Author Archives: Dan Stanton

Sanofi licensing deal validates Ab platform, says Biomunex

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Sanofi has licensed the plug-and-play BiXAb platform to generate multi-specific antibodies. The deal validates the technology and will help fund Biomunex’s internal pipeline, says CEO Pierre-Emmanuel Gerard. Under terms of the deal, Biomunex will receive an initial upfront payment from fellow French firm Sanofi, and will be eligible to receive future milestone payments. Specific figures have not been disclosed. This is the first licensing deal for Biomunex’s BiXAb bi- and multi-specific antibody generation and optimization technology, and according to CEO…

January 17, 2019

Cell and gene therapies: FDA expects 10 to 20 approvals per year by 2025

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The US FDA predicts it will receive more than 200 regenerative INDs per year from 2020 and will add 50 additional staff to review these products. There has been “a large upswing in the number of investigational new drug (IND) applications†for cell and gene therapies received by the US Food and Drug Administration (FDA), commissioner Scott Gottlieb and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) said in a statement yesterday. The Agency has so…

January 16, 2019

Phage of consent: AmpliPhi and C3J agree to merge

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AmpliPhi Biosciences will combine with C3J Therapeutics to create what it says will be a leader in targeted bacteriophage therapeutics. The combined NYSE American-listed company will boast a broad clinical-stage pipeline, including a Phase I/II-ready natural phage candidate targeting bacteremia, and a synthetic phage candidate targeting respiratory infections expected to enter Phase I later this year. In a conference call discussing the planned merger, Paul Grint, CEO of San Diego, California-based AmpliPhi Biosciences, said the joint entity will be “a…

January 15, 2019

Allogene eyes cell therapy manufacturing plant in Bay area

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After raising $324 million last year, Allogene Therapeutics says it is planning to construct a cell therapy manufacturing facility near San Francisco, California. Allogene Therapeutics is focused on developing allogeneic, or off-the-shelf, T cell. In October 2018, the San Francisco-headquartered firm raised $324 million (€283 million) in an initial public offering (IPO). Since its launch, the cell therapy firm has been working with a contract manufacturing organization (CMO) but now Allogene has told BioProcess Insider that it plans to build…

January 15, 2019

Sanofi turns to high titer E. Coli platform in AbSci deal

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The SoluPro E.coli manufacturing platform will be applied to two of Sanofi’s biologic candidates under a partnership deal with AbSci. Financial details of the deal have not been divulged, but the French Big Biopharma firm will use AbSci’s SoluPro expression platform on two of its molecules. The work will be undertaken at AbSci’s facilities in Vancouver, Washington, USA. According to AbSci, the platform can accelerate the time it takes to get new drugs to market through ultra-high titers of soluble,…

January 14, 2019

Lonza adding single-use capacity and 180 jobs at UK mammalian plant

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Lonza will increase its mammalian process development and small-scale cGMP manufacturing capabilities through a multi-million pound investment at its Slough, UK site. Swiss contract development and manufacturing organization (CDMO) has told BioProcess Insider it is making a “multi-million pound investment†into its facility in Slough, UK. The site, located around 40km west of London, serves as Lonza’s center of excellence for mammalian biopharmaceutical process development and small-scale cGMP manufacturing, primarily for clinical phases. It also offers a range of analytical…

January 11, 2019

Lack of large M&A not for the lack of trying, says Merck CEO

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Robust competition and a lack of willing sellers has stifled Merck’s M&A ambition, but CEO Ken Frazier says with valuations coming down possibilities are being created. Large mergers and acquisitions have dominated the start of 2019: Takeda has completed its $62 billion (€54 billion) takeover of Shire, Bristol-Myers Squibb is set to merge with Celgene in a $74 billion deal, and Eli Lilly has bought Loxo Oncology (albeit for a relatively low $8 billion). Therefore, it was no surprise that…

January 11, 2019

AstraZeneca closing two ex-Amgen CO sites, 210 jobs hit

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Two Colorado facilities acquired from Amgen will be closed as AstraZeneca looks to consolidate drug substance manufacturing at its site in Frederick, Maryland. Anglo-Swedish pharma giant AstraZeneca is ending operations at its facility in Boulder, Colorado and the nearby Longmont plant less than four years after acquiring them from Amgen. The decision to shutter the sites was made as part of AstraZeneca’s biomanufacturing consolidation strategy, a spokesperson from the firm told BioProcess Insider. “AstraZeneca has made the decision to consolidate…

January 11, 2019

Beyond Humira: AbbVie looks to $35bn pipeline for future growth

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With the world’s best-selling drug now facing direct biosimilar competition, AbbVie says it is confident its robust pipeline will deliver double-digit growth going forward. In 2018, the first biosimilar versions of Humira (adalimumab) were launched in Europe and other non-US markets. Meanwhile in October, Sandoz became the third firm to receive US Food and Drug Administration (FDA) approval for a Humira biosimilar. It is, therefore, fair to say sales of the world’s top selling drug – Humira clocked in sales…

January 10, 2019

JPM 2019: Lilly buys Loxo, Pfizer’s biosimilar bundle and $22 coffee

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The 37th JP Morgan Healthcare Conference took place this week. If the extortionate hotel prices kept you away, then BioProcess Insider you some of the highlights from San Francisco. It’s that time of year again where investors and healthcare executives flock to San Francisco for four days of dealmaking, financial forecasting and – if rumors are to be believed – intense partying. If other commitments and the decision not to take out a second mortgage (some hotel rooms reached $30,000…

January 10, 2019