The US Food and Drug Administration (FDA) has granted Fast Tack Designation for an immune medicine targeting triple-negative breast cancer. RPTR-1-201 is a novel T cell receptor (TCR) bispecific immune medicine, developed by biotechnology company Repertoire Immune Medicines, that is currently in a Phase I/II trial for the… Read More
The US Food and Drug Administration (FDA) has granted Fast Track Designation to a treatment for amyotrophic lateral sclerosis (ALS). Tazbentetol, developed by biopharmaceutical company Spinogenix, is a once-a-day pill with potential to restore synapses, the key connections between neurons that allow people to think, plan, remember… Read More
The US Food and Drug Administration (FDA) has granted Fast Track Designation to a treatment for the rare paediatric disease late-infantile neuronal ceroid lipofuscinosis (LINCL/CLN2 disease). PLX-200, developed by biotechnology company Polaryx Therapeutics, will now undergo an expedited review with the potential to address the paediatric disease with unmet… Read More
The US Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to TSRA-196, Tessera Therapeutics’ lead in vivo gene editing programme. TSRA-196 is being jointly developed with Regeneron for the treatment of adults with alpha-1 antitrypsin deficiency (AATD) who are homozygous… Read More
The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW’s Bruno Quinney narrates five key stories of the previous week to keep DDW subscribers up-to-date on the latest industry news. Last week, innovative therapies showed the way to more effective cancer treatments. Elsewhere, how can… Read More
News round-up for 2 – 6 February by Bruno Quinney, Content Team at DDW. This week in DDW, innovative therapies could pave the way to more effective cancer treatments. Elsewhere, how can brain function be improved in Alzheimer’s patients? The top stories: Immunotherapy before surgery… Read More
An investigational therapy could improve cognition, function and brain atrophy measures in Alzheimer’s patients, data shows. Valiltramiprosate, which received Fast Track designation from the US Food and Drug Administration (FDA) in 2017, is an investigational oral agent being evaluated as a potential first-in-class, disease-modifying treatment for Alzheimer’s disease… Read More
The US Food and Drug Administration (FDA) has granted Fast Track Designation to a first-in-class vectorised antibody for the treatment of amyotrophic lateral sclerosis (ALS). VTx-002, developed by biotechnology company VectorY Therapeutics, targets TDP-43 pathology, which drives up to 97% of ALS cases. Fast Track is a process designed… Read More
Sanofi’s investigational one-time intravitreal gene therapy for the treatment of neovascular age-related macular degeneration (AMD) has been granted fast track designation by the US Food and Drug Administration (FDA). Sanofi’s SAR402663 is currently being evaluated in a Phase I/II clinical trial for patients with neovascular AMD. Read More
The US Food and Drug Administration (FDA) has granted Fast Track designation to Cereno Scientific’s lead programme, CS1, for the treatment of pulmonary arterial hypertension (PAH). “The Fast Track designation for CS1 underscores the FDA’s recognition of its potential to address the significant unmet need in PAH,”… Read More
The US Food and Drug Administration (FDA) has revealed plans to issue new Commissioner’s National Priority Vouchers (CNPVs) to companies “supporting US national interests”. The new voucher may be redeemed by drug developers to participate in a novel priority programme that shortens drug review time from approximately… Read More
The US Food and Drug Administration (FDA) has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the potential of the vaccine candidate to address a serious condition and address an unmet public health need. The… Read More
PleoPharma has secured US Food and Drug Administration (FDA) Fast Track designation for PP-01, its lead asset for the mitigation of cannabis withdrawal syndrome in patients with cannabis use disorder. “We are pleased that PP-01 has been granted Fast Track designation and are grateful to the FDA… Read More
The US Food and Drug Administration (FDA) has granted Fast Track designation to SPG601 for the treatment of people with Fragile X syndrome (FXS). FXS, a known cause of autism, is the leading inherited form of intellectual disability that can produce a wide range of disabling symptoms,… Read More
The US Food and Drug Administration (FDA) has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb). The therapy from Johnson & Johnson is being investigated to treat patients with early Alzheimer’s disease (AD) in the Phase IIb AuTonomy study. It has… Read More
The US Food and Drug Administration (FDA) has granted Fast Track designation to Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. Tonmya is a non-opioid, centrally-acting analgesic drug under development for treating fibromyalgia, which is a common chronic pain condition affecting mostly… Read More
