Global Markets Archives - Page 10 of 41 - BioProcess InternationalBioProcess International

Chinese CDMO sector growing but unlikely to make global impact

China’s contract manufacturing space is growing at over 15% year-on-year but only WuXi Biologics has seen success in attracting global clients, says BioPlan Associates ahead of CPhI Discover. Third-party drug manufacturing is relatively new in China. Only since 2015 has a market authorization holder (MAH) system been in place, opening the doors through further reforms for commercial contract development and manufacturing organizations (CDMOs) to operate in the country. In 2019, China approved Hodgkin’s lymphoma drug tislelizumab – the first CDMO-made…

Pfizer mRNA risk paying off as it moves to make 3bn doses of COVID jab

by Dan Stanton

Pfizer says it will produce 3 billion doses of its COVID-19 vaccine this year and will further invest in its manufacturing network to support continued global demand. Through its partnership with BioNTech, Pfizer became the first company to bring a messenger RNA-based product to market, namely the COVID-19 vaccine Comirnaty (BNT162b2). Last month, the firm estimated it was set to make around $15 billion from global sales of the vaccine this year, based on production projections of 2 billion doses.…

Thermo Fisher to buy PPD to build in ‘high growth’ clinical services sector

by Gareth Macdonald

Thermo says buying PPD will position it as leader in the “high growth” CRO sector and help it win more business from new and existing customers. Thermo Fisher Scientific announced its intention to buy contract research organization (CRO) PPD for $17.4 billion in a statement on Thursday, citing demand from pharma and biotechnology sector customers. Thermo Fisher’s CEO Marc Casper said “The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers…

COVID-19 and cell and gene sector help to kickstart Pharma 4.0

by Millie Nelson

COVID-19 and the growth of the cell and gene therapy sector have pushed the pharma industry to use new and emerging technologies to solve manufacturing challenges. Speaking at the recent BPI West virtual conference, co-founder and CEO of Apprentice Angelo Stracquatanio said the coronavirus pandemic has forced companies across the pharma industry to adapt and operate differently, particularly altering how and what technologies it opts to use. With business “grossly disrupted,” he argued “the industry started to turn to new and emerging technologies to solve a lot of these key challenges that came up in…

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

by Dan Stanton

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

by Gareth Macdonald

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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…