Global Markets

Turning a corner in CAR-T: FDA approves ide-cel

The US FDA has approved Abecma (ide-cel); the first CAR-T for a non-CD19 target and the second cell therapy in eight weeks for Bristol-Myers Squibb. This weekend, the US Food and Drug Administration (FDA) approved Abecma (idecabtagene vicleucel, commonly referred to as ide-cel) as the first cell-based gene therapy for the treatment of multiple myeloma. Developed by Bristol-Myers Squibb acquisition Celgene and fellow advanced therapy maker bluebird bio, Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen…

BIO: Sputnik V should be judged on same data as other COVID jabs

Russia’s Sputnik V COVID-19 vaccine should be judged by the same safety and efficacy standards applied to jabs made by Moderna, Pfizer, AstraZeneca, and J&J according to industry group BIO. The Amsterdam-based EMA began reviewing the vaccine – also called Gam-COVID-Vac – last week after R-Pharm Germany GmbH submitted an approval application. A spokeswoman told us “The CHMP’s decision to start the rolling review of the Sputnik V COVID-19 vaccine is based on results from laboratory studies and clinical studies…

Pfizer exits Chinese biosimilars space, selling plant to WuXi

As part of a “difficult decision” to halt its biosimilars programs in China, Pfizer is offloading its single-use biologics manufacturing plant in Hangzhou to WuXi Biologics. Pfizer is one of the world’s largest biosimilar manufacturers, with seven commercialized products in the US alone (Inflectra, Retacrit, Nivestym, Nyvepria, Zirabev, Trazimera, Ruxience). In 2016, Pfizer took aim at the Chinese market by investing $350 million in the Hangzhou Economic Development Area (HEDA) to set up a biosimilars manufacturing facility. Five years on…

‘mRNA has been validated’ – Pfizer looks beyond COVID

Pfizer is set to make around $15 billion from its COVID vaccine this year, but going forward the firm expects mRNA to be key in other applications. Through its partnership with BioNTech, Pfizer became the first company to receive US and EU approval for a messenger RNA-based product, namely the COVID-19 vaccine BNT162b2. Rollout of the vaccine continues across the globe and as such Pfizer has estimated it will realize approximately $15 billion in sales in 2021 alone. Speaking at…

Podcast: Content is king in bioprocessing and beyond

In the latest episode of the BioProcess Insider Expression System, Brian Caine (remember him) talks content, marketing, and communications in the biomanufacturing industry. Brian Caine, founder and publisher of our parent publication BioProcess International, stepped down from his position late last year to pursue new ventures. After a quarter of a century in the life sciences space, he speaks to us about the evolving publishing landscape and while he stresses ‘content is king,’ he warns that you cannot just print…

Industry calls for standardization and simplification to boost manufacturing agility

Executives from Novavax, Fujifilm, and Biocon have called for standardized processes and simplified regulations after a Cytiva-led survey showed improving manufacturing agility is a major priority for biopharma. A survey of around 1,100 senior executives across 20 countries commissioned by bioprocess vendor Cytiva has highlighted industry’s confidence in the biopharma space. With respondents scoring several sectors within the industry, the Biopharma Resilience Index averaged an overall score of 6.6 out of 10. But according to Hannah Freegard, senior editor at…

Moderna investing $400m in mRNA capacity for COVID-19 and beyond

Moderna aims to up capacity for its COVID-19 vaccine to 1.4 billion doses through investment in ‘flexible’ manufacturing, which it says will offset any risk from variants or future overcapacity. What a year it has been for Moderna Therapeutics. For the fourth quarter 2020, the firm reported sales of $200 million – up from nothing the previous year – as regulatory approvals began rolling in for its messenger RNA (mRNA) COVID-19 vaccine mRNA-1273. Since it began working on a COVID-19…

Emergent CDMO biz ‘thriving’ in COVID-19 environment

The COVID-19 pandemic has highlighted the growing mammalian and viral vaccines market and placed Emergent in a “leading position” in the CDMO space, says CEO Bob Kramer. The fourth quarter 2020 produced record revenues for Emergent BioSolutions, with the firm reporting sales of $583 million, up 62% on the year prior. For the full year, sales tallied $1.56 billion, up 41% on 2019. While Emergent has its own product line (contributing $340 million in the quarter, with its smallpox vaccine…

Novo Nordisk and Vertex update on rival diabetes cell therapy efforts

Novo Nordisk plans to file an IND for cell therapy for type 1 diabetes in the next few years, setting the stage for a battle with Vertex which aims to start Phase I/II trials of its candidate this year. Denmark’s Novo Nordisk shared details of its stem cell-based candidate during its Q4 call recently, explaining it will submit the therapy along with several investigation new drug (IND) applications over the next few years. CSO Mads Thomsen told analysts “The first…

eBook: Vaccines — COVID-19 Invigorates a Stagnant Industry

The SARS-CoV-2 novel coronavirus has galvanized what was a stagnant and oligopoly-run vaccine industry. In this inaugural BioProcess Insider eBook, the first of four to be published in 2021, founding editor Dan Stanton explores economic and technical conditions that until now have hampered innovation in vaccine development and discouraged market entry for emerging biotechnology companies. Leveraging commentary from vaccine industry experts and analyzing the range of emerging vaccine modalities, Stanton surveys how industry responses to the COVID-19 pandemic are fostering…