Top News

Novartis to Acquire Endocyte in Deal Worth $2.1 Billion

Oct 18, 2018

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

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).

Industry News

FDA Promotes Complex Generics and Combination Products

Oct 19, 2018

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

EMA Recommends Six Medicines for Approval

Oct 19, 2018

The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indications.

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.

Supplier News

AbbVie, Morphic Therapeutic Join Forces for Fibrotic Disease Treatments

The companies will work together to advance a number of Morphic's oral integrin therapeutics for fibrosis-related indications in a deal with $100 million.

Recipharm Releases First Serialized Products to Europe

The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.

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.

Bio/Pharma News

AbbVie, Morphic Therapeutic Join Forces for Fibrotic Disease Treatments

The companies will work together to advance a number of Morphic's oral integrin therapeutics for fibrosis-related indications in a deal with $100 million.

Novartis to Acquire Endocyte in Deal Worth $2.1 Billion

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

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.

Drug Development

FDA Promotes Complex Generics and Combination Products

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

Novartis to Acquire Endocyte in Deal Worth $2.1 Billion

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

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.

Drug Manufacturing

Strategies for Managing the Impact of Brexit for US Biotech Companies

This article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.

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.

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

FDA Promotes Complex Generics and Combination Products

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

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.

PharmTech Europe News

EMA Recommends Six Medicines for Approval

The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indications.

Recipharm Releases First Serialized Products to Europe

The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.

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.

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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