BMS' marketing application for lung cancer combo accepted by FDA | Expanded indication approved for Novo Nordisk's Ozempic | FDA grants fast track status to Arena Pharma's heart failure drug
January 17, 2020
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BMS' marketing application for lung cancer combo accepted by FDA
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.
PMLive (UK) (1/16),  Seeking Alpha (1/15) 
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Health Care & Policy
Expanded indication approved for Novo Nordisk's Ozempic
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.
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FDA grants fast track status to Arena Pharma's heart failure drug
Arena Pharmaceuticals' investigational drug APD418 was granted fast track status by the FDA as a treatment for decompensated heart failure.
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PTC seeks EMA's approval for AADC gene therapy candidate
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.
PharmaTimes online (UK) (1/15) 
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Company & Financial News
BioMarin's hemophilia A gene therapy could cost between $2M and $3M
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.
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Children's hospital spins off gene therapy biotech
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.
BioPharma Dive (1/15) 
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Neon Therapeutics to be acquired by BioNTech for $67M
BioNTech announced it will acquire Neon Therapeutics through a $67 million stock deal. Neon has focused on researching personalized cancer vaccines.
Xconomy (1/16) 
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Japan's AnGes leads $61M round for biotech startup Emendo
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.
Xconomy (1/15) 
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Food & Agriculture
Mosquito genes edited to become resistant to all 4 dengue strains
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.
HealthDay News (1/16) 
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Industrial & Environmental
USDA launches RFI for biofuel infrastructure incentive program
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.
Ethanol Producer Magazine online (1/16) 
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Editor's Note
SmartBrief will not publish Monday
In observance of Martin Luther King Jr. Day in the US, SmartBrief will not publish Monday. Publication will resume Tuesday.
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