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News and Trends 21 Feb 2023

FDA approves alpha-mannosidosis drug

Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), says the U.S. Food and Drug Administration (FDA) has approved Lamzede (velmanase alfa-tycv) for the treatment of non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients. AM is an ultra-rare, progressive lysosomal storage disorder […]

February 21, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 17 Feb 2023

Positive results for INOVIO recurrent respiratory papillomatosis trial

INOVIO Pharmaceuticals has announced positive preliminary results from the second cohort of its phase 1/2 clinical trial evaluating INO-3107 for the treatment of HPV 6 and HPV 11-associated recurrent respiratory papillomatosis (RRP) in adults. In the second cohort of 11 patients who were administered INO-3107 via the exploratory side port needle, 10 of the 11 […]

February 17, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 16 Feb 2023

Bladder cancer investigational therapy may be given at home

UroGen Pharma Ltd. has announced preliminary results of a study to assess the feasibility of home instillation of UGN-102 (mitomycin) for intravesical solution, an investigational therapy in development for primary chemoablation of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). In the study, UGN-102 was suitable to administer at home by a visiting nurse under the […]

February 16, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 14 Feb 2023

Disc Medicine raises $62.5M for hematology programs

Disc Medicine, Inc., a U.S. clinical-stage biopharma company focused on the discovery, development and commercialization of treatments for patients suffering from serious hematologic diseases, has entered into a securities purchase agreement with investors resulting in an aggregate $62.5 million in gross proceeds through a registered direct offering. The financing was led by Bain Capital Life […]

February 14, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 10 Feb 2023

FDA approves GSK drug for recurrent or advanced mismatch repair-deficient endometrial cancer

GSK plc says the US Food and Drug Administration (FDA) has given full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not […]

February 10, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 9 Feb 2023

Cleveland Clinic breast cancer vaccine study moves forward

Researchers from global health system Cleveland Clinic have launched the next step in their novel study of a vaccine aimed at preventing triple-negative breast cancer, the most aggressive and lethal form of the disease. Funded by the U.S. Department of Defense, the new phase 1b study will enroll cancer-free individuals at high risk for developing […]

February 9, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 7 Feb 2023

Harvard spin-off cellvie closes $5.5M new funding

cellvie Inc., which works on therapeutic mitochondria transplantation (TMT), an approach developed at Harvard Medical School, has closed a $5.5 million financing to get Series A-ready by the end of 2023. Mitochondria dysfunction has been tied to a host of diseases, ranging from neurodegenerative ailments, heart attacks and strokes, to age-related degeneration. “Whilst mitochondria have […]

February 7, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 7 Feb 2023

AAHI bags $9.9M to develop nasal spray influenza RNA vaccine

The Access to Advanced Health Institute (AAHI) has been awarded a project agreement worth up to $9.9 million through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority (OTA) to develop a prototype intranasal bivalent influenza RNA vaccine candidate. The candidate will be based on AAHI’s self-amplifying RNA (saRNA) platform, which targets both pandemic A(H5N1) […]

February 7, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 7 Feb 2023

Endogena Therapeutics retinitis pigmentosa treatment gets FDA fast track designation

The US Food and Drug Administration (FDA) has designated the investigation of Endogena Therapeutics’ EA-2353 for the treatment of retinitis pigmentosa (RP) as a fast track development program. Fast track is a process designed to enable patients to benefit earlier from new drugs for serious conditions. Endogena Therapeutics’ EA-2353 takes a novel, small-molecule approach and […]

February 7, 2023 - 2 minutesmins - By Jim Cornall

In Depth 6 Feb 2023

The biggest private biotech investments in January 2023

The companies Asimov, BioRay Pharmaceuticals and Colossal Biosciences bagged the biggest biotech investments in January 2023. Around the world, synthetic biology players and firms developing treatments for hormonal disorders attracted the biggest funding rounds. 2023 began with a bang in terms of biotech funding, and there are signs of stabilization in biotech stocks after two […]

February 6, 2023 - 4 minutesmins - By Jonathan Smith

News and Trends 3 Feb 2023

Genoscience Pharma receives orphan drug designation for hepatocellular carcinoma drug

Genoscience Pharma has announced that its lead candidate, ezurpimtrostat, a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor, has been granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (HCC). ODD qualifies ezurpimtrostat for a potential seven years of market exclusivity after approval. The FDA’s ODD program provides […]

February 3, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 2 Feb 2023

Crown Bioscience acquiring Indivumed’s service business and biobank

Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, has entered into an agreement to acquire the IndivuServ business unit of Indivumed GmbH. A share purchase agreement (SPA) between was executed in December, 2022, and subject to customary closing adjustments, the transaction is expected to close in April 2023. Indivumed […]

February 2, 2023 - 3 minutesmins - By Jim Cornall

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USA

FDA approves alpha-mannosidosis drug

Positive results for INOVIO recurrent respiratory papillomatosis trial

Bladder cancer investigational therapy may be given at home

Disc Medicine raises $62.5M for hematology programs

FDA approves GSK drug for recurrent or advanced mismatch repair-deficient endometrial cancer

Cleveland Clinic breast cancer vaccine study moves forward

Harvard spin-off cellvie closes $5.5M new funding

AAHI bags $9.9M to develop nasal spray influenza RNA vaccine

Endogena Therapeutics retinitis pigmentosa treatment gets FDA fast track designation

The biggest private biotech investments in January 2023

Genoscience Pharma receives orphan drug designation for hepatocellular carcinoma drug

Crown Bioscience acquiring Indivumed’s service business and biobank

Subscribe to our newsletter to get the latest biotech news!

Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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