An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly and Company in early breast cancer.
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Fierce Pharma is the go-to destination for the news and trends shaping the industry. Our focus daily is on news about approved drugs and every aspect of pharma’s operations as well as the people who move pharma forward. Our coverage also feeds longer-form content, podcasts and events. In staying on top of the news, our journalists have developed a loyal audience. Critically, we explain the news—often complicated technology or business maneuvers—and put it in context that brings it home for our readers and listeners in their work lives. Delivering news, revealing insights straight to your inboxes: https://fiercepharma.questexinfo.com/loading.do?omedasite=Pharma_full. Our family of publications includes Fierce Pharma, Fierce Pharma PM Tracker, Fierce Pharma Marketing, Fierce Manufacturing, Fierce Drug Delivery and Fierce Life Sciences Weekly Digest. Follow our podcast ‘The Top Line’ on Apple Podcasts, Spotify, Amazon, iHeart or wherever you get your podcasts. We dig into high-impact trends and recount the week’s biggest headlines. For Biotech news you can’t miss: https://www.dhirubhai.net/showcase/fierce-biotech For Healthcare news you can’t miss: https://www.dhirubhai.net/showcase/fierce-healthcare
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Fierce Pharma员工
动态
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With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow.
Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama
fiercepharma.com
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As this year’s RSV season approaches, Beyfortus makers Sanofi and AstraZeneca are making preparations to avoid last year's supply issue with a newly approved filling line. In all, the partners plan to provide enough supply to cover every eligible infant in the U.S.
With amped up manufacturing effort, Sanofi and AZ look to avoid Beyfortus shortfalls this year
fiercepharma.com
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PhRMA is?pushing?the FDA to expand drug manufacturers’ powers to correct misinformation about their products, including by allowing them to respond to opinions, value judgments or personal experiences and communications made offline.
PhRMA pushes FDA to change 'overly simplistic' and 'unduly restrictive' online misinformation proposals
fiercepharma.com
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Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss to treat atopic dermatitis.
Lilly's immunology unit scores another FDA nod with eczema treatment Ebglyss
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In 2021, the FDA blasted Merck for using a premature endpoint to pursue a Keytruda approval in early-stage triple-negative breast cancer. Now, the PD-1 inhibitor has gold-standard overall survival data to back its case.
ESMO: With survival win, Merck's Keytruda redeems itself in early triple-negative breast cancer
fiercepharma.com
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It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initial launch plans last year.
After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drug
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As if a limited initial FDA approval was not bad enough, AstraZeneca’s Truqap has recorded a pivotal trial flop that could raise additional doubts around the first-in-class AKT inhibitor. From AZ’s perspective, a company executive argued the failure was probably a one-off.
ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flop
fiercepharma.com
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Eleven months after sustaining a?rejection?from the FDA for Dupixent to treat chronic spontaneous urticaria, Sanofi and Regeneron have presented data from a phase 3 trial that could help push the megablockbuster across the finish line in the indication.
After FDA rejection, Sanofi and Regeneron show data that could pave way for Dupixent to treat hives condition
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The companies named in the bill have been quick to defend themselves in recent months. Naturally, they’re none too pleased with the latest development in Congress.
After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned
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