FDA Puts Advaxis Cancer Immunotherapy on Hold Due to Patient Death
The clinical hold on the drug, axalimogene filolisbac, was issued after Advaxis submitted a safety report to the Food and Drug Administration.
The clinical hold on the drug, axalimogene filolisbac, was issued after Advaxis submitted a safety report to the Food and Drug Administration.
‘Advaxis will resume all clinical trials with its cancer products namely axalimogene filolisbac, ADXS-PSA and ADXS-HER2 after USFDA lifts its clinical hold on them.’
Tweet it Now
After discussions with FDA, the company has agreed to implement certain risk mitigation measures like post-administration antibiotic treatment, patient surveillance and monitoring measures.“We appreciate the FDA's review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis.
Now, Advaxis will resume all clinical trials with axalimogene filolisbac, ADXS-PSA and ADXS-HER2. Axalimogene filolisbac is a treatment for HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer and anal cancer.
Natco Pharma and Hetero Receives Indian Drug Regulatory Approval for Hepatitis-C Drug
The companies have decided to sell generic version of Daclatasvir tablets in the strengths of 30 mg and 60 mg to treat hepatitis C virus infection in India.
The companies have decided to sell generic version of Daclatasvir tablets in the strengths of 30 mg and 60 mg to treat hepatitis C virus infection in India.
Source-Medindia
USFDA Halts the Launch of AstraZeneca�s Fixed-Dose Diabetes Drug for Treatment
US heath regulators stated that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin for diabetes treatment.
US heath regulators stated that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin for diabetes treatment.
Germany Medical Company Alamedics Rejects Blame for Blinded Patients
The German medical company revealed that series of laboratory tests had shown no evidence of contamination or other abnormality in their product used in Spain.
The German medical company revealed that series of laboratory tests had shown no evidence of contamination or other abnormality in their product used in Spain.
