BioPharmaceutical

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.

Emerging Company Profile: The Maryland-based biotech is working on a functional cure for type 1 diabetes that is similar to Vertex’s VX-880 – but with some key differences.

The US major is investing over $360m in new money into the UK but the country has being losing its lustre as an appealing place to invest since Brexit and needs to offer more to multinationals.

Alvotech is the latest to join several other competitors who have already submitted their denosumab biosimilar marketing authorization applications to the EMA.

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.

Until the full data are released, it is difficult to weigh ANCHOR.

Impressed by the data to date on bexicaserin for epileptic encephalopathies syndromes, the Danish drugmaker hopes the drug, through the acquisition of Longboard, will become a cornerstone of its new neuro-rare disease franchise.

Fusion Pharmaceuticals Inc CEO John Valliant talked to In Vivo about Canadian leadership in radiopharmaceutical innovation, its differentiated approach, and excitement around combination therapies for precision cancer treatments.

Axcynsis is developing a derivative of the chemotherapy agent Yondelis as a new payload, which the Singapore venture will first apply to a Claudin 6-targeting ADC it plans to take into a Phase I trial in the US, its chairman, CEO and founder tells Scrip in an interview.

The US FDA approved the drug for hemophilia A and B, and while it may struggle to compete in hemophilia A against Roche’s Hemlibra, it has a big convenience advantage in hemophilia B.