Given the publicity that has come with FDA bans on a growing list of Indian facilities, even a report of an FDA shortfall at a plant can have consequences these days. That is where India's Cadila Healthcare found itself Thursday when news that it received an FDA Form 483 took a big bite out of its market cap.
Pfizer is picking up a "portion" of a Baxter International vaccine manufacturing facility in Orth, Austria, as part of a $635 million deal to buy that company's marketed vaccine portfolio.
Hospira's long troubled Rocky Mount, NC, manufacturing plant is troubled no more. CEO F. Michael Ball says a much anticipated reinspection of the plant by the FDA resulted in no observations. But now the FDA's focus has shifted to a new plant in India where manufacturing issues have caught its attention.
The daring burglary of an Eli Lilly warehouse in 2010 was a record-setter by any number of measures. The parsing of the losses in insurance documents serves as a primer for the collateral damage that accrues from a large theft.
Ranbaxy, India's largest generic drugmaker, reported a quarterly loss as plant bans sucked out sales and it made a $40 million provision for ongoing legal problems with U.S. authorities.
Amgen is cutting up to 2,900 jobs, and the ax-wielding will fall heavily on manufacturing and R&D sites in Colorado and Washington, whose futures were already dim.
After years of manufacturing lapses left it with four of its 5 FDA-approved plants banned, a consent decree and now a deal to be sold, Ranbaxy Laboratories has cleaned house in its quality oversight ranks.
The bad news just keeps piling up for Impax Laboratories and Rytary, its investigational drug for treating idiopathic Parkinson's disease. After a series of manufacturing ills at its California plant cost it its partnership with GlaxoSmithKline, the drug developer reports that its fallback facility in Taiwan has also been found lacking by the FDA.
Wales-based contract developer and manufacturer Penn Pharma last year opened a new manufacturing facility to handle highly potent compounds. Packaging Coordinators Inc. (PCI) is in the midst of building a 97,000-square-foot storage and distribution facility in the U.S. Now the two companies will put those operations together.
Germany's Merck KGaA is expanding its headquarters and manufacturing operations in Darmstadt, Germany. On Monday, Merck said it is investing about €27 million (about $36.3 million) to build two power plants that it says will provide more power more efficiently, while reducing carbon dioxide emissions in the area.
Jordan's Hikma has decided to pull the trigger on a deal to take ownership of the Boehringer Ingelheim plant in Bedford, OH, one of the largest sterile manufacturing sites in the world but one that sits idle after quality issues made it too expensive to operate.
When Boehringer Ingelheim closed its troubled sterile manufacturing site in Ohio, which had been the sole supplier of Johnson & Johnson's ovarian cancer drug Doxil, J&J's Janssen unit worked out a deal to take over manufacturing of the bulk drug product for 6 months. Now, with at least a 9-month supply of Doxil in hand, that arrangement is over.
Most companies voluntarily recall products, and sometimes even stop production, when they or the FDA find quality issues. In the case of a Texas compounder, the FDA has formally requested that it halt sterile drug work and pull back all of its sterile products.
Drug wholesaler AmerisourceBergen's saw its pharmaceutical distribution sales jump nearly 40% as it continues to expand work for pharmacy giant Walgreens, but it still came up with a nearly $13 million loss in its last quarter.
While a raft of India's largest drugmakers have had their shipments to the U.S. banned by the FDA over quality concerns, Ipca Laboratories has decided to do that on its own.
One of two men from Turkey that federal authorities accused of smuggling counterfeit cancer drugs to the U.S. labeled as gifts or documents has admitted he is guilty.
Problems with a new manufacturing process at the GlaxoSmithKline influenza vaccine plant in Canada caused some of the issues raised by regulators there, and so the U.K. drugmaker is reverting to its earlier process to get product to the market for the upcoming flu season.
Merck KGaA will start construction next month on a plant to make diabetes drugs in China, a market it says is key to its future. The market is so important that the executive board of the German drugmaker held an event there to reiterate that point to Chinese officials.
GlaxoSmithKline and Johnson & Johnson, which control most of the needed supplies for the industry, want authorities to approve genetic engineering so opium farming can be both expanded and made less susceptible to pests and so they can assure their customers they can keep up with demand.
The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.