Author Archives: Dan Stanton

Repligen strengthens downstream offering with $200m ARTeSYN acquisition

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Repligen says it has established itself as a premier player in single-use systems, integrated flow paths, and assemblies following a triumvirate of bolt-on acquisitions. According to Repligen Corporation, ARTeSYN Biosolutions’ single-use chromatography and filtration systems are considered “the gold standards in downstream bioprocessing.†The technologies – along with three manufacturing facilities in Ireland, Estonia, and California – are soon to become part of Repligen’s offering after the firm entered a definitive agreement to buy ARTeSYN for $130 million cash and…

October 28, 2020

Lilly confident in remediating troubled COVID mAb plant

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Eli Lilly has engaged an external firm to conduct a comprehensive independent review after the FDA found data integrity issues at a manufacturing facility in New Jersey. Earlier this month, Reuters broke the news that the US Food and Drug Administration (FDA) issued Eli Lilly’s Branchburg, New Jersey manufacturing site with an “Official Action Indicated†(OAI) notice. This came after an inspection in November last year found that processing data had been deleted and not appropriately reviewed by the firm’s…

October 28, 2020

Novartis awaiting Italian plant inspection for FDA’s Leqvio decision

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Novartis is confident of maintaining a December 2020 action date for its high cholesterol siRNA therapy Leqvio despite common COVID-related regulatory delays of three to five months. Earlier this month, Novartis received positive opinion from the European Medicines Agency (EMA) for Leqvio (inclisiran), a small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. The Swiss pharma giant is hoping for the same in the US, with a PDUFA date set for December 31 2020…

October 28, 2020

Bayer adds AAV-based gene therapy tech in $2bn AskBio buy

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The deal – which could be worth up to $4 billion – bolsters Bayer’s gene therapy ambitions through the addition of an AAV manufacturing platform, clinical-stage candidates, and a CDMO unit. German pharma giant Bayer is paying $2 billion up front with potential milestone payments up to another $2 billion for Research Triangle Park, North Carolina-based Asklepios BioPharmaceutical (AskBio). Founded in 2001 by Jude Samulski, the company’s present chief scientific officer, AskBio is developing gene therapies for neuromuscular diseases, central…

October 26, 2020

4D Pharma aims for NASDAQ as LBP space reaches maturity

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In a deal worth up to $37.6 million, live biotherapeutic (LBP) developer 4D Pharma has agreed to merge with Longevity Acquisition Corporation. The proposed merger will see the UK-based LBP developer receive $14.6 million from Longevity and could benefit from the proceeds of warrants to purchase Longevity shares worth up to $23 million. Longevity Acquisition Corporation is a NASDAQ-listed Special Purpose Acquisition Comp (SPAC) meaning once the merger is completed, the entity will be admitted to trading on NASDAQ under…

October 26, 2020

Pall and Cytiva reaping $1bn coronavirus bonus for Danaher

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Danaher Corporation says its bioprocessing businesses Pall Biotech and Cytiva have secured over $1 billion in COVID-19 related orders and expects further windfalls as vaccines and therapies reach approval. When the coronavirus pandemic emerged earlier this year, commentators noted the financial opportunity for bioprocess vendors in supporting industry’s efforts in developing and commercializing vaccines, therapeutics, and diagnostics. As the year progresses, these opportunities are materializing in quarterly statements, with Danaher Corporation the latest company showing a COVID-19 tailwind across its…

October 23, 2020

Thermo Fisher: ‘$700m COVID CapEx easily repurposed post-pandemic’

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An additional $700 million capacity buildout to meet COVID-related demand will serve the longer-term non-pandemic-related biopharma market, says Thermo Fisher An unprecedented third quarter saw Thermo Fisher report a 36% rise in revenues year-on-year to $8.52 billion across all its segments. Its Life Sciences Solutions Segment – which includes its biosciences and bioproduction business units – saw a 101% rise to $3.42 billion, while its Laboratory Products and Services Segment – which includes drug manufacturing – increased by 19% to…

October 22, 2020

Swiss plant demonstrates synergies of KBI and Selexis acquisitions for JSR

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A facility in Geneva will be home to two of JSR Life Sciences acquisitions offering customers both cell line development and drug substance manufacturing. Financial details of the new facility, occupying 8,700 square meters in the Stellar 32 campus in Geneva, Switzerland, have not been divulged, but will house both biologics manufacturer KBI Biopharma and cell line developer Selexis. Both companies are owned by JSR Life Sciences, a California-headquartered firm which has been upping its presence in the bioprocess space…

October 21, 2020

Filling up: Thermo Fisher plans $130m Singapore plant

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Thermo Fisher will add two filling lines in Singapore to support growing demand for sterile injectables. The $130 million facility will be established with the support of the Singapore Economic Development Board (EDB) and operated by Thermo Fisher. “Thermo Fisher will be building out and operating a new facility that will serve as a new regional steriles manufacturing site for our customers and, in addition, will provide priority access to the Singapore government during future health emergencies,†a Thermo Fisher…

October 19, 2020

With $30m in hand, Ori looks to advance closed cell therapy tech

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Ori Biotech will use $30 million from a Series A financing round to finalize and test its closed and automated cell and gene therapy technology. In January, Ori Biotech came out of stealth mode through a $9.4 million seed round, introducing the cell and gene therapy space to its technology platform, which aims to significantly reduce the cost of production of such therapies. Nine months on and the firm has raised a further $30 million in a Series A financing…

October 19, 2020