UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks
The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...
Europe – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines...
USA – FDA updates guidances to clarify new generic drug meeting requirements in GDUFA...
The US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments...
USA – Stakeholders ask FDA to harmonize adverse events terms with standards orgs
Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well...
UK – Grifols’ Tavlesse receives NICE recommendation
Therapy treats refractory chronic immune thrombocytopenia and is available across UK.
Grifols has announced that its treatment for adults with chronic immune thrombocytopenia (ITP), Tavlesse...
Europe – EMA pilot offers enhanced support to academic and non-profit developers of advanced...
EMA is launching a pilot to support the translation of basic research developments into medicines that could make a difference in patients’ lives in...
Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
EMA’s human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron...
USA – FDA Approves First Gene Therapy to Treat Adults with Hemophilia B
Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia...
USA – FDA officials offer advice on gene therapy trials
Officials from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) asserted...
USA – FDA seeks feedback on artificial intelligence in drug manufacturing
The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current...
