All articles by

Madrigal gets FDA nod for Rezdiffra to treat liver scarring patients

The accelerated approval was based on the findings from the ongoing Phase 3 MAESTRO-NASH trial in which Rezdiffra showed statistically significant improvement on two primary endpoints

FDA grants accelerated approval to BMS’ Breyanzi for CLL or SLL

The FDA has approved Breyanzi to treat adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a minimum of two prior lines of therapy

BeiGene earns FDA nod for Tevimbra to treat oesophageal cancer

The approval was based on the results from the Phase 3 RATIONALE 302 study in which Tevimbra indicated statistically significant and clinically meaningful survival benefit

Biocon Biologics Enters a Long-term Commercial Collaboration with Eris Lifesciences to Expand Patient Access in India

As a part of this collaboration, Biocon Biologics will continue to leverage Eris’ strong commercial footprint to significantly expand patient access to its world class biosimilars in India

Halton Healthcare selects Sectra’s cloud SaaS to optimize enterprise imaging workflows and strengthen security

The fully managed cloud service will enable the healthcare provider to streamline operations, consolidate IT systems maintenance, reinforce data security, and scale their use of the solution as needed for improved patient care

Mirum Pharmaceuticals’ Livmarli secures FDA nod to treat cholestatic pruritus

The approval of the IBAT inhibitor was based on findings from the Phase 3 MARCH study which included 93 patients with a variety of hereditary PFIC types

Novartis acquires IFM Therapeutics’ subsidiary IFM Due in deal worth up to $835m

Under the agreement, Novartis made fixed payments to fully fund IFM Due’s research and development expenses for the cGAS-STING programme in exchange for the acquisition option

Pfizer’s Adcetris meets primary endpoint in ECHELON-3 trial in DLBCL

The results of the late-stage trial showed a statistically significant and clinically meaningful changes in overall survival and key secondary endpoints of progression free survival and overall response rate

Astellas gets FDA orphan drug and paediatric exclusivities for Cresemba

The orphan drug exclusivity grants the drug seven years of US market exclusivity in its approved indication and the paediatric exclusivity gives Cresemba an additional six months to that timeframe

Assure to divest certain assets to MPOWERHealth for up to $4.5m

The asset sale consists of the majority of the company’s workforce and most of its clinical equipment and healthcare facility contracts