Author Archives: Dan Stanton

Cost of Goods Is Crucial for the Future of Regenerative Medicine: CAR-T Cell Therapy Provides a Case Study in Perspective

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In the history of regenerative medicine, 2017 was a critical year. With approvals for Kymriah (tisagenlecleucel) from Novartis AG, Yescarta (axicabtagene ciloleucel) from Kite Pharma (a Gilead company), and Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics, cell and gene therapies finally made their mark on the regulatory landscape. Then in 2018, those products began both treating patients and bringing in revenues for their sponsor companies. “Patients are being treated, and biotechnology and pharmaceutical companies are being paid for treating them,†said…

April 18, 2019

J&J keeping Remicade biosimilars at bay through price drops

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Johnson & Johnson’s Remicade continues to hold 92% of the market by volume three years since infliximab biosimilars arrived in the US. Johnson & Johnson (J&J) opened the first quarter 2019 reporting season this week by announcing an 8% year-on-year growth in its pharmaceutical’s division to $10.2 billion (€9 billion). For its immunosuppressive monoclonal antibody Remicade (infliximab), US sales – representing 70% of global sales for the firm – fell 15.5% compared to the same period last year, to $774…

April 18, 2019

Allele SCM partnership looks to stem cells to treat diabetes

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Allele Biotechnology has teamed with SCM Lifescience to develop diabetes therapies using pancreatic beta cells derived from induced pluripotent stem cells (iPSCs). “By nature, pluripotent stem cells like iPSCs can be expanded indefinitely and differentiated into all human tissue types, including pancreatic cells,†a spokesperson from the San Diego-based biotech Allele, told Bioprocess Insider. Therefore, they can be a viable option for diabetes treatment. “iPSC-derived cells are already known to have biological functions, such as blood sugar sensing and insulin…

April 18, 2019

Celularity leases NJ plant to make its off-the-shelf stem cell therapies

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Celularity says the 147,000 square-foot campus in Florham Park will support its allogeneic placental-derived natural killer (NK) cell therapy candidates, and more investment is to come. Clinical stage cell therapy firm Celularity has a pipeline of off-the-shelf placental-derived Natural Killer (PNK) therapies in development, with its lead program CYNK-001 set to move into Phase II trials for multiple myeloma and acute myeloid leukemia (AML) this year. To support its pipeline, the firm has entered a long-term lease agreement for a…

April 17, 2019

CRISPR consortium launched to improve CHO cell lines

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Horizon Discovery has launched an industry consortium aimed at improving the CHO expression platform using modern gene-editing tools such as CRISPR and rAAV. At BPI Europe in Vienna, Austria earlier this month, cell line technologies firm Horizon Discovery announced plans to create an industry group to address inadequacies with the prevalent Chinese hamster ovary (CHO) expression platform by using the gene-editing tools CRISPR (clustered regularly interspaced short palindromic repeats) and rAAV (recombinant adeno-associated virus). “The CHO cell line has hardly…

April 17, 2019

Shareholders’ nod puts $74bn BMS Celgene merger back on track

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Over 75% of Bristol-Myers Squibb shareholders voted in favor of the proposed megamerger with Celgene despite warnings from certain investor groups. In January, Big Pharma firm Bristol-Myers Squibb (BMS) announced its intentions to get bigger through the acquisition of its immune-oncology partner Celgene. The $74 billion (€65 billion), if it goes through, will be the largest ever merger in the biopharma space and create what Bristol-Myers Squibb CEO Giovanni Caforio described as “the number one oncology franchise.†The deal is on track…

April 16, 2019

Enesi and BARDA partner to develop solid dose flu vaccine

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The US Biomedical Advanced Research and Development Authority (BARDA) will use Enesi Pharma’s ImplaVax device and formulation technology to develop subcutaneous vaccines against influenza. The public-private collaboration, financials of which have not been divulged, will form part of BARDA’s Division of Research, Innovation, and Ventures (DRIVe) innovative health security technologies portfolio, and looks to provide a cost-effective alternative to traditional vaccines to help improve vaccination uptake. The aim is to help healthcare providers or individuals administer influenza vaccines through the…

April 16, 2019

Catalent jumps into ‘transformative’ gene therapy space with $1.2bn Paragon buy

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Contract manufacturer Catalent has agreed to buy the gene therapy CDMO Paragon Bioservices for $1.2 billion. Paragon Bioservices, a private-equity backed biologics contract development and manufacturing organization (CDMO) focused on gene therapy and next-generation vaccines, will be acquired by fellow CDMO Catalent, the firms announced this morning. According to its website, 50% of Paragon’s current contracts are for gene therapy. The CDMO also supports vaccine products and has previously won contracts from clients including the US Department of Defense (DoD).…

April 15, 2019

Aji Bio opens large-scale oligo production plant in Osaka

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Facilitated by its 2016 acquisition of GeneDesign, CDMO Ajinomoto Bio-Pharma has opened a 21,500 square-foot plant in Japan to service the growing oligonucleotide demand. In December 2016, Japan’s Ajinomoto OmniChem acquired nucleic acid drug contract development and manufacturing organization (CDMO) GeneDesign for an undisclosed fee. Nearly two-and-a-half years on and the subsidiary has become absorbed into Ajinomoto’s Bio-Pharma Services division. “GeneDesign – now Ajinomoto Bio-Pharma Services Osaka – provides solid-phase technology for oligonucleotide synthesis capabilities from µg to 10 kg…

April 12, 2019

World’s first Soliris biosimilar launched in Russia

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Russian biopharma Generium has launched Elizaria, a biosimilar version of Alexion’s Soliris (eculizumab) developed using the SUREtechnology Platform from Selexis. Approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), Soliris (eculizumab) pulled in $3.6 billion (€3.2 billion) in global sales for Alexion Pharmaceuticals in 2018. While Alexion is confident its IP will restrict direct competition in the US and Europe potentially up until 2027, the first biosimilar has been approved and launched in Russia in…

April 11, 2019