BioSpace News Archive

FDA

At Last, FDA Signs Off on Adamis’ Opioid Overdose Drug

Zimhi is indicated for use in both adults and children in the event of an emergency. It is to be given right away and does not take the place of emergency care.

October 19, 2021
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2 min read
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Vanessa Doctor, RN
Drug Development

Lilly’s Longest Diabetes Drug Trial Lowers A1C and Increases Weight Loss

SURPASS-4 is part of the Phase III trial evaluating tirzepatide as a possible treatment for type 2 diabetes.

October 19, 2021
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2 min read
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Vanessa Doctor, RN
Drug Development

Another Milestone: LogicBio Successfully Edits Genes in Children

On Monday, LogicBio Therapeutics unveiled clinical trial results demonstrating the first-ever in vivo, nuclease-free genome editing in little humans.

October 19, 2021
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4 min read
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Heather McKenzie
Drug Development

COVID-19 and the Spanish Flu - Drawing Comparisons

With the Delta variant of coronavirus spreading globally, the pandemic still has a tight grip on the world. Many people around globe are struggling to come to terms with the aftermath of the pandemic, much like a century ago with the Spanish flu.

October 19, 2021
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7 min read
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Mishayl Hanan
Drug Development

Roche-Partnered COVID-19 Antiviral Flunks in Phase II

AT-527, an oral direct-acting antiviral agent that blocks viral RNA polymerase needed for viral replication, failed to meet its primary endpoint in the Phase II MOONSONG study.

October 19, 2021
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2 min read
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Alex Keown
Deals

Boehringer Ingelheim Steps Up to the Plate for Cystic Fibrosis Patients

Choosing to exercise its options with a group of research and development partners, the pharma giant will accelerate a promising new C.F. gene therapy.

October 19, 2021
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2 min read
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Kate Goodwin
Genetown

Is mRNA the Future of Drug Development?

The idea of using mRNA has been around for some time, but only in recent years has it become practical. The COVID-19 pandemic provided the opportunity for the technology to push ahead.

October 19, 2021
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5 min read
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Mark Terry
Policy

Covid News Brief: Vaccine Boosters, Profits, Treatment Updates and More

With expectations that the U.S. FDA will announce a decision about booster shots for the Moderna and Johnson & Johnson vaccines this week, there is plenty of COVID-19-related news. Here’s a look.

October 19, 2021
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5 min read
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Mark Terry
Business

CAR-T Pioneer Carl June Will Lend Wisdom to Bioheng Biotech

June really broke out in 2012 when he saved the life of Emily Whitehead, a child suffering from relapsed acute lymphoblastic leukemia (ALL), with CD19 CAR-T.

October 19, 2021
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2 min read
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Heather McKenzie
Drug Development

Calithera Biosciences Scores Two Complementary Oncology Compounds in Takeda Deal

Calithera Biosciences is expanding its oncology portfolio with the addition of two clinical-stage compounds from Takeda Pharmaceuticals.

October 19, 2021
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3 min read
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Alex Keown