USA Archives

Interview 5 Dec 2022

Interview: why the recently approved fecal microbiome product is causing a rumble

The news last week of the FDA approving Ferring Pharmaceuticals’ first fecal microbiome product, Rebyota, caused quite a stir in the field. The news was described as a huge step, a giant leap forward and simply fantastic. Paul Feurstadt is the director of non-inflammatory bowel disease research at the Medical Research Center of Connecticut. He also […]

December 5, 2022 - 5 minutesmins - By Liza Laws

News and Trends 2 Dec 2022

Full-Life Technologies acquiring Focus-X Therapeutics

Full-Life Technologies, a global radiotherapeutics company, is acquiring New Jersey-based Focus-X Therapeutics, a company developing targeted radiopharmaceuticals to treat cancer based on peptide engineering technology. The acquisition expands Full-Life’s pipeline, including two compounds nearing clinical trials, provides a second innovative peptide focused discovery platform, and leverages its radiotechnology manufacturing and logistics platforms to advance compounds […]

December 2, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 1 Dec 2022

FDA’s approval of first fecal microbiota product, Rebyota, hailed an ‘enormous step forward’ for the field

The first fecal microbiota product, Rebyota, approved by the U.S. Food and Drug Administration (FDA) today has been hailed ‘fantastic news’ by those in the microbiome field. Ferring Pharmaceutical’s product is approved to stop Clostridiodes difficile infection (CDI) in people over 18 and to be given after they have completed an antibiotic treatment for the […]

December 1, 2022 - 6 minutesmins - By Liza Laws

Best in Biotech 1 Dec 2022

Five apps powering the future of at-home HIV tests

The smartphone revolution is providing a promising tool to combat the human immunodeficiency virus (HIV) epidemic. We’ve listed five HIV test apps in development that could help people carry out at-home HIV tests and prevent the spread of the infection. The COVID-19 pandemic in the last two years has demonstrated how vital rapid diagnostic tests […]

December 1, 2022 - 8 minutesmins - By Jonathan Smith

News and Trends 24 Nov 2022

Gene therapy approval “game changer” in hemophilia B treatment

The approval of CSL’s gene therapy Hemgenix has ushered in a new era for hemophilia B treatment. With the addition of other approvals like Rocktavian and Upstaza, 2022 could be a turning point for the broader gene therapy field. Earlier this week, etranacogene dezaparvovec (Hemgenix) made history as the first gene therapy approved by the […]

November 24, 2022 - 7 minutesmins - By Jonathan Smith

News and Trends 23 Nov 2022

Tevogen Bio to investigate T cell therapy in long Covid

Tevogen Bio is set to study the potential therapeutic use of its investigational Covid-19 T cell therapy, TVGN-489, in long Covid. The finding that none of the patients in the TVGN 489 proof-of-concept (POC) trial, treated for their initial Covid infection, developed long Covid to date is leading Tevogen to explore the potential of TVGN […]

November 23, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 23 Nov 2022

FDA approves CSL gene therapy for hemophilia B

CSL has revealed that the U.S. Food and Drug Administration (FDA) has approved HEMGENIX (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B. HEMGENIX is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or […]

November 23, 2022 - 5 minutesmins - By Jim Cornall

News and Trends 21 Nov 2022

FogPharma raises $178M to target cancer

U.S biotech company FogPharma has announced a $178 million series D financing. The financing round includes new investors ARCH Venture Partners, Milky Way Investments and Fidelity Management & Research Company and existing investors VenBio Partners, Deerfield Management, GV, Cormorant Asset Management, funds and accounts advised by T. Rowe Price Associates, Inc., Invus, Farallon Capital Management, […]

November 21, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 21 Nov 2022

Legend Biotech small cell lung cancer drug gets FDA ok for clinical development

Legend Biotech Corporation has announced that the U.S. Food and Drug Administration (FDA) has cleared Legend Biotech’s investigational new drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC). LB2102 is […]

November 21, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 21 Nov 2022

Immorna cleared for mRNA-based Covid-19 vaccine study

U.S. biotech company Immorna says the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to conduct a phase 1/2 multi-center study of JCXH-221, a lipid nanoparticle (LNP) complexed broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases. The goal of the multi-center study is to assess the safety and immunogenicity […]

November 21, 2022 - 3 minutesmins - By Jim Cornall

RDEB recessive dystrophic epidermolysis bullosa skin blisters

News and Trends 21 Nov 2022

New Replay HSV gene therapy company Telaria to focus on skin diseases

Replay has announced the launch of Telaria, a herpes simplex virus (HSV) gene therapy company targeting rare skin diseases. It is the second of Replay’s product companies to leverage its high payload capacity HSV delivery vector, synHSV. Telaria’s co-founders are HSV scientists, entrepreneurs, and specialists in genetic skin diseases. In addition to Joe Glorioso, Telaria’s […]

November 21, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 18 Nov 2022

MIF invests in KAHR to explore lead immunotherapy drug for multiple myeloma

KAHR Medical, a clinical stage biotech company that is developing a treatment for solid tumors and blood cancers has received investment from the Myeloma Investment Fund (MIF). MIF has made the investment to explore the potential of DSP107, KAHR’s leading immunotherapy drug candidate for the treatment of multiple myeloma. “We are thrilled to partner with […]

November 18, 2022 - 3 minutesmins - By Liza Laws

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Interview: why the recently approved fecal microbiome product is causing a rumble

Full-Life Technologies acquiring Focus-X Therapeutics

FDA’s approval of first fecal microbiota product, Rebyota, hailed an ‘enormous step forward’ for the field

Five apps powering the future of at-home HIV tests

Gene therapy approval “game changer” in hemophilia B treatment

Tevogen Bio to investigate T cell therapy in long Covid

FDA approves CSL gene therapy for hemophilia B

FogPharma raises $178M to target cancer

Legend Biotech small cell lung cancer drug gets FDA ok for clinical development

Immorna cleared for mRNA-based Covid-19 vaccine study

New Replay HSV gene therapy company Telaria to focus on skin diseases

MIF invests in KAHR to explore lead immunotherapy drug for multiple myeloma

Subscribe to our newsletter to get the latest biotech news!

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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