FDA issues warning letter for marketing unapproved products
A warning letter has been issued by the FDA for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms.
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Avacopan Phase III trial meets primary endpoints
A study to demonstrate the safety and efficacy of avacopan has produced topline results, according to the pharmaceutical company developing the drug.
New technique can closely control nanoparticle size and shape
A new technique has been demonstrated that will control the size and shape of nanoparticles which could lead to their use as a form of drug delivery.
Six pharma companies reported to be under investigation for opioid shipments
US prosecutors have handed subpoenas to six pharmaceutical companies and distributors for their role in the opioid crisis, as reported.
Key trends for pharma in 2020 reported from CPhI Worldwide
The content sessions at CPhI Worldwide have revealed the coming trends that the pharmaceutical industry will see next year.
Report predicts the medical marijuana market will reach $3.2bn by 2025
The global medical marijuana market will show impressive growth, a new report has said, but this could be hindered due to some doctors being reluctant to prescribe these products.
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.
Novartis announces $9.7bn acquisition of The Medicines Company
The M&A between Novartis and The Medicines Company will add inclisiran, the potentially first-in-class treatment to reduce cholesterol, to the former’s pipeline.
MHRA announces recall of 13 over-the-counter ranitidine medicines
Four companies are recalling batches of certain over-the-counter ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
UK leads Europe in early clinical research, says new report
According to a new report, the UK is leading the rest of Europe for early-stage clinical research into new medicines and vaccines, with more than 600 commercial clinical trials taking place in the NHS.
Enzalutamide treatment approved for use in China
The Chinese National Medical Products Administration has given its approval to XTANDI® to treat prostate cancer, following a successful Phase III trial.
Anti-epileptic drug XCOPRI® approved by the FDA
Based on results from two global randomised studies and a large open-label safety study, XCOPRI has been approved by the FDA as a treatment for partial-onset seizures in adults.
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.
Pelosi plan could lead to 56 fewer new medicines over decade
US Speaker Pelosi’s new drug pricing plan could impact small biotech companies, reducing their innovation by 90 percent, says new research.
Medical device design – a key consideration when entering biosimilars market
A recent industry report projects a boom in the biosimilars market over the next three years and highlights key considerations for meeting its potential.
