Bioclinica’s Individual Case Safety Report (ICSR) team has processed more than one million cases after doubling its processing volume since 2016 – as demand for ICSR outsourcing increases.
The detection of cracks of the surface of glass vials has prompted a voluntary recall of Labetalol Hydrochloride Injection made at Pfizer’s troubled McPherson, Kansas facility.
In the days of personalised medicine, 3D printing and nanotechnology, consultant David Chesney says regulators must “keep pace” to redefine current good manufacturing practice.
Scientist.com is working to implement an improved contractual landscape ahead of GDPR implementation in May, in order to ensure global compliance among sponsors and CROs.
Two Chinese and one Korean over-the-counter (OTC) drugmakers have received US FDA warnings for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.
PCI Pharma Services (PCI) has announced its intent to acquire Pharmaceutical Packaging Professionals (PPP) as the company focuses on growth and rapid expansion.
In response to stakeholder feedback, the US FDA has issued a final guidance detailing changes to the regulatory classification of co-crystals, from intermediate to API.
Parexel has launched a new offering that enables customers to manage patient biological sample assets across the supply chain, as precision medicine becomes more prominent, says VP.
Experts from Syneos Health and UDG Healthcare comment on the current state of the global pharma contract sales market – which is estimated to reach $9.48bn by 2023.
IQVIA has been contracted to expand the safety and efficacy monitoring of biologic products as part of a novel alliance with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).
Failure to test ingredients’ identity in an over-the-counter drug product is one of the violations that landed Polaroisin International a US FDA warning letter.
Advarra has selected TransPerfect Life Sciences as its strategic supplier of language services, including document translation, digital content localization, and interpretation services.
The Danish competition authority has determined pharmaceutical distributor CD Pharma “abused its dominant position” by unfairly increasing prices for oxytocin-based Syntocinon.
The number of new clinical trials in the regenerative market space continues to grow, says Cryport, which will provide global logistics support for TiGenix’s upcoming Phase Ib/IIa study.
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.
Smart Containers Group is accepting cryptocurrency payments to ship pharmaceutical products, which the firm says will free up manpower and reduce transport costs.
The US Government shutdown only lasted one working day but the US FDA could take weeks to make up the lost time according to the Alliance for a Stronger FDA.
Apotex has recalled a batch its diabetes drug APO-Metformin XR in Australia after a pill was plastic from a cable or zip tie was found embedded in a pill.
The Access to Medicines Foundation has launched a ‘benchmark’ that maps drug industry efforts to stem the spread of drug resistance at the World Economic Forum in Davos, Switzerland.
The Tjoa Group has launched Meditraq to help firms across the pharmaceutical supply chain meet data requirements, one year out from the EU serialization deadline.
Australia’s Therapeutic Goods Administration will reclassify all codeine products to ‘prescription only’ from February 1, in a bid to combat opioid tolerance, dependence and poisoning.
Eurodis says Brexit-related costs and admin burden placed on UK pharma may affect availability of drugs for rare diseases and discourage development of such products.
Massachusetts biopharma companies received $2.9bn in venture capital investment in 2016 – and as pressure continues to accelerate the drug development process, manufacturers will continue to turn to CROs and CMOs, says MassBio.
Recent changes in legislation are likely to increase the presence of foreign CMOs in China, says newly formed fill/finish firm Wuxi Griffin Pharmaceutical.
The overhaul of the tax system will allow US pharma firms to access billions in capital, but J&J and Merck & Co. play down any changes in their M&A strategy.
Chinese patients’ concerns about the quality of locally made drugs are an opportunity for US manufacturers to increase market share according to the US-China Economic and Security Review Commission.
McKesson Corporation has completed its acquisition of RxCrossroads to support customer needs beyond channel distribution as the industry faces increasing challenges.
INC Research/inVentiv Health is starting the new year with a rebrand after merging to create one of the largest biopharmaceutical outsourcing providers in 2017.
