| |
Mergers and acquisitions are common in clinical research, requiring flexibility and agility. When a sponsor changed mid-trial, Premier seamlessly maintained regulatory compliance, patient safety, and data integrity.
Learn how in our case study.
|
|
Today’s Big NewsNov 7, 2024 |
| By Nick Paul Taylor Sarepta Therapeutics has ended development of a late-phase Duchenne muscular dystrophy (DMD) drug candidate over a safety problem. The safety signal deprived Sarepta of a near-term shot at accelerated approval—and took down the biotech’s entire PPMO franchise. |
|
|
|
By James Waldron The FDA has placed a trial of Rapport Therapeutics’ epilepsy drug for a type of nerve pain on hold while the biotech tweaks the study design. |
By Nick Paul Taylor ADC Therapeutics has stopped development of lead solid tumor candidate ADCT-601. The biotech axed the AXL-directed antibody-drug conjugate after failing to show a favorable benefit-risk profile in a phase 1b trial. |
Sponsored by Dell Technologies While artificial intelligence is on everyone’s minds and in many R&D plans, adoption of generative AI has been slow so far in life sciences. |
|
Create an optimal path to the clinic that best suits your molecule and critical milestones. We now offer a full suite of integrated drug substance/drug product DNA-to-IND programs to accelerate any molecule type to the clinic. Download our white papers to learn more about our tailored CMC strategies.
|
|
By Nick Paul Taylor An influx of late-phase programs has prompted Genmab to reassess its bets. The biotech is axing three early-stage clinical programs to accelerate investment in its recently expanded phase 3 pipeline. |
By James Waldron Celldex Therapeutics has halted work on its solid-tumor-focused bispecific as the biotech prioritizes its work in inflammation. |
By Gabrielle Masson Biopharma Trevena has whittled its team down to four people, saying goodbye to several C-suite execs and continuing a strategic review that includes possible asset sale, merger or closure of the company. |
By James Waldron Viracta Therapeutics is implementing its second round of layoffs in just three months as the cash-strapped biotech tries to keep funds flowing to its lymphoma program. |
By Darren Incorvaia Charles River has been riding rough waters in 2024, and as the CRO’s CEO predicted, the third quarter proved no exception. |
By Darren Incorvaia A team of researchers led by Stanford University and San Diego-based Boundless Bio have identified an oral small molecule that specifically targets extrachromosomal DNA in cancer cells, preventing the DNA from repairing itself. When tested in mice, the compound—named BBI-2779—shrank gastric tumors and prevented the cancer from developing resistance to another cancer drug. |
By Fraiser Kansteiner Among Novo’s semaglutide-based drugs, diabetes blockbuster Ozempic fell short of analysts' expectations during the third quarter while weight-loss med Wegovy came above a consensus estimate. |
By Noah Tong Major health insurers are seeing stocks increase as investors ready for a Trump term receptive to Medicare Advantage and mergers. Health plans reliant on Medicaid and the ACA saw their stocks dip. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we explore how each presidential candidate’s approach to drug pricing could shape future policy. |
|
|---|
|
|
| WhitepaperExplore the robust cross-platform agreement between scRNA-seq and bulk RNA-seq, ensuring consistent and reproducible data on immune cell presence. Sponsored by: IQVIA Laboratories |
| WhitepaperThis e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products. It’s an essential resource for emerging companies with products in all stages of development. Sponsored by: Blue Matter |
| WhitepaperUnlock the secrets to faster, cost-effective biologics production with intensified biomanufacturing – download the whitepaper and power up your bioprocessing game! Sponsored by: Syngene International Ltd. |
| WhitepaperDiscover how independent adjudication can safeguard your clinical trials from misidentified adverse events and enhance the credibility of your results. Sponsored by: WCG |
| WhitepaperLearn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes. Presented by: Thermo Fisher Scientific |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
|
| |
|
