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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. 

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STAT+: Once again, child dies in gene-editing trial in China, rekindling debate on transparency and safety

Last year, a little-known Chinese startup took center stage at the American Society for Gene and Cell Therapy annual convention in New Orleans. 

Speaking before a sprawling conference hall for the presidential symposium, HuidaGene CEO Alvin Luk presented data from one of the world’s first trials to test if CRISPR gene editing could cure children with Duchenne muscular dystrophy, an intractable, fatal disease. Similar efforts in the U.S. ran aground amid technical challenges, but HuidaGene had surged ahead, using a regulatory pathway that lets Chinese hospitals start studies without oversight from government regulators. 

The results, from the first two patients, were not impressive. It wasn’t clear the therapy worked at all. But Luk said the data indicated benefit and the company was about to test a higher dose. Hopefully, that would have far better effects. 

Then HuidaGene went dark. For 15 months following that conference, the Shanghai-based company did not issue a single new press release. Luk quietly departed last summer, alongside Chief Technology Officer TJ Cradick, a longtime U.S.-based gene editing executive who had been there less than a year. In February, a listing on a clinical trial registry was updated to announce the study was “complete.” 

What happened to the remainder of patients in the study was unclear. But after a monthslong STAT investigation and repeated questions to the company, HuidaGene on Wednesday issued an update.

Continue to STAT+ to read the full story…

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Last year, a little-known Chinese startup took center stage at the American Society for Gene and Cell Therapy annual convention in New Orleans. 

Speaking before a sprawling conference hall for the presidential symposium, HuidaGene CEO Alvin Luk presented data from one of the world’s first trials to test if CRISPR gene editing could cure children with Duchenne muscular dystrophy, an intractable, fatal disease. Similar efforts in the U.S. ran aground amid technical challenges, but HuidaGene had surged ahead, using a regulatory pathway that lets Chinese hospitals start studies without oversight from government regulators. 

The results, from the first two patients, were not impressive. It wasn’t clear the therapy worked at all. But Luk said the data indicated benefit and the company was about to test a higher dose. Hopefully, that would have far better effects. 

Then HuidaGene went dark. For 15 months following that conference, the Shanghai-based company did not issue a single new press release. Luk quietly departed last summer, alongside Chief Technology Officer TJ Cradick, a longtime U.S.-based gene editing executive who had been there less than a year. In February, a listing on a clinical trial registry was updated to announce the study was “complete.” 

What happened to the remainder of patients in the study was unclear. But after a monthslong STAT investigation and repeated questions to the company, HuidaGene on Wednesday issued an update.

Continue to STAT+ to read the full story…

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Lilly, FDA retatrutide biologic dispute comes to a head as submission nears

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A legal dispute between the FDA and Eli Lilly over whether the highly anticipated obesity candidate retatrutide is indeed a biologic has come to a head as the company prepares to submit the medicine for approval.

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Attovia adds to biotech IPO momentum with $289M offering

The startup is the 12th drug company to bank at least $250 million in an IPO this year, nearly matching totals last seen during the sector’s pandemic peak, according to BioPharma Dive data.

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The startup is the 12th drug company to bank at least $250 million in an IPO this year, nearly matching totals last seen during the sector’s pandemic peak, according to BioPharma Dive data.

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