Drug Development, Protocols

Protocols: Retrophin shares soar on promising Phase II data; FDA readies Keytruda review for lung cancer

Retrophin CEO Stephen Aselage

Retrophin CEO Stephen Aselage

Shares of San Diego-based Retrophin $RTRX shot up 26% Wednesday morning after the company unveiled promising Phase II data for their lead drug. Investigators say they tracked a mean reduction of 44.8% in proteinuria among patients taking sparsentan, well over twice the rate of reduction tracked in the irbesartan group. CEO Stephen Aselage says the company will now meet with the FDA to map out the shortest possible route to the market. Retrophin is best known for its former CEO, the notorious Martin Shkreli, who was kicked out of the company amid fraud allegations and now faces federal charges related to his handling of the biotech’s finances and a now defunct hedge fund.

Just weeks after Bristol-Myers Squibb suffered a setback in the development of its checkpoint drug Opdivo for lung cancer, rival Merck says that the FDA is ready to review the use of Keytruda as a first-line therapy for lung cancer. Keytruda is already approved as a second-line therapy.

Cambridge, MA-based upstart Decibel Therapeutics has recruited Agios scientific co-founder Michael Su to the company as its new CSO. The new executive crew now also includes Paula K. Cobb, senior vice president of strategy, portfolio and programs; John J. Lee, senior vice president of pharmaceutical development; and Pete Castrichini, vice president of human resources. The company is helmed by ex-Biogen exec Steve Holtzman.

Japan’s Ministry of Foreign Affairs has a stern warning for the UK biopharma industry: If you lose the EMA, don’t expect Japanese pharma companies to keep their R&D operations in and around London. “Many Japanese pharmaceutical companies are operating in London, due to the EMA’s location in London,” reads the message. “If the EMA were to transfer to other EU Member States, the appeal of London as an environment for the development of pharmaceuticals would be lost, which could possibly lead to a shift in the flow of R&D [research and development] funds and personnel to Continental Europe. This could force Japanese companies to reconsider their business activities.”

Aurigene Discovery Technologies is swapping a batch of milestones for 10.2 million shares of Curis. They’re working on an oncology collaboration.

Takeda has vaccinated the first subject in the Tetravalent Immunization against Dengue Efficacy Study (TIDES), a Phase III trial of its live-attenuated tetravalent dengue vaccine candidate (TAK-003).

The contract development and manufacturing group Pharmaceutics International has raised $93 million from a consortium of investors led by Signet Healthcare Partners and including Athyrium Capital Management, Hildred Capital Partners and Pharmascience. The money comes as debt and equity.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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