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Medical conferences often are a platform to showcase new clinical trophies. But that wasn't the case for Merck at this year’s European Society for Medical Oncology meeting. The Big Pharma presented a series of trial flops for its megablockbuster cancer immunotherapy, Keytruda. We'll discuss if the Merck checkpoint inhibitor has reached a bottleneck or if it was just bad luck. 

Also under discussion is the monkeypox test Emergency Use Authorization. Because monkeypox continues to spread in the U.S. and worldwide, the FDA granted its first EUA for a diagnostic test. This regulatory path was also used for COVID-19 tests. But the FDA learned a few lessons from the pandemic and hopes the new guidelines will help avoid the problems seen then.  

To learn more about topics in this episode: 
ESMO: AstraZeneca, Merck tout Lynparza's 'clinically meaningful' ovarian cancer survival edge but lose one in prostate cancer
ESMO: Roche eyes untouched newly diagnosed lung cancer market for solo Tecentriq
ESMO: Adding bempeg to Opdivo lowered response rate in Bristol Myers-Nektar failed cancer trial
ESMO: GSK keeps the faith in anti-TIGIT plans; it's 'not always about being first'
UPDATED ESMO: Amgen's Lumakras confirmatory lung cancer data leave door open for KRAS competitors
ESMO: Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing
Here we go again: FDA opens up emergency authorizations to monkeypox tests
Moderna sizes up private COVID vaccine market in US, where shots could cost $100 a pop
Sony dives into nascent over-the-counter hearing aid market with WS Audiology partnership
OTC birth control could be on the way from Perrigo, as FDA gathers expert panel
Altimmune sees phase 1 success in tricky NASH indication with GLP-1 agonist
Oramed phase 2 insulin drug data 'paint an exciting picture' in rocky NASH landscape
Akero hits endpoints in midphase NASH trial, linking candidate to improvements in fibrosis
BMS’ preferred drug in its $74B Celgene buy is set to pay dividends, winning its first FDA nod

The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

Medical conferences often are a platform to showcase new clinical trophies. But that wasn't the case for Merck at this year’s European Society for Medical Oncology meeting. The Big Pharma presented a series of trial flops for its megablockbuster cancer immunotherapy, Keytruda. We'll discuss if the Merck checkpoint inhibitor has reached a bottleneck or if it was just bad luck. 
Also under discussion is the monkeypox test Emergency Use Authorization. Because monkeypox continues to spread in the U.S. and worldwide, the FDA granted its first EUA for a diagnostic test. This regulatory path was also used for COVID-19 tests. But the FDA learned a few lessons from the pandemic and hopes the new guidelines will help avoid the problems seen then.  
To learn more about topics in this episode: 
<ul>
<li><a href="https://www.fiercepharma.com/pharma/esmo-astrazeneca-merck-tout-lynparzas-clinically-meaningful-ovarian-cancer-survival-edge">ESMO: AstraZeneca, Merck tout Lynparza's 'clinically meaningful' ovarian cancer survival edge but lose one in prostate cancer</a></li>
<li><a href="https://www.fiercepharma.com/pharma/esmo-roche-spots-big-untouched-newly-diagnosed-lung-cancer-market-tecentriq-monotherapy">ESMO: Roche eyes untouched newly diagnosed lung cancer market for solo Tecentriq</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/esmo-adding-bempeg-opdivo-lowered-response-rate-bristol-myers-nektars-failed-cancer-trial">ESMO: Adding bempeg to Opdivo lowered response rate in Bristol Myers-Nektar failed cancer trial</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/gsk-forging-ahead-2b-anti-tigit-plans-says-its-not-always-about-being-first">ESMO: GSK keeps the faith in anti-TIGIT plans; it's 'not always about being first'</a></li>
<li><a href="https://www.fiercepharma.com/pharma/esmo-amgens-lumakras-lung-cancer-confirmatory-trial-data-are-here-fanning-kras-battle">UPDATED ESMO: Amgen's Lumakras confirmatory lung cancer data leave door open for KRAS competitors</a></li>
<li><a href="https://www.fiercepharma.com/pharma/esmo-gileads-trodelvy-makes-surprise-comeback-above-par-breast-cancer-survival-showing">ESMO: Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing</a></li>
<li><a href="https://www.fiercebiotech.com/medtech/here-we-go-again-fda-opens-emergency-authorizations-monkeypox-tests">Here we go again: FDA opens up emergency authorizations to monkeypox tests</a></li>
<li><a href="https://www.fiercepharma.com/pharma/moderna-sizes-13b-covid-market-us-where-shots-could-cost-100-pop">Moderna sizes up private COVID vaccine market in US, where shots could cost $100 a pop</a></li>
<li><a href="https://www.fiercebiotech.com/medtech/sony-dives-nascent-over-counter-hearing-aid-market-ws-audiology-partnership">Sony dives into nascent over-the-counter hearing aid market with WS Audiology partnership</a></li>
<li><a href="https://www.fiercepharma.com/pharma/otc-birth-control-could-be-available-soon-perrigo-pending-fda-adcomm-vote-novemeber">OTC birth control could be on the way from Perrigo, as FDA gathers expert panel</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/altimmunes-phase-1b-nash-trial-meets-target-though-stock-takes-hit">Altimmune sees phase 1 success in tricky NASH indication with GLP-1 agonist</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/encouraging-oramed-phase-2-data-paint-exciting-picture-rocky-nash-landscape">Oramed phase 2 insulin drug data 'paint an exciting picture' in rocky NASH landscape</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/akero-hits-endpoints-midphase-nash-trial-linking-candidate-improvements-fibrosis">Akero hits endpoints in midphase NASH trial, linking candidate to improvements in fibrosis</a></li>
<li><a href="https://www.fiercepharma.com/pharma/bristol-myers-squibbs-deucravactinib-scores-fda-approval-plaque-psoriasis">BMS’ preferred drug in its $74B Celgene buy is set to pay dividends, winning its first FDA nod</a></li>
</ul>
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

The Top Line

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
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