EMA
Keeping tabs on Covid-19: EMA approves Moderna vaccine for teens and Japan approves Roche–Regeneron’s treatment
July 30 by Emily UwemedimoThe EMA recommends Moderna’s Covid-19 vaccine for 12–17 year olds as discussions continue with the FDA for approval for children in the US
Keeping tabs on pharma: Pfizer aims for clinical trial diversity and EMA urges public to be aware of falsified medicines in face of Covid-19 pandemic
May 07 by Emily UwemedimoPfizer’s latest TV ad encourages underrepresented groups to consider participating in clinical trials
A regulatory perspective on real-world data and real-world evidence
April 23 by Sanyam GandhiDive into the thoughts and insights of a regulatory expert at Takeda as he evaluates how two data solutions can support drug development study requirements
Keeping tabs on Covid-19: Johnson & Johnson’s Covid-19 supply delay, Germany pauses its use of AstraZeneca’s vaccine and portable cold carrier launched to help with vaccine roll-out
April 01 by Emily UwemedimoThe European Medicines Agency sought to add clarity to the concerns surrounding AstraZeneca’s Covid-19 vaccine, but Germany has pressed the pause button as a “precaution” despite EMA backing
Keeping tabs on Covid-19: EMA say AstraZeneca vaccine outweighs risks and zero-emissions vehicle makes vaccines more accessible
March 19 by Emily UwemedimoFollowing concerns about AstraZeneca’s Covid-19 vaccine, the EMA continues to endorse its safety as findings reveal it does not increase the overall risk of blood clotting disorders
Keeping tabs on Covid-19: Sanofi and Luminostics develop self-testing smartphone app and physicians estimate patient vaccine hesitancy is at record low
September 25 by Emily UwemedimoSanofi and Lumionstics have announced an innovative solution for rapid at home testing of coronavirus using smartphone technology
7 common concerns about clinical trials in Eastern Europe
December 18 by Lester PowellAccell Clinical Research offer insights on some of the key sponsor concerns when considering trials in Eastern Europe and Russia
Will a "no-deal" Brexit lead to drug shortages?
July 31 by Adam MusprattA “no-deal” may result in drug shortages across the UK. Find out what drugs will be affected the most, how severe shortages will be and more.
IDMP Compliance — Get Ready
March 26 by Pharmaceuticals & Biotechnology EditorIDMP regulations (Identification of Medicinal Products) are currently being finalised by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). These regulations will b...
Top 5 Tips for User Engagement
December 08 by Pharmaceuticals & Biotechnology Editor22% of apps are used only once[1] this represents a problem for healthcare apps of all kinds as the success of your app depends not on shallow metrics like downloads, but by meaningful interactions...
The Future of Biosimilars - A Case of Untapped Potential?
March 26 by Gerald ClarkeThe patents on a majority of the top-selling biologic drugs currently on the market will have expired by 2020, an amount which may be equivalent to $67 billion. Can we expect then a rush of biosimil...
Ben Goldacre Makes the Case for Greater Transparency in Clinical Trials
January 20 by Gerald Clarke"Clinical trial information is being routinely and legally witheld and this needs to end". This is the assertion of Dr. Ben Goldacre; a doctor, science writer, campaigner on scientific issues inc...