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EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

PRAC Finds Link to Very Rare Cases of Myocarditis and Pericarditis with Comirnaty and Spikevax

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

EMA Advises Against Using Janssen’s COVID-19 Vaccine in People with Capillary Leak Syndrome

EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML). 

EMA Concludes There is No Link Between Zynteglo and AML

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.

Woodcock Seeks Outside Investigation to Restore FDA Credibility

Editor of Pharmaceutical Technology Europe

The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.

Considering Annex 1 Revisions: Expert Insights

Five therapeutic candidates for the treatment of COVID-19 are identified as promising by the European Commission.

Identifying Promising COVID-19 Therapies

Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.

FDA Adds Warning to mRNA Vaccine Fact Sheets

FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.

Lilly's Investigational Alzheimer's Therapeutic Gets Breakthrough Therapy Designation

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

EC Orders 150 Million Additional Doses of Moderna’s COVID-19 Vaccine

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

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