| |
Over our many years of preparing & filing FDA submissions, we have often encountered sponsors who cannot file a New Drug Application or Biologic License Application within expected timeframes; mostly due to a failure to start & complete prerequisite activities before the targeted filing date. Download our checklist to learn how to keep your NDA submission on track.
|
|
Today’s Big NewsOct 25, 2023 |
| By Gabrielle Masson Rachel King said few things would bring her out of retirement. Leading the Biotechnology Innovation Organization—the largest biotech advocacy body in the world—just happened to be one of those things. |
|
|
|
By Annalee Armstrong MADRID—Daiichi Sankyo started off ESMO with a mic drop moment: a $4 billion upfront deal giving Merck & Co. rights to the Japanese ADC powerhouse’s next three prospects. |
By Nick Paul Taylor Araclon Biotech has provided early evidence that its Alzheimer’s disease vaccine is effective, linking the candidate to a 38% slowdown in disease progression compared to placebo in an exploratory analysis of phase 2 data. |
Sponsored by WCG The FDA and EMA recommend EACs and DMCs be independent from sponsors and CROs. Our industry expert shares how and when to select the right EAC providers and more to de-risk your clinical trials. |
By Nick Paul Taylor BioSenic is continuing to skirt the biotech graveyard. Seeking to start a phase 3 graft-versus-host disease trial next year, the biotech has outlined how it plans to stretch out its six-figure bank balance to avoid going six feet under—and surface with the cash to resurrect its midterm ambitions. |
By Max Bayer Mediar is parterning up with Pfizer's Ignite program to help expand R&D capabilities ahead of two phase 1 trials. The smaller biotech says it will retain all decision-making authority and full rights, though financial details weren't disclosed. |
By Conor Hale Carl Icahn’s proxy battle against Illumina led to the replacement of its chairman and the resignation of its CEO. Now, the activist investor is going after the rest of the board. |
By Kevin Dunleavy In the biopharma industry, post-merger layoffs are often a question of when and how many. In the case of Amgen’s $27.8 billion buyout of Horizon, they came quickly. Around 350 former Horizon employees are being told this week that their positions will be eliminated. |
By Andrea Park The recall—which represents a product correction, rather than a removal of the machines from the market—began in late 2022, but it wasn’t until this month that the FDA handed down its classification. |
By Kevin Dunleavy Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. The company has revealed that a study investigating Arexvy’s effectiveness in adults ages 50 to 59 has achieved its two primary objectives. The results could pave the way for the shot to be approved for this age group. The FDA has already endorsed it for people 60 and older. |
Fierce podcastsDon’t miss an episode |
| | In this week's episode of “Podnosis,” we look at the major health disparities facing Native Americans and explore what can be done to make meaningful improvements. |
|
|---|
|
|
|
You don’t have to choose between oversized and clean-and-reuse systems. There’s a system that’s fit-for-purpose — which scales all the way up to 200 L and beyond. See how.
|
|
| eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
| Whitepaper From trial site feasibility and patient populations to data analysis, generative AI has the potential to revolutionize drug discovery and clinical trial recruitment at both the therapeutic area and indication level. Sponsored by: H1 |
| WhitepaperAccelerate drug discovery with high-performance computing (HPC) powered by the cloud Sponsored By: AWS, NVIDIA, and Rescale |
| WhitepaperCell and gene therapy development has exploded, with Q4 2022 showing more FDA approvals than over the past five years combined.[1] Sponsored by: Thermo Fisher Scientific |
| WhitepaperUncover the keys to efficient bioprocessing, including how outsourcing quality management can reduce risk, save time and money, and expedite biologics development. Sponsored by: Thermo Scientific™ Production Chemicals and Services |
| Webinar Embark on an in-depth journey through the pivotal Make-Test-Decide Workflow, where collaboration and data-driven decisions play a paramount role in the intricate landscape of drug discovery. Watch now to learn how cloud implementation fosters accessibility and collaboration, revolutionizing research across locations and companies. Sponsored by: Revvity Signals |
| WhitepaperEconomic and regulatory factors are making biopharma supply chains more complex in the EU. This paper explores strategies that biopharma companies can use to better manage complexity, cost, and risk. Presented by: AIM, the supply chain leader for life science entrants and midsize life science companies |
| WhitepaperFrom Assay Development Through Large Molecule Development. Streamline your R&D workflows and gain valuable insights with our Biology Solutions Brochure. Download now to discover how to control your laboratory workflows across various assay techniques, modalities, and data types. Sponsored by: Revvity Signals |
| |
|
