Hospira has initiated not one, but two, more recalls of injected drugs already on the FDA drug shortage list. One is saline solution and is being recalled after a human hair was found in a delivery bag. This is the second time this has happened since the first of the year.
Several factors in the manufacturing process can lead to a drug shortage. Now, the FDA has launched an effort to combat the effects of such shortages, bringing the battle to your smartphone.
The opening of Hospira's new plant in India that it is counting on to lower its manufacturing costs will be delayed again after it racked up another set of observations during a reinspection by the FDA last month. Unless quickly resolved, it will be an issue that Pfizer will inherit given its $15 billion buyout of Hospira announced last month.
Here is part two of comments from C-suite execs on emerging markets and Asia in the latest quarterly conference calls.
The FDA wants some more time to review Hospira and partner Celltrion's copy of Johnson & Johnson's blockbuster autoimmune drug Remicade, possibly delaying the drug's march onto the U.S. market.
Partners Hospira and Celltrion are marching forward with copies of Johnson & Johnson's blockbuster autoimmune drug Remicade, bulldozing into Europe with products expected to disrupt a multibillion-dollar market.
The U.S. Patent Office gives, and the U.S. Patent Office takes away. Unfortunately for Johnson & Johnson, it was the latter for Remicade. After a re-examination of Remicade's September 2018 patent, agency officials issued a big fat rejection.
Companies with the ability and capacity to manufacture sterile injectable drugs are becoming popular targets. The injectables business of Claris Lifesciences is now said to be drawing attention from potential buyers.
Hospira said on Tuesday that it was recalling more than 60 lots of the pain reliever ketorolac tromethamine injection in the U.S. and Singapore just 5 days after Pfizer said it would pay $15 billion for the specialist in sterile injectable drugs. In fact, on the day the deal was announced, the FDA announced a Hospira recall of the sedative propofol.
When Hospira's proxy was filed last year, CEO F. Michael Ball's $9.9 million in total compensation didn't even rank him among the top 15 highest paid biopharma execs. But with the $15 billion sale of his company to Pfizer, Ball will achieve that goal that CEOs strive for: the payout of the golden parachute. In his case, it is a package that adds up to more than $80 million.