When Pfizer announced its $15 billion deal to buy sterile injectable specialist Hospira, execs said they had studied FDA concerns over Hospira manufacturing before pulling the trigger. But Hospira just keeps giving Pfizer new lessons. Today, the FDA posted a warning letter it recently sent to Hospira CEO F. Michael Ball for a plant in Italy.
Hospira has just picked up an FDA warning letter for a plant in Italy, meaning it now has plants tagged with warning letters on four of the 7 continents: Europe, North America, Asia and Australia. But the problem will be Pfizer's to deal with since it has struck a $15 billion deal to buy the sterile injectable specialist.
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.