply Chain

As Europe's growing biomanufacturing and bioprocessing industries develop, now a crucial time for the small-molecule and biopharma industries to integrate in order to facilitate growth.

CPhI Names "Medical Futurist" as First CPhI North America 2018 Keynote Speaker

CPhI North America 2018, taking place Apr. 24-26 in Philadelphia, PA, has announced Dr. Bertalan Mesko as its first keynote speaker.

CPhI Report Predicts A Transformative Year for Japan in 2018

Growth is expected for the generic drugs and biosimilars sectors, driven by cost pressures on healthcare systems.

lorem ipsum