| Today’s Big NewsSep 22, 2023 |
| By Conor Hale The third time held no charm for Intarcia Therapeutics, which saw its long road through the FDA potentially forced down another detour. |
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By Fraiser Kansteiner Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Following a series of trial shortfalls this year in melanoma, colorectal cancer and head and neck squamous cell carcinoma, the duo has missed the mark in yet another set of clinical trials—this time in non-small cell lung cancer. |
By Nick Paul Taylor AstraZeneca and Daiichi Sankyo are coming for Gilead Sciences' breast cancer business. The partners plan to file for approval of datopotamab deruxtecan (Dato-DXd) after linking their antibody-drug conjugate to improved outcomes, although the immature overall survival data leave a key question unanswered. |
By Ayla Ellison,Annalee Armstrong,Gabrielle Masson,Kevin Dunleavy 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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October 16-18, 2023 | Boston, MA Brought to you by the editors behind Fierce Biotech, this conference is a unique venue where biotech executives can network and learn how to improve their partnership and pipeline strategies. It’s the only event that covers the entire pharma R&D spectrum, from basic research through clinical trials. Countdown is on! Register today to save $200 
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By Conor Hale According to the manufacturer, degrading capacitors could leak material and fry parts of the circuit board, potentially leading to interruptions in ventilation. |
By Annalee Armstrong Viral disease biotech Antios Therapeutics shut down earlier this year after an FDA hold on its lead hepatitis B therapy due to a serious adverse event proved insurmountable. |
By Angus Liu It’s not a proper market showdown without all the players. In the perioperative treatment of early-stage non-small cell lung cancer with a PD-1/L1 inhibitor, Bristol Myers Squibb is touting a new trial win. The results follow positive readouts from AstraZeneca and Merck. |
By Conor Hale Bayer and Hologic have teamed up with the goal of offering clearer breast cancer scans as a package deal. |
By Eric Sagonowsky Lilly's mirikizumab is one of several launches the company is counting on for growth in the near term. Even after an FDA rejection, the launch is gaining steam overseas. |
By Nick Paul Taylor Abpro is taking a second run at the public markets. Five years after pulling out of a planned IPO, the antibody specialist is back with a SPAC. |
By Kevin Dunleavy By divesting 75% of its API business, Glenmark has finally resolved its debt problem, described by an Indian news outlet as a “decade-long troubled affair.” |
By Conor Hale A VC round's not over until it's over: Virtual Incision described the proceeds as an extension to its previous $46 million series C, which it first made public in late December 2021. |
By Gabrielle Masson After an FDA rejection earlier this year, ImmunityBio has laid off around 50 employees across California and Florida, its second layoff wave in less than a year. |
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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Tuesday, September 26, 2023 | 11am ET / 8am PT This webinar will focus on the latest advancements in bioprocessing for cell and gene therapies (CGTs), including the improved consistency and reduced production costs associated with closed manufacturing. Register now. 
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