Sanofi, AZ’s RSV drug snags FDA approval

Today's Big News

Jul 17, 2023

Lilly shares full pivotal data on Alzheimer’s drug, revealing how it shapes up against Leqembi


Sanofi and AZ advance immunization master plan with US nod for infant RSV drug Beyfortus


BridgeBio heart disease drug vindicated with phase 3 victory, plots FDA submission this year


J&J touts Rybrevant win in newly diagnosed lung cancer, with key Tagrisso head-to-head readout up next


QuidelOrtho’s recall of potentially faulty heart attack blood tests lands FDA Class I tag


Sanofi taps Scribe for in vivo partnership worth more than $1.2B biobucks aimed at sickle cell and beyond


Novartis pays $500M to fly DTx's FALCON platform, 3 preclinical neuroscience programs


Catalent's Indiana site, linked with Regeneron's high-dose Eylea rejection, dinged with 3 FDA observations


FDA greenlights Urotronic's drug-coated balloon for BPH


Los Angeles VC Westlake Village BioPartners launches $450M biotech fund with ‘recipe for success’


Orthopedic implant maker CurvaFix collects $39M, new CEO to scale up sales

 

Featured

Lilly shares full pivotal data on Alzheimer’s drug, revealing how it shapes up against Leqembi

Eli Lilly has held the grand reveal of the Alzheimer’s disease trial data it hopes will secure FDA approval for donanemab by the end of the year. The update shows improvements over placebo continued to grow over the course of the study, even after patients stopped taking the drug, but confirmed concerns about safety and the value of treating patients early.
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July 18-19, 2023 | Jersey City, NJ
 

Top Stories

Sanofi and AZ advance immunization master plan with US nod for infant RSV drug Beyfortus

Sanofi’s immunization scheme is starting to fall into place, thanks to an approval that could propel it and its partner AstraZeneca to the frontlines of the RSV scene.

BridgeBio heart disease drug vindicated with phase 3 victory, plots FDA submission this year

BridgeBio's heart disease drug was victorious in a phase 3 trial, making up for earlier stumbles that threw into question the biotech's cardiorenal aspirations. The company is now planning to submit an approval application to the FDA before the end of the year.

J&J touts Rybrevant win in newly diagnosed lung cancer, with key Tagrisso head-to-head readout up next

Positive phase 3 data could move Johnson & Johnson's lung cancer drug Rybrevant into newly diagnosed patients. And a key phase 3 trial against AstraZeneca's Tagrisso could read out later this year.

QuidelOrtho’s recall of potentially faulty heart attack blood tests lands FDA Class I tag

QuidelOrtho is recalling thousands of blood tests used to help quickly diagnose myocardial infarctions and other heart conditions.

Sanofi taps Scribe for in vivo partnership worth more than $1.2B biobucks aimed at sickle cell and beyond

Sanofi is taking another dip in Scribe's CRISPR pool, inking a new in vivo gene editing partnership worth more than $1.2 billion. The two companies said that one focus of the development pact will be treating sickle cell disease.

Novartis pays $500M to fly DTx's FALCON platform, 3 preclinical neuroscience programs

Novartis is getting full rights to the San Diego-based biotech’s FALCON platform as well as a preclinical therapy for Charcot-Marie-Tooth disease type 1A, a neuromuscular disorder for which there are currently no approved meds.

Catalent's Indiana site, linked with Regeneron's high-dose Eylea rejection, dinged with 3 FDA observations

Regeneron's recent FDA rejection of the high-dose Eylea was attributed to manufacturing issues at Catalent's Indiana site, the company confirmed. The observations at the site have now been disclosed, revealing problems related to cleaning and sanitization procedures.

FDA greenlights Urotronic's drug-coated balloon for BPH

The FDA has expanded the use of a drug-coated balloon developed by Urotronic for male urinary procedures, which the company describes as one of the first of a new generation of devices in the space.

Los Angeles VC Westlake Village BioPartners launches $450M biotech fund with 'recipe for success'

Westlake Village BioPartners has launched its third fund, a $450 million vault for developing early-stage, next-gen biotechs in Los Angeles and beyond.

Orthopedic implant maker CurvaFix collects $39M, new CEO to scale up sales

Fresh off the launch of a second, smaller iteration of its curved intramedullary fixation device, CurvaFix is facing a flood of venture capital—and has tapped a new CEO to help navigate the rising waters.
 
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‘The Top Line’: Digital phenotyping, plus this week’s headlines

This week on "The Top Line," we discuss the state of digital phenotyping, plus the vaccine patent lawsuits, the smallest insulin pump, and the rest of the week's headlines.

 

Resources

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Medical Affairs Metamorphosis

This eBook identifies the trends driving major change in the Medical Affairs (MA) function. It also outlines the strategic and tactical implications for MA leaders and team members.
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6 Tools Trial Sponsors Need to Take Action Earlier in Enrollment

Take a look at the reporting tools sponsors need to access insights earlier in the clinical trial enrollment funnel, so you can take informed actions.
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Enhance the cost-effectiveness of your GMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows.
 

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