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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 10 Feb 2023

Janssen reports positive topline phase 2 HDFN results

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced positive topline results from the proof-of-concept phase 2 open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN). HDFN is a serious and rare condition that can cause life-threatening anemia in the […]

February 10, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 10 Feb 2023

Rocket Pharmaceuticals receives FDA RMAT designation for Danon disease gene therapy treatment

Rocket Pharmaceuticals, Inc says the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to RP-A501. RP-A501 is Rocket Pharmaceuticals’ investigational adeno-associated virus (AAV)-based gene therapy for the treatment of Danon disease, a devastating and fatal genetic cardiac disease for which there are no disease-altering therapies available. RMAT designation was […]

February 10, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 10 Feb 2023

Heartseed and Novo Nordisk dose first patient in heart failure cell therapy study

Heartseed Inc. and Novo Nordisk A/S say Heartseed has successfully dosed the first patient in a phase 1/2 clinical study (LAPiS Study) with HS-001 – an investigational cell therapy for heart failure. An independent safety evaluation committee has evaluated four-week data on the patient, who lives with advanced heart failure and has given approval for […]

February 10, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 10 Feb 2023

Europe approves childhood epilepsy treatment

UCB’s FINTEPLA (fenfluramine) oral solution has been approved in the European Union (EU) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. The approval by the European Commission (EC) was based on safety and efficacy data from a […]

February 10, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 10 Feb 2023

Beyond Biotech podcast 33: Astellas Pharma, Innovation Agency Lithuania, 4basebio

This week, our guests are Romualda Stragienė, director at Innovation Agency Lithuania and Andrius Sliuzas, export key account manager of high tech industries at Innovation Agency Lithuania; 4basebio CEO Heikki Lanckriet; and Yoshitsugu Shitaka, chief scientific officer at Astellas. 4basebio 4basebio, a spinout of 2Invest AG in 2020, is a life sciences company engaged in […]

February 10, 2023

News and Trends 9 Feb 2023

Talking about Alzheimer’s disease: current drugs, clinical trials, and the pipeline

Sometimes, there’s an interview that we do that’s just a bit long for the regular podcast. So we’re going to start an occasional series of podcasts where we look a bit more in depth at a condition, and what’s the current state of affairs in treatment. In this podcast, the first, we take a closer […]

February 9, 2023 - 2 minutesmins - By Jim Cornall

Opinion 9 Feb 2023

How AI and ML can transform clinical research

By Gary Shorter, head of artificial intelligence at IQVIA Clinical trials are currently in an era of transformation through digitization, with much of the change being attributed to the integration of technologies such as natural language processing (NLP), artificial intelligence (AI), and machine learning (ML). Like many industries, health and life sciences are experiencing rapid […]

February 9, 2023 - 4 minutesmins - By External Contributor

News and Trends 9 Feb 2023

New method to design new peptide therapeutics

Researchers at Hokkaido University in Japan have developed a novel method to design and develop peptide antibiotics in large numbers, which could prove critical to controlling antibiotic resistance. Applications of new molecules as drugs are expected to be effective in treating diseases that are difficult to cure with currently used conventional drugs. Peptides are one […]

February 9, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 9 Feb 2023

Cell and Gene Therapy Catapult boost for life science campus

The Cell and Gene Therapy Catapult (CGT Catapult), an independent U.K. innovation and technology organization specializing in the advancement of cell and gene therapies, has announced its involvement in the development of a major new campus for life science businesses in Stevenage. The new campus was announced by UBS Asset Management’s Real Estate & Private […]

February 9, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 9 Feb 2023

Icosagen receives €18M loan for R&D and new facility

The Estonian biopharma company Icosagen AS has reached an €18 million financing agreement with the European Investment Bank (EIB) backed by the InvestEU program. The funds will strengthen the company’s drug discovery, development and production services. The funds are part of Icosagen’s €40 million investment into increasing its innovative contract research and development capabilities as […]

February 9, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 9 Feb 2023

TILT Biotherapeutics closes €22M financing for oncology immunotherapy trials

TILT Biotherapeutics (TILT), a clinical-stage biotechnology company developing cancer immunotherapies, has closed its €22 million ($23.8 million) round. This follows on from the first close of €10 million in June 2022. The financing was led by Finland’s Lifeline Ventures, an early-stage venture capital firm founded by serial entrepreneurs. The funding will be used to advance […]

February 9, 2023 - 2 minutesmins - By Jim Cornall

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

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

Janssen reports positive topline phase 2 HDFN results

Rocket Pharmaceuticals receives FDA RMAT designation for Danon disease gene therapy treatment

Heartseed and Novo Nordisk dose first patient in heart failure cell therapy study

Europe approves childhood epilepsy treatment

Beyond Biotech podcast 33: Astellas Pharma, Innovation Agency Lithuania, 4basebio

Talking about Alzheimer’s disease: current drugs, clinical trials, and the pipeline

How AI and ML can transform clinical research

New method to design new peptide therapeutics

Cell and Gene Therapy Catapult boost for life science campus

Icosagen receives €18M loan for R&D and new facility

TILT Biotherapeutics closes €22M financing for oncology immunotherapy trials

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

Top biotech deals of February 2025

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

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

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

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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