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Thursday, July 22, 2025 | 10am ET / 7am PT Join us to take an exciting look at the forefront of REMS transformation. Learn how leading technology, integrated strategies and operational excellence are redefining what’s possible. Gain the insights you need to reduce complexity, enhance compliance and deliver more value across the REMS lifecycle. Register now.
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Today’s Big NewsJul 11, 2025 |
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A pipeline-supporting marketing plan that includes proven tools, well-executed tactics, and a clear strategy are key to keeping your pipeline full of qualified leads. Access this valuable resource to discover how your marketing team can support your business development team in three essential areas: audience, storytelling, and performance. Download today!
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| By James Waldron,Fraiser Kansteiner Although many of the complete response letters uploaded by the FDA this week have been subtly disclosed in drug approval packages over the years, the consolidation of the rejection notices offers an in-depth view into the high-stakes discussions that decide whether a medicine will ever make it to market. |
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By Nick Paul Taylor The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy cell therapy, raising questions about whether the agency's new leadership may be rowing back from some of the flexibility shown by the old regime. Capricor’s share price fell 38% to $7.11 in premarket trading. |
By Andrea Park According to a pair of recent rulings by the U.K.’s Prescription Medicines Code of Practice Authority, Jazz Pharmaceuticals struck the wrong chord in presentations about its Epidyolex. |
By Darren Incorvaia After prematurely ending two phase 3 depression trials last year, Relmada Therapeutics has formally given up on the asset they were testing. The Florida-based biotech terminated the license agreement for esmethadone on July 7, with all of their obligations under the deal set to expire on Oct. 5. |
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MedTech companies often launch groundbreaking devices, only to face slow adoption due to costly, time-intensive, and difficult-to-scale training. This whitepaper explores how Virtual Reality (VR) is changing that, helping teams engage physicians earlier, accelerate product adoption, and drive stronger commercial outcomes. Download now to learn more.
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By Conor Hale The Lumipulse G blood test measures the ratio between specific tau and beta amyloid proteins, to find patients likely to have plaque buildups in the brain. |
By Gabrielle Masson Karyopharm Therapeutics is laying off 20% of staffers as efforts to secure a strategic alternative have turned up short. |
By Angus Liu After years spent upgrading its manufacturing capabilities, Pacira BioSciences figures it’s time to retire a facility that has been running for more than a decade. Along with it, 8% of the company’s workforce is also headed for the exit. |
By Ayla Ellison,Gabrielle Masson,Andrea Park Biopharma layoffs have held steady through mid-2025, and in this episode of "The Top Line," we dig into the numbers, closures and policy changes shaping the trend. |
By Kevin Dunleavy Two years after Astellas became the first drugmaker to hit the market with a nonhormonal therapy for menopause symptoms, Bayer has followed suit, scoring its first worldwide nod for a similar treatment in the U.K. |
By Darren Incorvaia,Zoey Becker Sally Susman, the communications chief who has shepherded Pfizer’s reputation and branding for more than 18 years, is departing the pharma giant at the end of the year amid its ongoing cost-cutting efforts. |
By Andrea Park A new education and awareness campaign from Novartis shifts focus from the younger audiences that are typically the targets of such resources to the older teenagers and young adults who are going to college, starting careers and living independently while also managing spinal muscular atrophy. |
Fierce podcastsDon’t miss an episode |
| | Biopharma layoffs have held steady through mid-2025, and in this episode of "The Top Line," we dig into the numbers, closures and policy changes shaping the trend. |
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In all the “what if” chatter and fatigue around AI, predictive sales intelligence is a key opportunity that can easily be implemented and scaled to make omnichannel strategies even more potent. Our whitepaper explores the value of this capability, what role it plays in evolving HCP engagement trends, how to implement, and what to look for when engaging new partners and solutions. Download now.
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| WhitepaperThis white paper outlines how we apply industry-backed practices and proprietary technologies to proactively safeguard sterility and performance. Sponsored by: Lonza |
| WhitepaperPresented by Blue Matter, strategic consultants in the life sciences Sponsored by Blue Matter Consulting |
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