Amgen cancels plans of billion-dollar factory in Ireland
THOUSAND OAKS, Calif. Plans for a $1 billion manufacturing plant in Ireland by Amgen, the world’s biggest biotechnology company, were cancelled Thursday, and the company will be eliminating all of its 75 company jobs in the country, according to Bloomberg
Amgen’s decision was based on the “evolving business environment,” the company said in a statement. Amgen said it would shut down its operations in Ireland while plans for the plant were postponed indefinitely.
The California-based company announced last year that it would invest $1 billion into the new manufacturing facility, which would have employed about 1,100 workers in Cork. The plant was intended to produce drugs such as its Aranesp and Epogen anemia treatments, the company said at the time. This year, however, studies revealed that the anemia treatments raised the risk of heart attack, stroke and death at high doses. The stock regained some losses in the last month after the Food and Drug Administration said the medicines should continue to be given to patients at a maximum limit.
While it has been questioned that Amgen could have possibly backed out of its plans in Ireland because of the country’s current economical setting, some say that is not the case.
“Amgen’s decision has been made as a result of a review of Amgen’s operations and is based purely on developments related to the company’s global business,” Irish Trade Minister Michael Martin said in a statement.
FDA increases potency of levothyroxine products
WASHINGTON The Food and Drug Administration is strengthening the potency specifications for levothyroxine sodium to ensure the drug retains its potency over its entire shelf life.
The agency is increasing the specifications from a 90 to 110 percent potency range to a 95 to 105 percent range. The percent ranges were changed following concerns about the product by healthcare professionals and patients.
Data taken by the FDA showed that some of the levothyroxine products like blister packs degrade quicker than other package types. Also, some of the strengths have been shown to degrade more rapidly than others.
Manufacturers and marketers have two years to comply with the revised specification. Levothyroxine sodium products are used by over 13 million patients.
FDA to review heart problems from osteoporosis drugs
WASHINGTON The Food and Drug Administration is looking at new safety data on reports of atrial fibrillation in patients taking bisphosphonates.
Bisphosphonates are used to treat osteoporosis. The FDA is looking into the issue after a study in the May 3rd issue of the New England Journal of Medicine reported increased rates of serious atrial fibrillation in patients taking Fosamax and Reclast.
The FDA has performed an initial review and found that there was not a large enough group of people who were at risk for atrial fibrillation and would not as of right now ask for healthcare professionals to change their prescribing habits or to tell patients to change their use of the drugs.
The agency is seeking additional data to perform an in-depth review of the issue that could take up to one year to conclude.