Approvals

A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.

Samsung Bioepis is only the second firm to receive a US FDA endorsement for its denosumab biosimilars, with the nod coming at the same time as formal European Commission approval. But plenty more firms are waiting in line with their own rivals to Prolia and Xgeva.

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sanofi has bolstered its insulin offerings by bagging the first US FDA approval for a rapid-acting insulin aspart biosimilar, leaving several would-be sponsors in its wake.

The Swedish company is celebrating approval for the first treatment for MCT8 deficiency

Biocon Biologics’ management shared updates regarding their facilities, expansion, and fast upcoming ustekinumab biosimilar launch in the US. Also, Biocon made a final acquisition payment to Viatris, while increasing its stake in the biosimilars business.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Biocon reported another quarter of sluggish generics revenues but hopes that planned generic liraglutide launches and US facility expansion will grow this business segment.

A manufacturing inspection issue may have put paid to J&J getting a rapid approval for its subcutaneous version of Rybrevant in the US, but a positive opinion from the CHMP plus an expanded EU approval for the IV version are two recent boosts to a franchise taking aim at Tagrisso’s crown.