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News and Trends 31 Jan 2023

Active Biotech trial confirms eye treatment safety

Active Biotech has announced the completion of the phase I clinical study testing the safety and tolerability of its newly-developed laquinimod eye drop formulation in healthy subjects. According to the results, the eye drop was safe and well tolerated both at single ascending doses and after repeated doses for up to 21 days. No serious […]

January 31, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Stemline Therapeutics’ breast cancer treatment approved

The Menarini Group, an Italian pharmaceutical and diagnostics company, says that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline Therapeutics, a wholly-owned subsidiary […]

January 31, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Singapore researchers use old drug as new acute leukemia treatment

A team of researchers from the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore, has revisited an existing drug to combat a type of blood cancer called T-cell acute lymphoblastic leukemia, or T-ALL. The research was led by Takaomi Sanda and Lim Fang Qi. The drug, PIK-75, was initially discovered […]

January 31, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Stargardt disease treatment gets FDA fast track

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation (FTD) for MCO-010. MCO-010 is an ambient-light activatable multi-characteristic opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of Stargardt disease to […]

January 31, 2023 - 2 minutesmins - By Jim Cornall

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

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

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Active Biotech trial confirms eye treatment safety

Stemline Therapeutics’ breast cancer treatment approved

Singapore researchers use old drug as new acute leukemia treatment

Stargardt disease treatment gets FDA fast track

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

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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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