Sinclair Research offers full-service IND-enabling toxicology and safety pharmacology services at a single research site in Missouri. Whether your program is in late-stage discovery or entering clinical trials, Sinclair Research provides the services you need, the data you expect and the customer service you deserve.
Nonclinical safety studies are required to establish a safe starting dose for initial human clinical trials, but how do you know which studies are required to get your compound to the clinic and what special considerations need to be made for your program? Set up a consultation with Sinclair Research’s scientific experts who are available to review your program requirements and share insights tailored to your specific compound.
|
|
BioPharmGuy
It was brought to my attention that the Terms of Use at Nostrum Pharma (they of the retro 2008 website we featured last week) bans “Deep Linking” which, absurdly, means we were not allowed to link to any page except their homepage. Better call Saul!
Our pediatrician administered three vaccines to my kid recently and billed it at $1047. Two were nonexclusive (though not technically generic), while one was exclusive and patent-protected. American health care system at its finest right there.
Addition & Attrition
13 companies added, 16 removed. Summary file of companies added/removed available on our downloads page.
|
|
Boston Biotech Boom
If we haven't told you enough already, there is an astonishing biotech boom going on. Is this time different? Maybe slightly, but not enough to merit the wild amounts of money flying around. Just how high has the VC funding for biopharma companies been in Massachusetts specifically?
Put it this way – 2020 was the record year for VC fund raises at $5.8B. In 2021 VC funding hit $4.3B…by the end of March (page 21). So three months in, 2021 was already the third-highest VC funding year on record for Massachusetts biotech. Madness.
Intuitive Surgical
“Unauthorized use of robots” is something a medical device company can get into trouble for, at least in these primitive times in which we live. In 30 years, it will probably be “unauthorized use of human surgeons” that gets people angry.
The Name Game
Cerecor decided it was time for a rebrand. Nothing wrong with their existing name, but people do what they do. Henceforth they shall be known as...Avalo Therapeutics?
What a snoozer. We already have an Actavalon and an Avalyn Pharmaceuticals in San Diego. Then there’s Evelo Biosciences out in Cambridge, MA (fka Evelo Therapeutics) plus Avolynt in Durham, NC. Finally, in the graveyard we’ve got Avalon, Avalon Pharmaceuticals & Mavalon Therapeutics. Overall, a weak choice.
3/10: Cerecor was better
Aarkus Therapeutics was another rename we caught wind of this week. It was a pretty gross-looking name, so sure, let it burn. What'd they come up with? Aarvik Therapeutics. Wow, they really wanted to stay at the top of the phone book.
2/10: lazy, rhymes with Sid Farkus
Hide Your Kids, Hide Your Wife
In the past week Boston biotech entrepreneur David Sabatini & extensively bearded, anti-aging dreamer Aubrey de Grey have both been fired from at least one of their institutions for sexual harassment. Sabatini retains tenure at MIT for now. De Grey was technically fired for interfering with his sexual harassment probe, whereas Sabatini was fired at the conclusion of his. Been a while since any big biotech heads have rolled for sexual harassment – when it rains, it pours.
F**k Everything, We’re Doing 50
Merck and Pfizer have quite the pneumococcal vaccine rivalry going. Pfizer’s Prevnar 13 is the standard bearer for children, protecting against 13 serotypes of the disease. Merck’s phase 3 pediatric trial of their 15-serotype vaccine just showed positive results (it was approved for adults in the summer) but Pfizer is looking to hit right back with its own 20-serotype vaccine. At this point, Merck needs to go full Mach3 and jump straight to 50 serotypes.
Moderna
This week about a dozen protestors amassed outside Moderna’s Cambridge location to protest “Pandemic Profiteering”. They’re outraged at the $16.50/dose price tag of the life-saving vaccine. One protestor drew a parallel with the original HIV treatment which was priced at $6,400/yr in 1989 (or $14,000 in 2021 dollars).
