Xbiome Inc, a China headquartered AI-based microbiome therapeutics startup, has acquired the clinical-stage M201 program developed by Assembly Biosciences, a firm developing therapeutics targeting hepatitis B virus and other viral diseases.
Korean contract development and manufacturing organization, Samsung Biologics, announced strong financial results today for Q1 of its fiscal year 2022.
Valneva and Pfizer report positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15: and now plan to include this population in an upcoming Phase 3 trial.
Biogen has withdrawn its Marketing Authorization Application for Aduhelm (aducanumab) for the treatment of the early stages of Alzheimer’s disease in the EU.
The diagnostics and drug development company, Labcorp, is partnering with San Francisco based, Xcell Biosciences, to advance efforts to help clients bring cell and gene therapies to market.
Sanofi held a ground-breaking ceremony for its new vaccine facility in Singapore on April 20. The US$475m site is pegged to become fully operational by Q1 2026.
BioConnection, an independent contract development manufacturing organization (CDMO) based in Oss in The Netherlands has completed a new capital raising round led by the European investment company, Gimv.
Catalent has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities.
Last week saw the US Food and Drug Administration (FDA) approve the Biologics License Application (BLA) from Amneal Pharmaceuticals Inc for bevacizumab-maly, a biosimilar referencing Avastin, the Roche/Genentech product.
Bionova Scientific, a US biologics CDMO, is to be acquired by the US arm of Asahi Kasei Medical, part of the Asahi Kasei Group, owned by Tokyo based Asahi Kasei Corporation.
Arcturus Therapeutics Holdings Inc. has reported topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, its self-amplifying mRNA COVID-19 vaccine candidate.
Chinese companies, Biocytogen Pharmaceuticals and CtM Biotech Co Ltd, are collaborating on the development of antibody drugs against intracellular tumor-associated antigens.
Moderna’s bivalent COVID-19 booster vaccine candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to the original mRNA-1273 booster dose against all variants of concern, including Omicron, according to data released by the company...
Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
GC Corp, the holding company for GC group in South Korea, has moved to acquire 100% of the shares of BioCentriq, Inc, a US CDMO that designs and develops scalable cell and gene technologies (CGTs).
Dyadic licensee, Epygen Biotech, has received funding from the Government of India to advance a low-cost COVID-19 vaccine through Phase 1 and 2 clinical trials in India, using Dyadic’s C1 protein production platform.
ReiThera and Exothera are partnering to develop what they call a large-scale, low cost per dose manufacturing process to deliver novel vaccines to low- and middle-income countries (LMICs).
The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
Quay Pharma, a contract development and manufacturing organization (CDMO), has signed a contract with drug development specialist, Liveome, in relation to the Korean firm’s live biotherapeutic program.
Pfizer is set to acquire Australia’s ResApp - a company developing a smartphone app to detect COVID-19 and other respiratory diseases based on the user’s cough - for $100m AUD ($74m USD).
List Bio, together with List Labs, is set to build a new US$125m plant in Indiana, offering end-to-end manufacturing for early-stage development through to commercial production of new microbiome therapeutics.
A single dose of the Human Papillomavirus (HPV) vaccine offers comparable protection to the current two dose schedule, according to a review from the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) released this week.
Germany has made a series of contracts with vaccine manufacturers to reserve mRNA manufacturing capacity in the country as part of its pandemic preparedness plans.
Microbiome-focused company, Kaleido Biosciences, in a filing with the US Securities and Exchange Commission (SEC) on Friday, announced its intention to cease all company operations, lay off its remaining staff and delist from the Nasdaq Exchange.
Lonza has added new integrated capabilities in cell binding, cell separation, and bead removal to its closed, automated, and scalable platform for personalized therapy manufacturing.
After the success of mRNA with COVID-19 vaccines, a new partnership between Moderna and IAVI will seek to use the tech to target HIV/AIDS, tuberculosis, and antimicrobial-resistant enteric infections.
Pfizer will acquire ReViral, a privately-held clinical-stage company which is focused on novel antiviral therapeutics for respiratory syncytial virus (RSV), for up to $525m.
Spirulina has been converted into a biomanufacturing platform that offers a way to rapidly produce mass quantities of biologic drugs for common diseases that currently lack effective treatments, say US developers.
US company Catalent is acquiring the UK’s Vaccine Manufacturing and Innovation Centre in Harwell: a facility which had been planned to support COVID-19 and wider vaccine production and which is still under construction.
Thermo Fisher Scientific says its is leveraging the company’s global infrastructure to offer end-to-end services aimed at speeding up the introduction of cell and gene therapies.
The International Society for Cell & Gene Therapy (ISCT) has established a task force to ensure that the CGT field advances in an ethical manner and that the expanded access route is being used for its intended purpose.
The US Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’ Durham, N.C. site, a multi-product gene therapy manufacturing facility, which will start producing Zolgensma immediately.
Curate Biosciences reports that City of Hope, one of the largest cancer research and treatment organizations in the US, has given a thumbs up to the company’s cell processing system for advanced cell separation.
The Bill & Melinda Gates Medical Research Institute is conducting a tuberculosis epidemiology study: setting the stage for a Phase 3 efficacy trial for its investigational tuberculosis vaccine.
The first patient has been dosed in the Phase 1/2 clinical trial of OCU400, a modifier gene therapy candidate for the treatment of retinitis pigmentosa (RP) resulting from mutations in the nuclear receptor subfamily 2 group E member 3 (NR2E3) and Rhodopsin...
Biogen's Phase 4 trial for Aduhelm – required by the FDA as part of last year's accelerated approval of the Alzheimer’s drug – will start screening patients in May.
The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.
