The company held a ribbon cutting ceremony at its new Center for Innovation in Advanced Development and Manufacturing in Maryland.

The partnership provides Charter Medical the exclusive rights to market, sell, and distribute INCELL media products on a global basis.

MilliporeSigma released a new surface-active nonionic polymer to ensure lot-to-lot consistency.

The companies entered a license agreement that includes Sangamo’s SB-525, one of the company’s lead product candidates for the treatment of Hemophilia A.

FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.

More stringent R&D investment requirements for PhRMA membership reduces the association ranks by 22 associate and member companies.

The company has formed a Pediatric Center of Excellence in support of the development and manufacture of dosage forms for pediatric indications.

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.

Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.

The new DoseGuard design is compatible with standard 20-mm containers.

The company is expanding their April 2017 voluntary recall of phenobarbital tablets.

The agency released its report on pilot project to involve patients in the assessment of medicines.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.

The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.

Biomedical researcher shares insights from a career dedicated to advancing therapeutic innovations for unmet medical needs.

The company is the first multi-site excipient supplier to achieve accreditation across production facilities.

CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.

Novartis entered separate license agreements with bluebird bio and Celyad for patents related to the manufacture of CAR-T cells.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

The pharmaceutical market in Spain is showing signs of stability according to a report by GlobalData.

Learn how to prevent common causes of product loss.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.