Kate Goodwin

Kate Goodwin

Contributing Writer | News & Features

Kate Goodwin hails from a background primarily in marketing. A passion for health sciences and writing led her to the biopharma news world, and she’s never looked back. She’s been writing for BioSpace for more than two years with a focus on cutting edge research, Alzheimer’s disease and pediatrics. Her free time is filled by her husband, children, Beagles, books, crochet and creative writing. She can be reached at kate.goodwin@biospace.com.

While approved in non-small cell lung cancer, Keytruda failed to provide benefit for the TKI-resistant, EGFR-mutant subtype of the disease.
The Swiss pharma’s CDK4/6 inhibitor reduced risk for recurrence by 25% when added to the standard-of-care endocrine therapy, inviting comparisons to Lilly’s Verzenio.
The regulator will provide PepGen with a letter within 30 days explaining why a clinical hold was placed on the company’s Phase 1 study of patients with myotonic dystrophy Type 1.
Marstacimab decreased bleeding rates by 92% in patients with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.
FDA
The regulator approved Xacduro for treating hospital-acquired and ventilator-associated bacterial pneumonia. The NDA was filed by Entasis Therapeutics, which Innoviva acquired in 2022.
The Swiss pharma has canceled a second mid-stage trial for its investigational schizophrenia drug ralmitaront, as the competition shows promise in the space.
Sanofi and Regeneron reported positive results for the anti-inflammatory drug in a chronic obstructive pulmonary disease trial. The companies hope to see approval before a 2024 read-out of a second trial.
Fenebrutinib in a mid-phase trial reduced brain legions in relapsing forms of multiple sclerosis, the company reported. It is the only reversible BTK inhibitor currently in Phase III MS trials.
A collaborative research agreement will leverage Sony’s unique polymer, which the companies contend is a stable, effective linker for delivering antibody-drug conjugate payloads to cancer cells.
The company’s second antibody-drug conjugate deal of 2023, with Shanghai-based LaNova Medicines, adds a potential first-in-class GPRC5D-directed ADC for multiple myeloma.
The regulator in a Complete Response Letter rejected ImmunityBio’s bladder cancer hopeful due to deficiencies with the company’s third-party contract manufacturer.
The acquisition provides the Swedish company with an approved JAK inhibitor for myelofibrosis, a rare bone marrow cancer that disrupts the body’s normal production of blood cells.
Partnership seeks to identify novel therapeutic molecules to address diseases with high unmet patient needs. It’s the second target discovery company to link with BI in the last month.
Idea Pharma’s annual index reveals key drivers and metrics for large companies. AstraZeneca and Pfizer remain in the top positions this year for invention and innovation, respectively.
As the COVID-19 market dries up, Moderna looks to FDA approval of its other vaccines including a 2024 commercial launch of its investigational RSV vaccine for older adults.