Cellular Biomedicine Group Inc., a leading clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer, has announced its plan to configure part of its facility in Shanghai with GE Healthcare’s FlexFactory platform, which will be designed to speed up manufacturing timelines for its cell therapy clinical trials and commercial launch. There are more than 900 regenerative medicine trials …

Inform Diagnostics announced that therapeutic drug monitoring is commercially available for Renflexis (infliximab-abda), a biosimilar of Remicade (infliximab). Since launching the InformTx therapeutic drug monitoring (TDM) services in June 2016, the company has expanded its TDM testing to now eight biologic drugs that treat inflammatory bowel disease (IBD). Inform Diagnostics uses laboratory-validated ELISA technology for TDM. Testing measures the level …

OmegaFlex announced MediTrac as the world’s first corrugated medical tubing (CMT) for distribution of medical gases. Unlike rigid copper tubing which is installed in numerous brazed sections and elbow joints to accommodate a facility layout, MediTrac semi-rigid tubing installs in a single, bendable length that can be routed around existing structures. Made from copper alloy and sold in continuous-length rolls, …

Hologic’s Cynosure division announced the launch of TempSure™ Envi – an FDA-cleared advanced radiofrequency device that minimizes facial fine lines and wrinkles, tightens skin through soft tissue coagulation, and improves the appearance of cellulite. TempSure™ Envi is a simpler way for patients to maintain beautiful skin. The device heats the deep layers of skin to regenerate collagen and improve the …

French healthcare group Sanofi has agreed to buy U.S. peer Bioverativ for $11.6 billion, in a deal which Sanofi said would boost its earnings and strengthen its presence in the field of treatment for rare diseases. Sanofi has agreed to buy all of the outstanding shares of Bioverativ for $105 per share in cash, marking a premium of 64 percent …

Inform Diagnostics announced that therapeutic drug monitoring is commercially available for Renflexis (infliximab-abda), a biosimilar of Remicade (infliximab). Since launching the InformTx™ therapeutic drug monitoring (TDM) services in June 2016, the company has expanded its TDM testing to now eight biologic drugs that treat inflammatory bowel disease (IBD). Inform Diagnostics uses laboratory-validated ELISA technology for TDM. Testing measures the level …

Cellular Biomedicine Group Inc. has announced its plan to configure part of its facility in Shanghai with GE Healthcare’s FlexFactory™ platform, which will be designed to speed up manufacturing timelines for its cell therapy clinical trials and commercial launch. There are more than 900 regenerative medicine trials underway globally, including trials in cell and gene therapy, a 19 percent increase …

Cardiovascular Systems, Inc. announced two new partnerships broadening the company’s product portfolio. CSI is now the exclusive U.S. distributor of OrbusNeich balloon products. Additionally, the company has signed an original equipment manufacturer (OEM) agreement with Integer Holdings Corporation for CSI-branded ZILIENT™ guidewires. Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We intend to build on our market-leading position …

Laminate Medical Technologies announced the launch of its FDA pivotal study in the US. The first surgeries were performed by Dr. Jason Burgess and Dr. Paul Orland at the Carolinas Medical Center-Mercy, Charlotte, North Carolina. “We are excited to be the first site that enrolled patients in the US. The device was easy to implant and I am happy with …

International Biophysics Corporation announced they have received FDA 510k clearance for their FloPump 32 centrifugal disposable heart pump. The FloPump 32 is one of the smallest centrifugal pumps in the world at 32ml prime. The FloPump 32 is a single use, centrifugal heart pump designed and intended to be used in conjunction with the Maquet® RotaFlow™ console. International Biophysics founder …