European Pharmacopoeia Commission adopted a new general chapter for “Contaminant pyrrolizidine alkaloids (2.8.26)“.This chapter will be published in Supplement 10.6 of the European Pharmacopoeia on 1 July 2021 with an implementation date of 1 January 2022. ...

The European Medicines Agency (EMA)  confirmed on Wednesday that it had been subjected to a cyber attack but was reluctant to provide any details beyond saying a “full investigation” had been launched. U.S. drug maker Pfizer and its German partner ...

Following two reports of anaphylaxis and one report of a possible allergic reaction following the COVID -19 immunisation, MHRA issued updated guidance to COVID-19 vaccination centres about the management of anaphylaxis.  The precautionary advice to healthcare professionals says “Any person with ...

European Pharmacopoeia Commission decided to include a dissolution or disintegration test in each medicinal product monograph on an immediate-release solid dosage form. The details of the scope of such a test and the conditions for its use in a marketing ...

Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing. Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), ...

FDA has approved 48 novel drugs in 2020 & here are the most notable approvals 1.Palforzia for peanut allergy 2.Trodelvy for metastatic triple-negative breast cancer 3.Tauvid for Alzheimer disease imaging 4.Nurtec ODT for acute migraine 5.Nexletol for cholesterol and cardiovascular disease 6.Zeposia for multiple sclerosis PALFORZIAManufacturer: Aimmune Therapeutics, Inc. Approval date: Jan ...

In a short statement published on its website, The European Medicines Agency (EMA) said: “EMA has been the subject of a cyberattack. The agency has swiftly launched a full investigation, in close cooperation with law enforcement and other relevant entities. ...

The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances. The general chapter focuses mainly on the analysis of N-nitrosamine impurities in angiotensin-II-receptor antagonists (sartans) containing a tetrazole group. In order ...

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency The 9 page temporary guideline emphasizes to evaluate/monitor the following in the COVID-19 public emergency to ensure drug quality. Impact of manufacturing/testing deviations in the final product ...

FDA’s temporary guidance intended to provide answers on frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products. ...

Cancer, also known as malignancy, is the development of abnormal cells that divide in an uncontrolled manner and have the ability to destroy the normal body tissue. It all starts when a cell is somehow altered so that it multiplies ...

An experimental vaccine from Moderna Inc. showed promising early signs that it can create an immune-system response in the body that could help fend off the new coronavirus, according to sampling of data from a small, first human trial of ...

India’s Covid-19 recovery rate now stands at 64.54 per cent, said Union Health Minister Dr Harsh Vardhan here on Friday. “In the last 24 hours, we have crossed the 1-million mark of patients who have recovered from Covid-19. Today we ...