The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.

Having secured FDA approval, the UK's Acacia Pharma will market Byfavo, the first new product in the sedation space in decades, which was licensed from Italy's Cosmo and developed by Germany's Paion.

Mundipharma has announced the European Commission’s extension of the indications for Invokana to include renal outcomes data from the Phase III CREDENCE study.

The two-part vaccine becomes the second against Ebola to get approval. Janssen is now collaborating with the World Health Organization on vaccine pre-qualification to get it to people in need.

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.

A year after inking a multi-billion dollar deal to get hold of the Takeda eye drop, Novartis has given up on getting approval for Xiidra in Europe with the EMA unconvinced about the therapy's efficacy.

The average list price of $96,000 per year is three times the cost of GW’s competing drug Epidiolex, but Zogenix is betting that the reduction in seizures seen in clinical trials will justify the expense. 

Sweden's Hansa Biopharma has taken an important step closer to becoming a commercial-stage company with the backing of European regulators for Idefirix, although launch plans have been impacted by the COVID-19 crisis.

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.