Top News

Amgen Launches Adalimumab Biosimilar in Europe

Oct 17, 2018

Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

Sandoz Humira Biosimilar Patent Dispute Resolved

Oct 12, 2018

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Janssen, Arrowhead Enter $3.7-Billion Partnership to Treat Hep B

Oct 10, 2018

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

Industry News

Politics Drives Direct-to-Consumer Price Disclosure Rule

Oct 18, 2018

The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.

FDA Publishes Guidance on the Rare Disease Treatments

Oct 16, 2018

The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.

CMOs to Benefit from Double-Digit Approvals for ADCs, CPhI Reports

Oct 16, 2018

According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.

Supplier News

Cambrex Development Center in North Carolina Focuses on Continuous Flow

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

MilliporeSigma Wins CPhI Pharma Award for Excellence in Innovation

The company was awarded for excellence in innovation for Parteck MXP Excipient and modified amino acids.

MilliporeSigma Offers Insect Platform for Viral Vaccines and Gene Therapy Development

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

Bio/Pharma News

Roche, Ionis Partner to Develop Eye Disease Treatment

The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.

Amgen Launches Adalimumab Biosimilar in Europe

Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

Sandoz Humira Biosimilar Patent Dispute Resolved

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Drug Development

Roche, Ionis Partner to Develop Eye Disease Treatment

The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.

FDA Publishes Guidance on the Rare Disease Treatments

The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.

FDA Releases Guidance on Targeted Therapies

The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.

Drug Manufacturing

Cambrex Development Center in North Carolina Focuses on Continuous Flow

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

Robotic Automation Finds Use in the Pharma Lab

Collaborative robots work beside laboratory employees to improve efficiency in pharmaceutical research and quality control labs.

Advanced Paddle Blender for Labs

Ross, Charles & Son’s Laboratory Paddle Blender offers advanced features for automated powder blending and liquid spraying operation with recipe management.

Best Practices

Planning a Successful MES Deployment

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.

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.

Standards/Regulations

Disputes Over SPC Waivers

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.

PDA’s New Technical Report Highlights Data Integrity Management System for Pharma Labs

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

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.

Sponsored Videos

PharmTech Talk

Politics Drives Direct-to-Consumer Price Disclosure Rule

The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.

Congressional Action Alters FDA Policies, Pharma Practices

Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.

Manufacturers Face Challenges in Developing New Antimicrobials

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.

PharmTech Europe News

Amgen Launches Adalimumab Biosimilar in Europe

Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

Lonza Opens Monoplant for Clovis Oncology’s Rubraca

Clovis Oncology and Lonza celebrated the grand opening of a dedicated production train at Lonza’s Visp, Switzerland site for manufacturing Rubraca (rucaparib).

Sandoz Humira Biosimilar Patent Dispute Resolved

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

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

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

Rethinking Cleaning Validation for API Manufacturing

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

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.

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

CMOs to Benefit from Double-Digit Approvals for ADCs, CPhI Reports

According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.

MilliporeSigma Wins CPhI Pharma Award for Excellence in Innovation

The company was awarded for excellence in innovation for Parteck MXP Excipient and modified amino acids.

Protecting Antibody IP: Consider Regional Differences

Biotechnology developers should be aware of subtle differences between the way that European and United States patent authorities approach monoclonal antibodies.

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