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A schizophrenia drug that could reduce the risk of patient relapse is at risk of being hidden in a crowded long-acting injectable market.
The FDA has accepted priority review of epcoritamab for adults with relapsed/refractory large B-cell lymphoma, which could be the first subcutaneous bispecific antibody for large B-cell lymphoma.
After receiving an approval from France's National Agency for Medicinal Safety and Health Products (ANSM), Advanced BioDesign announced the enrolment of the first patient in its first-in-human clinical trial in acute myeloid leukaemia.
New therapy Mobocertinib, recommended by NICE, helps slow growth of EGFR-positive non-small-cell lung cancer in platinum-based chemo-treated patients.
Monoclonal antibody Zolbetuximab plus mFOLFOX6 achieved significant progression-free survival in a Phase III trial for advanced gastric and gastroesophageal junction cancers.
The 2022 Access to Medicine Index shows all 20 pharma companies have an over-arching access to medicine strategy, benefitting low and middle-income countries.
GSK’s low dose, daily oral antitubercular agent improved drug-susceptible pulmonary tuberculosis after 14 days, giving it potential as a simpler treatment option.
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
Tremfya® trial analysis showing early skin and enthesitis response for active psoriatic arthritis could indicate long-term clinical response including disease remission.
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
Bepirovirsen, an antisense oligonucleotide therapy aided in long-term prevention of chronic hepatitis B in patients on and not on nucleoside/nucleotide analogues in a Phase II trial.
A major trial evaluating Boehringer Ingelheim’s Jardiance®, showed it reduced the risk of cardiovascular death and chronic kidney disease progression by 28 percent.