The good news for pharma companies is that according to a recent report from PhRMA, 74% of medicines in clinical development are potentially first-in-class medicines. Some other findings: 822 projects—defined as unique molecule-indication combinations—are designated by the U.S. FDA as orphan drugs; 529 projects are using cell therapy; 202 projects are using gene therapy; and 173 are using DNA or RNA therapeutics. Recently, we’ve all had our fill of drug pricing commentary, and if the 74% holds true through approval, it will put the biopharma industry in a strong position to defend pricing strategies. While there are silver medals in some competitions, coming in second in the drug development race can be catastrophic. Maybe Ricky Bobby was right.
BTW, if you’re personally looking for something to be first in, we’re in the second week of our testimonial contest. Email us ([email protected]) a funny testimonial about why you love (or hate?) our newsletter—130 words or less, just like our writers have to do. The knee-slappingest, ROFLMAO-iest testimonial will win a $50 prepaid gift card. And we’ll send your write-up out in one of our newsletters—without your name, of course. You’ll be kinda famous, but in an anonymous sort of way. May the odds be ever in your favor.
Transparency and drug discovery don’t usually go together, what with patents, IP and paywalls hiding useful knowledge from researchers working on similar problems. But the Structural Genomics Consortium has a different approach. That’s right, crowdsourcing has made its way to drug discovery. The SGC partners with six research universities, nine of the largest pharma innovators, and government agencies to provide open source data about protein structures that can be used to develop hard-to-design drugs. They’re currently using the approach to, ahem, stick it to Huntington’s (see, it’s funny because they’re literally trying to bind molecules to the protein that causes the disease.) For a small contribution of $8 million—cheap by R&D standards—any organization can nominate proteins to the SGC’s master to-do list.
If Neil Armstrong were a scientist, we’re pretty sure he would’ve said that about this breakthrough study. For the first time ever, the spread of the HIV virus was stopped in its tracks in a living animal, including in a humanized model. Kudos to Dr. Wenhui Hu and his team at LKSOM. This was done by using the gene editing technology CRISPR/Cas9. After replicating the findings from their previous proof-of-concept study, the team tested mice infected with EcoHIV (mouse equivalent to human HIV-1) and mice that were engrafted with human immune and T cells (i.e., “humanized”) then HIV-1. In both tests they were able to successfully excise and block further infection. Take that, HIV.
Foghat reference aside, this is a pretty big deal. At the risk of glossing over the benefits of AUSTEDO, the second product approved for Huntington’s disease (yaaay), what stole the spotlight in Teva’s press release is the fact that this is the first ever approved deuterated product. Delaying drug metabolism has been an expensive problem that pharma has tried to solve for many years. In scientific-y terms, replacing a few hydrogen atoms with the heavier isotope deuterium causes a much stronger chemical bond that makes it more difficult to break down. What this means in the long run: lower doses of deuterated drugs can have the same effect as higher doses of normal meds and hopefully patients will have fewer side-effects. Hooray science!
Kidding, we here at InsightCity love a good 90s throwback in augmented reality, but why stop there? Phillips certainly didn’t when it recently announced development of the industry-first augmented reality surgical device for spinal operations. This “hybrid operating room” technology combines x-ray images with external shots of the patient’s body to create 3D constructions of the internal and external operating site. Open-spinal surgery traditionally requires deep incisions with a lot of poking and prodding of the exposed spinal column (so lovely). Recent technologies have given us minimally-invasive procedures that reduce cuts, but also reduce visibility. Cue AR, giving the visibility and accuracy of open-surgery without the blood loss, long recovery times or post-op pain. So, cheers! To a better reality.
In accordance with a new policy released last Wednesday, the FDA has increased patient accessibility to hearing aids. The guidance, which takes effect immediately, removes the requirement of medical evaluation or waiver-signing before buying a hearing device. The agency also said they’ll consider creating a category for OTC hearing aids. So go ahead and prepare yourself now for some campy, elderly-consumer-focused commercials. The move was done in part to encourage industry innovation/competition to create cheaper hearing devices, which would also serve to increase access for the 30 million Americans who live with hearing loss. That’s something we can all get behind, right? Hear, hear!
Takeda is building a Bbidge, both literally and figuratively. Their newest venture, Bridge Medicines, combines the innovative research from three leading US universities and Takeda’s checkbook along with the capital of two healthcare VC firms. The three universities, all part of the Tri-Institutional Therapeutics Discovery Institute (Tri-I TDI), discover new therapies that oftentimes don’t make it to clinical trials. This is where Bridge Medicines comes in. The most promising projects will now have resources and funding to expedite the development process to move from proof-of-concept to in-human clinical trials. Tip of the hat to Takeda on this one as they are then positioned to call dibs on the most appealing ones.
You know what sounds crazy? The FDA’s “2016 Naloxone App Competition.” The idea, to develop a location-based, social search service application (a la Tinder) that connects opioid users and first responders to someone nearby with a dose of naloxone, was presented as a challenge by the FDA to programmers, public health advocates, researchers and entrepreneurs in an attempt to slow the death rate from opioid overdoses. Naloxone is a prescription drug able to reverse the effects of an opioid overdose when administered quickly enough; the FDA believes this antidote is currently in too few hands to save all who might benefit. But an FDA sanctioned app that unites drug users with drugs? Just like opioids and smartphones, this app seems ripe for abuse.