news
EU marketing authorisation granted for rheumatoid arthritis treatment
Remsima SC™ is the world’s first subcutaneous formulation of infliximab and has been approved in the EU for the treatment of people with rheumatoid arthritis.
List view / Grid view
Formulation
news
Broadly neutralising antibody to be developed for HIV-1 treatment
The investigational broadly neutralising antibody, N6LS, is to be developed by ViiV Healthcare for the treatment and prevention of HIV-1.
news
First treatment for inherited rare disease approved by the FDA
Givlaari (givosiran) has been approved by the FDA for the treatment of adult patients with the rare genetic disorder, acute hepatic porphyria.
news
Ninety-seven percent response rate reported in advanced prostate cancer treatment study
A Phase III study of oral relugolix has met its primary efficacy endpoint in men with advanced prostate cancer, supporting a New Drug Application submission to the FDA.
news
Fast Track Designation received for Prader-Willi syndrome treatment
Levo Therapeutics has received Fast Track Designation from the FDA for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome.
article
Thermodynamic probes of cold instability: application to therapeutic proteins
Developing a stable therapeutic protein formulation requires an intimate knowledge of the protein and its physical and chemical properties. In this article, Bernardo Perez-Ramirez and Robert Simler discuss the thermodynamic consequences that low temperature can have on the aggregation tendencies of a protein.
news
Therapy approved for patients with sickle cell disease complication
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
article
Excipients in drug formulations
Excipients are integral components of pharmaceutical drug products. Their demand is expected to increase over the next five years owing to their ability to perform various functions such as improving active pharmaceutical ingredient (API) stability, modifying drug release and taste masking. Here, Prateeksha Kaul explores the factors and trends that…
article
Beyond nutrition: vitamins and n-3 polyunsaturated fatty acids as APIs
Active pharmaceutical ingredients (APIs) are important compounds used in the manufacture of pharmaceutical drug products. Eric Ciappio discusses the potential of vitamins and n-3 polyunsaturated fatty acids (PUFAs) as APIs, with a focus on their clinical relevance.
news
Data of rheumatoid arthritis treatment study released
New data shows the non-inferiority of efficacy for the subcutaneous (SC) formulation of CT-P13 to the intravenous (IV) formulation of CT-P13 in people with rheumatoid arthritis.
news
EU Marketing Authorisation submitted for Ebola vaccine regimen
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
news
Ziextenzo™ biosimilar has received approval from the FDA
The FDA has approved Sandoz's biosimilar Ziextenzo and the company now intends to launch it in the US as soon as possible this year.
news
Winners of the 2019 CPhI Pharma Awards announced
Thirteen winners have been announced for the 2019 CPhI Pharma Awards including Dr Ge Li for ‘CEO of the Year’ and a ‘Lifetime Achievement' award for John Chiminski.
news
Decision upheld in Merck hepatitis C drugs patent case
A US appeals court has upheld a ruling that threw out a $2.54 billion jury verdict Merck won against Gilead over hepatitis C treatments.
news
Ebola vaccines donated to Democratic Republic of Congo
500,000 regimens of Janssen's investigational Ebola vaccine are to be donated to support the Ebola outbreak response in the Democratic Republic of the Congo.
