Latest News

22 August

FDA grants approval for Pfizer’s RSV vaccine

Credit: Shutterstock/ Marina Demidiuk

The US Food and Drug Administration (FDA) has granted approval for Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, for use in pregnant women to offer protection for their babies. 

The bivalent RSV prefusion F (RSVpreF) vaccine is administered between 32 and 36 weeks of gestation. It is indicated to prevent RSV-caused lower respiratory tract disease (LRTD) and severe LRTD in infants from birth until the age of six months. 

Based on findings from the Phase III MATISSE clinical trial in 7,000 pregnant individuals and their infants, the regulatory agency granted the approval. 

The trial analysed the safety, efficacy and immunogenicity of the vaccine in infants born to healthy people who were inoculated during the gestation period. 

The company obtained FDA approval in May 2023 for the vaccine indicated to prevent LRTD in those aged 60 years and above. The company has also commenced two trials of Abrysvo for RSV in children aged two to 17 years and adults aged 18 to 60 years. 

25  August

FDA approves the first Tysabri biosimilar for MS and Crohn’s disease 

The first biosimilar of Biogen’s Tysabri (natalizumab) is set to hit the market with approval from the US Food and Drug Administration (FDA). 

Sandoz’s Tyruko has been approved for all multiple sclerosis (MS) settings where Tysabri is currently used, including relapsing-remitting MS, clinically isolated syndrome (CIS), and active secondary progressive disease, in addition to Crohn’s disease. 

Biosimilar sales have generated a record profit for Sandoz, with the company reporting $2.4bn in sales in Q2 2023. Sandoz has previously announced plans to launch four high-profile biosimilars in the next few years to further expand its biosimilar portfolio as it breaks free from its parent company Novartis by the end of 2023. 

Tysabri is an anti-α4 integrin monoclonal antibody disease-modifying therapy (DMT), which was first approved by the FDA in 2004. Biogen reported sales of $1.2bn in sales from MS therapies, including $483.1m with Tysabri, in Q2 2023. 

23 August

US HHS grants $1.4bn for Covid-19 vaccines development 

The US Department of Health and Human Services (HHS) has made a grant of more than $1.4bn to Project NextGen to facilitate the development of new vaccines and therapeutics for Covid-19. 

Project NextGen is a $5bn programme led by the Administration for Strategic Preparedness and Response’s (ASPR) Biomedical Advanced Research and Development Authority (BARDA) in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID).  

This initiative focuses on progressing vaccines and therapies into clinical trials, and their subsequent regulatory review and commercialisation for use by Americans.  

The latest funding includes a $1bn award to four BARDA clinical trial partners, ICON Government and Public Health Solutions, Pharm-Olam, Technical Resources and Rho Federal Systems, to carry out Phase IIb clinical trials of a vaccine. Regeneron will receive $326m to develop a new monoclonal antibody to prevent Covid-19 infection.  

10 August

Galera lays off 70% of workforce following FDA rejection 

Galera Therapeutics is winding down operations by reducing its workforce by 70% as a cash-reduction measure. 

This is due to the US Food and Drug Administration (FDA) issuing a complete response letter (CRL) for avasopasem manganese (avasopasem) for treating radiotherapy-induced severe oral mucositis. In the CRL, the FDA asked for additional safety and efficacy data before Galera files for resubmission. 

The news about the CRL and lay-offs led to a freefall of Galera’s stock. The company’s share price reduced by over 80% in pre-market trading on 10 August, compared to market close on the previous day.  

Avasopasem is an enzyme mimetic that converts superoxide-free radical molecules to hydrogen peroxide and oxygen, thereby reducing the intensity and duration of severe oral mucositis.  

The company said it plans to request a Type A meeting with the US FDA to gain further insight into the CRL and discuss resubmission for the approval of avasopasem.  

9 August

Merck and Astex investigate small molecule candidates for cancer 

Astex Pharmaceuticals and Merck (MSD) have expanded their collaboration to identify small molecule candidates to target different forms of the p53 tumour suppressor protein for cancer treatment. 

Under the research collaboration and licence agreement, Astex will leverage its fragment-based drug discovery platform to develop these compounds. They will then be provided to MSD for further optimisation and preclinical development. 

Astex Pharmaceuticals president and CEO Harren Jhoti stated: “This new alliance builds on our existing productive collaboration and allows us to combine our expertise and assets with MSD’s wide-ranging oncology capabilities.” 

Merck will gain an exclusive worldwide licence for the research, development and commercialisation of the candidates to be developed under the partnership. 

Astex will receive $35m in an upfront payment and subsequent milestone payments totalling $500m per programme, along with tiered royalties on product sales.