A partner to innovate, design and manufacture premier medical and pharmaceutical devices, components, and tubing
Freudenberg Medical is a global CMO / CDMO with 11 manufacturing operations worldwide. Manufacturing capabilities range from high precision components and tubing to drug coatings, finished devices, catheter shafts and hypotubes for minimally invasive and handheld devices. ISO 13485 certified quality systems and FDA registered sites are located throughout the Americas, Europe, and Asia.
For the Biopharma market, Freudenberg cleanroom manufactures the PharmaFocus® Premium and HelixMark® brands of platinum silicone tubing for bioprocessing and single-use applications.
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BioPharmGuy
Though this holiday is "a little out there", we'd still like to wish you all a Happy Festivus today. Be sure to let your family know all the ways they've disappointed you in the past year.
Let's rumble!
Monthly Update Subscription
You probably already know BioPharmGuy publishes a directory of 10,000+ biotech companies, but we also have many unpublished data fields available for purchase - Decision Maker Emails, Drug Pipelines, Number of Employees, etc.
One of the biggest challenges with any data set is keeping it up to date. We make changes almost daily, so keeping data fresh is our specialty. In fact, with the purchase of our All Companies/All Data Fields option for $2,557 you become eligible to subscribe to our Monthly Update. With that $100/mo subscription, at the beginning of each month you will receive a spreadsheet with the following tabs:
1) Current version of our entire database
2) All companies added in the past month, with full details
3) All companies removed in the past month
4) All data field changes made in the past month
5) Explanations for companies removed
6) Company name adjustments
It’s pretty involved but could be a good way for you to put any leftover 2021 marketing dollars to work next year.
Weekly Directory Edits
Added 16 companies, removed 15 this week.
Best new name:
20n Bio
Worst new name:
Cargene
Bye bye, but how did you ever think that was a good name:
PreciThera
Summary file available on our downloads page.
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Pfizer/BioNTech
News out Friday indicated their Covid vaccine did not show a strong immune response in children 2-5, but it did in children aged 6 mos - 2 yrs. The dosage used in this trial was was 1/10 of an adult dose, while the vaccine for children aged 5-11 used 1/3 of an adult dose.
Oddly, Pfizer’s answer is not to try a 1/7th dose (or similar) in kids aged 2-5, but to give them a third shot to see how that goes. Damn, that almost comes across as a ploy to sell as many shots as possible, doesn’t it? And if you’re a parent, this is a much bigger hurdle to getting these kids fully vaccinated. Convincing a 3 yr-old to take one shot is hard enough, but at least you normally have that 12 month forgetting period - three shots over the course of a month or two?
Good luck, parents.
Pfizer did have some good news yesterday when the FDA authorized their Covid-19 pill for emergency use. The US government is purchasing the supply and providing it to citizens free of charge. Logistics are yet to be worked out, and the product currently has a 9-month production time, which Pfizer hopes to halve next year. Expect a lot more details on this product in the near future.
B-Adu Helm-bug
Biogen just dropped the list price of Aduhelm in half. Given there is no clinical proof of symptomatic benefit, that still leaves it infinitely overpriced. Speaking of that lack of symptomatic benefit, Biogen issued a press release with what they said was “an important update” on the post-market clinical trial the FDA is requiring them to run on Aduhelm. That important update was that they are working on submitting the outline of the study to the FDA and they might submit it by March 2022 and the trial could be completed somewhere around March 2026. Wow, some real breaking news there.
Also, the EMA recommended not approving this product. Didn’t spend much time on it either - pretty much just said 'didn’t show clinical benefit, did show negative side effects'. Sometimes fewer words can say so much more.
"My son tells me your company stinks!"
Team Roast – Xelia
Excited to be a part of this amazing website photo shoot, everyone. Thanks for having me. Now let's get down to business.
Boom, nailed it.
Who’s next? President – slide them hands into your pockets.
