Regulatory Oversight and Compliance

EC Approves Dupixent for Treatment of Severe Asthma in Young Children

April 12, 2022

Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.

Legislation Targets High Cost of Clinical Trials

April 11, 2022

Democrats have proposed a measure to facilitate access to less costly comparator drugs needed in clinical trials, while another bill aims to increase transparency in the costs of clinical trials.

FDA Grants Priority Review to Intravenous Treatment of COVID-19 in Hospitalized Adults

April 08, 2022

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.

ECDC and EMA Issue Advice on Fourth Doses of mRNA COVID-19 Vaccines

April 08, 2022

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

Teva Issues Voluntary Nationwide Recall of IDArubicin Hydrochloride Injection USP 5 mg/5 mL

April 08, 2022

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Early Access Issued for Eligible Patients in the UK for Radioligand Therapy in Advanced Prostate Cancer

April 08, 2022

UK’s MHRA has issued a positive opinion for the Early Access to Medicines Scheme for radioligand therapy in patients with advanced prostate cancer.

FDA Accepts Dupixent for Priority Review for Patients with Eosinophilic Esophagitis

April 06, 2022

FDA has accepted Dupixent for Priority Review in patients aged 12 years and older with eosinophilic esophagitis.

ATMPS Ltd Wins US Patent for the Use of Blockchain in Advanced Medicinal Therapy Products

April 06, 2022

ATMPS Ltd has been granted a patent from the United States Patent and Trademark Office for the use of its Hataali blockchain technology used in personalized medicines.

FDA Seeks Expanded Authorities, Along with More Funds

April 06, 2022

Legislative proposals set the stage for debate on FDA policies and programs and whether to include some measures in legislation to reauthorize user fees.

Pfizer and BioNTech Receive Expanded US Emergency Use Authorization for an Additional COVID-19 Vaccine Booster

April 06, 2022

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.