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Home » Newsletters » BioWorld

BioWorld

March 9, 2023

View Archived Issues
Neurons and amyloid plaques

Lilly drops amyloid-targeting solanezumab for earliest stage of Alzheimer’s

Marking the latest Alzheimer’s disease (AD) disappointment, Eli Lilly and Co.’s solanezumab failed in a phase III trial to slow progression of cognitive decline in patients at the preclinical stage of the disease – those with amyloid plaque but no clinical symptoms – prompting the company to terminate development. The Indianapolis-based company is turning its attention instead to phase III AD products donanemab and remternetug. Read More

Still in the SUDS, Bionomics to STAI positive; can phase III lift SAD-ness?

Bionomics Ltd. is gearing up for an end-of-phase-II meeting with the U.S. FDA later this year to discuss the full results from the phase II study called Prevail in social anxiety disorder (SAD) with BNC-210, which missed its primary endpoint but yielded encouraging signs. Top-line data were disclosed last December. An oral alpha-7 nicotinic acetylcholine receptor negative allosteric modulator, BNC-210 fell short in change from baseline to the average of the Subjective Unites of Distress Scale (SUDS) during a five-minute public speaking challenge. Read More
Businesswoman pressing dollar sign on touchscreen

Quralis closes $88M series B round for trials of targeted ALS therapies

Quralis Inc. raised $88 million in series B round to fund clinical development of its two lead programs in amyotrophic lateral sclerosis (ALS) and to take forward earlier-stage pipeline projects in ALS and frontotemporal dementia. Read More

FDA accepts Mesoblast’s BLA resubmission for remestemcel-L in pediatric GVHD

The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children. Read More
DNA repair

Somatic genome editing pricey, germline editing still risky, researchers conclude

Somatic human genome editing has made huge strides in the past five years, but the likely extremely high prices will be unsustainable. A global commitment to affordable, equitable access is urgently needed because the costs and infrastructure needs of this form of treatment are not manageable for either patients or health care systems. Read More
IPO line graph

House subcommittee looks for rainmaker to end US IPO drought

While the U.S. is in an IPO drought, going public remains the only lifeline for many small life sciences companies facing a decade of development, R&D costs of $1 billion or more, and a hefty risk of failure, Susan Washer, former CEO of Applied Genetic Technologies Corp., testified in a March 9 hearing before the House Subcommittee on Capital Markets. Read More
regulatory-washington-white-house-president.png

Biden budget plan takes aim at drug costs, boosts ARPA-H funding to $2.5 billion

The Biden administration released a blueprint for the U.S. federal government’s fiscal 2024 budget year on March 9, which includes additional funding for pandemic preparedness. However, the White House has signaled its intent to drill down on drug prices with an increase in the scope of the number of drugs subject to Medicare price negotiations along with a 67% increase in the Advanced Research Projects Agency–Health (ARPA-H) to $2.5 billion, a boost that is sure to draw cheers from companies in the life sciences. Read More

Appointments and advancements for March 9, 2023

New hires and promotions in the biopharma industry, including: Asklepios, Centogene, Evofem, Fulcrum, Homology, Lava, Nkgen, Pliant, Rome, Transgene. Read More

Financings for March 9, 2023

Biopharmas raising money in public or private financings, including: Hemostemix, Iktos, Macrogenics, Nrx, Ring, Tiamat. Read More

In the clinic for March 9, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications:  Achieve, Alterity, Biocorrx, Biothera, Cel-Sci, DBV, Fresh Tracks, JW, Molecure, Redx, Renovorx, Sernova, Sparrow, Vistagen. Read More

Other news to note for March 9, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Fusion, Biocytogen, Bridgene, Carisma, Gilead, J&J, Neoleukin, Selonterra, Sesen, Surface Oncology, Takeda, Tessa. Read More

Regulatory actions for March 9, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antev, Biogen, Biomarin, Boehringer, Eli Lilly, Inhibikase, Mesoblast, Revive, Sage. Read More

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