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QPS is a GLP/GCP-compliant global contract research organization (CRO) delivering the highest grade of discovery, preclinical, and clinical drug development services. Since 1995, it has rapidly expanded into a full-service CRO with 1100+ employees in the US, Europe, India and Asia. Today, QPS offers expanded pharmaceutical contract R&D services with special expertise in Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine and all Phases of Clinical Development.
For more information, visit www.qps.com or email info@qps.com
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BioPharmGuy
Well, Covid has finally descended upon the BioPharmHouse. Kind of amazing it took almost two years. We went so far as to cancel some holiday family events out of an abundance of caution (sorry, Mom!) to ensure a safe return to school, so of course the day the kids went back after break it came home with them.
Thankfully all household members are fully vaccinated/boosted so we are managing fine right now. We discovered our new guest by visiting Purdue University’s local testing clinic. After waiting on site for the result, they told us it was negative. About an hour later when we requested the emailed result, it turned out it was actually positive, which we confirmed on a home test. Whoops!
Also this week I've had three phone calls with clients and all three were recovering from Covid. If you haven't gotten it yet, I guess just wait a few hours.
-BPG
Addition & Attrition
Added 14 companies, removed 12.
Best New Name:
Nine Square Therapeutics
Worst new name:
Protai
You will be missed:
Sapphire Biotech
Summary file available on our downloads page.
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A Born Leader
Julphar is a pharmaceutical manufacturer in the Middle East. It’s unique in that it was founded by the ruler of one of the seven Emirates that coalesced into the United Arab Emirates. The founder’s son is now chairman of the board. You can call him Mr. Chairman or His Highness Sheikh Saqer Humaid Al Qasimi, if you’re not into the whole brevity thing.
Persion Pharmaceuticals
We love us a vapid mission statement. How about this one:
“Persion’s strategy is to maximize value for our stakeholders by employing an effective operating model with focused and disciplined execution that allows us to pursue growth opportunities both through organic and strategic inorganic expansion.”
So to summarize, their mission is to be a business. They even felt so strongly about that credo it’s written twice. Because by repeating something, you can convince people what you're saying is important.
Three Vaccines, One Branding Agency
Pfizer & Moderna both retained The Brand Institute to come up with names for their Covid vaccines. Pfizer's was christened Comirnity while Moderna’s was dubbed Spikevax. Does anyone use either of those names? No...no one does. In fact, most people have never even heard those names.
Yet here comes Novavax with their step-child of a vaccine, also enlisting The Brand Institute to come up with the perfect name.
Question: If NO ONE uses the brand name for the other Covid vaccines, why on Earth is Novavax paying someone a bunch of money to name theirs? Anyways, what fantastic name did Novavax pick from the options presented? Nuvaxovid.
What the. It looks like they're telling you to avoid this vax. Plus it’s nine letters and four syllables, just like that mouthful, Comirnity. The only good name of the bunch is SpikeVax, due to its simplicity.
Know what...BioPharmGuy would have charged fiddy bucks and named this thing NovidVax. "Nov” from the company name, “vid’ from Covid plus "Vax". Put it together it’s a vaccine that says ‘no’ to Covid. Boom, ship it. Check can be made payable to BioPharmGuy.
The Bums Will Always Lose
As if they haven’t already gotten enough sour news about Aduhelm, Biogen got what could be the worst possible news this week. Medicare said they would not cover it outside of clinical trials.
If these clinical trials (which the FDA mandated Biogen run as part of their approval) show good results, Medicare will surely change its tune. And that's how it should be – the original trials did not show any improvement in symptoms, only an improvement in a blood biomarker. If you want taxpayers to pay for you product, you really should have to show that it actually, you know, works.
L.E.A.F. Pharmaceuticals
This outfit really wants you to know L.E.A.F. is an acronym, thus all those periods. Conveniently they spell out the meaning right in the logo: Lifting and Empowering All Families.
Bleh, that’s more like a S.T.E.M. (Seriously Trite Ennui-inducing Moniker).
I Can Get You a Pig Heart
Revivicor's genetically altered pigs have been approved by the FDA for use in food, but they’ve also been working on transplanting these organs into humans. An opportunity arose last week to attempt a pig-to-human heart transplant, as the patient had no other options.
The operation worked, in that the man is not dead as of yesterday. Typically, a groundbreaking transplant like this will not last very long, so survival beyond a short span is highly unlikely. Either way, he’ll go into the history books and help advance transplantation science. Kudos to him.
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Qosina Offers Stock Components for Single-Use Systems
Qosina is a leading global supplier of more than 5,000 stock components to the medical and pharmaceutical industries and offer a comprehensive selection of parts for the design, development and manufacture of single-use systems for bioprocessing.
We are your one-stop source for single-use components, with low minimum order quantities, a liberal sampling policy and bill of material kitting, all supported by regulatory documentation and backed by Qosina’s assurance of supply.
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Back to the Sewers
One comment on the pandemic topic – you’ve probably seen that hospitals have a record number of Covid patients and many are at or near capacity. Capacity issues are definitely real, but the figures for hospitalized Covid patients should be taken with a minor grain of salt.
Such a tremendous number of people are unknowingly infected, they’re showing up at the hospital for entirely different reasons and their Covid is only being detected when they are tested upon arrival. So while they are technically a patient in the hospital with Covid, more than a few are not there because of Covid.
Regardless, full is full, so when hospitals lack capacity, it’s an inarguable reality that people are getting sick like crazy.
The Pfizer Papers
A judge has decided the public will not have to wait 55 years to see the Pfizer vaccine submission documents. He decided they must produce 55,000 redacted pages per month. Maybe they’ll call in the investigators who have nothing going on now that inspections have again been cancelled due to the Omicron wave. Properly redacting 55,000 pages per month is going to be a superhuman task. More than likely, they'll simply over-redact and anger these FOIA requestors even more.
It’s kind of sad we have a bunch of attention seekers wasting the FDA’s time like this. If there were evidence of damages being caused by the vaccine, sure let’s take a look under the hood and see if pertinent info was hidden in the submission. But there simply are no negative health effects beyond what was known at or shortly after submission. We know the vaccine worked and we know the side effect profile was minor. That’s what matters.
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Featured Job
Clinical Research Associate - Premier Research
If you have a few years of experience as a Clinical Research Associate it may be a good time to move up a bit. Premier Research is looking for someone to work remotely (and on the road, of course) as their CRA II/Sr. CRA. Premier is a mid-sized company, so you won’t be totally lost in the shuffle like at the giant ones. The job posting is a bit extensive, but if you have a few years experience it should be a decent fit for you. Take a look.
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ETC.
FDA Waves the Slightly Reddish-Orange Flag
You remember French dressing, right? That abomination from the olden days that only exists today at Midwest buffet salad bars. Well, The Association for Dressings and Sauces has finally achieved victory in their 70-year fight to end the FDA's tyrannical regulation of what can be called French dressing.
This deregulation received 20 total comments, some of which "appeared to have been submitted as part of a university course assignment". Wow, the public was really all-in on this momentous case.
Funny, but this is the Association for Dressings and Sauces' second appearance in our ETC section. Since you made it this far, why don't you head over to their website for all things sauce. And why stop this maniacal sauce rant there...you want a delicious sauce, try Capital City Mambo Sauce, Sweet Hot. Chicken, brisket, great on anything. You'll be looking for excuses to eat the sauce itself which is the mark of a truly amazing product. (No they aren't paying us, we just love the sauce.)
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