BioSpace News Archive

FDA

Lilly’s Zepbound vs. Novo’s Wegovy: The Weight-Loss Drug Race Has Officially Started

The FDA’s approval of Eli Lilly’s obesity drug Zepbound intensifies an already heated battle with Novo Nordisk’s Wegovy in the lucrative weight-loss drug market, as other drugmakers hope to get a piece of the action.

November 10, 2023
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2 min read
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Greg Slabodkin
FDA

Takeda Wins First FDA Approval for Ultra-Rare Blood Clotting Disease

The biopharma’s Adzynma, a human recombinant ADAMST13 therapeutic, is the first approved therapy for the ultra-rare clotting disorder congenital thrombotic thrombocytopenic purpura.

November 10, 2023
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2 min read
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Tristan Manalac
FDA

Valneva Gets FDA’s First Chikungunya Vaccine Approval After Delay

Following a more than two-month delay to its PDUFA action date, Valneva’s chikungunya vaccine Ixchiq has won the regulatory race beating biotech Bavarian Nordic.

November 10, 2023
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2 min read
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Tyler Patchen
Novo Pumps $6B into Manufacturing to Help Meet Sky-High Wegovy Demand

In response to skyrocketing demand for its weight-loss drug Wegovy, Novo Nordisk announced Friday it is investing more than $6 billion to expand production capacity in its home country of Denmark.

November 10, 2023
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2 min read
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Tristan Manalac
Drug Development

Neurocrine Hit with Back-to-Back Phase II Failures in Neuropsychiatry

The two mid-stage flops—one in major depressive disorder and another in focal onset seizures—involve drug candidates from partnerships with Xenon Pharmaceuticals and Takeda, respectively.

November 10, 2023
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2 min read
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Tristan Manalac
Drug Development

Companies Devise New Ways to Smuggle Drugs Across the Blood-Brain Barrier

To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond.

November 10, 2023
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7 min read
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Heather McKenzie
Drug Development

AstraZeneca’s Imfinzi, Chemo Combo Meets Endpoint in Phase III Liver Cancer

The company’s immunotherapy, in combination with chemotherapy Avastin, showed favorable progression-free survival in a late-stage hepatocellular carcinoma study.

November 10, 2023
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2 min read
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Tyler Patchen
Business

Roivant Announces Appointment of Mayukh Sukhatme to Its Board of Directors

Roivant announced the appointment of Mayukh Sukhatme, M.D., to its Board of Directors, effective immediately.

November 10, 2023
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5 min read
Genetown

Ardelyx to Participate at the 2023 Jefferies London Healthcare Conference

Ardelyx, Inc. announced that Ardelyx management will participate in a fireside chat at the Jefferies London Healthcare Conference on Thursday, November 16, 2023, at 8:30 a.m. GMT in London, UK.

November 10, 2023
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1 min read
Genetown

Blueprint Medicines’ AYVAKYT® (avapritinib) Receives Positive CHMP Opinion as the First and Only Therapy for Indolent Systemic Mastocytosis

Blueprint Medicines Corporation (Nasdaq: BPMC) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of AYVAKYT.

November 10, 2023
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11 min read