Biotechnology company, Prothena, has announced positive topline P1 SAD study results for PRX005, an investigational tri-epitopic antibody for the treatment of Alzheimer’s disease.
Vector BioMed, a CDMO specializing in the manufacture of lentiviral vectors, launched this week; its first financing round was led by Viking Global Investors and Casdin Capital.
Amgen is launching Amjevita, or adalimumab-atto, a biosimilar to AbbVie’s Humira, in the US; it is the first such biosimilar to the blockbuster drug in that market.
Evotec has entered into a strategic collaboration and licence agreement with Janssen Biotech: with the partnership focusing on developing targeted immune-based therapies for oncology.
Novartis subsidiary, Sandoz, has secured a postive option from an EMA commitee in relation to its high concentration and citrate-free adalimumab biosimilar
The European Commission (EC) has expanded the marketing authorization for Regeneron and Sanofi’s Dupixent (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE).
Phase 3 data for efanesoctocog alfa has been published in the New England Journal of Medicine (NEJM): ahead of a decision on the therapy by the US Food and Drug Administration (FDA) at the end of next month.
Gilead’s CAR-T therapy Yescarta (Axicabtagene ciloleucel) has been recommended for routine use on the National Health Service (NHS) in England for patients with an aggressive form of lymphoma.
Finch Therapeutics announced its shock decision to discontinue the PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI) yesterday (Jan 25) saying instead it will focus on ‘realizing the value of its intellectual property estate and...
The European Medicines Agency (EMA) has validated the marketing authorization application of Vertex Pharmaceuticals and CRISPR Therapeutics for exa-cel.
Despite an uncertain macroeconomic environment, Lonza says its ‘resilient’ business model and sustained market demand delivered a strong financial performance in 2022, in line with the Swizterland based CDMO’s outlook.
CDMO AGC Biologics will produce Tzield (teplizumab-mzwv), a recently-approved T1D treatment from Provention Bio, at its Seattle protein biologics manufacturing site.
The FDA wants to simplify COVID-19 immunizations and will discuss various ideas for future immunization strategies at an advisory committee meeting this week.
Amgen joins the Winn Award Program that was set up by Bristol Myers Squibb, with plans to extend the reach of clinical trials into underserved patient populations in the US.
In the US, 2022 heralded the next chapter for biosimilars, including US FDA approval of in new therapeutic areas, additional interchangeable designations, and litigation relating to biosimilars of more recent biologics.
Charles River Laboratories International, Inc and Rznomics Inc, a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, have established a viral vector contract development and manufacturing organization...
Biotech company, Vaxxas, has secured a partnership agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of its needle-free vaccine-patch delivery technology for mRNA vaccines.
The unprecedented rise in approvals for new cell and gene therapies, and the increasing industry need for cell lines to support the production of therapeutics, has spurred US CDMO, the Center for Breakthrough Medicines (CBM), to act
Janssen’s experimental HIV vaccine regimen was found to be safe but ineffective in the Phase 3 Mosaico clinical trial: and as a result the company is discontinuing the study.
The candidate reported efficacy of 83.7% against RSV-associated lower respiratory tract disease: with Moderna set to file for regulatory approval for the vaccine within the first half of this year.
An agreement between the two countries means they can use each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities and avoid the need for duplicate inspections.
Many life science professionals say they are ‘cautiously positive’ about the outlook for their industry in 2023, although highlight it won’t be all plain sailing.
In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.
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.
German mRNA pioneer BioNTech will acquire InstaDeep, an artificial intelligence and machine learning specialist, for around £362m ($439m): pledging to incorporate rapidly evolving AI capabilities into its research, drug discovery, manufacturing and deployment...
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.
Moderna and CytomX Therapeutics have announced a collaboration and licensing agreement to create investigational mRNA-based conditionally activated therapies using Moderna's mRNA technologies and CytomX's Probody therapeutic platform.
BioNTech and the UK government have signed a wide-reaching Memorandum of Understanding (MoU): with one of the goals to provide up to 10,000 patients with personalized mRNA cancer immunotherapies by 2030.
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.
