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  • Pozen gets a second CRL as its API supplier awaits FDA reinspection

    Drugmaker Pozen says its API supplier has done everything the FDA asked after noting issues in an April plant inspection and the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."

Owners, employees of compounder NECC indicted over lethal meningitis outbreak

A federal indictment alleges that the now-defunct New England Compounding Center reaped millions of dollars by cutting corners in the manufacture of what were supposed to be sterile drugs, falsifying records, using expired ingredients and lying to clients about their safety.

U.K. building $85M cell therapy manufacturing operation

The Cell Therapy Catapult is part of a government program created a couple of years ago to pump up the cell therapy industry in the U.K. The group plans to invest more than $85 million to build a large-scale cell manufacturing facility in Stevenage that companies can contract with for early-stage to commercial work.

FDA finds issues with Hovione plant in Portugal

The latest FDA visit to Hovione's plant in Loures, Portugal, for a preapproval inspection resulted in a Form 483 with three observations.

Onyx Pharmaceuticals facility evacuated but no problems found

Workers at an Onyx Pharmaceuticals facility in South San Francisco filed out of the building and into a parking lot Wednesday afternoon after employees reported smelling gas.

Biocon to build new plant in Vizag, India

Biocon intends to build a new facility in Vizag, India, for manufacturing insulin products. It is a turnabout for the Indian company, which went to Malaysia with its first insulin facility, in part, over concerns that India was falling behind in providing dependable infrastructure to the pharma industry.

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FierceBiotech

AbbVie won an expected FDA approval for its next-generation treatment for hepatitis C, kicking off a race with Gilead Sciences for dominance in a blockbuster field.

FierceDiagnostics

Myriad Genetics won FDA approval for its companion diagnostic test for AstraZeneca's ovarian cancer drug Lynparza, giving the company a boost as it recoups from its latest patent battle loss and helping it gain ground in a fast-growing market.