SRF Limited has unveiled plans for a second chloromethane plant just two months after India imposed anti-dumping tariffs on Chinese and Russian imports.
Ashfield, a provider of outsourced healthcare services to pharmaceutical, device, and biotech companies, has announced a new international initiative, Ashfield Cares.
Pharmaceutical Product Development (PPD) is set to acquire evidence-based solutions provider Evidera, as the need for real-world data continues to grow.
The US FDA has criticised Chinese manufacturer Concept Products for not fixing cGMP violations observed by inspectors who visited its manufacturing site in Tianjin.
Catalent and Zumutor Biologics have combined their technologies to create antibodies with enhanced Antibody Dependent Cellular Cytotoxicity (ADCC) without compromising production levels.
Pfizer unit Hospira has recalled one lot of the anaesthetic made at its facility in Rocky Mount, North Carolina after particulate matter was found in a vial of the drug.
Charles River Laboratories has entered into a strategic partnership with the Milner Therapeutics Institute and Consortium and will provide the organization with access to its resources and services.
The global contract research organization (CRO) is increasing its focus on hepatotoxicity, one of the leading causes of adverse events in clinical trials.
Teva has recalled an injectable antibiotic that is one of only two products currently made at the Godollo, Hungary facility that was hit with a US import ban in May.
Pfizer has temporarily halted production at a former-Hospira aseptic plant in Chennai, India after regulators observed manufacturing issues during an inspection in June.
The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
US Senator Elizabeth Warren recently published a perspective calling for strengthening research through data sharing – but the perspective was not met without feedback.
Alnylam’s RNAi manufacturing plant will be operational by 2018 and the firm says it is willing to invest in a second facility depending on its pipeline success.
W.R. Grace has opened a pharma quality control laboratory at its manufacturing facility in Albany, Oregon and predicted higher drug intermediates sales in the second half of the year.
Steroid API firm Gadea Pharmaceuticals helped AMRI grow revenue in the second quarter offsetting flat royalties and the impact of the closure of its site in Holywell, Wales.
Charles River says it is capitalising on the growing number of biologics in development, with its manufacturing business seeing double-digit growth led by demand for biosafety and cell banking services.
As part of the company’s “site-centric” approach, inVentiv has expanded its relationship with the Society of Clinical Research Sites (SCRS) to elevate the “voice” of clinical sites.
The contract research organization (CRO) Velesco Pharma has opened a new laboratory in its Plymouth, MI-based facility to support an increased demand for materials management.
The US FDA says Xiamen Origin Biotech Co. lied to investigators during an inspection of its API facility in Fujian in which significant deviations from cGMP were identified.
India has relaxed its study rules to let clinical investigators to take part in multiple drug trials and to allow smaller sites to be used for research.
The US Department of Agriculture (USDA) has fined Covance Research Products for violating animal care rules at its preclinical testing facility in Alice, Texas.
The strategic alliance between Quintiles and the contract research organization (CRO) DaVita Clinical Research will focus on optimizing renal clinical trials.
INC Research has launched a Vaccine Catalyst Site network as part of the company’s Catalyst program, which was introduced earlier this year to strengthen collaborations with clinical research sites.
Acino has agreed to sell its transdermal delivery patch business Luye Pharma Group in a deal that will include its manufacturing site in Miesbach, Germany.
Jinan Jinda Pharmaceutical Chemi has not fixed GMP deficiencies at its Shandong plant say Spanish regulators calling for ban on nitrofurantoin shipments to the EU.