Manufacturing delays have resulted in an abraxane shortage, according to Bristol Myers Squibb.
The announcement follows the FDA’s rejection of a petition to block the generic version of the drug. Five years after the petition was filed, the FDA completely rejected it in July. The chemotherapy drug grossed more than $ 1.2 billion for Bristol Myers in 2020.
The shortage is for 100 mg vials of lyophilized powder intravenously.
Stephen Liu, thoracic medical oncologist and associate professor at Georgetown University, tweeted the announcement last week, wondering aloud if drug shortages were imminent after supply chain issues.
I just learned that abrxane is out of stock at the manufacturer with no release date. I wonder if drug shortages are the downstream effect of supply chain issues and if this is the start of something bigger. Hope this is just an isolated thing… pic.twitter.com/YjrOZYpYB0
– Stephen V Liu (@StephenVLiu) September 24, 2021
Sartorius cancels Michigan expansion plans
German manufacturer Sartorius has announced an expansion in Michigan with the addition of a 130,000 square foot plant in the Ann Arbor research park.
The project is expected to go live by 2023 and is expected to create 150 jobs over the next three years. Sartorius has 22 locations around the world. The Michigan location will allow the company to grow and, by 2025, the plan is to more than double its production capacity.
Sartorius Stedim Biotech has acquired a majority stake in German company CellGenix GmbH, the companies said in June. Sartorius acquired 51% of the company for $ 118.3 million and has announced its intention to acquire the remaining shares of the company in early 2023 and 2026. The company will expand the Freiburg site and make it a manufacturer of raw materials for cell and gene therapy.
Insulin factory in Malaysia handed in Form 483
A Malaysian subsidiary of Biocon has landed in more hot water with the FDA after another Form 483 reported six more sightings related to the drug substance, drug product and device installations.
The problems stem from an inspection in September. The site manufactures insulin aspart by injection.
“We are confident that we can respond to these observations with procedural improvements and an appropriate corrective and preventive action plan, which will be submitted to the US FDA on time,” Biocon said in a statement. “We do not expect the result of this inspection to have an impact on our plans to market insulin Aspart in the United States. Biocon Biologics remains committed to global quality and compliance standards.
Almac expands its presence in Ireland
Northern Ireland has a new manufacturing site that will create 60 additional jobs in the region.
Laboratories, storage space and offices are all part of the planned expansion, and the plan includes changes to access roads, parking lots and paths. Proposals have been submitted to Armagh City, Banbridge and Craigavon Borough Council for consideration, according to reports from Armaghi.
The new site will add an additional 42,000 square feet to the company’s footprint.