Another week, another roundup of the new developments in drugs for COVID-19, the many things that happened on the 10th of June, and other things that caught my eye.
REMDESIVIR AROUND THE WORLD
Gilead’s remdesivir is being granted conditional approval in more regions of the world. The European Medicines Agency (EMA) started the assessment of benefits and risks of the drug, following the application for a conditional marketing application. Singapore’s Health Sciences Authority (HSA) also communicated their conditional approval for remdesivir, stating that “although the data on its efficacy and safety is very limited at this point in time, HSA has expedited the review of remdesivir given the urgent public health need during the COVID-19 pandemic.”
This antiviral medicine, a viral RNA polymerase inhibitor, was originally developed for the treatment of Ebola virus disease but has shown broad in vitro activity for other RNA viruses, including SARS-CoV-2.
DAVID VS GOLIATH?
There are a lot of therapies being developed to combat COVID-19, and one can spend a lot of time discussing each of them.
What caught my attention with Constant Therapeutics candidate wasn’t the molecule, but the company itself. Constant Therapeutics is a privately held Boston biotech company with a small staff and an elementary website, completely at odds with many of the major players in the area, but it has a promising molecule: TXA127.
This is a pharmaceutical version of the naturally occurring peptide angiotensin-(1-7), which is the product of the enzymatic reaction catalysed by ACE-2. Some effects of angiotensin-(1-7) include decreased inflammation and a reduction in blood pressure as a consequence of blood vessel dilation. When ACE-2 in the respiratory epithelium is being used by SARS-CoV-2 to enter the cells, less angiotensin-(1-7) is produced, which can explain the severe effects of COVID-19 in the lungs. This way, boosting the natural peptide decreased production with its synthetic equivalent may help protect patients from a more severe disease course.
The first clinical trial with TXA127 for COVID-19 will start soon, comparing it with placebo. If it shows benefits, we’ll have a drug to protect the host, and proof that a small company can still make a splash. I’m rooting for them.
OBSERVED DATES ON THE 10TH OF JUNE
Few days have so much going on. I’ll start with MedComms day: this is a fairly new celebration (it’s nine years old), and it celebrates a ‘day in the life’ of medical communications. Check out this website for this year’s accounts of people from all over the world working in MedComms, or look out for the hashtag #medcomms on social media.
There was a new movement to increase awareness and try to eradicate anti-black racism in academia and STEM (Science, Technology, Engineering and Mathematics), with many universities and journals, including Nature, adhering to this cause. Social media was flooded with support messages and the hashtags #ShutdownStem, #shutdownacademia, and #strike4blacklives. From here, some other conversations have sprouted about how black people are treated in academia, like the ones you can now find on Twitter with the hashtag #BlackInTheIvory.
Last, but not least, comes the oldest celebration of the 10th of June, and not related to biopharma: Portugal Day. This date commemorates the death of Luís de Camões (10th June 1580), an important figure in the history of Portugal.
STILL THE VANISHING STUDIES
Last week I wrote about the COVID-19 studies that were retracted because independent auditors couldn’t access the raw data. This week I’m sharing a BMJ article by Jacqui Wise, who covers this issue and how nothing has changed in data transparency since Tamiflu days in a much more eloquent way than I can.
I also discovered another ugly case of scientific fraud, along with a new concept: paper mills. This and other cases of lack of scientific integrity are unveiled by Elisabeth Bik in her Science Integrity Digest blog. Her most recent post is about the earlier work of Sapan S. Desai, one of the authors of the retracted studies and founder of Surgisphere, the company that did not want to share the dataset used for both studies. Sigh. We need more Elisabeth Biks in the world.
To end this letter on a more cheerful note, I’ll leave you with an article by Randall Munroe, who frequently delves into the burning questions that pop into our minds and refuse to let go, such as…”Can You Boil an Egg Too Long?” You see, those really important things that keep us awake at night. 😊
That will be all from me this week, I hope you found it useful.
Let me know what you think in the comment box below 🙂
Other posts you may like:
- November highlights from the Biopharma Newsletter
- New to medical devices? Here are 3 insights about Clinical Evaluation Reports
- Are you an aspiring medical writer? Apply for the Geoff Hall scholarship
- This week, less is more
- How AI and gaming can improve pharma and medtech
- Biopharma this week—(nearly) COVID-free edition