FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines. / read more /
Check out the PharmTech Europe Supplement on APIs,
Excipients, and Manufacturing,
includes the
CPhI Worldwide
Planning Guide.
Researchers from Ruhr-Universität Bochum in Germany and the National Institutes of Health modified the protein Nurr1 to enter cells from the outside, possibly enabling the protein to become a drug development candidate for illnesses such as Parkinson’s disease. / read more /
FDA Commissioner Scott Gottlieb, MD, issued a statement regarding new warning letters FDA issued to Chillin Mix Kratom and Mitra Distributing, companies marketing kratom—a potential source of opioids—with unproven medical claims. / read more /
The agency approved Teva Pharmaceutical’s Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. / read more /
The companies will develop therapies targeting the in-vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform. / read more /
A collaboration integrates Sartorius Stedim Biotech’s BIOSTAT STR bioreactors and Repligen’s XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture. / read more /
Immobilizing the antibodies on a solid-phase support, such as a resin, and carrying out the conjugation of the payload-linker while the antibodies are bound to that support will prevent aggregation at its source. / read more /
SMA MicroParticle ICSTM
VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio. / Read more/
This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
