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BioWorld - Friday, June 26, 2026
Home » Authors » Karen Carey

Articles by Karen Carey

Concept of business partnership

Zealand Pharma, OTR, in $2.5B small-molecule metabolic deal

Dec. 16, 2025
By Karen Carey
No Comments
The quest for metabolic disease assets continues with another player promising top dollar for novel therapeutics that deliver. Copenhagen, Denmark-based Zealand Pharma A/S entered a collaboration and license agreement with newly formed OTR Therapeutics to pursue next-generation small-molecule therapeutics, beyond the Danish firm’s current peptide pipeline candidates focused on the GLP-1, GLP-2, GIP, amylin and glucagon mechanisms.
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Illustration of Neisseria gonorrhoeae

Nuzolvence, Blujepa win FDA nods for gonorrhea

Dec. 12, 2025
By Karen Carey
No Comments
Two new therapies are now FDA approved to treat the sexually transmitted infection gonorrhea, with Innoviva Inc.’s Nuzolvence (zoliflodacin) and GSK plc’s Blujepa (gepotidacin) offering additional antibiotic options comparable to standard of care. Both products had fast track, qualified infectious disease product and priority review designations.
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Concept of business partnership

Zealand Pharma, OTR, in $2.5B small-molecule metabolic deal

Dec. 11, 2025
By Karen Carey
No Comments
The quest for metabolic disease assets continues with another player promising top dollar for novel therapeutics that deliver. Copenhagen, Denmark-based Zealand Pharma A/S entered a collaboration and license agreement with newly formed OTR Therapeutics to pursue next-generation small-molecule therapeutics, beyond the Danish firm’s current peptide pipeline candidates focused on the GLP-1, GLP-2, GIP, amylin and glucagon mechanisms.
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Illustration of leg anatomy with target around knee

Lilly’s retatrutide shows solid weight loss, reduced knee pain

Dec. 11, 2025
By Karen Carey
No Comments
Eli Lilly and Co.’s latest phase III results for the obesity and overweight populations suggest its triple agonist, retatrutide, can deliver significant weight loss that, in turn, leads to reduced osteoarthritis knee pain.
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Platelets and red blood cells

ASH 2025: Ianalumab data offer break from chronic ITP therapy

Dec. 10, 2025
By Karen Carey
No Comments
Novartis AG’s monoclonal antibody, ianalumab (VAY-736), when added to standard-of-care eltrombopag, extended disease control of primary immune thrombocytopenia (ITP) by 45%, according to data presented Dec. 9 during a late-breaker abstract session at the 67th American Society of Hematology’s annual meeting in Orlando, Fla.
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Multiple myeloma illustration

ASH 2025: Tec-dara shines on ‘functional cure’ Majestec-3 MM data

Dec. 9, 2025
By Karen Carey
Impressive results of a potential second-line combination treatment for multiple myeloma from the Majestec-3 trial of teclistamab plus daratumumab raised eyebrows at the American Society of Hematology’s 67th annual meeting, with the combination showing an 83.4% rate of progression-free survival at three years vs. 29.7% for standard of care.
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IV drips

ASH 2025: New blood cancer therapies trump chemo, older drugs

Dec. 8, 2025
By Karen Carey
No Comments
Targeted therapies and immunotherapies continue to show better results than chemotherapy in investigator-initiated and company-sponsored cancer trials, and newer options demonstrate improvements over older ones, supporting potential shifts in how patients are treated.
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Acute myeloid leukemia

ASH 2025: Speeding AML research with MRD surrogate endpoint

Dec. 8, 2025
By Karen Carey
No Comments
While several targeted therapies are approved for acute myeloid leukemia, a 2023 U.K. study found that median survival following diagnosis was only about seven months, highlighting the need not only for new therapies, but for a faster regulatory strategy. At the American Society of Hematology’s 67th annual meeting in Orlando Dec. 6, researcher Jesse Tettero presented data supporting the use of a measurable residual disease (MRD) surrogate endpoint in acute myeloid leukemia (AML) research.
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ASH 2025: Casgevy for kids? Expanding, improving SCD gene therapies

Dec. 8, 2025
By Karen Carey
No Comments

Only a couple of years since the first sickle cell disease (SCD) gene therapies gained U.S. FDA approval, researchers are working to expand access for younger children, and to improve manufacturing and commercialization to reach patients faster.


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Tracy Beth Høeg, acting CDER director

Høeg appointment as acting CDER director tied to vaccine strategy?

Dec. 5, 2025
By Karen Carey
No Comments
After a more than 13-year period of stability with Janet Woodcock as the head of CDER, with Patrizia Cavazzoni taking charge during the next four years of former U.S. President Joe Biden’s tenure, the FDA division has had no fewer than five different people in charge throughout 2025. Up to bat now as acting director is Tracy Beth Høeg, a physician and epidemiologist who co-authored a paper in 2022 with CBER Director Vinay Prasad, FDA Commissioner Marty Makary and others demonstrating that COVID-19 boosters and college vaccine mandates were harmful to young men due to myocarditis risks.
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