PharmaFocus Today – Page 379 – media

Iovance’s PDUFA date for lifileucel pushed due to FDA backlog

The US Food and Drug Administration (FDA) is feeling the strain on its resources and has had to delay the priority review of Iovance Biotherapeutics’s lifileucel to 2024. The Prescription Drug User Fee Act (PDUFA) action date for the priority review of the Biologics License Application (BLA) for lifileucel has been postponed from 25 November 2023 to 24 February 2024. However, Iovance was quick to add that the reason for pushing the date was the FDA’s “insufficient resources” and that it was working with the agency to expedite the review for a potentially earlier approval date. The company also added that the FDA reported no major review issues, no concerns regarding the status of the confirmatory trial, and had no plans to hold an advisory committee meeting. The markets viewed the news favourably, as Iovance’s stock rose by more than 15% in pre-market trading. The company’s market cap stands at ...
- Source: drugdu
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- September 19, 2023
Bristol Myers Squibb reveals plans to double number of drugs in registrational trials

Bristol Myers Squibb (BMS) has revealed plans to double the number of drugs in registrational trials over the next 18 months. The drugmaker currently has six candidates in clinical trials, including an anti-IL-13 monoclonal antibody under development to treat eosinophilic oesophagitis and an LPA1 antagonist being evaluated in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The pipeline update includes a CD19-directed cell therapy expanding into clinical trials for immunologic diseases, a GPRC5D-targeting cell therapy starting a registrational trial in relapsed/refractory multiple myeloma (RRMM), and a BCMA x CD3 T-cell engager advancing into a phase 3 trial, also for RRMM. The company will also be progressing a protein degrader to a late-stage trial in first-line large B-cell lymphoma, moving an androgen receptor degrader into pivotal studies in metastatic castration-resistant prostate cancer, and is expecting proof-of-concept data for a BET inhibitor in myelofibrosis. In addition to its growing registrational portfolio, the company ...
- Source: drugdu
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- September 19, 2023
Sanofi and Ad Scientiam partner to assess MS disability progression

Sanofi and Ad Scientiam have partnered to launch an international, multicentre, longitudinal study to evaluate the ability of medical software, MSCopilot, to assess disability progression in people with multiple sclerosis (MS). The main objective of the MS-DETECT study, which explores digital biomarkers of MS, is to determine whether the MSCopilot software can effectively identify subtle and early signs of disability worsening. MS is a chronic immune-mediated, neurodegenerative disease of the central nervous system that currently affects 2.8 million people globally. The study will include 314 people with MS and will be conducted in the US, Canada, Germany, Italy, Spain, Denmark and France. Coordinating investigator and chairman of the study steering committee, professor Patrick Vermersch, believes that “these novel digital biomarkers are key to helping clinicians make appropriate treatment decisions and, ultimately, improve patients’ care.” As part of the agreement, the study will draw upon Ad Scientiam’s expertise in MS and ...
- Source: drugdu
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- September 19, 2023
Imported case of monkeypox leads to local transmission in China

Monkeypox (mpox) is a zoonotic disease caused by the mpox virus (MPXV) that has been primarily limited to Central and West African nations since its discovery. The recent spread of the West African lineage of MPXV in historically unaffected countries has raised concerns for global public health. Despite a significant decrease in global mpox cases, there is still a risk of a global resurgence. This study reports the first local case of mpox caused by an imported case in the Chinese mainland. Polymerase chain reaction (PCR) diagnosed the two cases, and the viral genomes were obtained by next-generation sequencing. Genomic analysis revealed that the two strains shared an identical genome sequence and belonged to the B.1.3 branch of the West African lineage, which is the first local case of mpox caused by an imported case in the Chinese mainland, highlighting the potential threat of mpox in China and the immediate ...
- Source: drugdu
- 186
- September 18, 2023
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

Dive Brief GE HealthCare has teamed with Mayo Clinic to advance medical imaging, artificial intelligence and theranostics, a type of cancer treatment that involves imaging and targeted therapeutics. The organizations will collaborate on the application of AI to magnetic resonance imaging, the automation of diagnostic and interventional ultrasound and other activities that could improve patient care. GE HealthCare has formed a series of partnerships since separating from its parent company, striking deals with companies including Boston Scientific, Johnson & Johnson and Medtronic. Dive Insight GE HealthCare and other parts of its former parent company, GE, have a long history of working with Rochester, Minnesota-based Mayo, teaming up with the hospital to test remote monitoring devices, found a gene therapy software startup and develop a medical electronic record system. The latest deal brings together scientists, technology developers and clinicians working at GE HealthCare and Mayo to collaborate on four core areas ...
- Source: drugdu
- 207
- September 18, 2023
FDA sends warning to CVS, Walgreens and other companies over unapproved eye products

