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.
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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.
The first BRCA-targeted treatment has been recommended for advanced breast or metastatic breast cancer by the National Institute for Health and Care Excellence (NICE).
Highlighting the potential of a novel antibiotic against acinetobacter infections, GlobalData explained that nine other drugs, alongside this promising treatment, are in clinical development for this indication.
The cell and gene therapy (CGT) sector in the UK is “robust”, with a stable clinical trials landscape, according to research from Cell and Gene Therapy Catapult (CGT Catapult) and the UK BioIndustry Association (BIA).
Challenges such as market exclusivity and patient treatment preference are expected to shape the insomnia and Gaucher disease therapy landscape in the seven major markets (7MM) in 2032, research predicts.
The manufacturing capacity for some of Boehringer Ingelheim’s medicines, in disease areas including mental health and cardio-renal-metabolic conditions, will benefit from the European facility expansion.
The first biosimilar to Stelara® is now approved in Europe, a biologic therapy with indications across gastroenterology, dermatology, and rheumatology.
TALZENNA® is the first PARP inhibitor approved in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC) in the EU.
With no currently approved medicines for the prevention of bronchopulmonary dysplasia (BPD) in extremely pre-term infants, a new pharmaceutical collaboration could produce the first major therapeutic breakthrough for this patient group in decades.