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Home » complete response letters

Articles Tagged with ''complete response letters''

Auvelity

After a year of delay, Axsome’s depression therapy wins US FDA approval

Aug. 19, 2022
By Lee Landenberger
A year from the U.S. FDA’s August 2021 citation of deficiencies in the labeling for Axsome Therapeutics Inc.’s major depressive disorder therapy, Auvelity (dextromethorphan + bupropion), the agency has approved the drug for use by adults. The New York-based company’s stock (NASDAQ:AXSM) took flight on the news, with shares rising 40% to close at $59.55 Aug. 19, surpassing their previous 52-week high of $48.82 and starkly contrasting with a same-period low of $19.38.
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Akebia regains vadadustat rights from Otsuka

July 1, 2022
By Lee Landenberger
More than five years after agreeing to collaborate in a deal that had the potential to top $1 billion, Akebia Therapeutics Inc. executed an agreement to terminate its troubled partnership to develop vadadustat with Otsuka Pharmaceutical Co. Ltd. Otsuka will pay Akebia a $55 million settlement fee.
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US FDA rejects Spero’s oral antibiotic tebipenem, demanding further trial

June 28, 2022
By Richard Staines

Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.


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Health professional pointing stethoscope at Clinical Trial words, icons

CRLs make week's start rough start for four companies

May 3, 2022
By Lee Landenberger
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
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CRLs make week's start rough start for four companies

May 2, 2022
By Lee Landenberger
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
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Risperidone molecule and packaging

Medincell stock drops as FDA hits Teva with CRL on long-acting risperidone

April 20, 2022
By Cormac Sheridan
Shares in Medincell SA dropped 29.1% Apr. 20 on news that the U.S. FDA slapped a complete response letter (CRL) on an NDA for an extended release, long-acting formulation of risperidone, which it is co-developing with Teva Pharmaceuticals Industries Ltd. as a maintenance treatment for schizophrenia.
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Innovent, Lilly receive CRL for NSCLC candidate sintilimab

March 29, 2022
By Michael Fitzhugh

Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. 



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Lung cancer illustration

Innovent, Lilly receive CRL for NSCLC candidate sintilimab

March 24, 2022
By Michael Fitzhugh

Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.



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U.S. FDA headquarters

US FDA issues CRLs to Reata, Amryt and GC Pharma

March 1, 2022
By Lee Landenberger

Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28. 


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U.S. FDA headquarters

US FDA issues CRLs to Reata, Amryt and GC Pharma

Feb. 28, 2022
By Lee Landenberger

Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28. The stock (NASDAQ:RETA) rose 25.3% as the company decides how it wants to handle the CRL.


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