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.

Late-stage data from two studies showed Novartis’ BTK inhibitor remibrutinib improves symptoms of chronic spontaneous urticaria. The company will file for regulatory approval in 2024.
Eli Lilly reported second-quarter revenue of over $8.3 billion, a 28% increase versus Q2 2022, beating estimates of $7.58 billion. The company Tuesday raised its full-year guidance by $2.2 billion.
Thursday, Gilead Sciences reported lower second-quarter profit due to a drop in sales of the company’s Veklury antiviral and a $525 million legal settlement, while slightly raising its sales outlook for the year.
The biotech Thursday reported that second-quarter sales of its COVID shot dropped 94%. However, it expects $6 billion to $8 billion in revenue this year, up from a previous forecast of $5 billion.
Following a year-long legal battle, Illumina is dropping the intellectual property allegations against Guardant. The companies have also entered into a new long-term purchase and supply commitment.
In its second-quarter earnings reported Tuesday, Pfizer announced total revenues declined 54% to $12.7 billion, primarily due to a plummet in Paxlovid and Comirnaty sales.
Ulotaront failed to meet primary endpoints in two studies. The companies said high COVID-19 placebo effect “may have masked molecule’s therapeutic effect” and plan to discuss next steps with the FDA.
The British drugmaker’s rare disease subsidiary Alexion will take on a number of Pfizer’s preclinical gene therapy programs and technologies to advance its genomic medicines pipeline.
Revenue for 2023 is now expected to decline to the low single digits instead of the 2% growth projected. Leadership pointed to the company’s multiple myeloma drugs as the main drags on earnings.
The Phase III trial, which will test the companies’ mRNA-based personalized cancer vaccine and Merck’s blockbuster Keytruda checkpoint inhibitor, is slated for completion by the fall of 2029.
The biotech’s “Fit for Growth” program, which includes the headcount reduction, is expected to generate a net savings of $700 million on operating expenses by 2025.
The Danish vaccine maker’s respiratory syncytial virus candidate did not meet all primary endpoints in a late-stage study in older adults and the company is discontinuing the program.
FDA
After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.
The company’s sales guidance for 2023 has been raised to $98.8 billion to $99.8 billion, driven by cancer drugs and medical devices. J&J’s stock rose about 5% in early trading Thursday.
Less than two years after launch, the startup posts positive Phase II results and heads into Phase III trials for major depressive disorder with a new CEO.