Friday, June 21, 2019 Daily Archives

Biopharmaceutical Characterization, Part 2: Applications and Strategies for Diverse Products — A Conference Report

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Last fall, KNect365 brought together more than 250 analytical specialists to discuss biological assays and characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies for case studies, regulatory interactions, sharing perspectives, and learning about emerging technologies. Part 1 of this report in January 2019 focused on the bioassay section of the meeting. Here in Part 2 sponsored by Sartorius, BPI’s senior technical editor reports…

June 21, 2019

Eli Lilly on R&D: Two thirds internal, one third external

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CFO Josh Smiley says Eli Lilly is looking to source around a third of its pipeline from outside its organization. Speaking at the Goldman Sachs 40th Annual Global Healthcare Conference, Josh Smiley, chief financial officer at Eli Lilly, said his firm’s pipeline is comprised of around two thirds internal molecules and one third external. “When we look historically, we’ve done a good job in late phase of partnering and bringing in assets in earlier phases of development, getting to about…

June 21, 2019

Biotech money: Global funding down despite spate of IPOs

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A decline in venture capital (VC) funding has been offset by a flood of IPOs with growth coming from non-US biotechs, according to a Jefferies analyst. For April and May 2019, biotech funding has declined 6.5% year-on-year to $9.3 billion (€8.3 billion) according to Jefferies analyst David Windley. This, he said in a note, is due to a 46% drop in VC funding as the private market continues to be less kind to biotech over the past few periods. “Both…

June 21, 2019

Catalent to invest up to $10m into ex-BMS fill/finish site

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Catalent will retain all 700 staff and invest up to $10 million into a site in Italy it is acquiring from Bristol-Myers Squibb. The deal, announced this week, will see the contract development and manufacturing organization expand its biologics network outside of the US through the addition of a sterile product manufacturing and packaging facility in Anagni, Italy. Financial details regarding Catalent’s first biologics manufacturing facility in Europe have not been divulged, but a spokesperson told this publication the CDMO…

June 21, 2019

Orgenesis talks cell therapy development for diabetes

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Orgenesis has received Orphan Drug Designation for a potential autologous insulin producing cell therapy to treat severe hypoglycemia-prone diabetes resulting from total pancreatectomy. With the designation, Orgenesis hopes to expedite its Autologous Insulin Producing (AIP) cells as a cell replacement therapy for the treatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy due to chronic pancreatitis. “The therapy is based on taking a small amount of liver cells from the patient. These are propagated to the desired amount of cells…

June 21, 2019