Abbott warns FreeStyle Libre users of battery risk

Today's Big News

Apr 4, 2023

Sanofi, BARDA break ground on another flu vaccine plant at campus in Swiftwater, Pennsylvania


Gossamer halts work on BTK inhibitor after 2 patient deaths


Abbott advises FreeStyle Libre users of potential battery overheating, swelling


Seeking full approval in Alzheimer's, Eisai dives into prominent Leqembi side effect


VBI Vaccines pares down pipeline and staff to focus on hepatitis B programs


Butterfly nets AI ultrasound clearance for spotting signs of lung disease


Ahead of Pfizer buyout, Seagen's Padcev gains Keytruda combo nod in first-line bladder cancer

 

Featured

Sanofi, BARDA break ground on another flu vaccine plant at campus in Swiftwater, Pennsylvania

Sanofi and the Biomedical Advanced Researched Development Authority (BARDA) are expanding their capacity to manufacture flu shots. They are breaking ground on a two-story formulation and filling facility at the company’s sprawling campus in Swiftwater, Pennsylvania.
 

Top Stories

Gossamer halts work on BTK inhibitor after 2 patient deaths

Gossamer is ending development of a lymphoma med after reports of two deaths and other serious adverse events in a phase 2 trial that was paused in March citing the “benefit/risk profile observed to date.”

Abbott advises FreeStyle Libre users of potential battery overheating, swelling

Abbott is reminding users of FreeStyle Libre diabetes monitors to take good care of their batteries, after reports swelling, overheating or fire. No devices are being recalled.

Seeking full approval in Alzheimer's, Eisai dives into prominent Leqembi side effect

Eisai's new Leqembi analyses, which debuted at the 2023 annual meeting of the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD), offer more context around the tough conversations patients and caregivers may need to have with their doctors before going on treatment. Plus, the new data will inform Eisai’s bid to translate its speedy green light into a full, traditional FDA approval.

VBI Vaccines pares down pipeline and staff to focus on hepatitis B programs

With an eye towards someday developing a “functional cure” for hepatitis B, VBI Vaccines is triaging the rest of its programs and sending 30-35% of staff out the door.

Butterfly nets AI ultrasound clearance for spotting signs of lung disease

Using a six-second video clip, Butterfly's software aims to spot the signs of excess wetness in the lungs that can hinder the ability to breathe.

Ahead of Pfizer buyout, Seagen's Padcev gains Keytruda combo nod in first-line bladder cancer

While Merck & Co.’s Seagen buyout wasn't fated to be, the companies’ clinical courtship in cancer has blossomed into a swift approval at the FDA.

OncoSec faces setback as blinded review reverses early impression, revealing Keytruda combo study flop

OncoSec Medical’s six-year pursuit of potentially pivotal data on its Keytruda combination has delivered a last-minute twist. After touting an 18.8% investigator-assessed response rate, the biotech has revealed that the final result per blinded independent central review (BICR) fell well short of the bar for success.

Masimo receives FDA clearance for first opioid overdose prevention monitor

Developed by Masimo, the Opioid Halo device checks for drug-induced respiratory depression, the leading cause of death from an overdose.

Returning the complement: Protein's role in pathway could bolster new Alzheimer's approach

It seems like every week brings another potential avenue to explore in combating Alzheimer's. The most recent update comes courtesy of the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard, which pinpointed a brain protein that could offer a fresh target.
 
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'The Top Line': Biotech's 2023 trends, plus this week's headlines

This week on "The Top Line," we discuss how 2023 is shaping up to be much the same as last year when it comes to financing trends for biotechs. We also cover Emergent's Narcan winning the first over-the-counter approval for an opioid-overdose drug and more of this week's top headlines.

 

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