Scott Gottlieb will step down from his position as commissioner of the US FDA next month. He issued more cell and gene therapy guidance in his two-year tenure than had appeared in the previous ten. In May 2017, the US Senate confirmed Dr Scott Gottlieb as commissioner of the US Food and Drug Administration (FDA). This week, nearly two years on, and Gottlieb announced he is to step down from the role in the next month. Among Gottlieb’s achievements are…
Having begun to build out its CAR-T network, Autolus says its fully contained, semi-automated manufacturing process will increase efficiencies and reduce costs. Last June, Autolus Therapeutics raised $150 million (€132 million) in its initial public offering (IPO) with the intention of using some of the funds to support the manufacturing of its personalized Chimeric Antigen Receptor (CAR) T-cell therapy pipeline. In January, the UK-headquartered firm began building out a commercial manufacturing facility in Enfield, London, and signed a long-term full…
The acquisition will give Biogen access to two potentially first-in-class later-stage gene therapy assets, NSR-REP1 and NSR-RPGR, for ophthalmologic disorders. The $800 million (€706 million) deal sees Biogen bolster its rare disease interest through the addition of Nightstar Therapeutics’ expertise in gene therapy and ophthalmology. Speaking on a conference call to discuss the acquisition, Michel Vounatsos, Biogen’s CEO, said the addition of Nightstar “fits hand-in-glove†with Biogen’s strategy and business. “This transaction will build on our progress of developing and…
Celltrion Pharm has pledged KRW 58.2 billion won ($51 million) to establish a production site for Remsima SC, a subcutaneous version of its Remicade biosimilar. Korean drugmaker Celltrion has achieved regulatory success for its biosimilar of J&J’s Remicade (infliximab) across several key markets and is now looking to receive approval and launch a subcutaneous version of the immunosuppressive monoclonal antibody. To prepare for launch, the firm has committed KRW 58.2 billion won ($51 million) to its site in Cheongju, South…
NASA will conduct studies assessing Pluristem’s placental-derived cell therapies in astronauts who are planning space travel. NASA’s Ames Research Center has been awarded a 2019 NASA Ames Research Innovation Award (ARIA) to look at how Pluristem Therapeutics’ cell therapies can tackle serious medical conditions during travels in space. “During space missions, astronauts are exposed to a challenging environment, which could lead to serious medical conditions, including muscle atrophy,†Efrat Kaduri, a spokesperson from Pluristem, told BioProcess Insider. “Given the promising…
Spark therapeutics has strengthened its manufacturing capabilities to achieve scale of 2×200-liter suspension upstream and 400-liter downstream to support its hemophilia A gene therapy candidate. Spark Therapeutics – set to be acquired by Roche for $4.3 billion – made history in December 2017 when it won approval for the first the first gene therapy for a genetic disease in the US in the form of Luxturna (voretigene neparvovec). Luxturna is approved to treat patients with a rare form of inherited…
Bristol-Myers Squibb has dismissed claims by investor groups that its proposed acquisition of Celgene “is poorly conceived and ill-advised.†In January, Bristol-Myers Squibb (BMS) announced it had entered into an agreement to buy Celgene for $74 billion (€65 billion). But this week Starboard Value LP, which holds a stake of 1.63 million shares in BMS, criticized the deal in a letter to fellow shareholders. “We believe that Bristol-Myers is deeply undervalued and the recent announcement of the Company’s proposed acquisition…
The $21.4 billion addition of GE Healthcare’s Biopharma business will complement Pall’s technologies to bring biomanufacturers a fully end-to-end bioprocessing offering. BioProcess Insider reported the news that Danaher Corporation has agreed to buy the Biopharma division of GE Healthcare’s Life Sciences business for approximately $21.4 billion (€18.9 billion) on Monday. If the deal is completed, it will be the biggest merger in the bioprocessing space, dwarfing Danaher’s previous $13.8 billion takeover of Pall Corporation in 2015, and the similar size…
Alder BioPharmaceuticals has extended a supply agreement with Novartis subsidiary Sandoz to provide the drug substance for eptinezumab, its migraine candidate anticipated to launch next year. Last Friday, Alder BioPharmaceuticals submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its investigational monoclonal antibody (MAb) targeting the calcitonin gene-related peptide (CGRP), eptinezumab. If approved, the firm expects the migraine prevention candidate to be launched in the first quarter 2020. As such, the firm has secured…
Key wins in gene therapy applications helped deliver a record year for bioprocessing vendor Repligen. For the full year 2018, Massachusetts-headquartered bioprocess technology firm Repligen Corporation reported sales of $194 million (€171 million), up 37% on the year prior. And looking forward, CEO Tony Hunt said his firm is “well positioned to gain further market share, as the industry continues to pivot towards flexible solutions and continuous processing to manufacture the growing number of biological drugs including promising new entrance…