All articles by Amit Thadani
Amit Thadani
Sanofi secures EC approval for two enzyme replacement treatments for rare diseases
The European regulator approved Nexviadyme to treat the full spectrum of Pompe disease and Xenpozyme to treat non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD)
Novartis gets expanded EC approval for Cosentyx to include paediatric arthritic conditions
The expanded approval is based on data from the JUNIPERA trial, which showed that Cosentyx reduced the risk of flare and disease activity compared to placebo in paediatric patients with ERA and PsA
Astellas, Sutro partner to develop novel iADCs for cancer treatment
The partnership leverages the cancer-fighting potential of iADCs as a novel modality, enabled by Sutro’s ability to engineer complex conjugated antibodies and Astellas’ expertise in oncology research and development
Saudi Arabia to invest over $3bn in vaccines and vital medicines industry
The investment will be implemented in two stages where the first stage will focus on developing vaccines, plasma, and insulin technologies, while the second stage on the immunological and cancer drugs industry
US FDA expands Merck’s Vaxneuvance indication to include infants and children
The FDA approval was based on data from seven randomised, double-blind clinical studies that evaluated Vaxneuvance in infants, children and adolescents
US FDA approves Pfizer-BioNTech, Moderna Covid-19 vaccines for kids aged six months
The US agency expanded EUAs for the Pfizer-BioNTech and Moderna Covid-19 vaccines to include their use in children aged six months to four years, and six months to 17 years, respectively
Plans for the MEDICA 2022 and COMPAMED 2022 are picking up speed – registrations are still possible for all segments of the fair
Medical technology industry needs strong platforms while current challenges continue
Roche gets EC approval for Lunsumio to treat follicular lymphoma
The EC approval is based on positive results from the Phase ½ GO29781 study, which assessed the safety, efficacy and pharmacokinetics of Lunsumio in people with B-cell non-Hodgkin lymphoma
Pfizer wraps up acquisition of RSV therapeutics company ReViral
The acquisition will provide Pfizer with ReViral’s portfolio of therapeutic candidates, including sisunatovir, along with another lead candidate, focused on RSV replication
US FDA requires patient notification about suicide risk related to finasteride
The US regulator required a patient notification about suicidal behaviour, where it has previously approved an expanded its label indication to include risks of persistent sexual dysfunction and depression