BioSpace News Archive

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  FDA

  Busy FDA gives rare disease sector complementary pathways, unanswered questions

  The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.

  June 8, 2026

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  8 min read

   · 

  Nick Paul Taylor
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  FDA

  Post-Makary, new rare disease framework faces fresh uncertainty

  As the FDA tries to clarify its intent for former FDA Commissioner Marty Makary’s plausible mechanism framework for bespoke therapies, experts emphasize the importance of expanding its scope to encompass rare diseases that affect more than just one or a few individuals.

  June 8, 2026

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  7 min read

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  Heather McKenzie
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  Layoff Tracker

  Fulcrum axes 85% of staff after walking away from lead asset

  Follow along as BioSpace tracks job cuts and restructuring initiatives.

  June 8, 2026

   · 

  58 min read

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  BioSpace Editorial Staff
• 

  Weight loss

  ADA: Kailera ‘back at work’ after record-breaking IPO with China data in hand

  After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.

  June 8, 2026

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  4 min read

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  Annalee Armstrong
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  Pancreatic cancer

  ‘WOW!’: RevMed and Tango’s pancreatic cancer combo achieves 92% response

  After Revolution Medicine’s groundbreaking data drop in April, its Tango-partnered combination approach has demonstrated what analysts called “unprecedented” results for 12 patients with pancreatic cancer, teeing up a late-stage study.

  June 8, 2026

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  2 min read

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  Gabrielle Masson
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  Obesity

  ADA: Lilly sets ‘new record in Weight Loss Olympics’ with next-gen asset

  Over two years of treatment, Eli Lilly’s triple-G drug cut body weight by more than 30% in certain patients with obesity, cementing the pharma’s position as the frontrunner in the metabolic space.

  June 8, 2026

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  2 min read

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  Tristan Manalac
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  Obesity

  ADA: Metsera asset data support Pfizer’s ‘entry point’ into obesity market

  Much work needs to be done for Pfizer to be able to catch up to the weight-loss frontrunners, according to Guggenheim Partners, but new data from Metsera’s lead asset could set the pharma apart from competitors with a monthly injection.

  June 8, 2026

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  4 min read

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  Tristan Manalac
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  Obesity

  ADA: Boehringer leans on fat mass benefits as obesity bet delivers ‘less competitive’ weight reduction

  While survodutide’s 16.6% overall weight loss was underwhelming, Boehringer Ingelheim and Zealand Pharma’s drug achieved “impressive” fat loss, according to BMO Capital Markets.

  June 8, 2026

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  2 min read

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  Tristan Manalac
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  Deals

  Roche makes up to $3B blood cancer play with Nurix’s protein degrader

  Roche and Nurix Therapeutics will advance their BTK degrader for chronic lymphocytic leukemia, as well as immunology and neurology indications.

  June 8, 2026

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  2 min read

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  Tristan Manalac
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  Mergers & acquisitions

  Incyte’s stars align as new CEO strikes $2B Vega takeover for blood disorder asset

  Incyte is acquiring Vega Therapeutics, a subsidiary of Star Therapeutics, for a bleeding disorder program that analysts say has “pipeline-in-a-product” potential.

  June 8, 2026

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  2 min read

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  Annalee Armstrong