Protocols

Mumbai-based Lupin gets FDA warning for two manufacturing sites; Ionis promotes inotersen head as new COO

→ Indian drug manufacturer Lupin received a warning letter from the FDA claiming that it had violated good manufacturing practices, the company disclosed in a filing to the Bombay Stock Exchange. Two facilities in Goa and Indore, which produce products that make up more than 40% of Lupin’s sales, were named in the letter. “This is a big negative for the company… The warning letter will not only delay new approvals, thus impacting US revenues, but also increase remediation cost that will put pressure on margins,” brokerage firm Edelweiss Securities is quoted as saying. That would take a direct hit on the Mumbai-based company, as almost half of its sales comes from the US. Stocks plunged 17% after the news broke.

Brett Monia

→ As current chief operation officer Lynne Parshall transitions into a strategic adviser role at Ionis Pharmaceuticals while Brett Monia, head of drug discovery, will assume the COO position. A founding member of Ionis $IONS, Monia also leads the inotersen program, which was filed for a marketing approval with the FDA today. His new responsibilities include moving research programs into development, regulatory, patient advocacy, human resources and business functions. “The board and I are confident that Brett is the ideal choice to be chief operating officer and is fully prepared to assume these new responsibilities,” said CEO Stanley Crooke in a statement.

→ Houston, TX-based OncoResponse announced today that it has completed the acquisition of California’s Paganini Biopharma and all its assets — the most noteworthy among them being ONCR-201, an anti-epithelial membrane protein 2 (EMP2) monoclonal antibody that has shown promise in the preclinical stage. First-in-human studies are expected early 2019. “We are thrilled to put our technology and antibodies in the hands of strong drug developers and look forward to seeing this medicine reach cancer patients,” said Paganini CEO Gary Lazar in a statement. Financial details of the deal were not disclosed.

Takeda has struck a deal to collaborate with Cambridge, MA-based Portal Instruments on the needle-free delivery tech it developed out of the lab of MIT’s Ian Hunter. Portal gets an upfront and milestones totaling $100 million.



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Biomanufacturing