For any company entering the immunotherapy field, manufacturing and logistics are huge challenges. At newly formed Juno Therapeutics, they have a plan to overcome these obstacles--find a CEO who has done it before and back him with $120 million.
When Gland Pharma became the first Indian company to win FDA approval for a liquid injectable in 2003, the drug shortage problem was in its infancy. Over the past decade, a FDA crackdown on sterile injectables has escalated the issue, creating opportunities for high-quality producers of these complex products.
Two smaller players in the OTC drug industry have decided to join their manufacturing and distribution forces to cash in on retailers' hunger for private-label products and position the expanded company as an alternative to OTC colossus Perrigo.
Jordan-based Hikma has been seeing huge success with its sterile drug manufacturing and is sharing some of that success downstream with a new 15-year agreement to buy sterile injectable devices from a U.S. manufacturer.
A longtime goal of the FDA is for the industry to put in place a national system that would allow it to follow a drug product from manufacturer to pharmacy. After years of back-and-forth with the industry about how that would be done, it is about to get started.
Regulation of pharmaceutical manufacturing generally involves more stick than carrot. While a production misstep will result in a regulatory slapdown, the reward for doing well is simply avoidance of punishment. Now the FDA is looking into how it can offer incentives to manufacturers.
Indian API makers often complain about cheap APIs coming into the country from China. The government has responded periodically with import duties and it will continue an "anti-dumping" charge against analgesic API paracetamol.
Danish drugmaker Novo Nordisk is recalling 33 batches of insulin pens in the U.K. because of a manufacturing issue that led to a very small number of them having a very large disparity in their insulin fills.
India supplies the U.S. with 10% of its drugs and APIs, and some of India's largest drugmakers have felt the sting of FDA citations for quality lapses as the agency steps up inspections there. The Indian drug industry, in turn, gets 90% of its raw materials from China, but it has failed to open an inspection operation there despite that country's reputation for dumping low-quality products on India.
No drugmaker likes to have regulators rain on its parade, but for Indian drugmaker Wockhardt, the bad news is pouring down like a monsoon. The U.K. has stopped most exports from a third plant in four months after finding problems.