News
While Harmony management has not disclosed future plans for ZYN002, Jefferies analysts expect the asset to be shelved.
FEATURED STORIES
After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role.
A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.
From a small team of researchers and skipped salaries, CEO Michelle Xia has steered Akeso to become one of the most exciting companies in the industry today.
Job Trends
Nine states in the Southeast showed growth in bioscience employment and establishments from 2019 to 2023, according to 2024 data from BIO and TEConomy Partners. NCBiotech and Bexion executives discuss the area and the pros and cons of setting up shop far from major hubs.
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Read our takes on the biggest stories happening in the industry.
Our CEO accidentally started a book club. Now we’re all dreaming of mega pharma mergers.
THE LATEST
With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval.
A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.”
Bluebird bio has re-emerged after a private equity buyout as Genetix Biotherapeutics, marking a return to its roots and a new path forward for manufacturing.
BMO Capital Markets analysts said the first day of the CDC vaccine advisory committee meeting Thursday had anti-vaccine overtones as the panel, which was revamped by Health Secretary Robert F. Kennedy, Jr. in June, voted to recommend that children under four receive the measles, mumps, rubella (MMR) vaccine separately from a chickenpox vaccine. Today the advisors will vote on changing the childhood schedule for the hepatitis B and COVID-19 vaccines.
Investors had been “holding out hope” that there remained a regulatory path forward for RP1, but results of Replimune’s Type A meeting with the FDA do not appear to support this, according to BMO Capital Markets.
The House Committee on Energy and Commerce has cleared proposed legislation that could bring back the FDA’s rare pediatric priority review voucher program, which allows for expedited drug reviews.
Nektar Therapeutics still needs to establish what differentiates rezpeg from other atopic dermatitis therapies, according to analysts at William Blair.
VectorY Therapeutics will evaluate the use of SHP-DB1, a capsid developed by Shape Therapeutics, to deliver therapies to the brain, including VectorY’s developmental Huntington’s and Alzheimer’s disease treatments.
This year, Novo Nordisk and Merck announced significant layoffs, with Novo planning to axe about 9,000 employees and Merck projecting it could let go of roughly 6,000. Meanwhile, Bayer, Bristol Myers Squibb, Novartis and Pfizer have also made noteworthy cuts.
In this episode of Denatured, BioSpace’s head of insights Lori Ellis and Colin Zick, partner at Foley Hoag LLP, spend time discussing some of the points brought up in the Bioprocessing Summit last month. They explore the connections between hammers, AI, The Planet of the Apes and monoliths.