I get a daily email summary about biopharma news f
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Posted On: 06/02/2022 7:03:43 PM
I get a daily email summary about biopharma news from Endpoints News. Here are two articles from today that touch on subjects that have been discussed on this board in months gone by.
I included most (but not all) of the articles below. If you want to read the entire articles, use link below for the first article and then scroll down the webpage for the second article.
https://endpts.com/fda-compliance-vet-heads-t...ic-career/
FDA compliance vet heads to India-based Lupin after long public career
In a rare move, a long-time veteran of the FDA’s pharma quality and compliance team is moving over to an India-based generic drugmaker with a history of noncompliance.
Diana Amador-Toro, who spent almost four decades with FDA including stints as a program director for the office of pharmaceutical quality operations, was hired in April by Indian generic drug manufacturer Lupin as the company’s senior vice president of global compliance, where she will be handling the company’s compliance function including training, internal audits and investigations.
According to her LinkedIn, Amador-Toro has amassed well over 36 years of FDA field experience in investigations and compliance activities, contributing to ICH and FDA guidance documents as well as having conducted GMP and pharmaceutical quality training in Europe and South America. Before serving as a program director, she was responsible for hundreds of field employees in seven districts and three laboratories including the ORA’s forensic chemistry center.
While a few former FDA employees have gone on to work for manufacturers in the past, the fact that Lupin was able to net a compliance officer is a major catch for the manufacturer. However, Amador-Tor is joining a company that has run afoul with US regulators and has been cited multiple times.
Another refuse-to-file for a small biotech — is the FDA using RTFs to manage its workload?
As the regular flow of NDA and BLA submissions continues to pick up, it’s little wonder that an already Covid-beleaguered FDA seems to be increasingly turning to refuse-to-file letters as a means to provide instructive feedback, and perhaps even to slow the pace of its workload.
The latest RTF letter, disclosed Thursday by Aeglea BioTherapeutics, a penny-stock, clinical-stage biotech company calls for new efficacy data to be included in its BLA for pegzilarginase for the treatment of the rare, progressive and debilitating disease characterized by high levels of arginine, and known as Arginase 1 Deficiency. The company’s stock price fell by more than 40% on Thursday.
Unlike complete response letters, which are essentially FDA rejections, RTFs allow the FDA to reject an application before beginning a more complete review. But some tracking the industry closely think the FDA has been turning more and more to these RTFs, and in instances where the agency may have seemed to be less than forthcoming, or so the companies say.
Nymox Pharmaceutical disclosed an RTF last week and similarly saw its share price plummet. In Nymox’s case, the company says it wasn’t informed by the FDA of what was coming.
The FDA requested longer-term safety data in its NDA for fexapotide triflutate as a potential treatment for benign prostatic hyperplasia or prostate enlargement. The company said longer-term safety data (as long as 6 years after a single low dose non-systemic injection given one time only) “was not requested by the FDA in any previous pre-NDA communications.”
The FDA also requested additional CMC data, and Aeglea said it intends to request a Type A meeting (i.e. for stalled development programs) with the FDA to clarify and respond to the RTF letter.
Those interactions are key as CBER’s Peter Marks recently indicated at a conference that his center is relying mostly on written communications to talk with sponsors.
Marks acknowledged CBER’s staff shortages, which should be ameliorated somewhat by the incoming user fee deals, and that this “is not an optimal situation. Even prior to the pandemic, we were understaffed. My key for 2022 is a recovery theme — my hope is that as we ease into the next calendar year, more robust exchanges with the agency occur, including teleconferences.”
I included most (but not all) of the articles below. If you want to read the entire articles, use link below for the first article and then scroll down the webpage for the second article.
https://endpts.com/fda-compliance-vet-heads-t...ic-career/
FDA compliance vet heads to India-based Lupin after long public career
In a rare move, a long-time veteran of the FDA’s pharma quality and compliance team is moving over to an India-based generic drugmaker with a history of noncompliance.
Diana Amador-Toro, who spent almost four decades with FDA including stints as a program director for the office of pharmaceutical quality operations, was hired in April by Indian generic drug manufacturer Lupin as the company’s senior vice president of global compliance, where she will be handling the company’s compliance function including training, internal audits and investigations.
According to her LinkedIn, Amador-Toro has amassed well over 36 years of FDA field experience in investigations and compliance activities, contributing to ICH and FDA guidance documents as well as having conducted GMP and pharmaceutical quality training in Europe and South America. Before serving as a program director, she was responsible for hundreds of field employees in seven districts and three laboratories including the ORA’s forensic chemistry center.
While a few former FDA employees have gone on to work for manufacturers in the past, the fact that Lupin was able to net a compliance officer is a major catch for the manufacturer. However, Amador-Tor is joining a company that has run afoul with US regulators and has been cited multiple times.
Another refuse-to-file for a small biotech — is the FDA using RTFs to manage its workload?
As the regular flow of NDA and BLA submissions continues to pick up, it’s little wonder that an already Covid-beleaguered FDA seems to be increasingly turning to refuse-to-file letters as a means to provide instructive feedback, and perhaps even to slow the pace of its workload.
The latest RTF letter, disclosed Thursday by Aeglea BioTherapeutics, a penny-stock, clinical-stage biotech company calls for new efficacy data to be included in its BLA for pegzilarginase for the treatment of the rare, progressive and debilitating disease characterized by high levels of arginine, and known as Arginase 1 Deficiency. The company’s stock price fell by more than 40% on Thursday.
Unlike complete response letters, which are essentially FDA rejections, RTFs allow the FDA to reject an application before beginning a more complete review. But some tracking the industry closely think the FDA has been turning more and more to these RTFs, and in instances where the agency may have seemed to be less than forthcoming, or so the companies say.
Nymox Pharmaceutical disclosed an RTF last week and similarly saw its share price plummet. In Nymox’s case, the company says it wasn’t informed by the FDA of what was coming.
The FDA requested longer-term safety data in its NDA for fexapotide triflutate as a potential treatment for benign prostatic hyperplasia or prostate enlargement. The company said longer-term safety data (as long as 6 years after a single low dose non-systemic injection given one time only) “was not requested by the FDA in any previous pre-NDA communications.”
The FDA also requested additional CMC data, and Aeglea said it intends to request a Type A meeting (i.e. for stalled development programs) with the FDA to clarify and respond to the RTF letter.
Those interactions are key as CBER’s Peter Marks recently indicated at a conference that his center is relying mostly on written communications to talk with sponsors.
Marks acknowledged CBER’s staff shortages, which should be ameliorated somewhat by the incoming user fee deals, and that this “is not an optimal situation. Even prior to the pandemic, we were understaffed. My key for 2022 is a recovery theme — my hope is that as we ease into the next calendar year, more robust exchanges with the agency occur, including teleconferences.”
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