HPAPI contract manufacturing to value $14.6 billion by 2030
Rising demand for cancer drugs, combined with high in-house manufacturing costs is driving growth in the high-potency API outsourcing market.
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CHMP recommends dengue vaccine for children
Takeda’s novel dengue vaccine has received positive opinion from the EMA’s human medicines committee (CHMP), demonstrating the vaccine is safe for patients from four years old.
Sanofi to sell Japanese manufacturing plant
Sanofi’s Japan-based manufacturing site near Tokyo will be sold to a European contract development and manufacturing organisation.
CHMP recommends Pluvicto® for treating advanced prostate cancer
CHMP issues positive opinion on Pluvicto®, paving the way for it to become the first European-approved radioligand therapy for metastatic prostate cancer patients.
Enterin and Parkinson’s UK to partner on dementia study
A new Phase II trial will study the drug ENT-01 for Parkinson’s Disease (PD)-associated dementia at sites in the UK and US.
RemeGen receives ODD for myasthenia gravis treatment
The FDA has granted ODD to Telitacicept, produced by RemeGen, for the treatment of myasthenia gravis.
Biosimilar competition saves US healthcare $21 billion
The US biosimilars market experienced dramatic growth in 2022, particularly for therapies helping to treat oncological and inflammatory conditions, Amgen suggested in a recent report.
Astellas reports effectiveness of potential treatment for VMS
Results from a clinical study by Astellas have demonstrated the effectiveness of fezolinetant as a treatment for menopause-associated VMS.
Robotic capsule could replace injected biologics
MIT researchers have developed a robotic capsule that tunnels through mucus in the GI tract to deliver large oral protein-based drugs like insulin.
NICE partners with health technology assessment bodies
Five health technology assessment (HTA) bodies will collaborate with NICE to help resolve regulatory and digital health technology challenges.
Could first anti-tau therapy be approved for Alzheimer’s?
The oral medication Hydromethylthionine mesylate (HMTM) is the first anti-tau disease-modifying therapy to offer sustained cognitive improvement in Alzheimer’s.
New initiative will calculate carbon footprint of clinical trials
The new methodology will assess the carbon impact of clinical trials and recommend ways to reduce it.
Are strategic partnerships the winning model for outsourcing?
A University of Cambridge report assessing the preferred relationship type between pharma and contract research organisations (CROs), showed strategic partnerships will continue as the primary collaboration model.
Funding boost for CPI’s RNA vaccine innovation centre
The UK Government’s Vaccine Taskforce (VTF) has funded CPI’s innovative training academy and manufacturing facility to further the development of novel RNA therapies and vaccines.
First FDA pregnancy-approved Pertussis vaccine to protect newborns
The FDA has approved Boostrix, the first vaccine for pregnant women in their third trimester, to stop whooping cough (Pertussis) in infants below two months.