So suave!
Moving along…CSO, ever seen that episode of Seinfeld where Elaine dances? Do. That. Dance.
Bellisima!
Now VP of people– whatcha got for me? Aha! The “c'mon” hands/face.
Classic!
Hey VP EHS & quality, can you beat that? Ooh, hand on wall and hip. At the same time.
Double nice!
R&D, how about you turn sideways, hold an imaginary mic and belt out Don’t Stop Believin’ in your mind...
*click*. Got it!
Let's bring this home. Last three – how about you laugh at nothing, be smug and show us your curveball grip.
Great work team, that’s a wrap!
Sorry He Got Caught
Usama Malik, the biotech CFO who was recently indicted for insider trading published an essay on LinkedIn this week but removed it a couple days later. If you missed it, it was part self-aggrandizement, part pity-party, but mostly a bunch of big words that were just hard to believe. He alluded to the fact that there were recently some 'allegations' against him, but didn't spend any time denying said allegations.
The most hard-to-swallow part was when this CFO, who was making $1.9M/yr and allegedly helped his girlfriend and brother steal $69k, said “we must move past…selfish capitalism and relearn some of the lessons from Adam Smith’s Theory of Moral Sentiments, which beyond selfishness highlights concepts of empathy, justice, conscience, virtues, and moral rules. It’s about the people, the planet, and non-zero-sum profits.”
Unbelievable. Enjoy the jail cell, a**hole.
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Qosina, a global supplier of single-use components, offers a comprehensive portfolio of more than 1,000 stock components for the design, development and manufacture of single-use systems. Leveraging over 40 years of experience as a trusted supplier of OEM medical components, Qosina provides a much-needed resource for bioprocess, vaccine production, and cell and gene therapy.
Our mission is to ensure security of supply and the best customer experience possible by helping our customers find, order and receive their required components quickly and accurately. We provide practical solutions to meet the changing needs of the bioprocess industry through innovation, technology and continuous improvement.
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Flu Vaccine
Every year, the WHO takes a look at which flu strains are circulating in the Southern hemisphere during its winter and uses that to try and predict what might end up circulating in the Northern hemisphere's winter. They then instruct vaccine manufacturers which strains to include in that year's vaccine batch.
Even in normal years this isn't a foolproof method, but this past flu season presented an extra problem – there was almost no influenza anywhere. So it was a total shot in the dark, and so far it seems to have been a total miss. The strains in the vaccine are not aligned with what is circulating up north.
Oh well, not like all the hospitals are full of people choosing to slowly succumb to an almost totally survivable illness.
Delta Blues
If you had two weeks as the amount of time between Omicron going from less than 1% to greater than 70%+ of detected US Covid cases, come on down and claim your prize. These figures are actually CDC estimates, but are likely ballpark accurate. Maybe it's only 50%. Still, that's blazing fast.
In fact, this new variant is said to pass 7x easier than Delta, which you may recall spread like wildfire. Death rates in South Africa have not budged despite an ongoing Omicron surge, so we can still be reasonably hopeful this variant will not be as deadly as prior ones.
What is Life
Poignant essay on Twitter from a women whose unvaccinated father passed away from Covid. One quote that really stood out: “he always said he'd die for us, but in the end he wouldn't live for us”
What the Deuce
Fecal transplants have been exploding in recent years. Organizations have been popping up to take donations from interested parties, but the best named has to be Number2.org. Go ahead and fill out the questionnaire to see if they will accept your...processed goods.
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Featured Job
Clinical Project Manager - Premier Research
This is a new opening Premier is looking to fill. They need someone with a good amount of experience in the clinical research game - 5-8 years depending on your past responsibilities. It's a remote position and as the job title probably let you know, it involves management of trials across regions or even internationally. Plenty more info here, so check it out.
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BioPharmGuy is a registered trademark of Wilsonian LLC, Content © 2021 Wilsonian LLC.
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