The FDA has accepted the marketing application filed by Bristol-Myers Squibb for its lung cancer combination of Opdivo, or nivolumab, plus Yervoy, or ipilimumab, as a first-line treatment for patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK mutations. An action date of May 15 was set by the agency.
Novo Nordisk announced that the FDA has approved its application for the expanded indication of its drug Ozempic, or semaglutide, to diminish the risk for major adverse cardiovascular events in adult patients with type 2 diabetes who have been previously diagnosed with heart disease. The approval was based on data from its SUSTAIN 6 trial.
A marketing authorization application was filed by PTC Therapeutics with the European Medicines Agency seeking the agency's approval for its gene therapy candidate PTC-AADC as a treatment for aromatic l-amino acid decarboxylase deficiency.
BioMarin Pharmaceutical announced that it is considering a price between $2 million and $3 million for its gene therapy Valrox, or valoctocogene roxaparvovec, a treatment for hemophilia A. BioMarin is also considering other payment options such as pay for performance.
Andelyn Biosciences is a biotech spun off by Nationwide Children's Hospital that will focus on manufacturing gene therapy components for use in clinical trials. "Commercial-scale manufacturing represents one of the next significant barriers to the continued development of the field," said Dennis Durbin, chief scientific officer of Nationwide's Abigail Wexner Research Institute.
Emendo Biotherapeutics, a startup that says it develops therapies for diseases that are currently untreatable by using the next generation of CRISPR gene editing technology, raised $61 million in its most recent funding round. Japan-based biopharmaceutical firm AnGes led the Series B round.
Novel biotech mosquitoes have been created by scientists that are resistant to the four strains of dengue, according to findings reported in the journal PLOS Pathogens. The development could boost disease control efforts in countries where dengue is endemic.
A request for information was launched by the Department of Agriculture on Jan. 16 to solicit the public's comments that would help the agency create its Higher Blends Infrastructure Incentive Program. The new initiative has a goal of expanding ethanol and biodiesel availability by providing incentives for the expansion and trade of renewable fuels.
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