By Jamie Gumbrecht, CNN CNN — The FDA sent warnings letters to eight companies for marketing and manufacturing of unapproved eye products. Sarah Silbiger/Getty Images The US Food and Drug Administration on Monday sent warning letters to CVS, Walgreens and other companies over manufacturing and marketing of unapproved eye products the agency says could pose a risk to people who use them. The agency said the products are illegally marketed to treat conditions including conjunctivitis — pink eye — glaucoma and cataracts, and some of the warnings cited sterility issues with the products. The agency issued warning letters to CVS Health, Walgreens Boots Alliance Inc., Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA and TRP Company Inc. Some companies have also been placed on import alert to stop products from entering the United States. “The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic ...
- Source: drugdu
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- September 18, 2023
New Biotech Targets Rare Respiratory Disorders with Inhaled Gene Therapies

By Kate Goodwin Pictured: Human lung anatomy concept/iStock, magicmine Oxford-based biotech AlveoGene launched Thursday with plans to leverage a proprietary platform from the U.K.’s Gene Therapy Consortium to develop inhaled gene therapies for rare respiratory disorders. With seed funding from Oxford Science Enterprises, alongside other academia venture capital funds, AlveoGene has exclusively licensed the Gene Therapy Consortium’s next-gen lentiviral delivery platform—called InGenuiTy—for the treatment of respiratory diseases with high unmet need. However, use of the CTFR gene is excluded from the deal as Boehringer Ingelheim exercised its option in 2021 to develop the inhaled formulation, which is in the works for cystic fibrosis. AlveoGene’s first target will be treating Alpha-1 Antitrypsin Deficiency (AATD), one of the most common rare disorders. AATD is inherited and leads to reduced levels of a plasma protein that protects the lungs, leading to increased risk for lung and other diseases. It’s a major genetic risk ...
- Source: drugdu
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- September 18, 2023
EMA CHMP recommends approval for Moderna’s updated Covid-19 vaccine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation for Moderna’s Spikevax, an updated Covid-19 vaccine targeting the SARS-CoV-2’s XBB.1.5 sublineage. The vaccine is intended for active immunisation for the prevention of Covid-19 in those aged six months and above. The latest development comes after the company filed a regulatory application seeking approval for the updated vaccine in July 2023. Based on the positive opinion from the committee, the European Commission will adopt a decision on the vaccine approval for autumn/winter 2023. Moderna has obtained clinical results for the monovalent XBB.1.5 vaccine candidate which offered an immune response against sublineages of XBB, XBB.1.5, XBB.1.16, and XBB.2.3.2, apart from BA.2.86, EG.5 and FL.1.5.1 variants. Injection site pain was reported to be the most frequently solicited local adverse event for the updated vaccine. Fatigue, myalgia, headache, chills and arthralgia were the ...
- Source: drugdu
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- September 18, 2023
Charles River and Related Sciences partner for AI drug platform

Charles River Laboratories International has signed a multi-programme collaboration agreement with Related Sciences (RS) for the artificial intelligence (AI)-powered drug platform, Logica. Last year, Charles River and Valo Health unveiled Logica, a solution that leverages the AI-powered Valo Opal Computational Platform, along with Charles River’s preclinical expertise. Logica will be used on multiple previously undrugged targets within the RS portfolio. RS will collaborate with the teams from both Charles River and Valo Health to deploy Logica to discover significant new medicines. These medicines will be used to meet unmet requirements across disease areas including autoimmunity, cancer immunotherapy and inflammatory diseases. Charles River senior vice-president and chief scientific officer Julie Frearson stated: “Logica’s unique platform, which combines AI/machine learning (ML)-enabled in silico discovery, high-powered DNA-encoded libraries and traditional screening techniques, has the capability to accelerate the drug discovery and development pipeline, transforming a target to a candidate in just over two ...
- Source: drugdu
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- September 18, 2023
ICON partners with US Government for clinical trials of Covid-19 vaccines

US Biomedical Advanced Research and Development Authority (BARDA) has partnered with Ireland-based ICON to conduct clinical trials of Covid-19 vaccine candidates selected as part of “Project NextGen”. A part of the US Government’s Strategic Preparedness and Response division, BARDA has launched Project NextGen to develop Covid-19 vaccines and therapies for current and future strains. To achieve this, BARDA plans to leverage its public-private partnerships. The government has plans to invest more than $5bn in the Project NextGen programme. In June, the European Medicines Agency (EMA) identified the need to update the Covid-19 vaccines to include the XBB Omicron variant. The US Government seconded that sentiment, and last month, BARDA partnered with Regeneron to develop a Covid-19 monoclonal antibody vaccine candidate. ICON’s government and public health solutions team will conduct a Phase IIb active comparator clinical trial to evaluate the efficacy of the next-generation Covid-19 vaccine, selected by BARDA, compared to ...
- Source: drugdu
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- September 18, 2023

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