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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Who is the highest paid CEO in all of pharma? In this special edition, BioSpace examines top paid CEOs and their pay packages.
Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners.
At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA.
Investment firm Deerfield Management is the latest to find a gem in China, which has been rising as a source of biotech innovation over the past few years.
With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in eczema severity.
The delay is largely “benign” for Praxis Precision Medicines, according to Jefferies, which emphasized that the FDA did not flag safety or manufacturing issues.
Earlier this year, Amgen refused the FDA’s request to withdraw Tavneos from the market. Now, two researchers who participated in the original study to support the drug’s approval claim they did not know the primary endpoint was readjudicated after the study was unblinded.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Zymeworks announced a new plan to become a royalty-driven company last year, making Theravance a perfect match.
The star of Ipsen’s acquisition is an MDM2 blocker being proposed as an add-on therapy to ruxolitinib for myelofibrosis. The drug could be available to patients “as early as 2028,” according to Ipsen CEO David Loew.
PRESS RELEASES
PharmaTher Evolves Platform Strategy with MEDBOTX(TM) Robotic 3D Printing for Personalized Medicines
MEDBOTX™ represents the evolution into a broader point-of-care manufacturing platform designed for personalized medicines, peptides and advanced dose formats Potential U.S. peptide reclassification and possible inclusion of select peptides on the Section 503A Bulks List could create a timely opportunity for MEDBOTX™ in compounding pharmacies, hospitals and personalized medicine settings