Gilead plans $4.3 billion deal to advance liver portfolio
As part of its proposed acquisition, Gilead will add a potential best-in-disease treatment for second-line primary biliary cholangitis (PBC) to its liver portfolio.
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Pharmaceutical suspension market to witness accelerated growth
The global pharmaceutical suspensions market is set to value $83.8 billion by 2032, due to the systems having key benefits such as supporting patient compliance.
USP recommends revisions to proposed RMM chapters
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
Vertex secures European approval for CRISPR cell therapy
Now conditionally approved in Europe for sickle cell disease and transfusion-dependent beta thalassemia, the CRISPR therapy offers eligible patients a functional cure.
Raman and machine learning show promise for online monitoring of bioreactors
The approach applied in the research on bioreactors represents a significant advancement over traditional methods, according to the researchers.
BioNTech agrees collaboration to accelerate autologous CAR-T therapies
The collaboration between BioNTech SE and Autolus Therapeutics utilises manufacturing and commercial infrastructure, supporting a shared goal of advancing autologous CAR-T programmes towards potential market authorisation.
Inhalable dry powder drug formulation could treat respiratory infections
The drug formulation study offers promise for treating different respiratory tract infections using a single antimicrobial agent, a paper reports.
Next-in-class combination treatment shows potential in cystic fibrosis
Phase III trials have found CFTR modulator vanzacaftor/tezacaftor/deutivacaftor (vanza triple) to be non-inferior to TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in improving cystic fibrosis lung function.
Rapid microbiology testing market to value nearly $13bn by 2034
Driven by a rise in infectious diseases and advancements in digital technologies, increased demand for rapid microbiology testing is set to accelerate the market’s growth.
AstraZeneca to boost cell therapy operations with $300m manufacturing investment
Investment in the US manufacturing facility will accelerate AstraZeneca’s ambition to make next-generation cell therapy a reality, the company asserts.
How will automation shape deviation management in continuous bioprocessing?
A paper has proposed how advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) could impact the future of deviation detection and control.
EMA Annex 1 Q&A discusses bioburden considerations
In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).
Suanfarma realigns brand to showcase innovative spirit
The new identity of Suanfarma’s industrial brands signifies integration of its manufacturing sites as part of Suanfarma CDMO.
Novo Nordisk $11b acquisition to support manufacturing capacity
As part of its acquisition of Catalent, Novo Holdings plans to sell three Catalent fill-finish sites, supporting the growth of the European and US manufacturing capacity.
US legislation to benefit small molecule drug innovation
Passing of two key legislations in the US is set to support innovation for small molecule drugs and the biotech sector, Biotechnology Innovation Organization (BIO) asserts.
