The first Omicron bivalent COVID-19 vaccine has been authorized: with the UK’s regulatory agency giving the green light to Moderna’s Spikevax Bivalent Original/Omicron booster shot.
A $76m investment in the facility in Grand Island, New York, will increase capacity to produce raw materials used in manufacture of vaccines and biologic therapies.
The ECDC and the EMA are recommending second COVID-19 booster shots for people between 60 and 79 years old as well as for individuals with medical conditions putting them at high risk of severe disease.
Biotech supply chains face an uncertain future in 2022 and beyond: up against myriad challenges ranging from future pandemic outbreaks to geopolitical tensions – and, indeed, unforeseen threats. Communication and collaboration between policymakers and...
The EU Ombudsman calls the EC's defense of its right not to keep records of text messages linked to COVID-19 vaccine negotiations between its president and the Pfizer CEO as “problematic”.
Pharma industry organizations say they are deeply disappointed by the decision taken by World Trade Organization (WTO) at its ministerial conference, MC12, to endorse a TRIPS waiver for COVID-19 vaccines.
Following the adoption of a critical list of COVID-19 vaccines and treatments, European Union member states and pharma companies will communicate to ensure sufficient supply to meet evolving demand.
Evonik will build a production facility for pharmaceutical lipids in Indiana: with the new site ‘positioning the group for future growth in novel mRNA-based therapies beyond COVID-19 vaccines’.
Capital investments in Swiss biotech companies reached CHF 3.33bn ($3.53bn) in 2021; while R&D investments increased to a record-high CHF 2.56bn ($2.71bn).
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.
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.
eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the eTheRNA group, has introduced a new lipid nanoparticle (LNP) formulation, development and production service.
While skills shortages present one of the main challenges to the biopharma industry, North Carolina believes its investments in the life science ecosystem have given it a ‘multiple decade jumpstart’ in building a successful biopharma hub for both manufacturing...
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
Moderna has finalized a strategic partnership with the Australian government to build an mRNA manufacturing facility in Melbourne: which is expected to produce up to 100 million mRNA respiratory vaccine doses annually.
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.
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.
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.
A global biomanufacturing training hub will be established in Korea to serve low- and middle-income countries wishing to produce biologicals such as vaccines, insulin, monoclonal antibodies and cancer treatments.
Valneva has been awarded up to £20m ($27m) in R&D funding from Scottish Enterprise: which will be used to revive its plans to increase vaccine manufacturing in Scotland.
Last week saw the WHO announce the first six countries that will receive the technology needed to produce mRNA vaccines on the African continent, as part of the global mRNA technology transfer hub project.
The US biotech says it will establish a commercial presence in Belgium, Denmark, Norway, the Netherlands, Poland, and Sweden to support the delivery of mRNA vaccines and therapeutics locally.
AES Clean Technology, a supplier of cleanroom facilities for the pharmaceutical and biopharmaceutical sectors, is ploughing $14.2m into a new US manufacturing facility.
US government agency, BARDA, is drawing on industry feedback to assist it in understanding the advanced developmental landscape of next-generation COVID-19 vaccines.
Valneva announced yesterday that results from a lab study showed three doses of its inactivated COVID-19 vaccine candidate, VLA2001, neutralized the Omicron variant.
Charles River and La Jolla Institute for Immunology (LJI) are collaborating on a new project to uncover how different cells in the human immune system respond to SARS-CoV-2 in early, acute infection.
The UK government's Vaccine Taskforce (VTF) is looking to increase its understanding of barriers, risks, and opportunities to facilitate investment in the vaccine supply chain.
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.
Evotec SE has received a €7.5m ($8.5m) grant from the German Federal Ministry of Education and Research (BMBF) for the development of EVT075, a potential immunomodulatory therapy against COVID-19.
Moderna and the Australian government have announced an agreement in principle to build a mRNA vaccine manufacturing facility in Victoria, Australia: providing up to 100 million doses a year.
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.
GreenLight Biosciences and CDMO Samsung Biologics have announced a partnership agreement, with Samsung Biologics to manufacture GreenLight’s messenger RNA COVID-19 vaccine candidate at commercial scale.
A new clinical trial of heterologous – or ‘mix-and-match’ – combinations of COVID-19 vaccines is set to start in Pakistan: seeking to add to research on the effectiveness of such combinations.
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+.
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.
