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News and Trends 31 Jan 2023

Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor

Abbisko Therapeutics Co., Ltd. has announced that its CSF-1R inhibitor Pimicotinib has been granted the breakthrough therapy designation from the FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. The designation approval is based on results from the phase Ib clinical trial of TGCT cohort for Pimicotinib. […]

January 31, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Sensorion and EVEON collaborating on injection system to deliver gene therapy inner ear treatments

Sensorion and EVEON are collaborating on the design and development of an injection system for the delivery of Sensorion’s gene therapy products to the inner ear. Therapies for treating genetic hearing loss are often challenging due to the need for delivery into the inner ear, a very small and delicate organ embedded in the temporal […]

January 31, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

BiVictriX announces positive data from leukemia study

BiVictriX Therapeutics plc has announced positive in vivo data from a toxicity evaluation study with BVX001, the company’s lead program, compared to gemtuzumab ozogamicin (GO). GO, marketed as Mylotarg, is the only approved antibody drug conjugate (ADC) indicated for the treatment of acute myeloid leukemia (AML). One of the significant toxicities of GO is the […]

January 31, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease

BioArctic AB’s partner Eisai says the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab. Lecanemab, known as LEQEMBI in the U.S., is an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed […]

January 27, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

Dupixent gets EU nod for children with severe atopic dermatitis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children six months to five years old who are candidates for systemic therapy. The European Commission is expected to announce a final […]

January 27, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

Psoriasis drug may help treat type 1 diabetes

A large clinical study is now beginning on an approved drug for treating psoriasis. The drug will be tested on patients who were recently diagnosed with type 1 diabetes. The theory is that the drug could preserve the patient’s remaining insulin production. Many hospitals in Sweden are participating in the project, which is funded by […]

January 27, 2023 - 5 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

Beyond Biotech podcast 31: Orgenesis, Phacilitate, Terumo, University of Birmingham, VIVEBiotech

Phacilitate’s Advanced Therapies Week took place last week in Miami Beach, Florida. This week, we speak with the organizers, as well as some of the companies in attendance. Our guests are Kim Barnes, EVP, Phacilitate; Kathie Schneider, director and global commercial lead at Terumo; Vered Caplan, CEO, Orgenesis; Ivan Wall, head of the Centre for […]

January 27, 2023

News and Trends 27 Jan 2023

HKUMed uncovers T cell exhaustion factor driving cancer immunotherapy resistance

A research team from the LKS Faculty of Medicine, the University of Hong Kong (HKUMed) has identified an unexpected driver of cancer immunotherapy resistance: the harmful effect of chronic Type I Interferon signaling on tumor-killing CD8+ T cells. The findings provided new insights into the development of exhausted CD8+ T cells, which no longer effectively […]

January 27, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

Onxeo to study prostate cancer drug

French biotech company Onxeo S.A. has given an update on the clinical development program of its first-in-class drug candidate AsiDNA. Onxeo has activated its first U.S. clinical study site, Next Oncology San Antonio. This phase 1b/2 multicenter, basket trial intends to assess the safety and preliminary activity of AsiDNA in combination with olaparib in patients […]

January 27, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

FDA clearance for ‘revolutionary’ approach to J-Pouch issue

ExeGi Pharma LLC, which develops live biotherapeutic drugs and probiotics, says the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. The clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or J-Pouch) who experience excessive stool frequency. “Excessive stool frequency […]

January 27, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 26 Jan 2023

Orbsen Therapeutics happy with interim diabetic kidney disease study results

Orbsen Therapeutics Limited has announced what it says are encouraging headline interim results from the EU Horizon 2020-funded NEPHSTROM clinical trial for diabetic kidney disease. NEPHSTROM is a randomized, double-blind, placebo-controlled phase 1/2a, trial evaluating the safety, tolerability and preliminary efficacy of an off-the-shelf allogeneic bone marrow-derived mesenchymal stromal cell immunotherapy, ORBCEL, in adult study […]

January 26, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 26 Jan 2023

New tool to fight antibiotic resistance

The World Health Organization (WHO) ranks antibiotic resistance as one of the top 10 threats to global health. In response, researchers at Chalmers University of Technology in Sweden have developed a new spray that can kill antibiotic-resistant bacteria, and that can be used for wound care and directly on implants and other medical devices. “Our […]

January 26, 2023 - 5 minutesmins - By Jim Cornall

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

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Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor

Sensorion and EVEON collaborating on injection system to deliver gene therapy inner ear treatments

BiVictriX announces positive data from leukemia study

EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease

Dupixent gets EU nod for children with severe atopic dermatitis

Psoriasis drug may help treat type 1 diabetes

Beyond Biotech podcast 31: Orgenesis, Phacilitate, Terumo, University of Birmingham, VIVEBiotech

HKUMed uncovers T cell exhaustion factor driving cancer immunotherapy resistance

Onxeo to study prostate cancer drug

FDA clearance for ‘revolutionary’ approach to J-Pouch issue

Orbsen Therapeutics happy with interim diabetic kidney disease study results

New tool to fight antibiotic resistance

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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