The only question is, what was that protestor smoking? $14,000/yr was a bad look...but less than twenty bucks is an absolute steal for such an important medicine. You can pay $16.50 for a damn hamburger in Cambridge. What a jerk.
|
|
Is your company a service provider? Are you selling products to biotech companies? If so, you really need to maximize your time selling and minimize your Internet digging. Good news: we've done the research. Check out our data options if you want to spend less time googling and more time selling.
|
|
FDA Resignations
Two of the FDA’s foremost experts on vaccines have stepped down from their positions. People are speculating as to why they would decide to do so at such a moment, but Dr. Marion Gruber was with the FDA for 32 years and was probably about 70 years old while Dr. Phil Krause was roughly the same age. Considering the stressful past 18 months and the undoubtedly stressful 6-12 months to come with the pressure the FDA is already receiving from the Biden administration to approve booster shots prematurely, as well as the growing pressure to quickly approve a pediatric Covid vaccine, it’s hard to blame them for wanting to head for the beach.
Meanwhile Biden still has not named a nominee for the FDA’s top job. This comes across to some as almost dereliction of duty given the current state of affairs. In reality, the acting commissioner, Janet Woodcock is a 35-year FDA veteran who is experienced and highly capable. Problem is some Senators do not like her, so she’s been ruled out as a permanent appointee. The status quo with her as acting commissioner is something the administration is probably fine with, which is likely why they have not acted with much urgency to appoint someone else.
Fake News, LinkedIn Edition
It's amazing how much vaccine disinformation is flying around the biotech industry on LinkedIn. This week people were sharing an article claiming that natural immunity was more effective at preventing Covid than the vaccine and therefore vaccines are pointless.
This is what you call a straw man argument - no one who understands infectious diseases and immunology was arguing that vaccination protected better than recovery from an actual Covid infection. It’s just the problem with getting that fancy natural immunity is you have to get Covid and the 1-in-1000 chance of dying. NO. THANKS.
We’ll take the vaccine, and it’s 95% protection against severe Covid & 99.999% protection against death, thank you very much.
What's Good Enough for the Horse...
People be goin’ crazy for the ivermectin. Dogs and horses already love it – it keeps the heartworm at bay. If it’s good enough for dogs and horses it’s good enough for people, right? I mean, everyone in middle America eats dried up bits of meaty/grain kibble and oats for dinner right?
Ivermectin is approved for human use for a couple parasitic diseases, but it has not been shown to be an anti-viral compound. However, the news talkers told people it was a cure, so they want the product (just don’t give 'em any of that vaccine voodoo!).
According to the ivermectin drug label, the clinical studies used for its approval only included about 1,000 people. That’s 190,000 times fewer than the people who have received a Covid vaccine, but never mind all that. That tiny clinical trial didn't show any major side effects, but the drug label mentions that ivermectin has been shown to be teratogenic in mice, rats & rabbits. If you don’t know what a teratogen is, it’s something that causes abnormalities in living things – birth defects and the like. (And if you want to have trouble sleeping tonight you can do some research on teratomas, which are one of the freakiest things you will ever see in your life. Seriously, don't go looking if you want to sleep tonight.)
One Ohio woman even went to court recently to get her comatose husband some ivermectin. The judge declared that the hospital must administer it. At first reading it seemed like the article was implying that the woman was telling the hospital doctors what to do, but the facts were slightly different. How it went down was she went and shopped around for a doctor who was willing to write her husband an ivermectin prescription (shades of the dark days of OxyContin there), then the hospital declined to administer it. So this lawsuit was more about ensuring that a patient at a hospital could receive a drug that their doctor had prescribed. There may be more to it, but it sounds like a somewhat reasonable application of the law if the comatose man had basically no alternative treatment options available.
|
|
Do you have a life sciences event to promote? Try spotlighting it right here. We only allow one per week, so you'll be the guaranteed headliner (of this section). Never know, might actually work. |
|
BioPharmGuy is a registered trademark of Wilsonian LLC, Content © 2021 Wilsonian LLC.
|
|
Check your website analytics - we are likely one of your top referrers. You may be able to boost those referrals with a Premium Listing. Try it for as short as one month. Full summary of all our upgrade options available here: Promoted Listings. Send us a message if interested!
|
|
|
|
|
|
|
|
