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4 days ago | 
bioworld.com | Lee Landenberger
Home » Compass Pathways succeeds in phase III depression study; stock slides BioWorld briefs for June 23, 2025. BioWorld MedTech briefs for June 20, 2025. To no great surprise, the U.K.’s health technology assessment body has found that the benefits of the first two approved Alzheimer’s disease drugs are too small...
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1 week ago | 
bioworld.com | Lee Landenberger
CBER shakeup points to further FDA realignment The realignment within the U.S. FDA continued with reports of the removal of two high level executives.
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1 week ago | 
bioworld.com | Lee Landenberger
Home » An early stage 85% remissions rate in AML drives Aptevo’s stock surgeAn early stage 85% remissions rate in AML drives Aptevo’s stock surgeAn 85% remissions rate was found in updated results from Aptevo Therapeutics Inc.’s ongoing phase Ib/II Ranier study of mipletamig in one of the toughest blood cancers to treat. BioWorld Clinical Cancer Bispecific antibody U.S.
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1 week ago | 
bioworld.com | Lee Landenberger
In a $1.3B deal, Lilly buys gene editor VerveWith plenty of GLP-1 money to spend, Eli Lilly and Co. is buying Verve Therapeutics Inc. and its gene-editing program for about $1.3 billion. Two of Verve’s one-time treatments are in the clinic. Lead candidate VERVE-102, a gene-editing treatment targeting PCSK9, is in a phase Ib study to reduce cholesterol levels. BioWorld Deals and M&A Cardiovascular Gene therapy U.S.
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1 week ago | 
bioworld.com | Lee Landenberger
For $795M, Sage is added to Supernus’ CNS quiverSupernus Pharmaceuticals Inc. is buying Sage Therapeutics Inc. for about $795 million. The deal brings Supernus, already firmly in the CNS market, the only U.S. FDA-approved oral treatment for postpartum depression. Supernus CEO Jack Khattar said he believes sales will support the acquisition, but some analysts had their doubts. BioWorld Deals and M&A Neurology/psychiatric Small molecule U.S.
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2 weeks ago | 
bioworld.com | Lee Landenberger
Deep Apple signs big Novo deal for cardiometabolic small moleculesDeep Apple Therapeutics Inc. could bring in as much as $812 million in a new collaboration and license deal with Novo Nordisk A/S. The total includes an unspecified up-front payment, research costs and milestones. The two plan to develop and commercialize oral small molecules for non-incretin G-protein coupled receptor targets for treating cardiometabolic diseases, including obesity, a core specialty for Novo Nordisk.
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2 weeks ago | 
bioworld.com | Lee Landenberger
Merck wins FDA approval in pediatric RSV and steps into CDC uncertaintyWith the U.S. FDA’s approval of Enflonsia (cesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and infants, Merck & Co. Inc. steps into a space of competition and regulatory shifts. The preventive, long-acting monoclonal antibody (MAb)will take its place in the market alongside the blockbuster Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc.
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2 weeks ago | 
bioworld.com | Lee Landenberger
Merck wins approval FDA in pediatric RSV and steps into CDC uncertaintyWith the U.S. FDA’s approval of Enflonsia (cesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and infants, Merck & Co. Inc. steps into a space of competition and regulatory shifts. The preventive, long-acting monoclonal antibody (MAb) will take its place in the market alongside the blockbuster Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc.
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2 weeks ago | 
bioworld.com | Lee Landenberger
In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterolIn two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The PCSK9 inhibitor is looking to fit into a crowded market that already has well-established therapies from other big pharmas and a potential competitor in development to treat another indication.
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3 weeks ago | 
bioworld.com | Lee Landenberger
The row between pharma companies and the U.K. government over rebates has intensified, with the Association of the British Pharmaceutical Industry calling up its...
