Free from the use of live or inactivated viruses, the production of synthetic vaccines would be simpler and safer, while cold-chain concerns would lessen, too. A paper published this week in PLoS Pathogens describes how researchers used a particle accelerator to develop a synthetic foot-and-mouth vaccine.
New manufacturing capacity has come online, and more is in the pipeline, as drugmakers see opportunity to fill vials with injectable drugs and shortages with higher-priced products.
In response to concerns about biodefense, the Department of Health and Human Services is helping GlaxoSmithKline and Texas A&M build a $91 million vaccine production plant.
Cook Pharmica says the FDA approved its manufacturing facility without doing a preapproval inspection so that it could begin producing a drug that is on the FDA shortage list.
The FDA and regulators in Europe have been throwing up protections against counterfeit and substandard drugs that have been making their way into supply chains.
Sanofi ($SNY) has picked up a new contract manufacturing client, one willing to pay half the cost of a manufacturing suite to make specialized immunotherapy products.
Alarm over counterfeits coming into the U.S. through Canadian Internet pharmacies reached new levels last year after a counterfeit version of the cancer drug Avastin made its way here through one. But even as efforts are made to buttress protections against that weak link in the pharmaceutical supply chain, state officials in Maine are working to change the state's legislation so its public employee health programs can keep buying drugs from a Canadian Internet pharmacy.
Serious manufacturing shortcomings at a Sanofi Pasteur plant last year created shortages of a vaccine that can protect patients against tuberculosis. Now because of manufacturing delays a drug Sanofi makes to treat the disease has landed on the FDA shortage list.
Walgreen last year decided to take on a more international frame of mind when it bought a 45% chunk of the Swiss drugstore chain Alliance Boots. Now the two have partnered with one of the largest supply-chain players to smooth out distribution and hopefully cut some costs.
As shortages of sterile injectables persist, the makeup of that part of the industry is in flux. Now that Mylan has agreed to buy Agila Specialties, the injectables unit of Strides Arcolab, for $1.6 billion, analysts think Claris Lifesciences could be next.