BioSpace News Archive

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  Complete response letters

  Incyte’s Lung Cancer Expansion Bid Thwarted by Issues at Novo’s Catalent-Acquired Site

  Incyte is looking to expand the use of its PD-1 blocker Zynyz to treat non-small cell lung cancer. The FDA’s rejection did not flag problems with the drug’s efficacy or safety.

  March 9, 2026

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  2 min read

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  Tristan Manalac
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  Adcomms

  Two AstraZeneca Drugs To Be Scrutinized in First FDA Cancer Advisory Panel in 9 Months

  The FDA’s cancer advisors will discuss AstraZeneca’s application for the oral SERD camizestrant in breast cancer and the AKT inhibitor Truqap in prostate cancer.

  March 9, 2026

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  3 min read

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  Tristan Manalac
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  Cancer

  5 Therapies Moving the Multiple Myeloma Space Forward

  A “significant number of patients” could see a cure for multiple myeloma within the next two decades, one expert told BioSpace. Here are five therapies that could change the treatment paradigm.

  March 9, 2026

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  8 min read

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  Tristan Manalac
• 

  Cancer

  Ipsen Pulls Cancer Drug Amid Risk of Secondary Malignancies

  Ipsen will withdraw Tazverik’s follicular lymphoma and epithelioid sarcoma indications as emerging data point to an elevated safety risk in patients undergoing treatment.

  March 9, 2026

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  2 min read

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  Tristan Manalac
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  Breast cancer

  Roche Breast Cancer Prospect Fails First-Line Test, Shares Fall

  Roche’s shares tumbled nearly 5% on news that a key pillar in the five-pronged clinical plan for the breast cancer asset giredestrant was unsuccessful.

  March 9, 2026

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  2 min read

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  Annalee Armstrong
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  Rare diseases

  Prasad’s Departure Could Be ‘Big Win’ for Biotech—Especially Rare Disease Space: Analysts

  Some biotechs that had seen regulatory setbacks under Center for Biologics Evaluation and Research director Vinay Prasad experienced stock bumps Monday morning. Under Prasad’s leadership, the rare disease space has suffered a series of controversial rejections.

  March 9, 2026

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  3 min read

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  Tristan Manalac
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  Weight loss

  Regeneron’s Weight Loss Partner Hansoh Delivers Much-Needed Phase 3 Win in China

  Hansoh’s olatorepatide achieved 19% weight loss at 48 weeks in a Phase 3 trial in China, handing partner Regeneron a glimmer of hope for a pipeline in desperate need of reinvigoration.

  March 9, 2026

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  2 min read

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  Annalee Armstrong
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  GLP-1s

  Novo Nordisk Agrees To Sell GLP-1 Drugs Via Hims & Hers, Ending Dispute

  The companies have been embroiled in a row about compounded GLP-1 drugs that escalated to a lawsuit last month. The legal action has now been dropped and the former adversaries have struck a deal that could increase access to Novo’s obesity medicines.

  March 9, 2026

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  2 min read

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  Nick Paul Taylor
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  Obesity

  AbbVie’s Amylin Candidate ‘Competitive’ in Early-Stage Trial

  AbbVie’s foray into the obesity space is successful so far, analysts agree, as amylin analog ABBV-295 elicited as much as 9.73% weight loss at 13 weeks in the multiple ascending dose portion of a Phase 1 trial.

  March 9, 2026

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  2 min read

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  Heather McKenzie
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  Drug Development

  Xenon To Seek Approval of First-in-Class Epilepsy Drug After Exceeding Phase 3 Expectations

  Azetukalner, a Kv7 potassium channel opener, reduced the frequency of focal onset seizures by a placebo-adjusted rate of 42.7%. Xenon Pharmaceuticals believes this is the highest such efficacy “observed in a pivotal epilepsy study,” CEO Ian Mortimer said Monday.

  March 9, 2026

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  3 min read

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  Heather McKenzie