News

Report of Form 483 for Cadila wreaks havoc with its shares

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 buys a portion of a vaccine plant from Baxter, J&J sells a vax facility to PaxVax

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 Rocky Mount plant meets FDA goals, but one in India does not

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.

Spectacular warehouse burglary left extensive collateral damage for Eli Lilly

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 rings up another loss as regulatory problems chew away profits

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.

Manufacturing takes it on the chin in Amgen cuts

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.

Ranbaxy shakes up its executive ranks for manufacturing oversight

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.

Impax now faces FDA issues at Taiwan plant that could affect Rytary

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. 

PCI buys contract manufacturer Penn Pharma in $215M deal

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.

Merck KGaA to cut carbon dioxide emissions at Darmstadt site

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.

Hikma buys closed Boehringer plant and strips out equipment

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.

J&J done with Boehringer plant after building a supply of Doxil

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.

FDA warns hospitals that Texas compounder's products are unsafe

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.

AmerisourceBergen deal with Walgreen reaps rewards, and costs

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.

Indian API maker voluntarily halts shipments to the U.S.

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.

Feds extract guilty plea from Turkish man accused of smuggling counterfeit Avastin

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.

Out with the new and in with the old after GSK trips up at vaccine plant

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.

German Merck to start work on new China plant

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.

GSK, J&J push for genetic engineering of opium

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.

FDA again warns that Texas compounder's products may not be sterile

The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.