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BIO 2019 Notebook: Merck; RMAT; Out-Licensing Deals

 
• By Joseph Haas and Sue Sutter

News and views from day one of the BIO International Convention: Merck reaffirms commitment to antibiotic space the same day Zerbaxa picks up a new indication; US FDA regenerative medicine advanced therapy designations now outnumber breakthrough designations for cell/gene therapies; BIO survey finds out-licensing cash for emerging firms more than doubled in 2018.

Bio 2019 Notebook for Pink
A total of 36 products within the purview of FDA's tissues/advanced therapies office have received RMAT and 32 got BTD. • Source: Shutterstock

On the same day that Merck & Co. Inc.'s Zerbaxa (ceftolozane/tazobactam) obtained a supplemental approval from the US FDA for hospital- and ventilator acquired pneumonia (HABP/VABP), the big pharma reaffirmed its commitment to the antibiotic space at the Biotechnology Innovation Organization’s annual convention in Philadelphia.

During a 3 June session on reimbursement reform for novel antibiotics in the US, Jenelle Krishnamoorthy, Merck & Co.’s associate VP for global policy, communications & population health, noted that...

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