With the effectiveness of this year's influenza vaccines so low as to have made most of this year's vaccinations pointless, the industry is searching for avenues to abbreviate the 6-month development and manufacturing process to deal better with the kinds of virus mutations that came into play this year.
The FDA says some of San Diego, CA-based Wallcur's products used to train healthcare providers, including vets, how to safely and effectively mix and administer injectable drugs and other products have made it into the U.S. supply chain and been used on patients with "serious adverse results."
In what is shaping into a major pharma supply chain scandal in Spain, investigators have accused one of the country's largest wholesalers of diverting millions of euros' worth of drugs subsidized by the government to the black market.
Genentech CEO Ian Clark is again being publicly chastised for his company's decision to move three of its best-selling cancer drugs to specialty distributors. Groups representing more than 5,000 hospitals say, besides higher costs, the move is as likely to encourage counterfeiting as to deter it.
A Sanofi spokesperson told The Wall Street Journal that it has delayed some forms of its Fluzone because the flu strains used to produce the shot did not grow as fast as expected. A GSK spokesman said in an email Monday that it has cut its production targets to 26 million to 27 million doses for the U.S. from the 28 million to 33 million doses originally anticipated.
Hospira is recalling "certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage." But the description does not get to the depth and breadth of the recall, which is for 54 lots of nearly a dozen products. That includes two dozen lots of saline solution in the 1000-mL size, an essential hospital product that has been in short supply for months.
Some Indian companies that had put off production of HIV/AIDS meds while they waited for the government to sign contracts are now having to seriously ramp up because of shortages of some meds, Reuters reports.
With Ebola rampaging through West Africa and now having reached the U.S., U.S. officials and the maker of an experimental Ebola drug manufactured from cells grown in tobacco leaves, ZMapp, want to expand the drug's current production while also seeing if traditional mammalian-cell methods might be used to quickly scale up production of the drug.
Consort Medical has placed a big bet on the convergence of drug and device production services, striking a £230 million ($374 million) deal to buy European contract manufacturer Aesica Pharmaceuticals.
When a shortage of BCG vaccine used to treat tuberculosis and bladder cancer developed two years ago because of serious problems at a Sanofi Pasteur plant, the FDA asked Merck to pick up the slack. But Merck has had supply issues that interrupted production that it is only now resolving.