BIO Notebook: Dealing With Rejection, Worrying About March-In Rights, And More

Insights from the first day of the international convention in San Diego also includes interviews on Alzheimer’s investments, dealmaking for mid-sized companies and reflections on the virtues of lean thinking.

BIO 2024 Day 1
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While biotech startups may be struggling to raise funds in today’s financial environment, Nina Kjellson, general partner/West Coast at Canaan Partners, quietly revels in the upside of scarcity. That force, she said, has led to some of the best companies in the industry.

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Could PDUFA VIII Align With Trump’s Efficiency Emphasis?

 
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Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.

‘A Lot Of That, It’s Meant To Start A Conversation’: How To Work With Trump

 

Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.

Who Can Represent Patients? Advocates Worry They Are Being Pushed Out Of The Conversation

 

Patient advocacy groups suggest US state and federal agencies are trying to exclude them from certain conversations due to drug industry connections and perceived bias. 

Can BIOSECURE Maintain Its Virality In The TikTok Era?

 

With the sheen of inevitability now scuffed off the BIOSECURE Act, diplomatic efforts to reduce US dependence on Chinese APIs are increasing in prominence. And the power of the legislation itself could be determined by litigation about a video app.

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How Big Pharma Is Redefining, Scaling India GCCs Amid Tech Advances

 

Senior executives from AstraZeneca, BMS, Novo Nordisk, Takeda and Regeneron outline how big pharma's global capability centers (GCCs) in India are evolving beyond cost efficiency, focusing on innovation, “agile experimentation” and new technology including GenAI, virtual & augmented reality, with some positioned as COEs. Will Indian multinationals use the GCC approach?

Quick Listen: Scrip’s Five Must-Know Things

 
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In this week's episode: Merck & Co. licenses Hengrui’s lipid lowerer; Novo gets United’s triple G obesity drug; J&J plans major US manufacturing investments; approval for GSK’s novel antibiotic; and a call for more aggressive Korean M&A activity.

Asia Deal Watch: Dr. Reddy’s Gets Regional Rights To Pair Of Bio-Thera Biosimilars

 

Plus deals involving GV20/Mitsubishi Tanabe, Kaken/Alumis, AstraZeneca/Alteogen and deal terminations involving Clover/Gavi Alliance and Rhythm/RareStone.