News

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.

Bosch’s Xelum platform is designed for continuous production of oral solid-dosage forms.

Industry experts forecast the changes to the pharma industry for 2017.

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

CPhI Worldwide announced new additions to its 2017 advisory board.

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.

New incubators, instrumentation, and staff will increase cell bioassay capabilities for EAG Laboratories.

New study will reveal bio/pharma practices and performance on quality issues.

The drug is approved to treat postmenopausal women with osteoporosis and is the first anabolic bone building agent approved in the US in approximately 15 years.

With two acquisitions, German company Fresenius Kabi enters biosimilars market and expands in US.

Avid, a wholly owned subsidiary of Peregrine Pharmaceuticals, will upgrade its Myford, California clinical and commercial manufacturing facility with multiple Mobius 2000-L single-use bioreactors from MilliporeSigma, the companies announced on May 1, 2017.

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.

On April 28, 2017, the European Medicines Agency announced that it met with members of the heads of the National Competent Authorities (NCAs) of the member states of the European Union to discuss the United Kingdom’s exit from the EU (Brexit) and how the agency and the member states will handle the evaluation and monitoring of drugs going forward.

Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.