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.
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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.
Drug manufacturer planned to shred cGMP documents ahead of inspection
An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
New system delivers drug straight into tumours with fewer side effects
A new drug delivery system disguises chemo-therapeutics as fat in order to destroy tumours.
Immunotherapy specialist benefits from Quantum bioprocessing pump
Quantum pump specified for critical UF/DF processes; user says “no other pump could meet all of our needs".
Little progress shown for gender diversity in major pharma companies
A new report shows that there is still a lack of female representation within the senior roles of the major pharmaceutical companies.
FDA rejects AstraZeneca’s Farxiga treatment
AstraZeneca has been issued with a complete response letter for Farxiga by the FDA meaning that it has rejected the treatment.
Drone temperature-controlled medicine delivery programme test completed
The successful pilot programme could represent an important step forward in biopharmaceutical supply chain innovation.
Altaire issues sterile product voluntary recall
Altaire Pharmaceuticals has announced a recall of 31 products due to a lack of sterility assurance from their manufacturing facility.
Suspected counterfeit vaccines seized in Hong Kong
A medical centre in Hong Kong had 76 boxes of an HPV vaccine seized after a complaint from a patient who experienced adverse side effects.
Amgen wins patent block on Sanofi drug rival
Amgen has successfully blocked the manufacture, sales and marketing of its Sanofi drug rival in Germany.
