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  • Sun faces class action suit over closure of Caraco plants 6 years ago

    It has been more than 6 years since Caraco Pharmaceutical Laboratories was forced to suddenly shut two Detroit-area manufacturing plants after the FDA sent in marshals to seize drugs, claiming the plants had contamination issues. One of the plants was even closed last year by Caraco owner Sun Pharmaceutical. But legal problems continue to reverberate for Sun for having laid off hundreds of workers without notice.

Shire works deal with Sanquin so it can boost production of rare disease drug

When Shire shelled out $4.2 billion for ViroPharma a couple of years ago, it picked up the rare disease drug Cinryze, but what it didn't get in the deal was complete control over manufacturing of the rare disease drug. That had been ceded by ViroPharma to Sanquin Blood Supply. But Shire has now worked a deal with Amsterdam-based Sanquin that will allow it to add more contract manufacturers and so boost production of the treatment.

UPDATED: Sucampo gets control of Amitiza production in deal for Japanese company

Sucampo sees a number of advantages to buying Japanese CDMO R-Tech Ueno, not the least of which will be owning the manufacturing for the two drugs that it sells.

Woodcock says FDA will keep new plant quality grades a secret

The FDA publishes warning letters and inspection reports on its websites. It issues public recalls and drug label warnings. However, it is not feeling in such a sharing mood when it comes to its proposed letter grades for manufacturing plants on the quality of their manufacturing.

Sterilization specialist on expansion streak

Sterigenics International, which counts vaccine and API sterilization among its irradiation services, is expanding.

GSK expanding OTC plant that had been slated for sale

Several years ago, GlaxoSmithKline sold off a portfolio of consumer products in the U.S. The drugmaker had indicated a plant in Memphis, TN, was going to be sacrificed as part of that decision but GSK still has the plant and is even planning to spend some money making improvements to it.

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FierceBiotech

Shire has been quiet since making its unwelcomed $30 billion bid to acquire Baxalta public earlier this month. But Baxalta evidently isn't waiting for the next step to play out in that dance. Bloomberg is reporting this afternoon that Baxalta is hunting for an acquisition around the $2 billion mark that would add to its hematology pipeline.

FierceMedicalDevices

Engineer Scott Leibrand and diabetes patient Dana Lewis have created an artificial pancreas, via years of constant experimentation and iterative upgrades.