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Rare disease development is complex, characterized by distinctive challenges due to small patient populations spread across many geographies, limited disease data, and narrow site pools. For sponsors, successful studies involve striking a balance among cost, quality, and innovative approaches that improve trial efficiency and patient engagement. Read our checklist to explore 9 best practices for optimizing the efficiency and quality of rare disease clinical trials. +(002)+120w.png)
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Today’s Big NewsApr 23, 2024 |
| By Max Bayer Incyte is dolloping another deal onto its 2024 partnership plate, buying San Diego-based Escient Pharmaceuticals for $750 million. |
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By Nick Paul Taylor Sanofi’s $3.7 billion Principia Biopharma buyout has delivered a phase 3 victory. The BTK inhibitor moved the needle in a clotting disorder, clearing Sanofi to file for approval of a “multi-indication blockbuster” that it predicts could contribute to more than 10 billion euros ($11 billion) of drug launch sales. |
By Nick Paul Taylor The cuts keep coming at BenevolentAI. Eleven months after restructuring, the AI-enabled drug developer is pulling another pivot, axing plans to launch software products, laying off another 30% of staff and closing its U.S. office. |
Sponsored by NSF NSF TraQtion software combines decades of quality expertise with real-time digital insight in one trusted, cloud-based digital solution. |
By Gabrielle Masson Neurocrine Biosciences has nabbed a phase 2 win, with its investigational med in-licensed from Takeda significantly reducing depression severity among adults with major depressive disorder who haven’t benefited from at least one previous antidepressant. |
By Helen Floersh A new study adds to the case that long-term daily aspirin use may prevent colorectal tumors from developing or spreading in some patients, with potential implications for future drugs. |
By Helen Floersh A new type of immunotherapy drug appears to be more effective than other approaches at stimulating the immune response. A drug developed using chains of natural proteins, or peptides, was better at slowing cancer growth than other types of immunotherapy in animal models, especially when paired with immune checkpoint inhibitors. |
By Helen Floersh Alcanza Clinical Research’s buying spree continues with the acquisition of FDI Clinical Research, a contract research organization based in Puerto Rico. The purchase gives Alcanza two new research facilities, one at FDI’s headquarters in San Juan and another in Mayagüez, a city on the island country’s west coast. |
By Angus Liu Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles over in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025. |
By Conor Hale The twin clinical testing giants Labcorp and Quest Diagnostics have each, in the past week, added to their portfolios new blood tests that aim to peek into the workings of the human brain. |
By Fraiser Kansteiner As the BIOSECURE Act threatens to upend relationships with Chinese contractors and western biopharma companies operating in the U.S., Novartis has elected not to adopt a “wait and see” attitude. |
By Nick Paul Taylor Eisai has recently outlined a range of ways to kick-start Leqembi’s lackluster launch, from increasing the number of neurology account specialists to adding a subcutaneous option. But a Reuters report suggests the company faces a more fundamental problem: Physicians still see Alzheimer’s disease as untreatable. |
By Emma Beavins Headspace is entering the direct-to-consumer mental health coaching market, broadening its reach beyond its model of contracting with health plans and employers. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we are joined by Annalee Armstrong, Senior Editor at Fierce Biotech, and Ben Adams, Senior Editor of Fierce Pharma Marketing, to discuss Fierce's take on March Madness. |
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eBook To 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 |
Whitepaper Discover the secrets behind successful patient engagement Sponsored by: ProofPilot |
Whitepaper Antibody biomarkers are redefining precision medicine, from diagnosing diseases earlier to stratifying patients – download your FREE white paper today! Sponsored by: Sengenics Corporation LLC |
Whitepaper The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors. Presented by Lonza |
eBook Unlock the future of monoclonal antibody (mAb) manufacturing with a complete guide to enhancing productivity and quality for exceptional outcomes. Sponsored by: Thermo Fisher Scientific |
Whitepaper This paper assesses the current state of the oncology market, reviewing key expectations for 2024. It addresses CAR-T therapies, KRAS, radiopharmaceuticals, & targeted protein degradation. Presented by Blue Matter, strategic consultants in the life sciences |
Whitepaper Choosing the right contract lab can help drug developers accelerate their timelines and generate cost-efficiencies. For insights into what to look for when selecting a GMP/CMC lab partner read this white paper which delves into a range of factors that can support your needs in both the short-term and in planning for the future. Sponsored by: PPD®️ Laboratory Services |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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