Targeted therapy for hard-to-treat leukaemia subtype approved in EU
A FLT3 inhibitor that has been shown to significantly improve FLT3-ITD positive acute myeloid leukaemia survival has been authorised in the EU.
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Sandoz and Teva achieve first-of-a-kind manufacturing certification
In their commitment to tackling global antimicrobial resistance (AMR), the first two Pharma companies have gained independent certification in responsible antibiotic manufacturing.
Innovative insomnia study aims to overcome major clinical trial bottleneck
A new UK trial investigating a standard insomnia treatment is a “significant step forward in patient-centric trial design”.
Rapid HPLC method could improve formulation QC studies
Researchers state the novel high-performance liquid chromatography with diode-array detection (HPLC-DAD) method can be utilised in routine quality control analysis of levofloxacin in pharmaceutical formulation and bioequivalence studies.
Gilead reveals positive data for potential first-line adenocarcinoma treatment
The only Fc-silent anti- T-cell immunoreceptor with Ig and ITIM domains (TIGIT) antibody in Phase III for upper GI adenocarcinomas could be the first to market for these cancers.
MHRA authorises new treatment for rare lung cancer
A “potential best-in-class treatment” for adults with KRASG12C-mutated non-small cell lung cancer (NSCLC) has been authorised in the UK.
Global cell line development to surge in next decade
Increased production of biologic drugs in the global cell line development market is anticipated to bring “significant growth” for mammalian cell line development between 2023-2033, a report shows.
AAO 2023: intravitreal treatment shows benefit in geographic atrophy
Results from Iveric Bio’s Phase III trial demonstrated that over a two-year period, IZERVAY™ (avacincaptad pegol intravitreal solution) reduced geographic atrophy (GA) lesion growth as early as six months.
MHRA authorises alopecia treatment
UK patients with severe alopecia areata could access Pfizer's enzyme inhibitor, Litfulo (ritlecitinib), to help treat their condition.
Study assesses vaginal film for HIV prevention
A study taking place in US and sub-Saharan Africa will also help inform final design of a monthly film containing antiretroviral drug dapivirine.
FDA approves first Stelara biosimilar, Wezlana
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
Antibiotics ‘no longer effective’ for childhood infections, finds study
Australian-led study highlights ‘alarmingly high’ rates of resistance to commonly-prescribed antibiotics in the Asia-Pacific region.
European approval for third adapted COVID-19 vaccine
The European Commission has authorised the first protein-based adapted vaccine for COVID-19.
Could centrifugal bioreactor accelerate cell-therapy manufacturing?
Researchers from Washington State University have developed a centrifugal bioreactor, which they claim can manufacture T cells 30 percent faster than current technologies.
Alfasigma to acquire Jyseleca from Galapagos
31 October 2023 | By
Italy-based Alfasigma has agreed to acquire the Jyseleca (filgotinib) business from Belgian biotech Galapagos for €170 million.
