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New investments in health tech have set the stage for industry players and revolutionary AI in imaging, drug discovery, digital therapeutics, and more. Download our whitepaper for trends industry experts believe will shape the virtual care landscape.
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Today’s Big NewsSep 25, 2023 |
| By Annalee Armstrong “Scientifically incomplete.” “Grossly deficient.” “Lacking scientific rigor.” These are just a few of the ways the FDA has described BrainStorm Cell Therapeutics’ application for the amyotrophic lateral sclerosis treatment NurOwn—a therapy that has already been rejected twice and is now getting its day before an agency advisory committee meeting after being filed over protest. |
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By Eric Sagonowsky Scynexis' drug launch is taking a severe detour after its 2021 approval. Monday, the company said it's pulling the medicine and halting trials over concerns of potential contamination. |
By Nick Paul Taylor AbbVie has put I-Mab out of its misery. More than one year after scrapping a pair of clinical trials, the Big Pharma has cut its ties to the anti-CD47 antibody lemzoparlimab altogether and deprived I-Mab of the chance to pocket up to $1.3 billion in milestones. |
By Conor Hale The transaction includes a 700 million euro payment in upfront cash, or about $741 million U.S., with the remainder made up in Enovis stock. |
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Tuesday, October 3, 2023 | 11am ET / 8am PT The life science industry has been growing rapidly. As a result, many biopharma companies are choosing to outsource their analytical method development and testing to CDMOs to fully meet their objectives and foster innovation. Join us to take a deep dive into these critical partnerships and learn key actionable insights. Register now.
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By Fraiser Kansteiner Authorities in Pakistan are investigating the use of altered versions of Roche's Avastin after several diabetic patients who received a sham version of the drug lost their sight. |
By Conor Hale United Therapeutics' Revivicor division has set its sights on human clinical trials in 2025 of its manufactured organs derived from genetically modified pigs. |
By Nick Paul Taylor A who’s who of biopharma companies have backed a push to raise awareness about lung cancer among Hispanic and Latino Americans, funding a project that has enlisted a Mission: Impossible star to educate the community about risk factors, early warning signs and screening. |
By Nick Paul Taylor Investors have found a flaw in Morphic’s glittering EMERALD-1 trial. Months after raising $240 million on the back of top-line results that sent its stock soaring, the biotech has shared a fuller look at the data on its oral ulcerative colitis candidate and wiped out its earlier gains. |
By Conor Hale Children brought to an emergency room with acute asthma symptoms—and who did not respond to initial drug treatments—received either standard oxygen or Vapotherm’s high-velocity air approach. |
By Angus Liu The road to an FDA nod for Coherus BioSciences’ China-made PD-1 inhibitor has been long and tortuous. Now, the FDA found a fresh problem at a clinical trial site for Coherus’ Junshi Biosciences-partnered toripalimab. |
By James Waldron Novo Nordisk may be enjoying a revenue boost courtesy of its next-gen diabetes and obesity drugs, but the company isn’t kicking back and counting the cash. Instead, the Danish Big Pharma is handing over $60 million to Valo Health in the hope that the Flagship-founded company’s AI expertise can reproduce the same success in cardiovascular disease. |
By Angus Liu,Kevin Dunleavy,Eric Sagonowsky In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. |
Fierce podcasts Don’t miss an episode |
| In this episode of "The Top Line," we shine a spotlight on some of the most promising companies in the biotech world and do a deep dive into drug commercialization strategies. |
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Thursday, October 5, 2023 | 11am ET / 8am PT Viral vectors used in gene therapies face complex and multifaceted analytical challenges. Developing standardized and validated analytical methods, reference standards, and reagents are critical to overcoming these challenges. Join us to learn how to accelerate the development and translation of safe and effective viral vector-based gene therapies with next-generation analytics. Register now.
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Whitepaper As the field of real-world data and evidence is constantly evolving, it can be hard to keep-up with best practices. Do you know the definitive characteristics of a high-quality dataset? What questions to ask if you decide to outsource your research to consultants? Here’s everything you need to know in one, must-have guide. Sponsored by: MarketScan by Merative |
eBook Emulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
Whitepaper Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives. Sponsored by: JLL |
Whitepaper Learn how outsourcing the buffer preparation can reallocate resources to support core activities of your bioprocess production. Sponsored by: Thermo Fisher Scientific |
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 |
Whitepaper Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
Whitepaper By 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially. Sponsored by: ThermoFisher Scientific |
Whitepaper 15 biotech executives from the Cambridge area discuss the current biotech landscape, as well as challenges, opportunities, and best practices for emerging biotech companies seeking success in the UK and beyond. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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