USA – FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy
The evolution of the coronavirus has knocked out another treatment.
The Food and Drug Administration on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to...
USA – Study: Certain cancer drugs saw widespread use before accelerated approval withdrawal
In the period between when three accelerated approval (AA) drugs received approval from the US Food and Drug Administration (FDA) for oncology indications and...
International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new...
Europe – ETF statement on the loss of activity of anti-spike protein monoclonal antibodies...
Since the declaration of the COVID-19 public health emergency in early 2020, four monoclonal antibody products have been approved in the European Union for...
USA – FDA finalizes guidance on suspect products under DSCSA
The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that...
UK – Otsuka’s Lupkynis receives NICE green light
Recommendation applies across England and Wales and the treatment is available now
Otsuka Pharmaceuticals has revealed that the National Institute for Health and Care Excellence...
Europe – EU regulator recommends revoking approval for Novartis’ sickle cell disease drug
The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab).
The...
UK – AstraZeneca/Merck’s Lynparza recommended by NICE for advanced prostate cancer
The PARP inhibitor has been specifically recommended for NHS use alongside anti-androgen therapy Zytiga (abiraterone) and prednisone or prednisolone in adults with untreated hormone-relapsed...
Europe – EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine
The COVID-19 vaccine candidate can now move from the initial rolling review process to the formal review process, which is overseen by the Committee...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
