CHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
The advanced drug delivery market is anticipated witness a compound annual growth rate (CAGR) of 4.6 percent by 2033, according to a report.
Clinical studies of Pfizer’s oral medicine for alopecia areata have demonstrated response rates continued to improve for up to two years.
Output volumes for UK manufacturing fell in the three months to February 2024, yet it is expected to rise slightly in the next three months, research reports.
A driving factor behind the expansion of the upstream bioprocessing market is the need for process improvement in the biopharma industry, research highlights.
A new World Health Organization (WHO)-driven initiative aims to enhance bioproduction capabilities for biological products in low- and middle-income countries (LMICs).
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.
Now conditionally approved in Europe for sickle cell disease and transfusion-dependent beta thalassemia, the CRISPR therapy offers eligible patients a functional cure.
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.
Part of Biogen’s prioritisation of its portfolio includes focusing on the advancement of its leading anti-amyloid beta Alzheimer’s treatment, LEQEMBI® (lecanemab-irmb).
Recommendation of AbbVie’s bispecific antibody for NHS use is based on a Phase I/II trial, which observed a 62 percent overall response rate in diffuse large B-cell lymphoma (DLBCL) patients.
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.
The rising demand for biopharmaceuticals and a greater focus on cross-contamination are two of the biggest factors expected to impact the extractable and leachable (E&L) testing services market between 2023 and 2030, research predicts.