Amid fears that millions of migrants may not have access to Covid-19 vaccines from Covax following liability fears, the Serum Institute of India has announced that it will waive its protection from legal liabilities for any AstraZeneca-Oxford doses it provides to the program, Reuters reported Wednesday.
Covishield can now be allocated to the Covax Humanitarian Buffer, a program designed to ensure that the most vulnerable portions of populations, such as conflict zones or humanitarian settings that are not able to be reached by government vaccination campaigns, are not left behind. Gavi sees it most effective in areas that have been impacted by state failure or areas controlled by groups that are not the government. Asylum seekers, refugees, detainees, and people who are stateless are all eligible.
Many manufacturers require protection from any side effects. That is not able to be guaranteed if there is no government.
The AstraZeneca shot is right now the main vaccine supplied to Covax. If all goes according to plan, the Pfizer-BioNTech jabs will take over that crown in 2022, Reuters said.
EMA approves new French site for J&J vaccine, approves Spain scale-up
A site in Marcy-l’Étoile, France has been given the OK by the EMA’s human medicines committee to manufacture the J&J Covid-19 vaccine.
The site, owned by Sanofi, will manufacture the finished product. It will support the continued supply of the vaccine, the agency said.
An Andover, MA site operated by Wyeth BioPharma has also been given the OK to up the production of the active substance for Pfizer-BioNTech’s Comirnaty. That will help support the supply for the EU. A Madrid, Spain site operated by Rovi will also be permitted a 50% scale-up of batch size for the finished product of Moderna’s Spikevax, and is allowed a second fill-finish line. These changes are expected to allow the production of another 25 million doses each month to the EU, and Covax.
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CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
The FDA on Thursday authorized another new pill to treat the Omicron variant, this time from Merck.
While Pfizer’s antiviral may prove to be more effective, and Merck’s pill has left some scientists questioning the dangers behind its mechanism of action, molnupiravir will be another weapon in the armamentarium of Covid-19 treatments for the US in a time of need, as two mAb treatments from Regeneron and Eli Lilly are no longer effective against Omicron, and as supplies of a third mAb from Vir/GlaxoSmithKline are very limited.
Khurem Farooq, Gyroscope CEO
Christmas is coming early for Gyroscope.
In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.
Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.
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It’s time for our holiday break here at Endpoints News, and like a lot of you, we’ve been prepping for 2022.
Anyone who’s spent some time in industry can tell you the past decade has shoved the drug-hunting field into the forefront of the world’s view of things, garnering tens of billions in investment as new technologies look to change the landscape of R&D. And anyone who qualifies for first-in-class and best-in-class can clean up.
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On the heels of a big FDA approval last week for its keystone asthma drug, Amgen is adding on at its Irish manufacturing site.
Amgen’s site in Dún Laoghaire is about to get a $100 million upgrade to improve its formulation, aseptic drug product filling, lyophilisation and packaging operations as the company celebrates its 10th year in Ireland. The addition will add another 150 jobs for construction workers in the Dublin suburb. The project is set to be the company’s largest outside of North America.
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Thomas Schmidt, 21st.BIO CEO (via 21st.BIO website)
A Danish bio industrial scale-up company has landed an $86 million investment from Novo Holdings, and it’s hoping to build on a technology base from Novozymes. And with that investment will come a new manufacturing site.
21st.BIO was founded in 2020, and is focused on supporting the upscaling of companies across the world, with the intention of helping those companies meet market demand. Its focus are peptides and proteins, and it wants to provide startups access to facilities to develop a molecule production process that can deliver a high-quality product in the most cost-effective way.
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Christopher Anzalone, Arrowhead Pharmaceuticals CEO
Arrowhead Pharmaceuticals has purchased 13 acres of land in Wisconsin’s Verona Technology Park and will build a 140,000-square-foot drug manufacturing facility.
The company will spend between $200 million and $250 million to build out the facilities, and the site is expected to create another 250 jobs for the region. Construction starts in Q1. Arrowhead already has operations in Madison, WI, about 10 miles away.
Mohan Rao, Expression Therapeutics CEO
Expression Therapeutics’ new cell and viral vector manufacturing site is up and running in Cincinnati.
The 43,000 square-foot site will provide end-to-end R&D capabilities and both early phase- and commercial-scale manufacturing of lentiviral and adeno-associated viral vectors. The site will have a mix of 30-180 liter runs in cell stacks and up to 1,000 liter runs in bioreactors, with the capability to manufacture up to 100 products per year. It also gives the necessary infrastructure to fulfill its ex vivo cell processing, and recombinant protein production needs.
Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)
The centerpiece of Novartis’s $9.7 billion buyout of the Medicines Company can finally go to market.
Branded Leqvio, the small interfering RNA therapy long known as inclisiran is the first and only FDA-approved treatment to reduce LDL-C, i.e. bad cholesterol, with just two maintenance doses a year after an initial dose and another one at three months.
Touting a ‘revolutionary approach,’ Novartis CEO Vas Narasimhan noted that the approval ‘creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time.’ The label covers both atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia.
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