Joe Turgeon Healthcare News

This is selected healthcare news for Joe Turgeon, which is filed under People. There are 54 news items for this page. A press release filter page is also available for Joe Turgeon.

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Date Headline (link) Source
8/19/2021 Spectrum Pharmaceuticals, inc (SPPI) Q2 2021 Earnings Call Transcript
... was sent out earlier this afternoon, and is available on our website at www.sppirx.com. Joining me on the call today from Spectrum Pharmaceuticals will be Joe Turgeon, President and CEO; and Dr. Francois Lebel, Chief Medical Officer. Before we get started, I would like to reference the notice regarding forward ...
illinoisnewstoday.com
8/13/2021 Spectrum Pharmaceuticals Reports Second Quarter 2021 Financial Results and Corporate Update | Financial Buzz
... a corporate update. ‚AuMomentum continues to build with poziotinib and the submission of the NDA later this year is our top corporate priority,‚Au said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. ‚AuWe are also seeking clarification on the recent CRL for ROLONTIS and are planning to have a ...
financialbuzz.com
8/12/2021 Spectrum Pharmaceuticals Reports Second Quarter 2021 Financial Results and Corporate Update
... a corporate update. ‚AuMomentum continues to build with poziotinib and the submission of the NDA later this year is our top corporate priority,‚Au said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. ‚AuWe are also seeking clarification on the recent CRL for ROLONTIS and are planning to have a ...
Business Wire
8/9/2021 Manufacturing Deficiencies Delay Decision on Eflapegrastim
... the treatment arms. Continue Reading ‚AuWe are disappointed with this outcome and look forward to fully understanding the remediation timelines for the program,‚Au said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. ‚AuWe continue to believe in Rolontis and plan to diligently complete the regulatory process to bring Rolontis ...
empr.com
8/6/2021 Spectrum’s Rolontis, angling to rival Amgen’s Neulasta, hit with FDA rejection over manufacturing ‘deficiencies’
... spokesperson said over email. While ‚Audisappointed‚Au by the decision, Spectrum is eager to get a sense of the ‚Auremediation timelines for the program,‚Au Joe Turgeon, president and CEO at Spectrum, said in a statement. The company remains confident in its medicine and plans to ‚Audiligently complete‚Au the ...
FiercePharma
8/6/2021 Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Rolontis (eflapegrastim)
... agency as soon as possible. ‚AuWe are disappointed with this outcome and look forward to fully understanding the remediation timelines for the program,‚Au said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. ‚AuWe continue to believe in Rolontis and plan to diligently complete the regulatory process to bring Rolontis ...
drugs.com
6/1/2021 Spectrum Pharmaceuticals Announces That the ROLONTIS® (eflapegrastim) Pre-Approval Inspection Has Been Initiated | 2021-06-01 | Press Releases | Stockhouse
... related to the COVID-19 pandemic. ‚AuI would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. About ROLONTIS ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication ...
stockhouse.com
6/1/2021 Spectrum Pharmaceuticals Announces That the ROLONTIS® (eflapegrastim) Pre-Approval Inspection Has Been Initiated | Business Wire
... related to the COVID-19 pandemic. ‚AuI would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility,‚Au said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. About ROLONTIS ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication ...
Business Wire
6/1/2021 Spectrum Pharmaceuticals Announces That the ROLONTIS® (eflapegrastim) Pre-Approval Inspection Has Been Initiated - Stocks News Feed
... related to the COVID-19 pandemic. ‚AuI would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility,‚Au said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals . About ROLONTIS ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication ...
stocksnewsfeed.com
5/13/2021 Spectrum Pharmaceuticals Reports First Quarter 2021 Financial Results and Corporate Update
... priority is submission of the NDA to the FDA for poziotinib based on the positive data from Cohort 2 of the ZENITH20 clinical trial," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The additional data on twice daily dosing presented at AACR has the potential to significantly expand the ...
Yahoo News
3/31/2021 Spectrum Pharmaceuticals Reports Fourth Quarter 2020 and Full Year 2020 Financial Results and Pipeline Update
... month period and full year ended December 31, 2020. ‚AuThe Fast Track designation for poziotinib is a significant achievement towards an expedited review,‚Au said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. ‚AuIn addition, we are delighted that the FDA has scheduled the pre-approval inspection at the ROLONTIS ...
financialbuzz.com
3/16/2021 Spectrum Pharmaceuticals Provides Update on ROLONTIS® (eflapegrastim) Pre-Approval Inspection
... I am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We believe the pre-approval inspection marks the final step in the ROLONTIS review process." About ROLONTIS ...
