B. Braun Medical Archives - Medical Design Sourcing

Healiva buys critical cell therapy manufacturing assets from B. Braun

Healiva announced today that it acquired critical manufacturing assets from B. Braun’s B. Braun Medical AG Switzerland affiliate.

The companies declined to disclose financial details for the acquisition.

Lugano, Switzerland-based Healiva develops precision medicine for patients with chronic and acute wounds. It acquired a qualified cell bank for the manufacturing of its first cell therapy product.

The company said in a news release that the cell bank is “essential” for the GMP-compliant manufacturing of EpiDex. It designed EpiDex as an autologous epidermis derived from the patients own hair cells.

“This transaction will enable Healiva to accelerate the launch of EpiDex, which is projected for Q4 2023,” said Priyanka Dutta-Passecker, co-founder and CEO of Healiva. “This will allow us to deliver our clinically proven, surgery-free solution to patients with severe chronic wounds more promptly, shortening the path to market for EpiDe…

B. Braun receives FDA approval for Florida pharmaceutical manufacturing plant

B. Braun’s new Daytona Beach, Florida manufacturing plant. [Image from B. Braun]

B. Braun Medical announced today that it received final approval from the FDA for its new pharmaceutical manufacturing plant.

Bethlehem, Pennsylvania-based B. Braun’s Daytona Beach, Florida-based plant will produce 0.9% sodium chloride for injection available in B. Braun’s Excel Plus IV bags in 1,000 mL and 500 mL sizes.

Get the full story at our sister site, Pharmaceutical Processing World.

B. Braun receives FDA approval for Florida pharmaceutical manufacturing plant

B. Braun’s new Daytona Beach, Florida manufacturing plant. [Image from B. Braun]

B. Braun Medical announced today that it received final approval from the FDA for its new pharmaceutical manufacturing plant.

Bethlehem, Pennsylvania-based B. Braun’s Daytona Beach, Florida-based plant will produce 0.9% sodium chloride for injection available in B. Braun’s Excel Plus IV bags in 1,000 mL and 500 mL sizes.

According to a news release, the B. Braun Excel Plus IV bags are not made with PVC, DEHP or natural rubber latex in an effort to protect patients from exposure to harmful chemicals.

The company said its new Daytona Beach facility represents part of its commitment to invest more than $1 billion to alleviate IV fluid shortages through the addition of supply and manufacturing capacity in the U.S. Adding a Florida manufacturing plant complements the company’s existing IV solution…

B. Braun wins FDA clearance for MRI-safe infusion pumps

B. Braun this week said it received FDA 510(k) clearance for its SpaceStation MRI to allow infusion pumps to continuously deliver medications to patients in an MRI.

SpaceStation MRI is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to protect MR scanners while providing interference-free images. Space infusion pumps are able to safely transition patients into the imaging suite with the SpaceStation MRI, eliminating the need for long infusion lines, according to B. Braun.

Get the full story on our sister site Drug Delivery Business News.

B. Braun wins FDA clearance for MRI-safe infusion pumps

B. Braun this week said it received FDA 510(k) clearance for its SpaceStation MRI to allow infusion pumps to continuously deliver medications to patients in an MRI.

SpaceStation MRI is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to protect MR scanners while providing interference-free images. Space infusion pumps are able to safely transition patients into the imaging suite with the SpaceStation MRI, eliminating the need for long infusion lines.

“This clearance allows us to expand our infusion therapy portfolio by providing seamless infusion management across multiple care settings,” B. Braun director of marketing for infusion systems Jonathan Stapley said in a news release. “Our Space Infusion System allows standardization of large volume and syringe pumps on the same workflow with one integration.”

Each SpaceStation MRI holds up to 4 Space pumps and the TeslaSpy continuously monitors magnetic …

B. Braun’s top North American executive to retire

Caroll H. Neubauer will retire at the end of August as the head of B. Braun’s North America operations.

B. Braun announced today that Caroll H. Neubauer will retire at the end of August after 24 years leading the Melsungen, Germany–based medical and drug delivery device giant’s North America operations.

Jean-Claude Dubacher, a former Johnson & Johnson and Abbott executive who already took over Neubauer’s role as CEO of B. Braun Medical at the start of the year, has now also assumed Neubauer’s position as chair and CEO of B. Braun of America, effective June 1. Neubauer will stay on until Aug. 31 as executive director of B. Braun of America.

Get the full story on our sister site MassDevice.

B. Braun’s top North American executive to retire

Caroll H. Neubauer will retire at the end of August as the head of B. Braun’s North America operations.

B. Braun announced today that Caroll H. Neubauer will retire at the end of August after 24 years leading the Melsungen, Germany–based medical and drug delivery device giant’s North America operations.

Jean-Claude Dubacher, a former Johnson & Johnson and Abbott executive who already took over Neubauer’s role as CEO of B. Braun Medical at the start of the year, has now also assumed Neubauer’s position as chair and CEO of B. Braun of America, effective June 1. Neubauer will stay on until Aug. 31 as executive director of B. Braun of America.

Get the full story on our sister site MassDevice.