Oral tolerability concerns have prompted the US biotech to close Ph II clinical trial investigations of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT).
Sanofi Pasteur has teamed with Translate Bio to develop mRNA vaccines for infectious diseases, using a platform developed by subsidiaries of Shire plc.
SIGA is slated to receive FDA approval for the world’s first antiviral drug to treat smallpox – a milestone not reached in isolation, but in collaboration with several CROs, government agencies, and others.
The Centre for Process Innovation (CPI) has confirmed its role in a UK initiative to accelerate vaccine production and eliminate the need for cold-chain shipping.
Motif Bio plc has secured £10m ($14m) to support the potential commercialization of its lead candidate – iclaprim – which was granted FDA fast-track status in 2015.
A new partnership between Haselmeier and Common Sensing aims to develop smart connected monitoring and support solutions for users of injectable medicines.
Mayne Pharma has opened a new 126,000-square-foot oral solid-dose manufacturing facility to meet demand driven by new product launches – and new revenue stream from its CDMO business.
Pills embedded with sensor technology that verifies a patient has taken their medication can improve adherence and provide data on adverse effects, says Proteus Digital Health’s Nik Leist.
Almac Group has expanded its commercial packaging capabilities to meet a “significant increase” in demand for complex kit assembly as biopharma brings more advanced sterile and biological products to the market, says CDMO.
The US FDA has issued a recall of non-expired products marketed as sterile made by Coastal Meds after an investigation of the outsourcing facility found poor sterile production practices.