Yahoo News
3/16/2021 Spectrum Pharmaceuticals Provides Update on ROLONTIS® (eflapegrastim) Pre-Approval Inspection
... am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May,‚Au said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. ‚AuWe believe the pre-approval inspection marks the final step in the ROLONTIS review process.‚Au About ...
Business Wire
3/12/2021 FDA grants fast track status to poziotinib for HER2-mutated NSCLC
... approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted fast track designation for poziotinib,‚Au Joe Turgeon, president and CEO of Spectrum Pharmaceuticals, said in the release. ‚AuMomentum is building to unlock the potential of poziotinib.‚Au ...
healio.com
3/11/2021 SPPI Stock Price Increases Over 20% Pre-Market: Why It Happened
... and we are pleased that the FDA has granted Fast Track designation for poziotinib. Momentum is building to unlock the potential of poziotinib.‚Au Joe Turgeon, President and CEO of Spectrum Pharmaceuticals ‚AuWe are actively preparing the NDA and delighted with this Fast Track designation. In addition, last week ...
pulse2.com
3/11/2021 FDA Grants Fast Track Designation to Spectrum Pharmaceuticals’ Poziotinib
... approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted Fast Track designation for poziotinib," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Momentum is building to unlock the potential of poziotinib." "We are actively preparing the NDA and delighted ...
Yahoo News
3/11/2021 Spectrum Pharma Climbs as FDA to Fast-Track Cancer Drug Review
... a new-drug application for poziotinib later this year. ‚AuThere are currently no approved therapies to treat patients with HER2 exon 20 mutations,‚Au said Joe Turgeon, chief executive of Spectrum Pharmaceuticals. Fast track is "designed to facilitate the development, and expedite the review of drugs to treat serious conditions ...
TheStreet
11/18/2020 Spectrum Therapeutics Inc. (NASDAQ:SPPI) Announced Q3 2020 Results And Poziotinib and ROLONTIS Developement Update
... 18, 2020 Spectrum Therapeutics Inc. (NASDAQ:SPPI) has announced its financial results for the third quarter ended September 30, 2020. FDA to review poziotinib NDA Joe Turgeon the company's CEO and President, stated that in Q3 Spectrum Therapeutics made significant progress in its drug development programs and also strengthened ...
biopharmajournal.com
10/27/2020 FDA Delays Review of Spectrum’s Investigational Neutropenia Drug
... COVID-19-related deaths. “We are actively working with the FDA to find a way to expedite the plant inspection,” said Spectrum President and CEO Joe Turgeon. “The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible ...
fdanews.com
10/26/2020 FDA delays decision on Spectrum Pharma’s drug candidate due to travel curbs
... of the drug, the company said. "We are actively working with the FDA to find a way to expedite the plant inspection," Chief Executive Officer Joe Turgeon said in a statement. The regulator had warned in April it may not be able to sustain its current level of timely reviews ...
MSN
10/26/2020 Spectrum Pharmaceuticals Announces that the FDA is Deferring its Action on the BLA for ROLONTIS® (eflapegrastim)
... that this is not a Complete Response Letter. “We are actively working with the FDA to find a way to expedite the plant inspection,” said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. “The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their ...
Business Wire
10/26/2020 Spectrum Pharmaceuticals Announces that the FDA is Deferring its Action on the BLA for ROLONTIS® (eflapegrastim)
... that this is not a Complete Response Letter. “We are actively working with the FDA to find a way to expedite the plant inspection,” said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. “The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their ...
intellasia.net
10/26/2020 FDA Delays Decision on Spectrum Pharma’s Drug Candidate Due to Travel Curbs
... shares down 2.3% before the bell. "We are actively working with the FDA to find a way to expedite the plant inspection," Chief Executive Officer Joe Turgeon said in a statement. The company clarified that the move was not a Complete Response Letter (CRL) from the FDA. Receiving a CRL ...
U.S. News & World Report
10/26/2020 FDA delays decision on Spectrum Pharma’s drug candidate due to travel curbs
... shares down 2.3% before the bell. "We are actively working with the FDA to find a way to expedite the plant inspection," Chief Executive Officer Joe Turgeon said in a statement. The company clarified that the move was not a Complete Response Letter (CRL) from the FDA. Receiving a CRL ...
hi99.com
9/29/2020 Spectrum Pharmaceuticals Announces Positive Topline Results in HER2 Exon20 Insertion Mutations from Cohort 2 of the Poziotinib ZENITH20 Trial
... insertion mutations (Cohort 2). “The positive results of Cohort 2 are a significant milestone and we are looking forward to meeting with the FDA,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “We believe that poziotinib is a significant advancement for patients with this deadly disease in an area ...
biotech-finances.com