Amgen CEO Robert Bradway hinted several years ago that the company was on the "cusp" of a new manufacturing process for making cell-based drugs that would upend the industry, being faster and cheaper. Today, Amgen said that time has arrived, with completion in Singapore of a $200 million plant that incorporates continuous processing.
Debate about the appropriate price for drugs is ongoing. It costs a lot of money to discover and develop drugs, including the money that gets sunk into candidates that don't succeed. And because of the way the U.S. market works, it will have the highest prices that the market will bear.
When it comes to selling big, cancer drugs have a lot going for them. Their targets--deadly diseases that in many cases can kill quickly--put them in high demand, even as they continue to redefine "premium pricing." Some newer drugs can be targeted at patient groups who have the best chances of benefiting, helping justify those high costs. And biologics, for now, don't face the same generic onslaughts that pummel pharma sales come patent expiration time.
That's not to say they don't face roadblocks. Plenty of cancer heavyweights have run into failed label expansions, governmental cost critics, patent woes and biosimilar threats. But even so, the top 10 managed to rake in worldwide sales between $1.7 billion and $7.8 billion, according to EvaluatePharma data.
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In March, Hospira announced it had reached a $60 million agreement to settle a three-year-old lawsuit that said investors had been kept in the dark about the quality problems at its manufacturing operations. But another suit was filed last June, and now the Lake Forest, IL, company says it has been rolled into the settlement.
A U.S. oncologist who thought he was getting a great deal on drugs that were almost the same thing as Avastin has found they will cost him an extra $2 million and a federal misdemeanor conviction.
Organized crime has moved into selling counterfeit and compromised prescription drugs in Europe, exploiting the mishmash of customs laws and weak points in some border protection. Those weaknesses allowed the "Mafia" to get fake manifests, use suspect wholesalers, and sell counterfeits of Roche's Herceptin and other cancer drugs across Europe.
A small generics maker from the U.K. has decided on Birmingham, AL, for its first manufacturing facility, enticed there by a hefty dose of incentives.
A U.S. federal judge has turned down Ranbaxy Laboratories' request for a temporary restraining order against the FDA after the agency revoked the Indian drugmaker's approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's antiviral Valcyte because of its manufacturing shortcomings.
This month, the FDA yanked the approvals it granted Ranbaxy to make generics of two blockbuster drugs, saying it was a mistake to grant the approval given that the plants where they were to be made were out of compliance. Ranbaxy has now filed a federal lawsuit against the FDA for canceling the approvals.
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A U.K. consortium led by Zoetis announced a $3 million project that will use visual imaging and digital technology to improve the health and wellness of pig herds with a goal of better production.
Thanks in part to its all-hands approach to immuno-oncology, AstraZeneca's pipeline is now nearly 50% biologics, leading the company to lay out $200 million to build the capacity it will need to follow through on those in-development projects.