| Today's Big NewsJun 29, 2023 |
| By Nick Paul Taylor Eli Lilly has dug into the biotech bargain bin for its latest buyout, emerging with a deal to buy its Type 1 diabetes partner Sigilon Therapeutics for $34.6 million upfront. The value of the deal could balloon if the biotech passes milestones from a first-in-human trial through to authorization in a major market. |
|
|
|
By Nick Paul Taylor An FDA advisory committee voted 10 to four in favor of Ipsen’s rare disease drug palovarotene despite members of the panel expressing significant concerns with the data. The vote boosts the prospects of the French drugmaker finally starting to deliver a return on its $1 billion bet on the drug candidate. |
By Annalee Armstrong Immunome and Morphimmune will come together as one company through a reverse merger, placing Clay Siegall, Ph.D.—who left his role as CEO of Seagen last year after being arrested for alleged domestic abuse—in the chief executive chair. |
Sponsored by Context Therapeutics Inc. In the ongoing search for new cancer treatments, companies including Context Therapeutics are developing potential therapies focused on the emerging novel oncology target Claudin 6. |
By Gabrielle Masson The Bill & Melinda Gates Foundation and Wellcome Trust are giving a combined $550 million to push forward a tuberculosis vaccine candidate formerly owned by GSK. The investigational shot holds the potential to become the first vaccine aimed at preventing pulmonary TB to enter the market in over 100 years. |
Sponsored by Sciensus Are you considering expanding your orphan drug in Europe? Discover key strategies to identify, engage and support rare disease patients, ensuring treatment adherence that makes a real difference. |
By Max Bayer Eiger was poised for a new strategy after the FDA declined to authorize the company's COVID-19 treatment at the end of 2022. The company says it will now prioritize a late-stage metabolic asset, shedding 25% of its staff as part of the reprioritization. |
By Gabrielle Masson Despite recent efforts, major changes are still needed to properly prioritize participant diversity in oncology drug development and meet the reimagined Cancer Moonshot’s goal of halving the cancer death rate in 25 years, according to several FDA officials and Big Pharma leaders. |
By James Waldron Australian biotech HaemaLogix has posted phase 2b data that show its monoclonal antibody “significantly” improves response rates for multiple myeloma patients when paired with Revlimid. |
By Angus Liu After growing the Institute for Clinical and Economic Review into an influential drug pricing watchdog, Steve Pearson is stepping down. |
By Andrea Park Roche is on a roll: For the second time in less than a year, the company has scored FDA clearance for a pair of assays that can be used together to help spot signs of Alzheimer’s disease. |
By Kevin Dunleavy Much attention has been paid to Vertex’s efforts to develop a stem-cell therapy for Type 1 diabetes. But flying under the radar with an allogenic (donor) gene therapy for the disorder has been Chicago startup CellTrans. Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes. |
By Ben Adams AbbVie’s Botox is a major blockbuster and king of the anti-wrinkle aesthetics market, but there are new contenders coming for its crown. |
By Dave Muoio The federal regulator said its proposed updates would enable more efficient review of pending deals during the initial 30-day waiting period. As is, the changes are estimated to add, on average, more than 100 hours to companies' paperwork burden per filing. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss the most expensive drugs in the U.S., plus Eli Lilly's recent acquisition, the latest company to challenge the Inflation Reduction Act, and the rest of the week's headlines. |
|
|---|
|
|
|
September 26-28, 2023 | Philadelphia, PA Hear how to drive greater sponsor-CRO-site collaboration and communication, and the latest on oversight approaches for external stakeholders. Save $400 on Registration with the Early Bird Rate!
|
|
| WhitepaperLearn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
| WhitepaperAutoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| eBookSee how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
| WhitepaperThis paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| |
|
