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In a first for the biotech industry, the European Commission (EC) has imposed a €7.5 million (US$9.05 million) fine on Sigma-Aldrich, under the EU’s 2004 Merger Regulation, for providing incorrect or misleading information during a merger investigation.
Astrazeneca plc followed up its win a year ago in heart failure (HF) with yet another approval for its oral SGLT2 inhibitor, Farxiga (dapagliflozin), now cleared by the FDA to reduce the odds of kidney function decline, failure, cardiovascular death and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic plc., Molli Surgical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Amicus, Avrobio, Astrazeneca, Camurus, Chiesi, Clearside, Galmed, Intra-Cellular, Jacobio, Moderna.
The negotiations for the next device user fee agreement are well underway, and there are signs that the FDA is looking for a significant boost in user fees from device makers. However, Rep. Anna Eshoo (D-Calif.) told members of the MDMA that no member of Congress should believe that user fees relieve Congress of its responsibility “for funding the agency in a robust way.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS tacks three years onto CJR, revises target price calculation; Connect for Health Act back in play; More bezel troubles for Alaris 8100; CMS announces two meetings for FY 2022 lab fee schedule.
Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we're going to do everything we can to resolve these issues quickly, and as safely as possible,” he said during an April 29 conference call on first-quarter financial results.
The FDA slapped Leo Pharma A/S’ BLA for IL-13 inhibitor tralokinumab with a complete response letter (CRL), making it the latest atopic dermatitis candidate to hit a regulatory setback in the U.S., following delays for three oral JAK inhibitor drugs earlier this month.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Biocryst, Biomarin, Biontech, BMS, Eagle, Hikma, Janssen, Legend, Leo, Pfizer, Praxis Precision Medicines, Therapeutic Solutions International, Xeris.
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