| Today’s Big NewsOct 23, 2023 |
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Wednesday, November 1, 2023 | 1pm ET / 10am PT Join us to hear about a new, fully integrated and interoperable solution for Health at Home (Remote Care Delivery), with key insights on the journey from idea to market. You'll learn about EMR integration, managing data at scale, best practices on accelerating startup innovation, and much more. Register today! 
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| By Annalee Armstrong BioNTech’s new manufacturing process for CAR-T seems to have done the trick in boosting the potency of the solid tumor therapy BNT211, but that bit of extra juice seems to have upped the side effect profile as well. |
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By Kevin Dunleavy At ESMO, Merck is encouraged by Welireg's potential to treat clear cell renal cell carcinoma (ccRCC), a common type of kidney cancer. The first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor was approved by the FDA in 2021 for the rare von Hippel-Lindau (VHL) disease. |
By Nick Paul Taylor Roche really was lining up a $7 billion challenge to Merck & Co. Months after a media report about a potential deal, the Swiss drugmaker has agreed to pay Roivant and Pfizer $7.1 billion upfront for regional rights to a bowel disease candidate that is on the cusp of phase 3. |
By Angus Liu Eli Lilly is on a roll with its RET inhibitor Retevmo, with new trial results showing the drug can offer dramatic benefits in the treatment of certain lung and thyroid cancers. This comes just as an experienced competitor leaves the field. |
By Annalee Armstrong Daiichi Sankyo and AstraZeneca finally have some clarity on the deaths that occurred in two phase 3 studies for their Enhertu follow up Dato-DXd. The gist of the safety update is that more patients in the lung cancer study experienced a key adverse event when taking Dato-DXd compared to breast cancer. |
By Conor Hale Unlike other ICDs that are wired into beating hearts through the body’s veins, the Aurora’s electrical leads can be placed outside of the cardiac muscle and blood vessels to help reduce the risks of long-term complications. |
By Annalee Armstrong,Max Bayer A nearly year-long clinical hold on Verve Therapeutics’ base editing therapy meant to treat a genetic form of high cholesterol has been lifted in the U.S., thanks to data from an ongoing human trial elsewhere in the world and some preclinical work that has allayed the FDA’s concerns. |
By Conor Hale After introducing itself earlier this month, Precede Biosciences is delivering the first clinical data for its cancer-focused liquid biopsy platform. |
By Angus Liu Moving drugs into early-stage cancers is in vogue these days. Roche has just posted a trial win for its targeted lung cancer therapy Alecensa that should enable earlier use, while eliciting a sense of déjà vu from a study of AstraZeneca’s Tagrisso. |
By James Waldron If it wasn’t enough for Cargo Therapeutics to raise $200 million and recruit a C-suite of biopharma veterans so far this year, the CAR-T-focused company is now eying up an IPO. |
By Andrea Park Once again, Philips has been hit with an FDA Class I label for a correction to certain of its respiratory support devices. |
By Nick Paul Taylor Alright, alright, alright, Matthew McConaughey is lending his smooth Texan voice to a cancer awareness campaign. Working with Stand Up To Cancer (SU2C) and Visit Myrtle Beach, the Oscar-winning actor has created a public service announcement to raise awareness of the importance of funding cancer research. |
By Zoey Becker The deal follows previous settlements worth $102 million and $30 million with two other claimant groups. |
By Andrea Park As Americans flock to nearby orchards for festive bouts of autumn apple-picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself. |
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. |
By Conor Hale Both companies have sought to build digital platforms with the ability to tap into patient communities and collect real-world information that could be useful to medical product designers and drug developers. |
Fierce podcasts Don’t miss an episode |
| In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients. |
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