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Home » Authors » Lee Landenberger

Lee Landenberger

Articles

ARTICLES

Cardiff Oncology shares surge as first-line colorectal cancer study begins

March 1, 2024
By Lee Landenberger
As Cardiff Oncology Inc. dosed the first patient in its phase II study of onvansertib (CRDF-004) in a first-line setting to treat RAS-mutated metastatic colorectal cancer (mCRC), the company also revealed positive efficacy data from its discontinued phase II of onvansertib as a second-line treatment of bevacizumab-naïve RAS-mutated mCRC.
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BIO CEO 2024: AI applications will only become broader

Feb. 29, 2024
By Lee Landenberger
In a panel discussion with executives at the 2024 BIO CEO conference this week in New York, the consensus emerged that artificial intelligence is here to stay, despite its occasional moments of hype, as its applications continually grow.
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Hand holding ballot over box, US flag backdrop

BIO CEO 2024: Policy impact on US election year will linger

Feb. 27, 2024
By Lee Landenberger
Drug pricing is playing an outsized role in the dynamics of the November U.S. election, creating turbulence for drug companies and for patients that will extend years after the votes are counted. During a Feb. 27 morning session on drug pricing trends during an election year at the BIO CEO & Investor Conference in New York, key opinion leaders spoke about their concerns, including the need to explain drug-pricing rationale to voters and patients in plain terms.
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Coins and charts

BIO CEO 2024: This downturn will end … eventually

Feb. 26, 2024
By Lee Landenberger
Companies and investors, well aware of the natural up and down fluctuations of the market, keep expecting the current downturn to end. They’ve been expecting it to begin an upturn for the past two years. During a Feb. 26 session on venture capital trends at the BIO CEO & Investor Conference in New York, investors said the tough times might well extend further into 2024 than they would like.
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Tentarix joins a $64M collaboration with Abbvie

Feb. 22, 2024
By Lee Landenberger
In its second big collaboration of the past six months, privately held Tentarix Biotherapeutics LP plans to discover and develop biologics for treating oncology and immunology indications with Abbvie Inc. The deal comes at a time of change at Abbvie, which is getting a new CEO, watching the marketplace erosion of bestselling Humira (adalimumab) and digesting two major acquisitions at a cost of billions.
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BIO CEO 2024: Prepping for better times

Feb. 21, 2024
By Lee Landenberger
Helping executive and investors prepare for better economic times is a strong theme in the upcoming BIO CEO 2024 conference, which runs Feb. 26 and 27 in New York. The annual conference, sponsored by the Biotechnology Innovation Organization, is designed to present a broad, unbiased view of investment opportunities. Panels of experts are set to discuss hot therapeutic areas and the key business issues facing companies and the industry.
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FDA Approved stamp

Takeda quickly follows Sanofi-Regeneron with esophagitis approval

Feb. 20, 2024
By Lee Landenberger
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
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3D illustration of a nerve cell

Live by the SORD: Applied Therapeutics looks to rare disease NDA

Feb. 15, 2024
By Lee Landenberger
Based on positive phase III study data, Applied Therapeutics Inc. plans to take its CNS-penetrant aldose reductase inhibitor to the U.S. FDA to talk about an NDA for treating the rare disease sorbitol dehydrogenase (SORD) deficiency. Interim data from 12 months of treatment showed govorestat (AT-007) hit the study’s primary endpoints along with several key secondary endpoints. The double-blind, placebo-controlled registrational study of patients ages 16 to 55 is ongoing, with another 12 months of data yet to come. SORD, a hereditary axonal neuropathy created by sorbitol dehydrogenase gene mutations, affects about 3,300 people in the U.S. and about 4,000 in Europe, according to Applied Therapeutics.
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Cold hands against snowy background

First-ever frostbite treatment gets US approval

Feb. 14, 2024
By Lee Landenberger
The U.S. FDA has approved Eicos Sciences Inc.’s Aurlumyn (iloprost) for treating severe frostbite. The injectable vasodilator, which opens blood vessels and stops blood from clotting, is now approved for adults to reduce finger or toe amputations and is, according to the FDA, the first-ever treatment option for severe frostbite. The drug, also referred to as ES-2001, had the FDA’s priority review and orphan drug designations for treating severe frostbite.
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FDA Approved stamp

Takeda quickly follows Sanofi-Regeneron with esophagitis approval

Feb. 12, 2024
By Lee Landenberger
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
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