CPhI North America 2022 host city Philadelphia is set to become one of the world’s biggest cell and gene therapy manufacturing hubs. But it’s just one of many centers of innovation that are helping drive the US pharma and biopharma industry.
The US will play a key role in the development of advanced manufacturing technologies, predicts a report commissioned by CPhI North America ahead of the 2022 show.
Astorg will acquire CDMO CordenPharma from ICIG: noting strong organic growth for the CDMO thanks to its position in fast-growing drug modalities such as mRNA vaccines, peptides and high-potency compounds notably for oncology therapeutics.
The US Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’ Durham, N.C. site, a multi-product gene therapy manufacturing facility, which will start producing Zolgensma immediately.
Syner-G BioPharma Group, a provider of Chemistry, Manufacturing, and Controls (CMC) technical, regulatory, and compliance consulting services to the pharmaceutical and biotechnology industry, has acquired Impact Pharmaceutical Services.
As of January 1, 2022, Biogen will cut the price of its Alzheimer’s drug Aduhelm (aducanumab-avwa) in half: saying too many patients are not currently being offered the choice of the drug due to financial considerations.
Cincinnati Children's Hospital Medical Center and research service provider CTI Clinical Trial & Consulting Services will form a company to provide cell and gene therapy manufacturing services to the biotech and pharmaceutical industries.
Australian biotech EnGeneIC, which is developing its nanocell tech for use in infectious diseases (including a COVID-19 vaccine) as well as a cancer treatment, has announced a deal with US biotech ImmunityBio to develop, manufacture and commercialize...
bluebird bio has signed a long-term lease for a 61,000 square foot facility at Assembly Row, Greater Boston: saying the new headquarters has been designed to reflect modern ways of working and deliver significant cost savings.
The US National Institutes of Health (NIH) has begun a clinical trial to assess the antibody response to a COVID-19 vaccine booster in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen.
CDMO AGC Biologics has acquired a commercial manufacturing facility in Longmont, Colorado: giving it significant additional capacity and space to expand its global end-to-end cell and gene therapy offering.
An industry study from the producer of CPhI North America shows the pandemic and other factors are contributing to a very dynamic pharmaceutical market.
The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTech’s COVID-19 vaccine Biologics License Application (BLA).
Ocugen has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVID-19 vaccine candidate COVAXIN, ready for potential commercial manufacture for the US and Canadian markets.
The US says it will support the proposed waiver of IP protections on COVID-19 vaccines: but the country’s industry says this sets a ‘dangerous precedent for future pandemics’.
The US National Institute of Allergy and Infectious Diseases (NIAID) says it is concerned that AstraZeneca 'may have included outdated information’ when releasing initial data from its COVID-19 vaccine clinical trial.
Merck’s US facilities will help manufacture Johnson & Johnson’s COVID-19 vaccine: which a $268.8m injection from the US government helping it adapt existing facilities for COVID-19 vaccines and medicines.
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit: the first COVID-19 diagnostic test for self-testing at home.
Novavax’s Phase 3 COVID-19 vaccine trial in the UK has been expanded to 15,000 participants; while a 30,000 strong Phase 3 clinical trial is due to start in the US and Mexico next month.
Regeneron has submitted a request for Emergency Use Authorization (EUA) for its REGN-COV2 investigational antibody combination for COVID-19: which was given to US President Donald Trump last week.
This month marks a major US milestone for biosimilar medicines as five years ago, September 2015, saw the first biosimilar made available to US patients – the Sandoz developed Zarxio (filgrastim-sndz).
During this year’s Festival of Biologics conference, one track saw a focus on biosimilars that brought together experts from across the industry to map the future for such treatments in the EU and US.
GSK’s biopharmaceutical manufacturing facility will be focused on the company’s pipeline of biologic medicines, including gene therapies, and vaccines.
With US spending on biologics reaching $125.5bn in 2018, a new report looks at the level of savings that could potentially be made and contrasts the US with the European market.
As the US faces a measles outbreak, and bills removing rights to exempt from vaccination are debated, vaccine manufacturers stress the need to educate the public.
The Senate has passed a bill authorising spending on the development of products to protect the US against pandemic influenza and other biological threats to public health.
The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.
BioPharma-Reporter (BPR) discusses with Jennifer Fox (JF), co-chair of Brinks Gilson & Lione’s biopharma practice group, the provisional detail revealed from the US administration’s proposed trade deal with Mexico, and its potential impact on the...