article
The lingering menace of diethylene glycol / ethylene glycol adulteration
Although it was first identified in the 1930s, diethylene and ethylene glycol contamination remains an issue today, as Dave Elder explains.
List view / Grid view
Regulation & Legislation
news
Utrogestan accepted as HRT in Scotland
Utrogestan, the only adjunctive micronised progesterone as hormone replacement therapy alongside any oestrogen therapy has been accepted by the SMC for women in Scotland.
news
Dapagliflozin approved for heart failure across LVEFs
The MHRA has approved dapagliflozin for chronic heart failure across the full spectrum of left ventricular ejection fraction.
news
Comirnaty® authorised for patients six months to four years
Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.
whitepaper
Whitepaper: rFC adoption for bacterial endotoxin testing
What is driving the adoption of rFC for BET? Alternative methods are the obvious sustainable solution for efficient manufacturing.
article
France’s ATU reform: early access remains possible, but not all diseases are equal
When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
news
EMA accepts marketing application for ALS treatment
The EMA has accepted the marketing authorisation application for tofersen, which could be the first treatment for a rare genetic cause of ALS.
news
EMA accepts momelotinib marketing application
The marketing authorisation application for momelotinib, a new oral treatment for myelofibrosis has been accepted by the EMA.
news
FDA approves Rezlidhia™ for leukaemia
Rezlidhia™ has been approved for adults with mIDH1 relapsed/refractory acute myeloid leukaemia by the US Food and Drug Administration (FDA).
news
First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
news
First paediatric EC approval of HIV drug
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
news
EC approves Libtayo® for metastatic cervical cancer
The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.
news
NICE recommends combo therapy for gastroesophageal cancer
Nivolumab together with chemotherapy has been recommended in NICE final draft guidance for treatment of gastroesophageal cancer.
article
Can holograms help in the frontline fight against pharmaceutical counterfeiting?
With Europol advising that counterfeit pharmaceuticals continue to pose ‘…a substantial threat to the EU and affect most, if not all, member states’, Dr Paul Dunn, chair of the International Hologram Manufacturers Association, looks at developments in authentication holography.
news
EMA launches quality control group to aid medicine innovation
A new regulatory group, part of the European Medicines Agency, will aid innovative approaches for the development and quality control of medicines, including new technologies for EU patients.
