The EMA covid-19 data leak, and what it tells us about mRNA instability

https://www.bmj.com/content/372/bmj.n627 Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari Read more at bmj.com Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized byContinue reading “The EMA covid-19 data leak, and what it tells us about mRNA instability”

The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway.

Two members of the U.S. Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee resigned after the agency’s approved the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen/Eisai), against the committee’s recommendation. The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway. Price forContinue reading “The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway.”

Rare IMMUNE DISORDER now linked to AZ vaccine?

The European Medicines Agency (EMA) has revealed it’s “assessing reports” of AstraZeneca’s Covid jab causing Guillain-Barre syndrome. According to the UK’s NHS: Guillain-Barre syndrome is a “very rare and serious condition that affects the nerves.” The condition can be life-threatening, although the NHS states “most people will eventually make a full recovery” although “long-term problems”Continue reading “Rare IMMUNE DISORDER now linked to AZ vaccine?”

BREAKING NEWS: Doctors and Scientists Write to European Medicines Agency Warning of COVID-19 Vaccine Dangers

PRESS RELEASE – FOR IMMEDIATE RELEASE BREAKING NEWS: Doctors and Scientists Write to European Medicines Agency Warning of COVID-19 Vaccine Dangers 10th March 2021 A group of scientists and doctors has today issued an open letter calling on the European Medicines Agency (EMA) to answer urgent safety questions regarding COVID-19 vaccines, or withdraw the vaccines’Continue reading “BREAKING NEWS: Doctors and Scientists Write to European Medicines Agency Warning of COVID-19 Vaccine Dangers”

EMA and The Netherlands Biopharm Opportunities

The European Medicines Agency (EMA) is relocating from London to Amsterdam. According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands. On Friday, 13 April 2018, the Dutch Council of Ministers agreed to sign the document. Quantify research reported earlier thisContinue reading “EMA and The Netherlands Biopharm Opportunities”

ICH is coming to Town – European Medicines Agency (EMA)

The International Conference on Harmonization (ICH)  is involved in promoting public health, improve efficiency of new drug development and registration process among other objectives. In order to accomplish this, ICH has developed and implemented harmonized guidelines and standards, also known as ICH6. Over 50 guidelines on technical requirements on: Quality, Safety and Efficacy • Efficacy –Continue reading “ICH is coming to Town – European Medicines Agency (EMA)”