Protocols

FDA gives priority review to new Keytruda sBLA; AstraZeneca’s Pearl signs asthma development pact with Avillion

→ The FDA is giving priority review to Merck’s $MRK anti-PD-1 therapy, Keytruda, for a new supplemental biologics license application (sBLA). The application is asking for an OK to use Keytruda as a treatment for cervical cancer patients whose cancer has progressed while on (or after) chemotherapy. The sBLA is based in part on data from the company’s Phase II KEYNOTE-158 trial, according to a Merck statement. The FDA set a PDUFA date of June 28, 2018.

→ AstraZeneca company Pearl Therapeutics has inked a co-development deal with London-based drug developer Avillion to push forward an asthma program called PT027. The investigational therapy is a fixed dose combo of budesonide (an inhaled corticosteroid) and albuterol (a short-acting beta-2 agonist). In a statement, Avillion says it will be responsible for developing PT027 and will finance the program all the way through to regulatory approval. No specific financial terms were disclosed.

→ Austin-based Savara $SVRA has dumped a drug it obtained in its reverse merger with Mast Therapeutics last year. The biotech says that Aironite (sodium nitrite inhalation solution) failed a Phase II study among patients suffering from heart failure with preserved ejection fraction.


With additional reporting by John Carroll.


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Biotech Primer Toronto 2018

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