Hemispherx Biopharma has had a somewhat rocky relationship with both the FDA and the Street. But with a manufacturing upgrade complete and a distribution agreement in hand, it expects to return to the market its only approved product after a 7-year hiatus.
The weeklong production hiatus at a GlaxoSmithKline plant in the U.S. is over. The British drugmaker has resumed making products at its plant in North Carolina that it closed a week ago after routine testing detected the bacteria for Legionnaires' disease in two cooling towers at the site.
India has lashed out at the European Union, miffed over the EU ban of more than 700 drugs after finding issues in the clinical trials conducted by India's GVK BioSciences.
Baxter International is working with the FDA to add a plant in Mexico to the list of providers approved to ship saline to the U.S. as a shortage of the solution plagues healthcare providers. But while the drugmaker is expanding production, it has also had to repeatedly recall lots of saline because of manufacturing missteps. On Friday, it issued yet another.
Upsher-Smith had to quit shipping fluoxymesterone tablets last fall when its supplier quit making the API for Androxy. The problem was that Upsher-Smith is the only supplier in the U.S. for the drug, which is used to treat breast cancer in women and low testosterone in men. Now Upsher-Smith says Androxy is back.
With the completion of a spinoff July 1, Baxter International let go of most of its drug operations go with Baxalta while keeping its dialysis equipment, IV pumps and solutions, and injectable drugs and intravenous nutrition. In that category falls saline solution, and Baxter is again having to recall some of that; in this case, two lots because a customer discovered particulate that turned out to be insects.
For the third time this year, a drugmaker is having to recall birth control pills in North America. This time, it is Actavis, which is voluntarily recalling more than half a million boxes of contraceptives because of packaging problems.
The HIV-oriented joint venture of Pfizer, GlaxoSmithKline and Japan's Shionogi is turning to a Chinese manufacturer for a cheap supply of dolutegravir, the active ingredient in its Tivicay. The deal is seen as a way to cut the cost in China and some other developing countries of the JV's newest HIV fighter.
This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.
China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.