RUXIENCE™ biosimilar granted approval from FDA
The FDA has approved RUXIENCE (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for treatment of non-Hogkin’s lymphoma and other conditions.
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Two lots of Kogenate® recalled due to mislabelling
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
Bipartisan bill revealed to lower drug prices in US
The Senate Finance Committee has unveiled its bipartisan bill in an effort to lower drug prices, requiring drug manufacturers to justify price increases.
Warning issued to company for using unfounded CBD treatment claims
FDA issues warning to a company that claimed its CBD products can be used to treat cancer and Alzheimer's disease.
First patient enrolled on clinical study for denosumab biosimilar
An integrated Phase I/III trial has enrolled its first patient to test a biosimilar for denosumab to treat postmenopausal osteoporosis.
FDA approves nine generics for Lyrica drug
The FDA has announced that it has granted approval to the first nine generic drug applications for Pfizer’s Lyrica treatment.
New model could be used to predict shelf life of drugs
Researchers have developed a model that describes how antibody solutions separate into different phases and could be used to anticipate the stability and shelf-life of drugs.
China set to begin Phase II HIV vaccine trials
A vaccine containing the DNA of HIV is poised to enter a Phase II trial, making it the first vaccine of its kind to do so.
EMA grants AR-501 with Orphan Drug Designation
Orphan Drug Designation has been given to AR-501 for the treatment of lung infection in patients with cystic fibrosis.
Complete response letter given to ALS treatment for API concern
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
Downstream processing market will grow to record $40bn by 2026
The global downstream processing market is predicted to witness record-breaking growth due to a surge in the adoption of biotech processes.
Sickle cell drug wins Priority Review by the FDA
The US Food and Drug Administration (FDA) has given an investigational sickle cell medicine, crizanlizumab (SEG101), Priority Review.
Jet milling industrialisation of sticky active pharmaceutical ingredient using quality-by-design approach
FPS has recently cooperated with pharmaceutical industry experts in research on jet mills' practices in pharmaceutical industries.
Quotient Sciences to recapitalise with global private equity firm Permira
New investment provides substantial new funding to fuel the next stage of Quotient’s growth.
DRC rejects clinical trial for experimental Ebola vaccine
The health minister for the Democratic Republic of the Congo has stated an experimental Ebola vaccine will not be trialled in the country.
