Innovative small molecule shows promise in obesity
The GLP-1 receptor agonist demonstrated good safety and tolerability in both healthy and overweight/obese adult participants, the Phase I study found.
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New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
New US fill finish facility receives $4.1 billion investment
Novo Nordisk plans to allocate $6.8 billion towards production to expand its overall US manufacturing capacity.
New multiple sclerosis treatment option granted in EU
The newly authorised formulation of the anti-CD20 therapy provides certain multiple sclerosis patients with another treatment option comparable to intravenous infusion.
Optimising iPS cell-based platelet manufacturing scale up
Large-scale platelet manufacturing must consider turbulent energy and shear stress as well as the undesired turbulent flow space within a bioreactor, the paper concluded.
Press Release: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
SGS’s Birsfelden, Switzerland lab is now a “one-stop shop” for biopharma firms in GMP/non-GMP analytics, featuring a new stability studies capability.
Gilead small molecule demonstrates strong capability for HIV prevention
According to Gilead, the study is the first Phase III HIV prevention trial to demonstrate a zero-infection rate.
Semi-automation of manual interventions in high-speed filling lines
Research has highlighted the potential of using robotics for isolator filling line interventions, enabling gloveless executions by operators.
Non-chemotherapy lymphoma treatment may provide durable remission
Fifty four percent of evaluable patients with DLBCL attained a substantial tumour reduction with the five-drug regimen, trial data shows.
Novel immunotherapy combination approved for endometrial cancer
The new approval of KEYTRUDA (pembrolizumab) combined with chemotherapy is indicated for certain patients with the most common gynaecologic cancer, according to Merck/MSD.
J&J commits five-year investment in Italian medicine manufacturing
Currently, the Latina site exports 97 percent of the medicine it produces, according to Johnson & Johnson Innovative Medicine.
AbbVie to advance TL1A antibody for IBD
The new, potentially multi-billion-dollar deal will help bring a next-generation therapy to patients with inflammatory bowel disease (IBD), an autoimmune condition.
Haemophilia drug could reduce treated bleeding episodes
Once-weekly or once-monthly dosing of Mim8 provides optionality and flexibility for people living with haemophilia A with or without inhibitors, stated Novo Nordisk’s EVP for Development.
Analysis of chiral compounds using supercritical fluid chromatography
Sub/supercritical fluid chromatography is becoming a “dominant” technique for enantiomeric separation, especially purification, the researchers explained.
ABPI embraces proposals for pharma’s growth ahead of UK elections
The UK pharmaceutical industry body has invited proposals on economic investment, support for manufacturing, clinical trials and R&D.
