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.
Biogen has withdrawn its Marketing Authorization Application for Aduhelm (aducanumab) for the treatment of the early stages of Alzheimer’s disease in the EU.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.
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.
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).
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.
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.
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.
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 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.
Abzena, a global CDMO specializing in the integrated development and manufacture of complex biologics and bioconjugates, has secured $65M in new funding.
V-Bio Ventures, a venture capital firm supporting young pioneering biotech companies raises €110m (US$122m) in its second fund, V-Bio Fund 2, exceeding its target of €100m.
Prothena has announced FDA clearance of IND for PRX012, a subcutaneous anti-amyloid beta antibody under investigation for the treatment of Alzheimer’s disease (AD).
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
Exothera, a CDMO specializing in the industrialization of vaccine and gene therapy processes, reports that it has achieved GMP certification for its facilities in Jumet, Belgium.
Fujifilm Irvine Scientific, Inc, has announced the acquisition of Shenandoah Biotechnology, a company supplying recombinant proteins to the drug discovery, life science research, and cell and gene therapy markets.
There were 168 Advanced Therapy Medicinal Product (ATMP) trials ongoing in the UK in 2021, compared to the 154 studies reported the previous year, a 9% increase, finds a new report.
The US Food and Drug Administration (FDA) has cleared a new plasma collection system developed by Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company based in Colorado.
The two co-founders of JHL Biotech, Racho Jordanov and Rose Lin, were sentenced by the US Department of Justice for their roles in conspiring to commit trade secret theft and wire fraud.
Catalent completes expansion of its biologics manufacturing network by upgrading its Limoges, France, location with additional capacity and the ability to produce large molecules.
Moderna announced a new supply agreement with the Swiss federal government today for seven million doses of its COVID-19 booster vaccine for anticipated delivery in 2023.
The European Medicines Agency (EMA) recommended 92 medicines for marketing authorization in 2021: 54 of which had a new active substance which had never been authorized in the EU before.
The initiative is seeking proposals from final year MD, PhD students and postdoctoral researchers in relation to drug discovery and development across AstraZeneca’s core disease areas.
The selected companies, the inaugural cohort for MassBioDrive, get to participate in an eight-week program focused on growing businesses and advancing breakthrough science.
Novartis continues down the third-party manufacturing route, as it secures an agreement with Carisma Therapeutics, a firm developing a cell therapy platform focused on engineered macrophage-based therapeutics.
Pfizer Inc says it will maintain its supply of medicines to Russia but it will not initiate new clinical trials in the country, while Bayer is suspending investment projects and new-business development in that market.
Adiso Therapeutics has emerged from stealth mode with a pipeline of therapies including live biotherapeutic (LBP) strains focused on tackling inflammatory diseases.
Finnish company, Biovian Oy, has been engaged by a South Korea biotechnology company to carry out process development and manufacturing of an AAV-based innovative drug candidate.
Biogen has started the process of laying off some US staff, following the less than optimal rollout of its Alzheimer’s disease drug, approved by the FDA in June 2021.
Clinical Research Organization Veristat has acquired SLF (Solutions for Life Sciences): adding capabilities to support biotech, pharmaceutical and medtech companies.
WuXi STA says its drug product facility in Wuxi City, China has successfully passed its first pre-approval inspection (PAI) and received the GMP compliance certificate from the European Medicines Agency (EMA).
mRNA pioneer Moderna will establish an Enterprise Solutions Hub in Atlanta: which will host finance, human resources, procurement and digital functions.
