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.
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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.
FDA grants Orphan Drug Designation to Imfinzi for SCLC
The FDA has announced Orphan Drug Designation for Imfinzi (durvalumab) to treat small cell lung cancer in combination with other therapies.
Controlled release drug delivery market to rise 14.3 percent
The global controlled release drug delivery market will be worth an estimated $91.2 billion by 2026, according to a new study.
FDA publishes guidance for Inactive Ingredient Database
The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.
NICE recommends risankizumab to treat severe psoriasis
NICE has issued a recommendation for risankizumab to treat patients with severe plaque psoriasis.
FDA sends warning letter to sterile injectables plant
A pharmaceutical manufacturing site in New Jersey receives FDA warning letter for failing to thoroughly investigate quality problems and data integrity issues.
US and EU enter Mutual Recognition Agreement for drug manufacturing inspections
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
