| Today’s Big NewsSep 19, 2023 |
| By Annalee Armstrong Biopharmas looking to submit a drug for approval to the FDA based on just one clinical trial better be thorough in the data they include—good and bad—and they should get in touch with the agency as early as possible. |
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By Fraiser Kansteiner After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma. |
By Andrea Park A year after joining forces with a goal of improving health management for people with Type 2 diabetes, Abbott and WeightWatchers’ partnership has borne fruit. |
By Kevin Dunleavy A survey of 100 doctors in the U.S. who prescribe weight loss medications shows that more than 75% consider new obesity drugs from Eli Lilly and Novo Nordisk as “paradigm shifting.” But the physicians also have significant concerns about the cost of the treatments, patient eligibility for coverage and long-term safety risks. |
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Fierce Biotech SummitOctober 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 Andrea Park After its planned $230 million acquisition of Korean stent maker M.I.Tech sputtered out earlier this year, Boston Scientific is making up for it with an even bigger buy in chronic back pain. |
By Nick Paul Taylor Kinnate Biopharma is cutting deep. Months after its delayed cancer data disappointed investors, the biotech has revealed it is laying off 70% of its staff and narrowing its pipeline to stretch its cash reserves into the second quarter of 2026. |
By James Waldron Two months after halting its remaining development program in a last-ditch attempt to conserve cash, Histogen has run out of options and will wind down. |
By Zoey Becker The FDA's Form 483 filing, obtained by Fierce Pharma, details quality oversight and control issues, plus equipment sanitation problems. |
By Conor Hale Just because pulsed field ablation therapy for afib has yet to make its mark in the U.S. by clearing the FDA, that doesn’t mean there’s any reason to wait on developing version 2.0. |
By Annalee Armstrong Boston, the San Francisco Bay Area and San Diego are once again the top markets for life sciences commercial real estate in the U.S., with plenty of opportunities for growth as biotech readies for a comeback, according to a new report. |
By Fraiser Kansteiner Novo Nordisk is teaming up with Aspen Pharmacare to shore up insulin supplies in Africa, which currently imports more than 80% of its medicine. |
Fierce podcastsDon’t miss an episode |
| This week on "The Top Line," we discuss the trends seen at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage |
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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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| Whitepaper15 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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