BioCentury | Jan 12, 2021
Product Development

Lilly’s amyloid therapy not a big step forward from Biogen’s

With a more sophisticated protocol for selecting patients and positive Phase II data in hand, Eli Lilly is heading into a confirmatory trial of its Alzheimer’s therapy donanemab in an arguably stronger...
BioCentury | Dec 31, 2020
Emerging Company Profile

Cardior: targeting microRNAs to treat heart failure

Cardior plans to build on early clinical data for its antisense oligonucleotide in heart failure patients by moving the RNA therapy into niche indications where it believes the product can help dysfunctional...
BioCentury | Dec 17, 2020
Deals

Dec. 16 Quick Takes: MacroGenics' margetuximab approved for breast cancer; plus sotorasib, Mesoblast, Cardior, Takeda, Allero

First approval for MacroGenics FDA approved Margenza margetuximab-cmkb from MacroGenics Inc. (NASDAQ:MGNX) — the company’s first approved drug — to treat metastatic HER2-positive breast cancer patients...
BioCentury | Nov 21, 2020
Product Development

Could an approval of Biogen’s Alzheimer’s therapy still be an option?

For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishingly small. But this mAb...
BioCentury | Nov 10, 2020
Product Development

First biomarker data from pioneering tau program in Alzheimer’s cloud use of antibodies for the target

Data presented at the annual CTAD meeting hint that anti-tau therapy semorinemab from Genentech and AC Immune may have engaged its target yet failed to decrease tau aggregation in a Phase II study to treat...
BioCentury | Nov 7, 2020
Regulation

Aducanumab panel criticizes FDA as it rebukes Alzheimer’s candidate

FDA’s advisers not only roundly rebuffed Biogen’s Alzheimer’s candidate aducanumab, tanking its odds of approval, they also lambasted the agency for bias in its presentation of the analyses. In Friday’s meeting of the Peripheral and...
BioCentury | Nov 4, 2020
Regulation

Seven questions for FDA’s adcomm raised by Biogen’s aducanumab data

As the advisory committee meeting on Nov. 6 for Biogen’s anti-amyloid therapy aducanumab to treat Alzheimer’s disease swiftly approaches, seven key questions could make the agenda. Approval of the mAb is far from certain. The data...
BioCentury | Oct 24, 2020
Translation in Brief

UNC Chapel Hill Angelman gene therapy rescues motor function; plus data backing planned Pacylex, Kronos clinical trials and more

AAV gene editing therapy for Angelman syndromeUniversity of North Carolina at Chapel Hill scientists have created a CRISPR gene therapy for Angelman syndrome that ameliorated motor function deficits in a mouse model of the maternally...
BioCentury | Feb 28, 2020
Distillery Therapeutics

An antisense oligo inhibitor of miR-132 for heart failure

DISEASE CATEGORY: Cardiovascular INDICATION: Heart failure The miR-132 inhibitor CDR132L could treat heart failure. In pigs with post-myocardial infarction heart failure, CDR132L improved cardiac function, prevented end-systolic volume enlargement and reduced histologic evidence of interstitial...
BioCentury | Feb 1, 2020
Preclinical News

Cardior eyes heart failure cure with miRNA inhibitor

Cardior unveiled data on Friday that demonstrates its first clinical candidate goes beyond treating the cardiovascular symptoms of heart failure to reversing established disease in animal models. Cardior Pharmaceuticals GmbH, which spun out of Hannover...
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