Axol Bioscience Ltd, a pluripotent stem cell technology provider for drug discovery, has signed an exclusive agreement with StrataStem to access and commercialize its extensive collection of Alzheimer’s Disease (AD) patient samples.
SiSaf has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (PRDD) by the US Food and Drug Administration (FDA) for its osteopetrosis treatment, SIS-101-ADO.
Acesion Pharma has announced positive data from pre-clinical studies with AP31969, developed for chronic oral maintenance treatment to prevent atrial fibrillation (AF) recurrence.
More than a year after imposing a clinical hold on MaaT Pharma’s lead microbiome therapeutic in 2021, the US Food and Drug Administration (FDA) has given clearance for the French firm to begin a phase 3 trial in the US.
Finch Therapeutics announced its shock decision to discontinue the PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI) yesterday (Jan 25) saying instead it will focus on ‘realizing the value of its intellectual property estate and...
The WHO has set out a new blueprint for dementia research: outlining the potential of precision medicine, repurposed drugs and revamped clinical trials. “Addressing dementia is one of the greatest health challenges of our generation,” says the organization.
The recent lecanemab trial read-out will have a sizeable impact on the path forward for other biopharma’s developing treatments for Alzheimer’s disease, says the chief executive of a company developing investigational therapies for rare peripheral amyloid...
An investigational Alzheimer's drug made by Eisai Co Ltd and Biogen slowed cognitive and functional decline in a trial involving a large group of patients in the early stages of the disease.
The DATAcc has released a collection of open-access resources that are intended to help users build inclusivity into digital health measurement products.
EU systems need to become more streamlined to help bring novel technologies to market - which would in turn encourage investment and activity in healthcare biotech, says EuropaBio as it publishes key policy recommendations for the sector.
Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the world’s first Phase 3 study of oral insulin under FDA approved protocols.
The Bill & Melinda Gates Medical Research Institute is conducting a tuberculosis epidemiology study: setting the stage for a Phase 3 efficacy trial for its investigational tuberculosis vaccine.
While skills shortages present one of the main challenges to the biopharma industry, North Carolina believes its investments in the life science ecosystem have given it a ‘multiple decade jumpstart’ in building a successful biopharma hub for both manufacturing...
Biogen has announced new Phase 3 data showing that, after nearly 2.5 years of treatment, Aduhelm continued to reduce two key Alzheimer’s disease pathologies.
Pfizer Inc says it will maintain its supply of medicines to Russia but it will not initiate new clinical trials in the country, while Bayer is suspending investment projects and new-business development in that market.
The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.
The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the...
AstraZeneca has resumed UK clinical trials for its Oxford coronavirus vaccine, having paused all trials last week for a safety review. Other late-stage global trials, however, remain on hold while AstraZeneca waits for regulators in each market.
Novartis investigates the death of an infant in a gene therapy clinical trial to determine whether it was related to the treatment but does not anticipate an impact on FDA approval.
Thermo Fisher opened a new business center and biorepository along with an expanded distribution center, to help support mounting demand for clinical trial supply chain logistics.
MSD announced that the EMA’s CHMP has adopted a positive opinion recommending approval of Keytruda as an adjuvant therapy for the treatment of patients with melanoma.
Sarepta Therapeutics signed a long-term, strategic manufacturing partnership with Paragon Bioservices to produce micro-dystrophin to grow its gene therapy program.
Daiichi Sankyo announced it has entered into a clinical trial collaboration agreement with Merck & Co. to evaluate an investigational lung cancer treatment.
PTC Therapeutics will acquire Agilis Biotherapeutics to continue work on gene therapy for rare monogenic diseases affecting the central nervous system.
Clover Biopharmaceuticals will adopt GE Healthcare’s centrally automated FlexFactory platform at its facility in Zhejiang, China where it plans to make a biosimilar to Amgen’s Enbrel.
Fibrocell Science will make its gene therapy candidate FCX-007 from a facility in Pennsylvania previously dedicated to making its autologous personalised cosmetic Laviv (azficel-T).
Vineti has developed a cloud-based software platform for creating and delivering cell and gene cell therapies, which the company says is better suited to high production loads than paper-driven processes.
LSNE Contract Manufacturing has signed a manufacturing supply agreement with Selecta Biosciences, Inc. through which the CDMO will advance Selecta’s lead candidate, SEL-212.
Merck & Co and Aduro Biotech have announced plans to test Keytruda combined with CRS-207 in patients suffering malignant pleural mesothelioma as a result of exposure to asbestos.
Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.
Medcision has started pushing its cell therapy thawing technology through an early adopter scheme designed to encourage adoption by firms with candidates in trials.
Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.
PharmaCyte has announced a pre-application meeting with the US FDA, to advise on their investigational new drug (IND) filing for a clinical trial its live cell encapsulation therapy.
Absorption Systems has announced a technology licensing agreement with Pfizer Inc., in which the pharma company will use the preclinical CRO’s cell lines to test potential drug candidates.
The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.
Cel-Sci has responded to the partial clinical hold imposed on a Phase III trial of its candidate head and neck cancer cell therapy Multikine in September.
