Author Archives: Dan Stanton

MilliporeSigma buys data platform to bolster its Biopharma 4.0 offering

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MilliporeSigma has bought the rights to the ProcessPad platform from Simplyfeye Softwares, adding the latest “building block” to its BioContinuum Platform. The ProcessPad platform from Simplyfeye Softwares Private Limited brings MilliporeSigma a data management and analytics solution capable of capturing development, scale-up, commercial and process data on a single platform as well as analyzing quantitative and qualitative batch manufacturing data. Financial details around the acquisition were not disclosed, but Michael Felo, director of Integrated Solutions Marketing, BioContinuum Platform, at MilliporeSigma,…

September 6, 2019

Avid contemplates pulling the trigger on capacity expansion

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With new customers on board and a significant backlog, Avid Bioservices says it is making incremental expansions in its network ahead of a major investment. Contract development and manufacturing organization (CDMO) Avid Bioservices presented its Q1 FY2020 financials this week. Revenues stood at $15.3 million (€13.9 million) for the quarter, up 21% year-on-year, while revenue backlog increased 34% to $61 million. “The highlights for the first quarter of 2020 were new customer contracts, significant backlog growth and another successful process…

September 6, 2019

Introducing Cytiva: GE plans name change ahead of $21bn Danaher buy

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GE Healthcare’s Biopharma business has announced plans to change its name and logo in anticipation of its acquisition by Danaher Corporation later this year. “On February 25 our lives changed,†Dodi Axelson, head of Communications, Life Sciences at GE Healthcare told Bioprocess Insider. She spoke, of course, about the agreement by Danaher Corporation to acquire the BioPharma portion of GE Healthcare’s Life Sciences business for a cash price of $21.4 billion (€19.4 billion). The deal is still under regulatory review…

September 6, 2019

FDA warns another unapproved cell therapy firm

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The US FDA has slammed a self-described regenerative cellular therapy manufacturer for selling unapproved umbilical cord blood and umbilical cord products. California-based Stemell describes itself as an “organization dedicated to leadership, education, service, research and manufacturing of regenerative cellular and cell-free products,†making products StemL UCB-Plus and StemL UCT-Plus, derived from human umbilical cord blood and umbilical cord, for allogeneic use. However, in the latest example of a crackdown on unapproved stem cell therapies the firm has been at the…

September 6, 2019

Vertex looks to stem cell islets for diabetes in $950m ‘toolbox’ deal

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Vertex has acquired Semma Therapeutics adding a program using pluripotent stem cell-derived islets as a potentially treatment for type 1 diabetes. While Semma is yet to have brought a therapy into the clinic, the Massachusetts-based firm has created a process it claims can produce stem cell-derived islets (SC-islets) starting from human pluripotent stem cells capable of developing into any cell type in the body. Its lead candidate has completed preclinical proof-of-concept studies demonstrating evidence of the potential of such technology…

September 4, 2019

FDA rejects Mylan and Biocon’s insulin glargine again

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The US FDA has issued a second complete response letter for a follow-on insulin glargine product referencing Lantus made by Biocon at its facility in Malaysia. In June 2018, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Mylan and its manufacturing partner Biocon rejecting their insulin glargine product submitted through the 505(b)(2) regulatory pathway as a follow-on biologic referencing Sanofi’s Lantus. Just over a year later and the firms have reported a second CRL…

September 4, 2019

Novartis to take on Biogen with Tysabri biosimilar pact

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Novartis division Sandoz has teamed with Polpharma for the commercialization rights to a Phase III biosimilar of Biogen’s multiple sclerosis monoclonal antibody Tysabri (natalizumab). The deal sees Sandoz enter into an agreement with Polpharma Biologics to commercialize and distribute worldwide the Polish biopharma firm’s natalizumab program, currently in Phase III trials. The molecule is being developed as a biosimilar of the relapsing-remitting multiple sclerosis (RRMS) monoclonal antibody Tysabri, which pulled in $1.86 billion (€1.7 billion) for Biogen in 2018. “Polpharma…

September 3, 2019

Celltrion turns to CDMO Lonza for infliximab biosimilar

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Supply of drug substance from Lonza’s stainless-steel facility in Singapore will complement production of Remsima (infliximab) within its own network, Celltrion says. Remsima is Celltrion’s biosimilar of J&J’s autoimmune best-seller Remicade (infliximab), approved by the EMA in 2013 and by the US FDA in 2016. It became the first biosimilar monoclonal antibody to be launched in Europe in 2015 and according to the Korean drugmaker it captured over 50% of the EU infliximab market by the third quarter 2018. While…

September 3, 2019

Not all about that base: Catalent organic downside offset by M&A

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Biologics now represent 32% of Catalent’s revenues, but unfavorable product mix, plant maintenance and a customer moving drug substance in-house hit the CDMO’s pre-existing business in Q4 FY2019. For the fourth quarter fiscal year 2019, Catalent reported revenue of $726 million (€662 million) across all its business units. While the contract development and manufacturing organization (CDMO) saw an 18% increase in sales year-on-year to $231 million within its Biologics and Specialty Drug Delivery segment, removing revenues from the recently acquired…

September 2, 2019

Moderna talks vaccines, from mRNA to Zika

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Moderna, Inc has received US FDA Fast Track designation for its investigational Zika vaccine based on its messenger RNA (mRNA) technology. The US Food and Drug Administration (FDA) has been granted to mRNA-1893, a vaccine intended to treat Zika currently in Phase I clinical studies. The Fast Track designation is designed to speed up development and review of therapies and vaccines needed to fill an unmet medical need. “Our Zika program is part of Moderna’s broader commitment to improving global…

August 28, 2019