Author Archives: Dan Stanton

GSK confident traditional vaccine tech has major role in COVID-19 efforts

The headline-makers in the race to develop a COVID-19 vaccine are not the traditional firms, but GSK says its proven adjuvant approach will set its offering apart. During GlaxoSmithKline’s (GSK’s) second quarter financial call, an analyst from Wolfe Research pointed out the vanguard of COVID-19 vaccines were not being developed and made by the big three traditional vaccine firms: GSK, Merck & Co., and Sanofi. Chinese efforts aside, the frontrunners dominating the media coverage are AstraZeneca/University of Oxford’s effort based…

ABC news: Lonza to scale-up ophthalmic therapy for Kodiak

CDMO Lonza will use its global network, including a dedicated facility in Switzerland, to produce Kodiak Sciences’ antibody biopolymer conjugate (ABC) KSI-301. KSI-301 is an anti-VEGF biopolymer conjugate being developed by Kodiak Sciences for various ophthalmic retinal diseases. The candidate is in Phase II/III studies for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and as the firm looks to commercialization it has inked a deal for manufacturing scale-up with Lonza. The contract development and manufacturing organization…

Pfizer blasts Trump’s pricing plans, threatens to pull US investments

CEO Albert Bourla says Pfizer will rethink plans to invest in US R&D and manufacturing after lambasting four executive orders aimed at reducing drug prices unveiled last week. Like most areas of society, Big Pharma’s relationship with US President Donald Trump has been tumultuous. Initial fears of a clampdown on drug pricing through promises to ‘drain the swamp’ were abated through Trump cozying up with the sector once in office. And reforms passed by Congress in 2017 through the ‘Tax Cuts…

COVID-19: ‘Pandemic-ready’ set-up placing Emergent apart in CDMO space

Emergent BioSolutions is at the frontline of COVID-19, supporting vaccine candidate production for AstraZeneca, J&J, and others. Head of Emergent’s CDMO business explains why. Before January, the biologics contract development and manufacturing organization (CDMO) landscape was “very, very exciting,” Syed Husain, senior vice president and CDMO business unit head at Emergent, tells Bioprocess Insider over a Zoom interview. On the drug substance side, there was a healthy amount of demand for capacity coming from industry with a lot of opportunities…

Danaher: Integrating Cytiva in the time of coronavirus

Cytiva, the former GE Healthcare Life Sciences business, is “off to a blistering start” at Danaher, according to an analyst despite face-to-face restrictions imposed by COVID-19. For the second quarter 2020, Danaher Corporation reported revenues of $5.3 billon, up 19% year-on-year. This was attributed to high sales across its life sciences services divisions, including a boost from Cytiva – previously known as the Biopharma Business of GE Life Sciences – which Danaher acquired for $21 billion and became part of…

Kite flies high with second CAR-T approval

Gilead’s Kite has won US FDA approval for Tecartus (brexucabtagene autoleucel), a CAR-T cell therapy for the treatment of mantle cell lymphoma (MCL). Tecartus becomes the third chimeric antigen receptor (CAR) T-cell therapy to be granted approval by the US Food and Drug Administration after Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), both of which were approved in 2017. Tecartus is designed to target CD19, a protein found in high amounts in cancerous B cells, and the regulatory decision…

Fujifilm to make Warp Speed vaccine for Novavax from NC site

With $1.6 billion of US government funds in hand, Novavax has contracted CDMO Fujifilm Diosynth Biotechnologies (FDB) to produce Phase III trial material for its COVID-19 vaccine candidate. Earlier this month, the US government handed Novavax – a firm with no approved products – $1.6 billion to progress the development of its vaccine candidate NVX‑CoV2373 against the novel coronavirus (SARS-CoV-2). Until a $2 billion deal was struck this week with Pfizer/BioNTech, the funding was the largest under the Operation Warp…

Novartis offering COVID-19 capacity but won’t play in vaccine space

Novartis has no plans to join its Big Pharma peers in developing a coronavirus vaccine but says it will continue supporting efforts to tackle the virus. Developing a vaccine is deemed key in the global fight against the novel coronavirus. As such, industry has mobilized to speed development efforts through the clinic, with numerous Big Pharma firms jumping on board. AstraZeneca is racing away in bringing its Oxford vaccine to fruition. J&J is pushing forwards with its adenovector-based vaccine. Pfizer…

Valneva to supply vero-cell based COVID vaccine to UK

Valneva will supply up to 100 million doses of a SARS-CoV-2 vaccine candidate and is looking to expand capacity at facilities in Scotland and Sweden. Under the terms of the deal, French vaccine firm Valneva SE will manufacture up to 100 million doses of its candidate VLA2001 as part of a UK government strategy to secure COVID-19 vaccines. Doses will be supplied from Valneva’s production site for other commercially available travel vaccines and candidates in Livingston, Scotland. “Today’s agreement from the UK…

Catalent expands contract with Humanigen for COVID-19 MAb

Catalent will provide end-to-end services to support lenzilumab in a Phase III study in COVID-19 patients. In May, Catalent announced it was clinically supporting Humanigen’s anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody lenzilumab for a Phase III clinical trials for COVID-19. This week, the contract development and manufacturing organization (CDMO) says it has expanded its work with Humanigen to include full end-to-end services for the candidate. “Humanigen and Catalent have been working together since 2007, but shifted focus earlier…