Cambrex adds new development and analytical equipment in Italy
Cambrex Corporation has announced a new investment in its research and development (R&D) and manufacturing capabilities at its site in Paullo, Milan, Italy.
Archives for October 12, 2017
Study database tribulations stunt trial timelines
Clinical study database challenges are delaying clinical trial timelines as CROs and sponsors must manage an increasing variety of trial data, according to a recent study.
SRI teams up with ShangPharma to target Alzheimer’s
ShangPharma Innovation and SRI International are collaborating to develop treatments for neurodegenerative and inflammatory conditions, such as Alzheimer’s disease.
Patients as partners, communication key to designing rare disease clinical trials
Researchers are creating a “roadmap” for nephrology clinical trial design, which stresses the role patients and their families can play in rare disease study design.
Nestle licenses Codexis' enzyme platform and protein drugs for $14m
Nestle Health Science has licensed a protein engineering platform from Codexis in a $14m deal that includes an option to co-develop a phenylketonuria drug candidate called CDX-6114.
update
EDQM and Anvisa sign MoU on future use of CEPs in Brazil
The EDQM and Anvisa have signed an agreement that may allow drug firms seeking clearance to sell products in Brazil to file CEPs in approval applications.
US FDA approves production at Samsung Biologics 152,000L plant
The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.
update
Switzerland to streamline approval process for cross-border inspections
Swiss drug and API manufacturers will soon be able to allow foreign regulators to inspect their facilities without seeking Government approval.