The FDA is making some changes in the accelerated approval process. In this episode, we’ll discuss the recent changes with the FDA’s regulation of cancer drugs and how these shifts will impact the biopharma industry.  

Also in this episode, we cover the week's biggest headlines from the annual J.P. Morgan Healthcare conference. 

To learn more about topics in this episode:
Fierce JPM Week
Podnosis: The Pulse of the Healthcare Industry
FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says
Capitalizing on share price crash, AstraZeneca inks $1.8B CinCor takeover for blood pressure drug
JPM23: Chiesi gets jump-start on JPM buzz with $1.48B Amryt buyout
JPM23: Ipsen scoops up liver disease specialist Albireo for $952M
Editas rewrites its own code after tough 2022, sending staff packing and editing down programs
JPM23: Editas touts skinnier pipeline after major shake-up to ride out 'unfriendly' markets
With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch
AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use
Baxter bids adieu to $5B kidney care division with spinout plan

"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.

The FDA is making some changes in the accelerated approval process. In this episode, we’ll discuss the recent changes with the FDA’s regulation of cancer drugs and how these shifts will impact the biopharma industry.  
Also in this episode, we cover the week's biggest headlines from the annual J.P. Morgan Healthcare conference. 
To learn more about topics in this episode:
<ul>
<li><a href="https://www.fiercejpmweek.com/" data-cke-saved-href="https://www.fiercejpmweek.com/">Fierce JPM Week</a></li>
<li><a href="https://podcasts.apple.com/us/podcast/podnosis/id1643773823" data-cke-saved-href="https://podcasts.apple.com/us/podcast/podnosis/id1643773823">Podnosis: The Pulse of the Healthcare Industry</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/fdas-pazdur-have-your-cancer-confirmatory-trial-underway-accelerated-approval-expect" data-cke-saved-href="https://www.fiercebiotech.com/biotech/fdas-pazdur-have-your-cancer-confirmatory-trial-underway-accelerated-approval-expect">FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/capitalizing-share-price-crash-astrazeneca-inks-18b-cincor-takeover-blood-pressure-drug-0" data-cke-saved-href="https://www.fiercebiotech.com/biotech/capitalizing-share-price-crash-astrazeneca-inks-18b-cincor-takeover-blood-pressure-drug-0">Capitalizing on share price crash, AstraZeneca inks $1.8B CinCor takeover for blood pressure drug</a></li>
<li><a href="https://www.fiercepharma.com/pharma/chiesi-gets-jump-start-jpm-buzz-148b-amyrt-buyout" data-cke-saved-href="https://www.fiercepharma.com/pharma/chiesi-gets-jump-start-jpm-buzz-148b-amyrt-buyout">JPM23: Chiesi gets jump-start on JPM buzz with $1.48B Amryt buyout</a></li>
<li><a href="https://www.fiercepharma.com/pharma/ipsen-scoops-pediatric-liver-disease-specialist-albireo-952m" data-cke-saved-href="https://www.fiercepharma.com/pharma/ipsen-scoops-pediatric-liver-disease-specialist-albireo-952m">JPM23: Ipsen scoops up liver disease specialist Albireo for $952M</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/editas-rewrites-its-own-code-after-tough-2022-sending-staff-packing-and-editing-down" data-cke-saved-href="https://www.fiercebiotech.com/biotech/editas-rewrites-its-own-code-after-tough-2022-sending-staff-packing-and-editing-down">Editas rewrites its own code after tough 2022, sending staff packing and editing down programs</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/jpm23-editas-keeps-focus-future-after-major-pipeline-workforce-shake" data-cke-saved-href="https://www.fiercebiotech.com/biotech/jpm23-editas-keeps-focus-future-after-major-pipeline-workforce-shake">JPM23: Editas touts skinnier pipeline after major shake-up to ride out 'unfriendly' markets</a></li>
<li><a href="https://www.fiercepharma.com/pharma/lecanemabs-alzheimers-approval-eisai-and-biogen-plot-meticulous-launch" data-cke-saved-href="https://www.fiercepharma.com/pharma/lecanemabs-alzheimers-approval-eisai-and-biogen-plot-meticulous-launch">With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch</a></li>
<li><a href="https://www.fiercepharma.com/pharma/astrazenecas-first-class-rescue-inhaler-airsupra-wins-fda-nod-only-adult-use" data-cke-saved-href="https://www.fiercepharma.com/pharma/astrazenecas-first-class-rescue-inhaler-airsupra-wins-fda-nod-only-adult-use">AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use</a></li>
<li><a href="https://www.fiercebiotech.com/medtech/baxter-bids-adieu-5b-kidney-care-division-spinout-plan" data-cke-saved-href="https://www.fiercebiotech.com/medtech/baxter-bids-adieu-5b-kidney-care-division-spinout-plan">Baxter bids adieu to $5B kidney care division with spinout plan</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.
&nbsp;

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