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Innovative immune therapy advancements don't just happen anywhere. Discover why the industry's leaders choose Puerto Rico to impact the world. It's not what's next, it's where. 
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Today’s Big NewsMar 29, 2024 |
| By Annalee Armstrong Days after Regeneron received a complete response letter for the blood cancer medicine odronextamab, hematology executive Andres Sirulnik says the trial is enrolling just fine—it’s just that randomization hasn’t begun. |
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By Kevin Dunleavy Bristol Myers Squibb’s Zeposia has attracted attention as a treatment for an odd pair of unrelated diseases—multiple sclerosis (MS) and ulcerative colitis (UC). But the approval roll for the sphingosine 1-phosphate (S1P) receptor modulator may be over. On Thursday, the New Jersey company said that its trial assessing Zeposia in Crohn’s disease had come up short. |
By Conor Hale The FDA elevated the voluntary device removal with a public safety announcement earlier this month before handing the action a Class I recall label March 28. InfuTronix will cease supporting the systems June 20. |
By Annalee Armstrong,Max Bayer,Gabrielle Masson,James Waldron What's the best biotech name? It's time to vote in the Fierce Madness #biotechbracket. |
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Monday, April 22, 2024 | 10am ET / 7am PT Explore cutting-edge NASH research with a novel NAFLD/NASH animal model mirroring patient experiences. Witness Resmetirom's impact on fat accumulation using human cell-based in vitro models. Expect clinical relevance, quick insights in 12-16 weeks, and cost savings. Register now! 
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By Zoey Becker While the drug is not listed on the FDA's shortage list, some pharmacies are facing supply issues. Amazon Pharmacy, for instance, notes that several dosage strengths are "unavailable." |
By Gabrielle Masson Even after a failed phase 3 pediatric clinical trial, Applied Therapeutics forged ahead with an FDA filing for potential market approval. Now the regulatory agency has extended the review period for the rare disease prospect, pushing back a possible decision date into November and sending the biotech’s stock tumbling. |
By Nick Paul Taylor Pfizer is learning there is a kernel of truth in the saying “the internet never forgets.” More than three years after the offense, the drugmaker has received a telling-off from the U.K. drug promotion watchdog over a retweet by one of its employees. |
By Conor Hale Maverix said its new testing division will develop a multiomic catalog spanning screening and management. The amount of the deal was not disclosed. |
By Fraiser Kansteiner A little more than a year after Hikma Pharmaceuticals accused Amarin of “deliberately and meticulously” hamstringing supplies of the main ingredient in its only marketed drug, Vascepa, to thwart potential generic competition, Teva Pharmaceuticals has levied a similar challenge. |
By Kevin Dunleavy With sales on the rise for Legend and Johnson & Johnson’s multiple myeloma CAR-T Caryvkti and in decline for Novartis’ leukemia CAR-T Kymriah, a manufacturing partnership makes sense—especially considering they produce their respective treatments 20 miles apart in northern New Jersey. This week, the companies expanded a previous agreement, with Legend and J&J tapping Novartis to perform commercial manufacturing for Carvykti. |
By Andrea Park As it advances its therapeutic vaccine for recurrent respiratory papillomatosis through clinical trials, Precigen is also working to raise awareness for the rare disease. |
By Max Bayer,Gabrielle Masson John Cox is back in the biotech CEO seat, tapped to lead Dyne Therapeutics. Ex-Madrigal US sales chief named CCO of Nuvation. 35-year NIAID vet jumps for industry, taking CSO job at Calico. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry. Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode. |
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Thursday, April 11, 2024 | 11am ET / 8am PT As clinical trials increase in complexity, drug developers face growing pressure to deliver on-time, on-budget studies. FSP partnerships have emerged as a pivotal strategy to help address current challenges. Join us to learn moreas we explore the findings of The 2024 FSP Trends Report from the PPD clinical research business of Thermo Fisher Scientific. Sign up now! 
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Whitepaper Explore the nuanced approaches necessary for successful pediatric drug development. Sponsored by: PPD |
Whitepaper This paper assesses the current state of the broad CNS market, reviewing key expectations for 2024. It addresses Alzheimer’s disease, biomarkers, and advances in psychiatry in detail. It also provides a high-level look at the pain market and the evolving regulatory environment. Presented by Blue Matter, strategic consultants in the life sciences |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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