news
FDA releases new guidance for drug and biological product data
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
List view / Grid view
Regulation & Legislation
article
Formulation, Development & Delivery In-Depth Focus 2021
Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.
news
Opdivo® approved in Europe to treat a range of cancers
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
article
European Pharmaceutical Review Issue 5 2021
Articles in this issue discuss the importance of diversity and inclusion in pharma, how packaging can improve big pharma's bottom line and why innovation has been vital to saving lives during the COVID-19 pandemic. Also in this journal, 10 key considerations when creating an ATMP manufacturing facility and how to…
whitepaper
Whitepaper: Faster isolation of PBMC with Centrifuge 5910 Ri
Save up to 88% of deceleration time for your PBMC isolation due to optimized breaking ramps of Eppendorf Centrifuge 5910 Ri.
news
FDA sets up Novel Excipient Review Pilot Program
Manufacturers can submit their novel excipients for FDA review under the voluntary Novel Excipient Review Pilot Program.
news
FDA awards 11 grants for rare disease treatment developments
The FDA has awarded 11 grants equating to about $25 million of funding to clinical trials for the development of rare disease treatments.
video
On-demand webinar: Spores in my cleanroom
This webinar considers the problems bacterial and fungal spores present for contamination control and remediation and disinfection strategies.
news
Anti-amyloid antibody receives Breakthrough Therapy Designation in US
Roche's gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
news
EFPIA calls for harmonisation of GMO procedures in investigational drugs
The European Federation of Pharmaceutical Industries will implement a new regulation to co-ordinate genetically modified organism procedures.
news
WHO recommends groundbreaking malaria vaccine for children
The World Health Organization (WHO) recommends GSK's RTS,S/AS01 (RTS,S) malaria vaccine for use in children in sub-Saharan Africa.
news
EMA approve Comirnaty®and Spikevax booster doses
The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
news
New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
news
NICE recommends first sickle cell disease treatment in 20 years
Crizanlizumab recommended as a treatment option for preventing recurrent sickle cell crises for people aged 16 and over in the UK.
