Author Archives: Dan Stanton

AbbVie: Lack of Botox biosimilars a factor in $63bn Allergan buy

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AbbVie, a firm all too familiar with biosimilar threats, says the low risk of Botox competition was a factor in its decision to acquire Allergan. The agreed $63 billion (€55 billion) megamerger with Allergan strengthens AbbVie’s pharma assets and provides the firm with a healthy growth platform, Bioprocess Insider reported last week. Allergan’s lead product neurotoxic protein Botox (botulinum toxin) brought in $3.6 billion in sales revenue in 2018 and will add immediate add scale to AbbVie in neuroscience, as…

July 1, 2019

Stem cell clinic compliance slower than expected, says FDA

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The US FDA continues its clampdown on unapproved stem cell therapies but says the pace of progress in making clinics comply is slower than expected. In November 2017, the US Food and Drug Administration (FDA) laid down a comprehensive regenerative medicine framework aimed at spurring innovation and access to potentially transformative products, while ensuring safety and efficacy for such products. This included warnings against providers of unapproved and unproven stem cell therapies, and a period of a risk-based approach to…

June 28, 2019

ambr alert: Sartorius vessel specialized for cell & gene therapies

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Sartorius has launched an ambr 250 vessel for cell and gene therapy applications it says taps into industry’s transition from adherent to suspension cell culture formats. Sartorius Stedim Biotech (SSB) has added to its range of ambr 250 modular benchtop bioreactor systems with a single-use vessel designed to accelerate the process development of cell and gene therapy applications, before scaling-up into single-use bioreactors and bags. Existing ambr mammalian vessels are often used for process development of monoclonal antibodies (MAbs) in…

June 28, 2019

Bluebird’s gene therapy latest to feel ‘inevitable’ teething problems

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Bluebird Bio’s $1.8 million gene therapy Zynteglo is the latest such therapy to suffer from manufacturing issues, causing a delay to its EU launch. The European Medicines Agency (EMA) approved orphan drug Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – previously known as LentiGlobin – as a one-off treatment for beta-thalassaemia in June. Developer Bluebird Bio has priced the therapy at €1.58 million ($1.8 million). However, a setback due to manufacturing problems means Bluebird is delaying launch to at least…

June 27, 2019

Cobra’s Symbiosis relationship making UK cell and gene competitive

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CDMOs Cobra Biologics and Symbiosis have completed a collaboration they say has increased and simplified viral vector production and increased the UK’s competitiveness in cell and gene therapy services. After 18 months, the £4.8 million ($6 million) project has come to an end. The collaboration intended to build up viral vector capabilities while supporting the development of gene therapies in the UK, and the two contract development and manufacturing organizations (CDMOs) say these aims have been achieved. “One key aim…

June 26, 2019

WuXi invests in ADCs again to prep for commercial products

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WuXi Biologics will further expand an antibody-drug conjugate (ADC) facility in China on the expectation of its clients’ projects moving to commercial production. In June 2018, WuXi Biologics announced plans to construct a $20 million (€17.6 million), 6,000 square meter facility for protein conjugates, including ADCs, set to be operational later this year. A year on, and the Chinese contract development and manufacturing organization (CDMO) has said it is further expanding the site in Wuxi city, China adding cGMP commercial…

June 26, 2019

$63bn Allergan deal: ‘Humira is buying the assets that will replace it’

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The acquisition of Allergan will bring AbbVie’s growth platform to critical mass as revenues from lead biologic Humira (adalimumab) feel the heat from biosimilar competition. What is expected to become the second largest megamerger in the pharma space was announced yesterday, with AbbVie entering into a $63 billion (€55 billion) agreement to buy Allergan. (The largest deal is Bristol-Myers Squibb’s proposed $74 billion megamerger with Celgene, announced in January.) The merger will bring AbbVie numerous assets in the neuroscience, medical…

June 26, 2019

CEO changing, but Avid continues its versatile CDMO strategy

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Having relaunched itself in 2018, Avid Bioservices says it is going from strength-to-strength in the contract manufacturing space and its strategy will continue with a new CEO. Avid Bioservices emerged from drug developer Peregrine Pharmaceuticals in January 2018 as a pureplay contract development and manufacturing organization (CDMO). “While we were a product development organization, we also had manufacturing facilities to support the manufacturing of our pipeline. While we were focused on developing products, we were also offering our services for…

June 24, 2019

Eli Lilly on R&D: Two thirds internal, one third external

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CFO Josh Smiley says Eli Lilly is looking to source around a third of its pipeline from outside its organization. Speaking at the Goldman Sachs 40th Annual Global Healthcare Conference, Josh Smiley, chief financial officer at Eli Lilly, said his firm’s pipeline is comprised of around two thirds internal molecules and one third external. “When we look historically, we’ve done a good job in late phase of partnering and bringing in assets in earlier phases of development, getting to about…

June 21, 2019

Catalent to invest up to $10m into ex-BMS fill/finish site

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Catalent will retain all 700 staff and invest up to $10 million into a site in Italy it is acquiring from Bristol-Myers Squibb. The deal, announced this week, will see the contract development and manufacturing organization expand its biologics network outside of the US through the addition of a sterile product manufacturing and packaging facility in Anagni, Italy. Financial details regarding Catalent’s first biologics manufacturing facility in Europe have not been divulged, but a spokesperson told this publication the CDMO…

June 21, 2019