Novo Nordisk will have to fulfill requests from the FDA regarding the manufacturing process and the indication before it can receive approval for insulin icodec.
The contract development and manufacturing organization (CDMO) Rentschler Biopharma has doubled its Current Good Manufacturing Practice (cGMP) global production capacity for complex therapies as its new production line kicks into action in the US.
With a rich background in biochemistry and extensive experience in the pharmaceutical industry, Himanshu Gadgil shares insights into Enzene's journey, its innovative approach to biosimilars.
In a recent interview, Hayley Crowe, head of Ecolab's global life sciences business, shed light on Purolite's latest developments and its significant contributions to the biopharmaceutical industry.
Bio Pharma Reporter and Outsourcing Pharma is back with our latest instalment of movers and shakers - breaking down all the key pharma industry appointments that you should know about. KBI Biopharma, Veranova and Kindeva Drug Delivery are among the companies...
This week, the pharma industry will descend on Pennsylvania Convention Center for Reuters Pharma USA, North America’s largest cross-functional pharma gathering.
Novartis announced today (Monday August 28) that new long-term data from its open-label trial extension demonstrated twice-yearly dosing inclisiran with statin therapy provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six...
A research team led by University of California, Irvine scientists has developed an ‘innovative’ method for quickly creating vast collections of chemical compounds used in drug discovery by using ribosomes, the molecules found in all cells that synthesize...
Shionogi has enrolled the first participant in Japan in its phase 3 clinical trial of oral antiviral ensitrelvir to stop the post-infection progression of Covid-19.
LabGenius, which uses machine learning (ML) for antibody discovery, has presented data in a poster presentation at the Protein Engineering and Biotherapeutics (PEGS) annual meeting.
Cytiva and the life sciences business of Pall Corporation are now united as one business under the Cytiva brand, with the completion of the integration announced this morning. Emmanuel Ligner, Danaher Group Executive, President and CEO of Cytiva, tells...
Bristol Myers Squibb will boost its cell therapy manufacturing network with in-house viral vector production thanks to the acquisition of Novartis’ Libertyville, Illinois facility.
BioMarin Pharmaceutical has opened the expansion of its manufacturing plant at Shanbally, Co. Cork: with the site now able to provide end-to-end manufacturing for a number of the company’s commercial products.
Asahi Kasei Bioprocess America and GeminiBio have entered into a strategic partnership to advance the application of inline buffer formulation (IBF) in the biopharmaceutical industry.
CDMO Sterling Pharma Solutions has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Evonik has opened a new GMP facility to manufacture lipids for advanced pharmaceutical drug delivery applications, which is situated at the company’s site in Hanau, Germany.
Everest Medicines held a ceremony today to celebrate the start of operations at its new global manufacturing site in Jiashan, Zhejiang Province, in China: with the facility boasting the capacity to produce 700 million doses of mRNA vaccines annually.
PackGene Biotech, an adeno-associated virus (AAV) vector contract research organization (CRO) and contract development and manufacturing organization (CDMO), is expanding its US services with a new cGMP biomanufacturing and processing facility in Houston....
Minaris Regenerative Medicine, a contract development and manufacturing organization (CDMO) for cell and gene therapies, is pairing up with LIfT BioSciences on development and manufacturing for a first-generation advanced therapy medicinal product (ATMP).
SK bioscience has announced its largest ever investment to establish the Songdo Global Research & Process Development Center. As well as supporting the company’s work in mRNA, CGT and viral vectors; the site’s Open Lab will welcome external stakeholders...
Vector BioMed, a CDMO specializing in the manufacture of lentiviral vectors, launched this week; its first financing round was led by Viking Global Investors and Casdin Capital.
CDMO AGC Biologics will produce Tzield (teplizumab-mzwv), a recently-approved T1D treatment from Provention Bio, at its Seattle protein biologics manufacturing site.
The unprecedented rise in approvals for new cell and gene therapies, and the increasing industry need for cell lines to support the production of therapeutics, has spurred US CDMO, the Center for Breakthrough Medicines (CBM), to act
Thermo Fisher Scientific will provide biologic manufacturing capabilities and scale-up capacity to manage clinical supply of eblasakimab for future Phase 3 studies.
BioNTech will create its first regional clinical trial sites in East Asia: with the launch of activities in Taiwan for an mRNA head and neck cancer candidate.
Merck has signed a Memorandum of Understanding (MoU) with Synplogen, a startup spun out of Kobe University's Graduate School of Science, Technology and Innovation.
BioNTech will create an mRNA facility in Singapore through the acquisition of a Novartis site: which will become its Regional Headquarters and production center for the Asia Pacific region.
The biopharma sector has seen recent advancements in process intensification, especially in relation to upstream processing, with the technology employed aimed at increasing drug output. One of the quickest and simplest ways to achieve process intensification...
ReiThera has received operational authorization from the Italian Medicines Agency (AIFA) to open a new production area at its facility near Rome for the large-scale production of viral vectors for vaccines and gene therapy.
