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).
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.
