Australia’s Vaxxas has initiated a Phase I clinical trial with the first needle-free inactivated seasonal influenza vaccine quadrivalent (IIV4) candidate.
Genentech is to build a new biologics facility at its Oceanside, California campus that it says will be at the forefront of next-generation manufacturing and environmentally sustainable production for small-batch commercial biologics.
The South Korean player plans to expand its recently acquired US facility, to provide contract manufacturing services for Antibody Drug Conjugates (ADC), and to add drug product fill & finish facilities to establish a foothold in the North American...
TILT Biotherapeutics, a Finnish company developing cancer immunotherapies, reported the final close of its €22m (US$23.8m) round, which was led by Finland’s Lifeline Ventures, an early-stage venture capital firm.
US contract development and manufacturing organization, Catalent, reported results today for the second quarter of fiscal 2023, which ended December 31, 2022.
Pfizer currently has an unprecedented number of anticipated launches, says its CEO: with the company expecting to have up to 19 new products or indications in the market in the next 18 months.
The project is the first phase of a wider strategic initiative to expand capacity and enhance end-to-end biologics development and manufacturing services at the US CDMO.
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.
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).
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.
The FDA wants to simplify COVID-19 immunizations and will discuss various ideas for future immunization strategies at an advisory committee meeting this week.
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.
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.
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.
