United States

As demand for mRNA continues to surge, two new facilities have been launched to boost production in Australia and the US. Work is underway at The University of Queensland’s (UQ) BASE facility which has become Australia’s leading provider of mRNA for research and pilot studies since its launch in 2021. The Commonwealth Government’s Medical Research […]

The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend Pfizer’s Penbraya (meningococcal group A, B, C, W and Y vaccine) for the prevention of the five most common meningococcal serogroups. These serogroups cause the majority of invasive meningococcal disease (IMD) in adolescents and young adults […]

The White House Cancer Moonshot initiative has announced a new public-private partnership to boost innovation in the fight against cancer. CancerX will be co-hosted by the Digital Medicine Society (DiMe) and Moffitt Cancer Center. It blends DiMe’s expertise in convening cross-disciplinary groups to develop clinical-quality resources on a tech timeline with Moffitt’s top research and […]

Charles River Laboratories has revealed plans to open Charles River Accelerator and Development Lab (CRADL) locations in Seattle and Philadelphia, expanding the company’s contract vivarium space for the biopharmaceutical industry. CRADL Seattle is opening this September as Charles River’s most recent investment in Seattle, providing flexible vivarium space and on-demand in vivo study support services. […]

The US Food and Drug Administration (FDA) has granted marketing authorisations to several new therapeutics over the last month that will have a significant impact on areas of unmet need and the evolution of future treatments. Elevidys, Sarepta Therapeutics Elevidys became the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in […]

Biopharmaceutical company InflaRx has launched Gohibic (vilobelimab) in the US for the treatment of Covid-19. In April 2023, Gohibic was granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) in hospitalised adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Professor Niels […]

The US market for medicines grew by 5% in 2022, reaching a total value of $429Bn on a net price basis. This was driven by a range of factors, including an increase in health services utilisation, which is now back to pre-pandemic levels, and the entry of new medicines into the market. Balancing these drivers […]

DDW’s Megan Thomas takes a snapshot of the US biotech market and some of the ongoing research coming out of the US. In 2021, Savills put together a report on the regional hubs attracting science/pharma investment1. The report notes that the focus on science and pharma throughout the Covid-19 pandemic has resulted in the emergence of […]

Sequana Medical has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure. Fluid accumulation in heart failure patients is caused by the retention of too much sodium. The DSR drug-based approach works in partnership with […]

Italian research institute and contract research organisation IRBM has become the only company from outside the United States to join cancer drug discovery network the Chemical Biology Consortium (CBC). The CBC is the discovery engine of the National Cancer Institute (NCI) Experimental Therapeutics (NExT) Program, administered through the Frederick National Laboratory for Cancer Research (FNLCR), […]

The Food and Drug Administration (FDA) in the US has made several key drug decisions over the last few weeks. Here’s a summary. Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. The […]

A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases.  GSK’s retrospective study looked at clinical trial demographic data from 495 GSK and ViiV clinical trials involving US-based participants from the […]

Intercept Pharmaceuticals’ obeticholic acid (OCA) could be first drug to be approved in the US for non-alcoholic steatohepatitis (NASH), according to analysts GlobalData.  The Food and Drug Administration (FDA) accepted the company’s resubmission of its new drug application (NDA) for OCA in patients with pre-cirrhotic liver fibrosis due to NASH in December 2022.  According to […]

Leqembi’s prospects in the Alzheimer’s disease market remain uncertain despite its advantages over Aduhelm, says analytics company GlobalData.  Eisai and Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (mAb), Leqembi (lecanemab), recently gained approval from the Food and Drug Administration (FDA) under the accelerated approval pathway for the treatment of Alzheimer’s disease (AD) in patients with early […]

Airsupra (albuterol/budesonide) has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.  Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS). It […]

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for VAX-24, Vaxcyte’s 24-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease.  The decision was based on positive topline results from a Phase I/II proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18-64 years of age.  […]