| Editor's Note: Fierce PM Tracker will not publish on Monday, May 27, in observance of the Memorial Day holiday. We'll be back in your inbox on Tuesday, May 28. Enjoy your long weekend! |
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Turnkey pharmaceutical manufacturing facilities and a 75% property tax exemption make expanding your bioscience business to Puerto Rico easier than ever. It's not what's next, it's where. Puerto Rico.
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Today’s Big NewsMay 24, 2024 |
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Thursday, June 6, 2024 | 11am ET / 7am PT Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. However, conventional screening methods are often ineffective in screening newer therapeutic modalities, and their predictive value for in vivo safety and toxicity is poor. Join us for a look at the new alternatives for success. Register now.
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| By Ben Adams CAR-T cell therapies have boomed in the past few years since the first FDA approval of this revolutionary new way of treating blood cancer back in 2017, but while the technology has sped through, cancer doctors are feeling a little left behind. |
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By Kevin Dunleavy Eli Lilly will invest an additional $5.3 billion in its sprawling construction project in Lebanon, Indiana, where it is building a massive manufacturing complex. The expenditure brings the company's investment in the facility to $9 billion. The project will boost production of active pharmaceutical ingredient (API) for Lilly's injected tirzepatide products Mounjaro, for type 2 diabetes, and Zepbound, for obesity. |
By Gabrielle Masson,Andrea Park Almost exactly five months after CRISPR Therapeutics’ former chief medical officer P.K. Morrow announced her impending departure, the gene editing company has found a replacement in Naimish Patel, M.D. |
By Conor Hale Guardant Health’s Shield blood test, designed to help screen the population for hidden cases of colorectal cancer, may have taken a step closer to FDA approval. |
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Wednesday, June 12, 2024 | 11am ET / 8am PT If you are a company developing gene therapies, don’t miss this opportunity to learn about containment and aseptic filling solutions – how to prepare for fill finish early and ensure products are ready to ship immediately upon approval, providing life-saving drugs to patients as quickly as possible. Register now.
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By Annalee Armstrong Johnson & Johnson’s radiopharmaceutical spurred “profound and durable” responses, however, four patient deaths in the early-stage trial marred the results. |
By Angus Liu With prior approvals in melanoma, Bristol Myers Squibb and Iovance are now showcasing early clinical data for their novel combinations in small first-line melanoma trials. |
By Gabrielle Masson With analysts looking for a meaningful increase in the number of responses for Regeneron's phase 1/2 solid tumor trial, a fresh data slice shows just one complete response across 94 patients. |
By Angus Liu Eli Lilly recently unveiled two back-to-back trial flops for Verzenio in prostate cancer. Now, we know exactly how one sputtered. |
By James Waldron Analysts have hailed Merus’ latest data drop in head and neck cancer as meeting investors’ expectations for the bispecific antibody. |
By Kevin Dunleavy In the first personal injury case that has gone to trial over Zantac, GSK and Boehringer Ingelheim have emerged with an important victory in Chicago. |
By Conor Hale This week the agency handed down a Class I recall label to the issue, its most serious designation. The notice does not require any hardware to be returned to the manufacturer. |
By Andrea Park Apellis Pharmaceuticals is taking a slow and steady approach to advertising Syfovre, its treatment for geographic atrophy, a late-stage form of age-related macular degeneration. |
Fierce podcastsDon’t miss an episode |
| | This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing. |
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Wednesday, June 19, 2024 |10am ET / 7am PT Join us on Monday, June 19, 2024 for one hour all about oral cyclic peptide drug development. Smaller breakthroughs in our own labs demonstrate results worth registering for.
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| WhitepaperPrecision collection of cell therapy source material doesn’t happen by chance. Our new whitepaper illuminates the science and strategies for successful apheresis. Sponsored by: Comprehensive Cell Solutions |
| WhitepaperLearn how Specifica’s in vitro antibody discovery platform can deliver better antibodies than traditional immunization approaches. Sponsored by: Specifica, a Q2 Solutions company |
| WhitepaperThis paper defines “digital companions” in biopharma, explores their value from the patient & company perspectives, & outlines a process for successfully fielding a new digital companion. Presented by: Blue Matter, strategic consultants in the life sciences |
| eBookTo make every rare disease trial count, we design patient-centric, relevant strategies for sponsors and caregivers to produce impactful results every time. Sponsored by: Emmes Company |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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