Protocols

In wake of a trial disaster, Seattle Genetics files sBLA; Egalet takes a dive on a CRL

→ One day after scrapping a Phase III study, Seattle Genetics filed an sBLA for Adcetris to treat patients with cutaneous T-cell lymphoma. The sBLA is based on positive results from a Phase III study published this month in The Lancet.

→ Shares of Egalet dropped 20% on the news that it received a complete response letter from the FDA requesting information about its prior approval supplement of Oxaydo tablets. The drug was designed to reduce the risk of abuse but there is currently no evidence that the formulation has less abuse potential than immediate-release oxycodone.

Cell Medica acquired WT1, a T-cell receptor therapy for the treatment of acute myeloid leukaemia and myelodysplastic syndrome from Cell and Gene Therapy Catapult. The financial terms of the deal were not disclosed, but Cell Medica will manufacture and continue to develop the drug, which recently completed a Phase I/II trial showing promising results in eight patients.

The European Investment Bank has agreed to loan €20 million to BiondVax for the development of a universal flu vaccine candidate M-001.

Alnylam CEO John Maraganore was elected chair of BIO for 2017-2018. He’ll continue in his role as CEO at Alnylam, which had a troublesome 2016, though things seem to be looking up for 2017.

Dova hopes to raise $65 million from its IPO by offering 4.1 million shares at a price range of $15 to $17.


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RAPS Regulatory Convergence 2017