Author Archives: Dan Stanton

First US Epogen Biosimilar Approved as Pfizer Fixes GMP Issues in Kansas

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The FDA upgraded Pfizer’s troubled McPherson, Kansas facility in January paving the way for the approval of Retacrit – a biosimilar version of Amgen’s Epogen (epoetin alfa). The US Food and Drug Administration (FDA) approved Retacrit as the first biosimilar version of Amgen’s anemia drug Epogen yesterday. “The FDA’s decision to approve Retacrit for all indications of the reference product marks a critical and positive step forward in helping create a marketplace for biosimilars in the US, further advancing opportunities…

May 16, 2018

Lilly Buys Back Early Phase Oncology Kinase in $110m AurKa Deal

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Eli Lilly adds AK-01 – an Aurora kinase A inhibitor it originally discovered – to its early-stage pipeline. The acquisition comes days after Lilly bought Armo BioSciences for US$1.6 billion. In 2016, biopharma giant Eli Lilly sold AK-01 to venture capital firm TVM Capital Life Science, which went on to establish AurKa Pharma. This week, the firm has announced it is buying it back through the acquisition of AurKa. The is an Aurora kinase A inhibitor being tested in multiple…

May 15, 2018

Rise of the Insects: Thermo Fisher Hails Non-Mammalian Expression for Vaccines

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Encouraged by success of Flublok and Cervarix, Thermo Fisher says insect protein expression systems are one of the most promising technologies being used in the development of next-generation vaccines. Thermo Fisher has launched the Gibco ExpiSf system, an insect protein expression system aimed at generating baculovirus using a suspension-based transfection protocol it says delivers protein in half the time compared to traditional insect platforms. BioProcess Insider spoke with Amy Butler (AB), vice president and general manager, Cell Biology at Thermo…

May 14, 2018

Takeda: ‘$62bn Shire Megamerger Brings Greater Geography and Scale’

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After weeks of negotiations, Shire has agreed to a Takeda takeover bid worth US$62 billion. The combined company will consist of over 35 manufacturing sites globally. Japanese firm Takeda first made a bid for Ireland-headquartered rare diseases biopharmaceutical company Shire in March. After several rebuffed offers, the firms agreed to merge this week in a deal worth $62 billion (€52 billion). The deal is subject to shareholder and regulatory approvals. A $32 billion bid for Shire made by AbbVie in…

May 9, 2018

Repligen Reports Record Revenue, Continues on M&A Hunt

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Repligen will launch several new filtration and chromatography offerings this year as its strategy of developing products based on technology acquisitions pays off. For the first quarter 2018, Repligen Corporation reported record revenues of US$45 million (€38 million), up 46% on the same period last year. The bioprocessing company attributed the results to strong sales of its filtration and chromatography products – up by over 90% year-on-year – bolstered by the $359 million acquisition of Spectrum in June 2017. “Our…

May 9, 2018

Samsung BioLogics: Rise of Biosimilars Behind Bioepis Accounting Change

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Samsung BioLogics says it did not violate accounting rules. Change in its financial reporting related to plans by Biogen to up its stake in biosimilar JV, Samsung Bioepis. South Korea’s Financial Supervisory Service (FSS) released a preliminary statement last week accusing contract development and manufacturing organization (CDMO) Samsung BioLogics of accounting fraud. The special yearlong audit investigated a turnaround in Samsung BioLogics’ financials, when after years of losses it reported profits of KRW 1.9 trillion (US$1.8 billion) in 2015 ahead…

May 7, 2018

Lonza Building Hybrid Biomanufacturing Plant at NH Site

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Lonza plans to bolster its mid-scale biomanufacturing and cell therapy capabilities at its site in Portsmouth, New Hampshire on the back of growing demand. The expansion will include mid-scale mammalian capacity through the installation of several 6,000 L bioreactors which will eventually replace stainless steel 5,000 L systems operating at the site. “This will be a hybrid facility combining stainless steel for the main reactor with single use technologies for some of the upstream and downstream processing,†Sylke Hassel, SVP…

May 4, 2018

Teva: Migraine Mab Delay After ‘Negative Surprise’ of Celltrion Warning

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Manufacturing issues are likely to delay the approval of fremanezumab but Teva remains confident its migraine drug will launch this year. Teva Pharmaceutical Industries’ monoclonal antibody (mAb) candidate fremanezumab is under regulatory review as a preventive treatment for chronic migraine. The US Food and Drug Administration (FDA) has assigned fremanezumab a Prescription Drug User Fee Act (PDUFA) action date mid-June, but the firm announced yesterday it expects a delay on the decision due to manufacturing issues. “There’s not much doubt about…

May 4, 2018

Sandoz Receives CRL for Rituxan Biosimilar

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Novartis’ Sandoz remains committed to further discussions with the US FDA after receiving a complete response letter (CRL) for its rituximab biosimilar candidate. The Biologics Licensing Application (BLA) for Sandoz’ proposed biosimilar of Roche’s autoimmune disease drug Rituxan (rituximab) suffered a setback yesterday when the US Food and Drug Administration issued a CRL. A Sandoz spokesperson told BioProcess Insider that the firm is “still evaluating the content†of the letter and specific details are not being divulged for now. “The…

May 3, 2018

Jazz Pays Spark $110m for Luxturna Priority Review Voucher

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Spark Therapeutics has sold its Rare Pediatric Disease Priority Review Voucher (PRV) to Jazz Pharmaceuticals for US$110 Million (€92 million). Spark Therapeutics received the PRV from the US Food and Drug Administration (FDA) when its gene therapy for inherited retinal disease, Luxturna (voretigene neparvovec), was approved. But the firm disclosed in an SEC filing it is selling the voucher to Ireland-headquartered biopharma firm Jazz to help support its future R&D. “We will invest the proceeds from the sale back into the…

May 3, 2018