Latest News
& Press Releases

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
In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demeetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates.
The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics.
Roche’s decision to discontinue the Ionis-partnered trials came soon after the biotech sustained a late-stage failure in ATTR-CM.
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.
FDA
The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
The late-stage miss is “surprising,” Stifel analysts said, given that Wainua’s mechanism of silencing transthyretin protein expression has previously proven effective.
GSK and Alector first partnered in 2021 to advance two antibodies for neurodegenerative diseases. Both assets have since failed to show significant clinical benefit.
UPCOMING EVENTS
PRESS RELEASES
Financing was led by new investor and top-tier healthcare fund Nantahala Capital and longtime Envoy Medical shareholder, billionaire Glen Taylor Closing of $30 million in gross proceeds in upsized offering, with up to an additional $48 Million upon exercise of milestone warrants, provides potential funding through commercialization Company hosting Fireside Chat with Dr. Theodore McRackan, on February 25th at 10 a.m. ET, to discuss his initial experiences as clinical trial’s leading implanter
Naturally-Derived 5 mg Psilocybin Capsules Mark the Company’s Second Drug in Market Under Australia’s Authorised Prescriber Scheme
Leadership Enhancements Position Company for Upcoming Regulatory Engagement and Clinical Milestones New Appointments Reinforce Operational Readiness Across Finance, Regulatory Affairs and Program Leadership
MARKET RESEARCH REPORTS