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New Drug Designations - May 2024
INSIGHTS+

New Drug Designations – May 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices  This…
June 25, 2024

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Astrazeneca
NEWS

AstraZeneca’s Truqap Plus Faslodex Receives the CHMP’s Positive Opinion for Treating Breast Cancer 

Shots:  The CHMP's positive opinion was based on the P-III (CAPItello-291) study assessing Truqap + Faslodex vs PBO + Faslodex to treat ER+, HER2‑ locally advanced or metastatic breast cancer patients (n=708) having ≥1 PIK3CA, AKT1 or PTEN-alterations after recurrence or progression on or after an endocrine-based regimen  The study demonstrated reduction in the disease…
April 29, 2024

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VIEWPOINTS_Nirja Patel_2023
VIEWPOINTS

Nirja Patel, Senior International Product Manager at Roche Shares her Views on the US FDA Approval of the PATHWAY anti-HER2 Test

Shots:  Nirja gave the details of the PATHWAY anti-HER2 (4B5) to identify metastatic breast cancer patients with low HER2 expression through its scoring algorithm that helps pathologists to identify “low expressors” of HER2  She told PharmaShots about how this test is able to identify patients who may benefit from Enhertu as a treatment option. She…
March 7, 2023

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Viewpoints_Denis Corin
VIEWPOINTS

PharmaShots Interview: Q BioMed’s Denis Corin Shares Insights on the Agreement to Serve US Department of Defense and Veterans Affairs

In an interview with PharmaShots, Denis Corin, Chief Executive Officer and Chairman of the Board at Q BioMed share his views on the supply agreement for Strontium89 with the US Department of Defense and Veterans Affairs. Shots: BioMed has signed a 5-year agreement to commercially serve the US Department of Veterans Affairs (VA) and Department of Defense…
July 13, 2021

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Viewpoints_Ken Keller
VIEWPOINTS

PharmaShots Interview: Daiichi Sankyo’s Ken Keller Shares Insights on NICE Recommendation for Enhertu in HER2 Positive Breast Cancer

In an interview with PharmaShots, Ken Keller, President and Chief Executive Officer at Daiichi Sankyo and Global Head of the Daiichi Sankyo Oncology Business shared his views on the NICE CDF recommendation for Enhertu in unresectable or metastatic HER2 positive breast cancer and the company's growth and pipeline. Shots: The recommendation from NICE is based on the…
June 2, 2021

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