New cancer drugs approvals underpinned by flawed evidence
A new report has shown that trial evidence alone is not enough when approving new cancer drugs and that an assessment of that evidence is also needed.
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FDA accepts Biologics License Application for V920 Ebola vaccine
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
Hereditary angioedema treatment recommended by NICE
Lanadelumab, a preventive treatment for hereditary angioedema, has been recommended as a cost-effective use of NHS resources.
Company sues FDA over rejecting opioids intended to deter abuse
Pharmaceutical Manufacturing Research Services has filed a lawsuit against the FDA after it rejected its application for opioids with updated labelling and appearance, meant to discourage misuse.
Collaborative oncology drugs review initiative announced by FDA
A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.
MHRA updates biologic quality guidance document
The UK Medicine and Healthcare products Regulatory Agency has released a revision to its standards for ensuring high quality of biologic products.
Multiple myeloma treatment granted Orphan Drug Designation
Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma.
Cosentyx® (secukinumab) meets clinical trial endpoints
Cosentyx®, a treatment for an inflammatory disease has met its primary endpoints in patients during a Phase III trial.
Demand for containment facilities and manufacturing to grow
The market for containment facilities and containment manufacturing will increase in the future, due to a growing demand for oncology treatments.
Fast Track designation given to heart failure treatment
Farxiga (dapagliflozin) has been given Fast Track designation by the FDA to reduce the risk of cardiovascular death.
New flu patch could lead to needle-free vaccination methods
New vaccine patch has showed no negative side effects and could lead to a replacement of needle-based vaccination methods.
EMA to provide guidance on avoiding nitrosamines in medicines
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
Three decades of pharmaceutical excellence: CPhI Worldwide
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
Treatment approved for young children with severe eosinophilic asthma
Nucala is the first biologic approved in the US for six- to 11-year-old children with severe eosinophilic asthma by the FDA.
Purdue Pharma files for bankruptcy protection in the US
Purdue has filed for bankruptcy protection after a settlement offer from the company over the opioid crisis was rejected by 24 states.
