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Home » complete response letters

Articles Tagged with ''complete response letters''

FDA icons

COVID-19 pandemic delays FDA approvals, causes CRL

Nov. 23, 2020
By Brian Orelli
Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected.
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Psychiatric disorders illustration

No need to sugar-coat CRL as Alkermes forges ahead with launch plans

Nov. 17, 2020
By Randy Osborne
Even as Alkermes plc works to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, labeling talks are underway for the compound, an oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the firm said, and shares (NASDAQ:ALKS) hardly moved, closing Nov. 17 at $18.30, up 45 cents.
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Red blood cells, artery

A CRL for sutimlimab is Sanofi’s Friday 13th bad luck charm

Nov. 16, 2020
By Lee Landenberger
The FDA has issued Sanofi SA a complete response letter (CRL) regarding its complement pathway inhibitor sutimlimab, citing deficiencies found during a pre-license inspection of a third-party manufacturing facility.
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CRL makes for parked Avenue; I.V. tramadol traffic stacked

Oct. 12, 2020
By Randy Osborne
New York-based Avenue Therapeutics Inc. took receipt from the FDA of a surprise complete response letter (CRL) – characterized by Wainwright analyst Joseph Pantginis as “bizarre” – with regard to the NDA for intravenous (I.V.) tramadol in acute pain.
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Stem cells

Mesoblast stock tanks on news of FDA CRL for Ryoncil BLA in pediatric GVHD

Oct. 6, 2020
By Tamra Sami
PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.
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Stem cells

Mesoblast stock tanks on news of FDA CRL for Ryoncil BLA in pediatric GVHD

Oct. 2, 2020
By Tamra Sami
PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.
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Regulatory front

FDA issues ANDA guidance

Sep. 28, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma.
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Charmless: Third CRL for Mallinckrodt’s terlipressin

Sep. 14, 2020
By Lee Landenberger
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug.
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As expected, Tricida’s veverimer gets a CRL

Aug. 24, 2020
By Michael Fitzhugh and Lee Landenberger
Tricida Inc. executives were not surprised when the FDA issued a complete response letter for veverimer to treat chronic metabolic acidosis. Despite an Aug. 22 PDUFA date, the company had received an FDA notification on July 16 that there were deficiencies that would preclude discussion of labeling and postmarketing requirements and commitments.
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A surprised Biomarin fields a CRL on its hemophilia BLA

Aug. 19, 2020
By Lee Landenberger
Biomarin Pharmaceutical Inc.’s complete response letter (CRL) for Roctavian (valoctocogene roxaparvovec; Valrox) gene therapy for severe hemophilia A shocked the company, its investors and analysts mere days before its Aug. 21 PDUFA date. Now an approval and launch for what would have been the first approved hemophilia gene therapy is likely pushed back roughly two years.
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