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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.
Stemline Therapeutics is set to pay Insilico Medicine an initial $12 million for its novel AI-designed KAT6 inhibitor as a potential breast cancer treatment.
A new breast cancer treatment that reduced the risk of progression or death by 45 percent compared to standard of care in a Phase III trial, has been authorised by the UK Medicines & Healthcare products Regulatory Agency (MHRA).
While constraints such as inflation and drug pricing pressures will impact pharma’s growth in 2024, patent expiration of biologics is expected to support the industry over the next few years, research suggests.
Anne Dhulesia and Sean Dyson, Partners at L.E.K. Consulting, discuss the proposed revisions to EU pharma legislation and potential implications for biopharma companies operating in Europe.
