After years of hesitating to enforce the clinical trial reporting requirements, this week FDA released its guidance on penalties for non-compliance with clinicaltrials.gov posting rule. It satisfies the critics of the non-enforcement but at the same time gives a huge break to the current violators by wiping the slate clean and restarting the clock, in … Read more
While coronavirus vaccines have constantly been in the news, there is little noise about treatments. Vaccines cannot help those who are already infected and seriously ill, so, it should be surprising that there so little news about treatments. In fact, there are about 10 times as many Phase 2 and 3 treatment clinical trials for … Read more
The Russian government made a splash this week by announcing the World’s first approval of a coronavirus vaccine for mass use and, to rub it in, named it “Sputnik V” after the first Soviet satellite that launched the space race. If you set the politics aside and look at the science, the Russian vaccine, if … Read more
A couple of reports this week show disparity in the use of telemedicine in older individuals. Adults older than 72 years of age were found to prefer in-person visits over telemedicine highlighting a hurdle in the expansion of telemedicine. But that’s not necessarily a bad thing. The data can be used to prioritize in-person visits … Read more
We have been told for decades that it takes about 10 years and more than $2 billion to develop a new treatment, so how does one explain that we may have a working vaccine less than 6 months from the start of the first-in-man trials? It may seem like a myth, a conspiracy to deceive … Read more
Celebrity endorsements and testimonials are a prominent way to market a medical product; our media and airways are filled with drug advertisements featuring famous people. But one could use celebrity testimonials to boost the prospects of an investigational product as well. ImmunityBio, Inc., a California company owned by Dr. Patrick Soon-Shiong, treated two celebrities with … Read more
The pandemic has created enormous wealth for Moderna, Novavax, and several other companies developing vaccines and treatments for the virus, much of it at the taxpayer’s expense, so it’s a fair question to ask, what the public “investors” are getting in return. Short answer, not much. Companies often use the cost and risk of developing … Read more
This week FDA announced that it has extended its enforcement date for illegal stem cell clinics by six months due to the pandemic. At the same time, FDA released a blog targeted towards patients telling them about the dangers of the illegal stem cell therapies, and a final guidance document reiterating FDA’s policies that almost … Read more
Sinopharm, the Chinese government owned company announced that 30 of its employees, including some in senior management roles, were the first to receive its experimental Covid vaccine. And this would be legal even in the US. It is often assumed, incorrectly, that the regulations prohibit employee participation in company-sponsored clinical trials. On the contrary, under … Read more
FDA announced earlier this week that the domestic GMP inspections would commence on Monday, 20 July. However, there would still be several conditions that must be met before FDA inspectors travel to a manufacturing site and FDA would allow several concessions to the site being audited such as no-unannounced visits, using PPEs during the visit … Read more
