Life science investor group, Novo Holdings, has agreed to buy Ritedose, the largest sterile CDMO in the US focused on advanced blow-fill-seal technology, from Hong-Kong based, AGIC Capital, and China’s Humanwell.
Belgium’s Univercells has acquired SynHelix, a biotechnology company that aims to debottleneck biotherapeutics development through automated DNA synthesis.
ATMPS Ltd, a UK developer of blockchain-based cell orchestration platforms for advanced therapies is collaborating with US quality and compliance consultancy, Assurea LLC, to develop a fully complaint blockchain approach for end-to-end supply chain management...
Indian multinational, Piramal Pharma Limited (PPL), has taken a minority stake in Yapan Bio, a CDMO, based in Hyderabad, with expertise in biologics and vaccines.
Lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer's disease, has been granted Fast Track designation by the US Food and Drug Administration (FDA).
Abu Dhabi-based entities, the sovereign wealth fund, Mubadala Investment Company, and AI and cloud computing specialist, G42, are to set up a biopharma campus there; the move is aimed at bolstering biopharma linked innovation, R&D and manufacturing...
Live biotherapeutic product (LBP) developer, 4D Pharma, which has been NASDAQ listed since March this year, has announced positive topline results for the first part of its Phase I/II trial of an LBP strain for the treatment of asthma.
There is a healthy appetite for continued investment in gene therapy, in new modalities and more indications, says an industry insider as he reflected on the prospects for the US gene therapy sector next year.
Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).
As of January 1, 2022, Biogen will cut the price of its Alzheimer’s drug Aduhelm (aducanumab-avwa) in half: saying too many patients are not currently being offered the choice of the drug due to financial considerations.
The European Commission has granted conditional marketing authorisation to Novavax for its COVID-19 vaccine: making it the first protein-based COVID-19 vaccine in the EU.
AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Biogen will ask the European Medicines Agency (EMA) to re-examine its Alzheimer’s drug application, following the agency’s recommendation to refuse authorization of the drug in the EU.
Australia company, Inventia Life Science, which is focused on advanced 3D cell cultures for research and clinical purposes, has just closed a US$25M Series B funding round, led by Blackbird Ventures.
The Parkinson’s Progression Markers Initiative, built using Evidation Health’s research platform, aims to triple enrollment and recruit online participants.
SGS, the Swiss-based testing, inspection and certification company, has acquired Quay Pharma, a UK based pharmaceutical industry targeted contract development and manufacturing organization (CDMO).
Moderna released what it deemed to be positive interim data from the phase 1 study of its quadrivalent flu vaccine, mRNA-1010, on Friday. But the markets were left underwhelmed.
Taiwan based contract manufacturer, Bora Pharmaceuticals, in partnership with Taishin Healthcare Limited, is ready to spend millions to expand its footprint in the CDMO sector.
PDC*line Pharma, a clinical stage biotech company developing cancer vaccines, has completed its Series B2 round of financing, raising a total of €17.5m (US$20.3m) with Belgian and South-Korean investors.
The European Commission has extended the marketing authorisation for Actemra/RoActemra (tocilizumab) to include the treatment of severe COVID-19 in adults.
Australia’s Noxopharm has in-licensed novel RNA tech developed by Hudson Institute of Medical Research: focusing on RNA drug discovery and mRNA vaccine manufacture via Noxopharm’s subsidiary Pharmorage.
The European Medicines Agency (EMA) has started a rolling review of VLA2001, Valneva’s COVID-19 vaccine candidate, with the company set to supply up to 60 million doses to the European Union.
The EMA has validated Atara Biotherapeutics' Marketing Authorization Application (MAA) for tabelecleucel (tab-cel), the first time an off-the-shelf allogeneic T-cell therapy will be evaluated by any regulatory agency in the world.
As capital project delivery ramps back up to pre-pandemic levels over the coming months and years, the smaller biopharma players are looking outside their own resources for strategic manufacturing and research support, confirms a new market outlook from...
A new report reveals that “speed-to-market” has jumped up from a lower-ranking business driver before the pandemic to the top priority today for biopharma companies, overtaking cost-based considerations by a healthy margin.
Ncardia, a human-induced pluripotent stem cell-based (iPSC) technology company, has secured more than US$60m in capital through a strategic partnership with Kiniciti, a US based investor with a focus on the global cell and gene therapy ecosystem.
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for the Pfizer/BioNTech COVID-19 vaccine to include use in children aged 5 to 11.
Korean company, SK, is investing in the Philadelphia-based Center for Breakthrough Medicines (CBM), a move that will support the US company in its bid to become the world's largest end-to-end cell and gene therapy contract development and manufacturing...
Vaccibody, a Norway-based pioneer in the neoantigen cancer vaccine space, has changed its name to Nykode Therapeutics, and has entered into a license and collaboration agreement with US company, Regeneron, to develop vaccines against cancer and infectious...
The US Food and Drug Administration (FDA) has amended the emergency use authorizations (EUA) for Pfizer/BioNTech and Moderna COVID-19 vaccines: authorizing the use of a booster shot for all individuals aged 18+.
Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps.
The COVID-19 pandemic has triggered a surge in investment at providers of bioprocess consumables, with companies including Danaher and Thermo Fisher Scientific spending quickly to meet demand for single-use systems and other technologies.
EIT Health and Biogen have launched the ‘neurotechprize’ to help develop promising technology from all over the world that looks to address Alzheimer’s disease (AD).
Johnson & Johnson has announced its intent to separate its Consumer Health business into a new publicly traded company: allowing J&J to put a sharpened focus on pharmaceuticals and medical devices.
Be the Match BioTherapies (BTMB) says it is critical that resilient cell sourcing infrastructures exist when cell and gene therapies (CGT) surge to market.
The infusion of funds in the Halle/Westfalen, Germany manufacturing complex is intended to help meet growing global demand for injectable pharmaceuticals.
A new specialized lab, office and collaboration space for over 100 life science and health technology professionals, entrepreneurs, and researchers was recently announced for The Campus, Cherrywood in South Dublin, Ireland.
