Eisai has submitted marketing authorization applications for lecanemab in Europe and Japan as it builds up its global plans for the Alzheimer’s drug, which was approved in the US earlier this month.
The European Medicines Agency (EMA) is planning to alert healthcare professions about liver failure cases linked to Zolgensma, a gene therapy against spinal muscular atrophy (SMA), which is developed by Novartis.
Lumen Bioscience has been highlighting recent progress made on its clinical and regulatory journey while also announcing several funding milestones supporting the development of its therapeutics to prevent serious diarrheal diseases.
Sanofi Ventures has announced an additional multi-year commitment from Sanofi, with an increase in capital to more than $750m to the evergreen venture fund.
Last year was a slow one in terms of dealmaking in the life sciences sector but the final quarter saw a major uptick, finds the EY annual M&A Firepower report.
Celltrion, one of Korea’s largest biopharma companies, will be Rani’s exclusive supplier of ustekinumab biosimilar, CT-P43, for its oral RT-111 RaniPill program.
With Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) approved by the US Food and Drug Administration (FDA) last week, Eisai has revealed more details on its rollout plans for the drug.
There has been a flurry of antibody-drug conjugate (ADC) agreements in recent weeks, and today sees the inking of another deal involving Tokyo headquartered Ajinomoto Co Inc and US biotech, Exelixis.
On Friday (Jan 6), the US Food and Drink Administration (FDA) granted a licence for another anti-amyloid drug – lecanemab – to treat Alzheimer’s disease.
The collaboration will combine ReCode’s delivery technology with AskBio’s gene editing and DNA cargoes to develop gene correction therapies for liver and lung diseases.
Synaffix, a Netherlands based company providing clinical-stage platform technology for the development of antibody-drug conjugates (ADCs), has signed off on two new licensing deals this week.
France headquartered CDMO, Delpharm, has expanded its pharmaceutical development services with the acquisition of the Leiden Development Centre from Dr Reddy's in the Netherlands.
AstraZeneca and Sanofi said their Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA).
Last week saw Opus Genetics announce it had acquired the rights to two preclinical-stage adeno-associated virus (AAV)-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio.
Expanding generic drug competition and a decline in the demand for COVID-19 vaccines and therapies have brought down the aggregate market capitalization of the global top 20 biopharmaceutical companies by 9.1%.
While the pandemic brought new entrants into the market, vaccine manufacturing remains a complex activity undertaken by a limited number of companies with the overall picture largely unchanged by COVID-19.
France’s Polyplus has made two acquisitions of late, one to expand its plasmid DNA engineering technology and services portfolio, and another to enhance its GMP fill and finish capacities.
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) are collaborating on vaccine safety and effectiveness monitoring studies.
Global pharma giants, GSK, Sanofi, and Takeda, are set to collaborate with Singapore-based researchers to boost innovation in local biologics and vaccines manufacturing.
Curamys, a South Korean biotech developing cell and gene therapy using cell fusion technology to treat rare intractable diseases, has signed a strategic platform licensing agreement with US tech developer, MaxCyte.
Valneva is pushing forward with its live-attenuated, single-shot vaccine candidate, VLA1553, for chikungunya, a mosquito-borne viral disease for which there are no preventive vaccines or effective treatments available.
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for review of tofersen, an investigational drug for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
Pyxis Oncology has received clearance for two IND applications from the US Food and Drug Administration (FDA) to initiate two Phase 1 clinical studies.
Touchlight has secured a grant from the Bill & Melinda Gates Foundation for a research program aimed at demonstrating that its enzymatically produced novel DNA format can support a rapid, scalable, durable, and thermostable vaccine solution for future...
Yposkesi, an SK pharmteco company, has been witnessing a marked uptick in cell and gene therapy projects and has learnt to effectively manage challenges within the supply chain.
The Centre for Advanced Therapies Manufacturing Training, which is based at the University of Birmingham in the UK, today announced a program aimed at growing the industry’s skills base for advanced cell and gene therapy manufacturing.
Enhancing the skills of employees working in the UK’s advanced therapy medicinal products (ATMP) sector and the broader cell and gene therapy industry is mission critical for the CGT Catapult.
Oramed Pharmaceuticals, a company focused on the development of oral drug delivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate....
Bavarian Nordic has signed a joint procurement agreement with HERA, the European Commission’s Health Emergency Preparedness and Response Authority, for the supply of up to 2 million doses of the Imvanex (Jynneos) monkeypox vaccine during 2023 and 2024.
Corbus says new data shows its monoclonal antibody demonstrates robust pre-clinical anti-tumor activity alone and in combination with anti-PD-1 therapy.
Orgenesis, the biotech specializing in cell and gene therapy (CGT) at the point of care, and private equity firm, Metalmark, have signed a major investment partnership.
GSK’s Blenrep has proved unsuccessful in a Phase III study in multiple myeloma. The news comes two years after the drug received US Food and Drug Administration (FDA) accelerated approval.
