Drug Development

Can an Irish analytics company and its CEO bring pharma closer to 21st-century practice?

A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead's Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned.

PharmaMar has released the results of MI130004, a novel antibody drug conjucate created using a molecule of marine origin.

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

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

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

A new suite for the encapsulation of highly potent drugs will be added.

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.

Colorcon's Opadry EZ provides superior slip and significantly reduces the probability of the tablet sticking to the throat or esophagus.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

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

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

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

The Awards honor innovations in drug delivery and packaging, for better patient safety and compliance.

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

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

Mark Egerton, PhD, chief executive officer of Quotient Sciences, shares insights on a new approach to accelerate drug development, which integrates formulation development, real-time adaptive GMP manufacturing, and clinical research within a single platform.

Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.

A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.

Cambrex invests in development and laboratory facilities and adds staff.

Avista Pharma's strengthens early phase drug development offerings with acquisition of Solid Form Solutions.

Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.

Successful outsourcing relationships in early phase drug-development analytics are driven by partnership.

This article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products.

Particulate modelling has the potential to transform productivity within the pharmaceutical manufacturing industry, speeding up production cycles, reducing manufacturing costs, improving efficiency, and driving inward investment, with the potential to reinstate the UK as a global manufacturing powerhouse.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

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

Corning will feature its 3D bioprinting technology and tools to support 3D cell culture at booth #1029 during the SLAS 2018 conference on Feb. 3-7, 2018 in San Diego, CA.