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FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking

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Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Energy & Commerce committee ranking member Diana DeGette.

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Novo’s late-stage IL-6 stumble shakes inflammation space

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Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week’s Phase 3 failure dashed not just the Danish pharma’s hopes but that of other drugmakers working on the same pathway.

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STAT+: BioNTech names Guido Oelkers its new CEO

BioNTech on Monday named Guido Oelkers, formerly the leader of the Swedish biopharma company Sobi, as its new CEO, as the Covid-19 vaccine developer continues its shift to oncology.

Oelkers will replace Ugur Sahin as CEO. In March, BioNTech announced that Sahin and his cofounder and wife Özlem Türeci, the company’s chief medical officer, would depart the company to lead a new biotech focused on developing mRNA medicines. 

Oelkers, who has worked in biopharma for more than 30 years, will start by Feb. 1, 2027, the company said. He said that he would continue BioNTech’s work to be a global company with multiple approved medicines by 2030. 

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BioNTech on Monday named Guido Oelkers, formerly the leader of the Swedish biopharma company Sobi, as its new CEO, as the Covid-19 vaccine developer continues its shift to oncology.

Oelkers will replace Ugur Sahin as CEO. In March, BioNTech announced that Sahin and his cofounder and wife Özlem Türeci, the company’s chief medical officer, would depart the company to lead a new biotech focused on developing mRNA medicines. 

Oelkers, who has worked in biopharma for more than 30 years, will start by Feb. 1, 2027, the company said. He said that he would continue BioNTech’s work to be a global company with multiple approved medicines by 2030. 

Continue to STAT+ to read the full story…

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‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever

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If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.

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