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The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.
FEATURED STORIES
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Job Trends
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate PF-06928316 or RSVpreF for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Tome Biosciences, a gene editing startup that launched in late 2023 with $213 million in funding, will eliminate 131 positions in November, according to a Worker Adjustment and Retraining Act notice.
Johnson & Johnson’s proposed changes to the hospital drug discount program are inconsistent with the federal statute, according to the Health Resources and Services Administration.
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
Venture capital in the sector hit $9.2 billion in the second quarter of 2024, up from $7.4 billion in Q1, while exits fell on a slower M&A cycle and picky IPO market.
Project 2025, a blueprint for a potential second Trump term that highlights the IRA as a potential target, took a starring role in this week’s Democratic National Convention.
The regulator on Thursday said the mRNA vaccines, Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, will better protect against currently circulating variants as COVID continues to surge in many parts of the U.S.
Despite the promise of its technology and funding from big backers, Tome Biosciences is “operating at reduced capacity” and weighing its “strategic options” as the Massachusetts-based company faces an uncertain future.
The Danish biotech on Thursday reported stronger-than-expected earnings and forecasts hitting the upper range of its full-year revenue target amid the ongoing mpox outbreak.
The Oncologic Drugs Advisory Committee in a Sept. 26 meeting will discuss whether the regulator should restrict approval of checkpoint inhibitors based on PD-L1 expression levels.
Looking to build on the success of Chinook Therapeutics, founded by Versant in 2019 and acquired by Novartis last year, the companies on Thursday launched Borealis Biosciences with $150 million in funding to develop RNA therapeutics for kidney diseases.