Kevin Cook, Sterling Pharma Solutions CEO
A British CDMO and the University of Manchester have teamed up to support the development of low-cost manufacturing of molnupiravir, the antiviral pill for Covid-19 that an FDA adcomm recommended for an EUA earlier this week.
Manchester’s Institute of Biotechnology enlisted Sterling to provide chemical scale-up and process development expertise. That could potentially provide broader access of molnupiravir to lower-income countries. The school has received grant funding from the Bill & Melinda Gates Foundation for the project.
Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it’s free.
While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.
Merck’s new antiviral molnupiravir (Quality Stock Arts / Shutterstock)
After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.
‘I think it is super worrisome,’ Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, ‘This is not going to be good.’
Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it’s free.
A press release referred to it as simply, ‘the incident.’ But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.
Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm, as the result of an ‘accident,’ a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.
Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the ‘beating heart’ of the UK’s North East Life Sciences ecosystem.
A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.
Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it’s free.
The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.
For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.
Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it’s free.
Just three years after the UK government announced the creation of the VMIC as a part of a plan to develop and make vaccines in preparation for a potential pandemic, the flagship center is up for sale.
Several companies have submitted bids for the center, which is located near Oxford. Construction was set to be completed in 2023 but was later pushed up to spring 2022. The site has received more than £200 million in public funding throughout the pandemic, but need for a state-backed manufacturing center has lessened, as companies have stepped up to meet the growing demand for vaccines.
Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it’s free.
Samsung Biologics has entered an agreement with South Korean biotech GreenLight BioSciences to manufacture its mRNA Covid-19 vaccine at commercial scale, the two companies announced.
Samsung Biologics, one of the fastest growing manufacturers in the world right now, will use its vaccine manufacturing expertise to help patients in lower-income countries, CEO John Rim said in a press release. This will help expand their capabilities from drug substance to aseptic fill-finish and all the way to commercial release from one site.
GenScript, Suzhou Abogen, and Walvax Biotechnology have announced the three companies will be collaborating on a Covid-19 mRNA vaccine project dubbed ABO-O28M.
WalVax will submit a BLA for the project, and GenScript will provide exclusive manufacturing services, according to Asia One.
The project stems form an agreement between Abogen, the Academy of Military Medical Sciences (AMMS) of the PLA Academy of Military Science and Walvax, which gained clinical trial approval in June 2020. It was one of the first vaccine projects approved by China’s government, and GenScript used its plasmid GMP manufacturing to accelerate into clinical trials.
Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)
Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.
The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.
https://endpts.com/british-cdmo-sterling-partners-up-on-low-cost-manufacturing-of-molnupiravir/
