InflaRx’s Gohibic (vilobelimab), a monoclonal anti-human complement factor C5a antibody, has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults.
The Danish biotech Adcendo has bagged a Series A extension round of €31 million ($33.8 million), taking its Series A winnings so far to €82 million ($89.5 million). The round will bankroll the development of Adcendo’s pipeline of antibody-drug...
The company finalizes a deal to establish its first manufacturing facility in Africa, which will have the capacity to produce 500 million vaccine doses per year.
Breath biopsy specialist, Owlstone Medical, has entered into a research agreement with biotech company, Bicycle Therapeutics plc, to access its bicyclic peptide technology.
A T-cell engaging bispecific antibody developed by Roche has got its first green light in Canada for the treatment of relapsed or refractory forms of the blood cancer diffuse large B-cell lymphoma (DLBCL).
The US biotech CytomX has lost a collaboration partner as AbbVie pulled out of a collaboration developing an antibody-drug conjugate (ADC) for the treatment of solid tumours.
Pharmaron Beijing Co Ltd says its Liverpool, UK based gene therapy CDMO has obtained a grant from the UK government’s life sciences innovation manufacturing fund (LSMIF) to expand its facilities.
BrainStorm Cell Therapeutics reports that the FDA is to hold an advisory committee meeting to discuss the company’s BLA for NurOwn, a personalized stem cell treatment targeted at ALS.
Vertex will pay CRISPR Therapeutics $100m up-front for non-exclusive rights to its technology with the goal of developing a certain type of therapy for diabetes.
UPS Healthcare says its first dedicated healthcare logistics facility in Giessen, Germany is now up and running. Up to 150 jobs have been created as a result of this operation, added the provider.
A US FDA panel of advisors concluded that there was a lack of substantial evidence to indicate that Biogen’s investigational drug, tofersen, was effective in treating a rare and aggressive form of ALS. But the experts voted unanimously that the investigational...
Orgenesis is pairing up with University of California, Davis (UC Davis) to deploy cell and gene therapy mobile processing units and labs across California.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) will receive £10m ($12m) in extra government funding over the next two years: targeted at helping the agency adapt post-Brexit and accelerating routes for bringing new medicines onto the...
Teitur Trophics, a startup looking to prevent the death of neurons in neurodegenerative diseases, has completed a €28m (US$29.9m) Series A financing round co-led by Sunstone Life Science Ventures and Sound Bioventures.
The extremely high costs of gene therapies are unsustainable, and a global commitment to affordable, equitable access to these treatments is urgently needed, concluded the organising committee of a conference on human genome editing.
In acquiring antibody-drug conjugates technology pioneer Seagen, Pfizer eyes up the strong growth trajectories of Seagen's medicines and the potential of its pipeline and technology.
Sanofi will acquire US-based Provention Bio: gaining Tzield (teplizumab-mzwv), which was approved by the FDA last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes.
Businesses and individuals that have money deposited with failed US bank Silicon Valley Bank (SVB) will be able to access all their cash from today, said the US government.
Moderna’s RSV vaccine launch – expected either late this year or early in 2024 – will draw on the infrastructure and learnings gained from the company's COVID-19 vaccine launch.
The Biosimilars Forum has welcomed a move by US congressman, Richard Hudson, to introduce legislation that would establish a shared savings reimbursement model for biosimilars in Medicare Part B.
A US Food and Drug Administration (FDA) advisory committee has recommended both Pfizer and GSK’s RSV vaccines: with a decision from the agency expected in May.
Spark Therapeutics, a Roche company, has officially started work on its US$575m gene therapy innovation center in West Philadelphia. The center is expected to be completed by 2026.
The Boston-based messenger RNA (mRNA) specialist Moderna revealed $19.3bn in revenues last year, but rising costs and falling demand for its COVID-19 vaccine cut into its earnings in the fourth quarter of 2022.
The US Food and Drug Administration (FDA) has approved Sanofi and Sobi’s Altuviiio (efanesoctocog alfa): a first-in-class, high-sustained factor VIII replacement therapy.
Chinese companies Porton Advanced Solutions and Yinjia Biosciences have signed a pact aimed at supporting further development of cell and gene therapies.
An experimental antibody drug developed by Regeneron Pharmaceuticals called pozelimab could become the first approved treatment of the hereditary immune disease CHAPLE, with a US Food and Drug Administration (FDA) approval decision expected by August...
mRNA therapeutics have received increased amounts of attention and funding ever since mRNA vaccines proved effective in curbing the spread of the COVID-19 pandemic. Now, researchers are exploring mRNA therapeutics’ use in other disease spaces, reports...
Daiichi Sankyo is kitting out a plant, based near Tokyo in Kitamoto, with equipment to enable the production of an mRNA vaccine against COVID-19, according to a Nikkei Asia report.
The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV...
Three months after receiving the US green light, CSL’s candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.
In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization: including six advanced therapy medicinal products and eight biosimilars.
California based, Theragent, a cell therapy CDMO, has signed a multi-year exclusive contract with Insight68, an AI-driven software provider that aims to digitalize and streamline the cell therapy manufacturing process.
Switzerland headquartered Lonza said it is expanding its early development services (EDS) to North America, opening a new laboratory in Cambridge, Massachusetts (US).
