FDA approves IND application for coeliac treatment
The FDA has accepted an IND application for AG017, a new drug designed to treat the causes of coeliac disease which will soon enter new trials.
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Complete response letter handed to Sarepta Therapeutics
The pharmaceutical company has received a complete response letter for its golodirsen injection, which had been submitted for accelerated approval.
RINVOQ™ arthritis treatment granted approval by FDA
The FDA has given its approval to RINVOQ for the treatment of active rheumatoid arthritis after the drug reached its endpoints in clinical trials.
US appeals court overturns patent case for Jevtana
Sanofi has won the latest appeal for the patent of its top oncology product, Jevtana (cabazitaxel).
Global cephalosporin drugs market projected to rise 3.34 percent
The worldwide trade of the cephalosporin class of antibiotics will increase to $14.1 billion by the end of 2025.
Two lots of migraine medication have been recalled
Pfizer has volountarily recalled the migraine medication Relpax because of the potential presence of Pseudomonas and Burkholderia.
Leaked government document reveals possibility of no-deal Brexit drug shortages
A leaked government dossier has stated that in the event of a no-deal Brexit, the UK will face severe medicinal shortages.
OneVision: creating a global standardised laboratory network for SGS Life Sciences
SGS Life Sciences launches OneVision, a global digitalisation initiative to create a single, integrated network of testing laboratories.
MHRA consultation on application of AQbD principles enters last month
An MHRA consultation is due to end on 31 August, with public comments on AQbD principles closing soon.
FDA grants Rozlytrek cancer treatment approval
The cancer therapeutic, Rozlytrek, has gained FDA approval as well as Priority Review, Breakthrough Therapy and Orphan Drug Designations.
Silica-based drug delivery could improve anticancer drugs
Researchers have developed silica spheres to contain cancer therapeutics that melt at certain temperatures and have the potential to improve drug delivery.
Complete response letter sent for two generic products
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
Pharma bodies confirm signing NDAs for no-deal Brexit plans
The DHSC has confirmed that several pharmaceutical industry bodies have agreed to NDAs regarding plans for a no-deal Brexit.
Drug supplier Aspen to pay NHS £8m after competition probe
The CMA alleges that Aspen broke competition law, prompting the drug supplier to offer a payment and other compensations to the NHS.
New drug for treatment-resistant forms of tuberculosis approved
Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.
