Argos Therapeutics, which has a personalized immunotherapy drug to treat renal cell carcinoma in trials, has kicked off work on a $57 million manufacturing facility in North Carolina. The biotech will get nearly $10 million in public support for the project.
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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The U.S. biopharma industry has been battling a drug take-back law in Alameda County, CA, for several years, concerned that if it is approved, other jurisdictions would start asking them to pay for drug disposal. That law was upheld by a federal court, and now San Francisco is looking to the industry to pay the full cost of its drug-disposal law.
GlaxoSmithKline's manufacturing network will take a hit as the company cuts costs in the face of falling revenues. The U.K. drugmaker was shy on details but said in an earnings release Wednesday that it needed to "rescale" R&D and manufacturing, as well as other operations. It reported a 3% revenue decline for its third quarter.
Trying hard to fight off a hostile takeover by Canada's Valeant, Botox maker Allergan has sent out press releases every time it stumbles onto something that appears to besmirch its pursuer. New fodder is in this week's FDA Enforcement Report. Valeant is recalling a couple hundred thousand bottles and tubes of products.
According to an FDA Medwatch alert, drug repackager Contract Packaging Resources is voluntarily recalling 11,640 boxes of Assured brand naproxen sodium tablets in the 220-mg dose because some of the cartons actually contain bottles of 200-mg ibuprofen softgels instead.
More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.
Puerto Rico, which has seen a number of plant closings recently, is facing another. Eli Lilly said it will close a facility in Guayama next year and put it up for sale.
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Pfizer execs can sigh with relief now that a federal court has backed the company's patents on kidney cancer drug Sutent. The med has become increasingly important to Pfizer as sales of off-patent drugs have faded, and so it was alarming to the U.S. drugmaker when generics maker Mylan challenged the patent in 2010 and filed to make its own copy.
The patent cliff may still be taking a toll on Bristol-Myers Squibb, but the company's Q3 sales haul was enough to impress analysts thanks to star performances from a few key new products.