Reforms to a US national security regulation are putting off foreign investors and driving down VC investment in the biotech space by as much as 20 percent, says BIO’s David Thomas. In August 2018, Congress passed the Foreign Investment Risk Review Modernization Act (FIRRMA) as part of the Fiscal 2019 National Defense Authorization Act. The Act broadened the scope and oversight of the Committee on Foreign Investment in the United States (CFIUS) to include the review of foreign investments in companies…
Deal-Making
The 12 trends of Christmas: A look back at 2019
CAR-T partnerships, Biopharma megamergers, biotech funding, and an eye on China. Bioprocess Insider presents the biggest stories of the year… through song! T’was the days before Christmas, And all through the dept. Not a story was breaking and journalists wept. So why not look back at the news of the year, The editor suggested over a beer… In the past twelve months Bioprocess Insider brought to you (To the tune of traditional Christmas song ‘The Twelve Days of Christmas’): A…
Novartis inks 5 years vector supply extension with Oxford Biomedica
Oxford Biomedica will keep supplying Novartis with the vectors needed to make Kymriah and other CAR-T products under a five-year deal extension. The new agreement will see Oxford Biomedica receive $75 million for manufacturing, undisclosed process development payments, a facility reservation fee as well as previously agreed royalties on chimeric antigen receptor (CAR-T) product sales. The extension deal also requires the firm ensure at least two manufacturing facilities are capable of commercial supply. Oxford Biomedica will make the vectors at…
Hemophilia A-OK! FTC thumbs up effectively closes Roche’s $4.3bn Spark buy
There is no risk of competitive harm between Roche’s approved hemophila A monoclonal antibody and Spark’s gene therapy candidates, say the US and UK competition bodies. In February, Swiss Biopharma firm struck a deal to buy Philadelphia, Pennsylvania-based Spark Therapeutics for $4.3 billion (€3.8 billion). Now after months of investigation by the US Federal Trade Commission (FTC), Roche is on the verge of closing the deal. The FTC’s concerns centered on the potential competitive harm of overlaps between Roche and…
Charles River bids $380m to buy cell therapy services firm HemaCare
HemaCare will boost Charles River Laboratories’ offering in the cell therapy materials and leukapheresis space – a market predicted to grow to $2 billion in the next decade. The deal will add expand Charles River’s cell therapy offering. HemaCare provides human primary cells as well as services used in the discovery, development and commercial production of cell therapies. Leukapheresis – the separation of white cells from blood samples – is a core HemaCare offering. The firm provides leukapheresis services for…
Sanofi wins US HHS $226m contract to expand PA vaccine capacity
The US Government has contracted Sanofi Pasteur to increase recombinant vaccine capacity at its Pennsylvania plant as part of US efforts to prepare for a flu pandemic. The US Department of Health and Human Services (HHS) shared details of the six-year, $226 million contract this week. Sanofi will work with the Biomedical Advanced Research and Development Authority to (BARDA) double capacity at the plant. The contract includes options that would see Sanofi retrofit a second facility to make adjuvant; develop…
AI will help Novartis make personalized meds, says Amazon
Amazon says Novartis’ personalized medicines operations will benefit from AI and machine learning collaboration. Novartis confirmed it had asked Amazon Web Services (AWS) to rejig is supply lines last week. The drug firm said it “will leverage AWS’s broadest portfolio of cloud services to build an enterprise-wide data and analytics platform that will transform business operations. According to AWS, the plan is to use artificial intelligence and machine learning to “reimagine†the Swiss firm’s manufacturing, supply chain, and delivery operations.…
Zelluna and Glycostem team on natural killer TCRs for solid tumors
Zelluna Immunotherapy and Glycostem Therapeutics have teamed up to develop TCR cell therapies for cancers, including hard-to-treat solid tumors. The partnership will combine Zelluna’s T-cell receptors (TCR) with The Netherlands-based Glycostem’s umbilical cord-derived natural killer cells. The TCR-NK cells will be made at the latter’s manufacturing facility in the Netherlands. A Zelluna spokesman told us TCR-NKs can target a broader range of tumors than cell therapies made using chimeric antigen receptors (CARs). “Adoptive cell therapies, both CAR and TCR, use…
Astellas: Large-scale gene therapy plant major driver in $3bn Audentes deal
Gaining clinical and commercial manufacturing capabilities through the acquisition of Audentes will reduce reliance on third-party manufacturers in the gene therapy space, Astellas says. Japan’s Astellas increased its presence in the gene therapy space yesterday by announcing plans to buy San Francisco-based Audentes Therapeutics for approximately $3 billion (€2.7 billion) in cash. The deal, expected to close in the first quarter 2020, will add Audentes’ lead candidate AT132 – a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM)…
Blame the messenger: Novartis cites RNAi candidate in $9.7bn Medicines Company deal
Novartis’ $9.7 billion move for inclisiran developer, the Medicines Co, and US approval for Alnylam’s Givlaarim have put RNA interference back in the headlines. RNAi therapies treat disease by interfering with – or “silencing†– genes. Drugs like inclisiran and Givlaarim bind mRNA transcribed from target genes, forming double stranded molecules that cannot be translated into protein. Inclisiran’s target mRNA encodes PCSK9, a protein that hampers the body’s ability to absorb low-density lipoprotein (LDL) [1]. By minimizing PCSK9 levels inclisiran…