News

Spectrum Pharmacy Products opens pharmacy institute for training in pharmaceutical compounding.

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.

Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

The company entered two separate collaborations with Advaxis and Array Biopharma involving its PD-1 immune checkpoint inhibitor Opdivo.

The company entered a collaboration with Protagonist to develop, manufacture, and commercialize PTG-200.

The company was cited for cGMP violations at its Irvine, California facility.

The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.

This marks the first FDA approval of a treatment based on a specific biomarker.

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

The Competition and Market’s Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.

In Lazard's Global Healthcare Leaders 2017 survey, most respondents said pricing and reimbursement were the most significant challenge, but nearly half of the pharma executives who responded see value-based pricing as having the greatest impact on the business, potentially even more than scientific breakthroughs.

CBER is moving forward with the development and approval of regenerative medicine advanced therapies.

FDA cited the facility for violations of quality management and data integrity CGMPs.

FDA’s new commissioner asks staff for suggestions for fighting the opioid crisis.

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.

The agency’s Committee for Medicinal Products for Human Use recommended AstraZeneca’s brodalumab for the treatment of moderate-to-severe plaque psoriasis.

The company expanded its UK storage facility to meet increasing demand from its growing customer base.

Ablynx will receive EUR15 million in milestone payment following Merck’s decision to advance ALX-1141 into clinical development. The nanobody was developed by Ablynx under a 2011 collaboration between both parties.

Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company’s new biosimilar infringed on its Remicade patents.

The company installed the FlexFactory to support its biosimilar production.

The compendium provides a resource to identify and locate targeted suitable patient-derived xenografts based on specific histology and molecular properties.

The company developed proxy-CRISPR which provides access to previously unreachable areas of the genome.

The new storage and distribution facility provides PCI with additional space, complementing its existing footprint currently used for specialist clinical-trial logistics as well as packaging, labeling, and qualified person activities for investigational medicinal products.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

Due to weak penalties and lax enforcement, illicit pharmaceuticals continue to slip into the US, European and global supply chains.

The agency released several new and revised guidance documents regarding product-specific generic drug development.

Saneca has been granted approval to manufacture and supply multiple dosage forms to Russia.  

Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt.