Cambridge, Massachusetts based, Alnylam Pharmaceuticals, along with collaborators, has identified mutations in the INHBE gene linked with protection against abdominal obesity.
Construction of Samsung Biologics’ Plant 4 is on schedule with operations set to start in October, the company confirmed in its Q2 results this morning.
Bavarian Nordic A/S has received approvals from the US and EU regulatory authorities to manufacture its Jynneos/Imvanex smallpox and monkeypox vaccine at its fill and finish facility in Denmark.
Avista Therapeutics, a University of Pittsburgh Medical Center (UPMC) spinout, is teaming up with Roche to develop novel AAV gene therapy vectors for eye diseases.
The US Centers for Disease Control and Prevention (CDC) says COVID-19 has ‘pushed back years of progress’ in combating antimicrobial resistance (AR) in the US – adding that the threat from AR has also got worse.
The Coalition for Epidemic Preparedness Innovations (CEPI) will provide funding of up to $375,000 to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Health Security Agency (UKHSA) to support the development of laboratory tools...
Sandoz said the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a natalizumab biosimilar, developed by Polpharma Biologics.
The European Commission has extended the marketing authorization for Bavarian Nordic’s smallpox vaccine, Imvanex, to include protection from monkeypox and disease caused by vaccinia virus.
The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.
US biotech, CAMP4 Therapeutics, has secured US$100m in a Series B financing round that it says will be used to accelerate expansion of its regulatory RNA (regRNA) platform.
Moderna and the International Vaccine Institute (IVI) have signed a Memorandum of Understanding (MOU) to establish a partnership for vaccine research and development.
The research institutions are joining on a community-based collaborative initiative to work toward greater study inclusion, supported by funding from PhRMA.
CDMO WuXi Biologics will invest $1.4bn in a 10 year investment plan to expand its research, development, and large-scale drug substance and drug product manufacturing capacity and capabilities in Singapore.
Polpharma Biologics’ Marketing Authorization Application for natalizumab – a proposed biosimilar to Biogen’s Tysabri – has been accepted by the European Medicines Agency (EMA).
Recruiting and nurturing talent will be incredibly important in the biosimilar industry as it continues its rapid evolution, according to RSA Talent Equity.
Bavarian Nordic continues to sign contracts for its smallpox vaccine in response to the monkeypox outbreak, with the company again raising its financial guidance for 2022 and noting orders now stretch into 2023.
SK bioscience has extended its partnership with Novavax to include the manufacture and supply of Novavax’s Omicron COVID-19 vaccine candidate, which could become available later this year.
The EU Ombudsman has closed the inquiry into the EU Commission’s handling of a request for text messages between its president and the CEO of Pfizer, upholding the finding of maladministration.
Amazon is partnering with the Fred Hutchinson Cancer Research Center on a Phase I trial for a cancer vaccine targeting metastatic melanoma and breast cancer.
Samsung Biologics says it is actively working to engage its suppliers to transition to net zero emissions in multiple areas and invest in renewable energy.
A representative from life-science services company Azzur Group explains how flexibility and speed can help in reaching the best solution more efficiently.
Releasing its first-ever report on the pipeline of vaccines in development to prevent infections caused by antimicrobial-resistant (AMR) bacterial pathogens, the WHO is calling for more AMR vaccine development.
Moderna has dosed the first participant in a Phase 1 trial of its Nipah virus vaccine candidate, mRNA-1215, that has been developed in collaboration with the US National Institutes of Health (NIH).
Novo Nordisk has announced positive results from a Phase 3 study assessing the efficacy and safety of concizumab, its prophylactic treatment of hemophilia A or B with inhibitors.
Vertex Pharmaceuticals will acquire ViaCyte, a privately held biotech focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320m.
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.
Wacker Biotech’s site in Halle, Germany will be expanded in the coming months into a competence center for actives based on messenger ribonucleic acid (mRNA).
Merck (MSD outside the US and Canada) is welcoming applications from early-stage biomedical start-ups for its newly launched Merck Digital Sciences Studio (MDSS): which seeks to support technologies for drug discovery and development.
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...
A new type of vaccine - which could provide broad protection against a variety of SARS-like betacoronaviruses, including SARS-CoV-2 variants - has received backing of up to $30m from CEPI.
CureVac has filed a lawsuit in a German regional court against BioNTech SE: seeking ‘fair compensation for infringement… of CureVac’s intellectual property rights’ regarding tech used in the manufacture of the Pfizer/BioNTech COVID-19 vaccine. BioNTech,...
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”.