FDA approves first drug to delay type 1 diabetes
The US Food and Drug Administration (FDA) has approved Tzield, the first drug that can help delay the onset of stage 3 type 1 diabetes in patients over eight years old with stage 2 type 1 diabetes.
List view / Grid view
The US Food and Drug Administration (FDA) has approved Tzield, the first drug that can help delay the onset of stage 3 type 1 diabetes in patients over eight years old with stage 2 type 1 diabetes.
Upstaza™, approved for UK patients 18 months and over, is the first gene replacement therapy infused directly into the brain for the treatment of AADC deficiency.
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.
Indivior’s $145 million acquisition of Opiant Pharmaceuticals will support the launch of OPNT003, an opioid overdose reversal agent.
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.
The first implantable pump system bypassed the blood-brain barrier to deliver chemotherapy to brain cancer patients in a Phase I study.
Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
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.
The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.
EPR rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022.
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.