The bad news just keeps piling up for Impax Laboratories and Rytary, its investigational drug for treating idiopathic Parkinson's disease. After a series of manufacturing ills at its California plant cost it its partnership with GlaxoSmithKline, the drug developer reports that its fallback facility in Taiwan has also been found lacking by the FDA.
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.
There has been talk in recent years about how the industry should expect fewer blockbusters and how drugmakers need to look toward selling more products for fewer dollars, euros, pounds or yen. But it is the big sellers, the blockbusters--no, megablockbusters--that drug execs aspire to develop. And a look at the top 10 best-selling drugs globally can't help but impress with its big numbers.
First of all, each of the top 10 best-selling drugs in the world knocked out more than $5.5 billion in sales last year, according to data provided by the market intelligence gurus at EvaluatePharma. Together, the top 10 turned in $76.38 billion in sales. Yes, that's more than $75 billion in sales from just 10 products. One other drug, Eli Lilly's Cymbalta, topped the $5 billion mark, but having lost its patent in December, it's headed for a serious nosedive this year.
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Jordan's Hikma has decided to pull the trigger on a deal to take ownership of the Boehringer Ingelheim plant in Bedford, OH, one of the largest sterile manufacturing sites in the world but one that sits idle after quality issues made it too expensive to operate. Read more >>
When Boehringer Ingelheim closed its troubled sterile manufacturing site in Ohio, which had been the sole supplier of Johnson & Johnson's ovarian cancer drug Doxil, J&J's Janssen unit worked out a deal to take over manufacturing of the bulk drug product for 6 months. Now, with at least a 9-month supply of Doxil in hand, that arrangement is over.
Germany's Merck KGaA is expanding its headquarters and manufacturing operations in Darmstadt, Germany. On Monday, Merck said it is investing about €27 million (about $36.3 million) to build two power plants that it says will provide more power more efficiently, while reducing carbon dioxide emissions in the area.
Wales-based contract developer and manufacturer Penn Pharma last year opened a new manufacturing facility to handle highly potent compounds. Packaging Coordinators Inc. (PCI) is in the midst of building a 97,000-square-foot storage and distribution facility in the U.S. Now the two companies will put those operations together.
After years of manufacturing lapses left it with four of its 5 FDA-approved plants banned, a consent decree and now a deal to be sold, Ranbaxy Laboratories has cleaned house in its quality oversight ranks.
While a raft of India's largest drugmakers have had their shipments to the U.S. banned by the FDA over quality concerns, Ipca Laboratories has decided to do that on its own.
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After Sarepta Therapeutics' former head scientist blamed his swift ouster on "serious disagreements" with CEO Chris Garabedian, the company has moved to limit its chief executive's power, according to a report, especially when it comes to meetings with the FDA over the biotech's much-scrutinized lead drug.
Bracing for an expensive round of late-stage studies and potential drug launches as it ramps up work on a slate of new biosimilars, Amgen reported Tuesday evening that it plans to trim up to 15% of the company's workforce, shutting down facilities in Colorado and Washington state as it slashes up to 2,900 staffers.