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
Bio SmartBrief
SIGN UP ⋅   SHARE
Today's Top Story
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) 
LinkedIn Twitter Facebook Email
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.
Seeking Alpha (1/16) 
LinkedIn Twitter Facebook Email
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.
Seeking Alpha (1/16) 
LinkedIn Twitter Facebook Email
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) 
LinkedIn Twitter Facebook Email
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.
Seeking Alpha (1/16) 
LinkedIn Twitter Facebook Email
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) 
LinkedIn Twitter Facebook Email
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) 
LinkedIn Twitter Facebook Email
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) 
LinkedIn Twitter Facebook Email
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) 
LinkedIn Twitter Facebook Email
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) 
LinkedIn Twitter Facebook Email
The Latest From BIO
BIO Asia International Conference: Mar. 10-11 in Tokyo
Join this exclusive, customized partnering event that brings together U.S. and European drug development companies with Asian biotech and pharmaceutical companies interested in licensing and investor engagement. Learn more and register today.
LinkedIn Twitter Facebook Email
BIO members can benefit from Business Wire
BIO has partnered with Business Wire to help you effectively distribute your news releases with easy, powerful, and targeted tools at preferred pricing. BIO members pre-qualify for a minimum 10% discount. See a full list of discounts and benefits.
LinkedIn Twitter Facebook Email
  
  
You know there are moments such as these when time stands still and all you do is hold your breath and hope it will wait for you.
Dorothea Lange,
documentary photographer, photojournalist
LinkedIn Twitter Facebook Email
  
  
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.
LinkedIn Twitter Facebook Email
Learn more about BIO:
Conferences | Join Bio | Media | Issues | Industry
The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.
 
Sign Up
SmartBrief offers 200+ newsletters
Advertise
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Advertising  -  Sarah Hostetler
Editor  -  Maria Gifford
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2020 SmartBrief, Inc.®
Privacy Policy (updated May 25, 2018) |  Legal Information