Lilly & Lox(o)

While New Yorkers have their famed duo of bagels and lox, Eli Lilly is making its own combo with its $8B purchase of Loxo Oncology. The cancer-focused biopharma just recently had its first US approval in Vitrakvi, which can target multiple cancers by focusing on tumor biomarkers instead of the affected tissue area. The deal cements Eli Lilly’s presence in the oncology space, but follows the trend noted in a recent report by EY that says drugmakers have been spending too much on stock buybacks and bolt-on acquisitions instead of megamergers like Takeda/Shire and BMS/Celgene. Loxo stockholders should be pretty happy with the deal—when Loxo shares went public in 2014 they cost $13, and Eli Lilly will be purchasing them for $235 a pop.

Brother, can you spare a dime

Turns out pharma companies can spare a dime (or more) for cancer patients who want to participate in clinical trials. Pennsylvania recently became the 2nd state (after California) to sign a bill that “provides for reimbursement of patient expenses associated with participation in cancer clinical trials.” Wait, we need a bill for that? Guess so. The participation rate for people with cancer in the US is really low, like 3% low. Maybe these bills will create some positive momentum for clinical trial participation. Just a 1% increase in participation rates would be huge, given there are over 1,000 assets in the development pipeline targeting cancer. Apparently FDA came out with some guidance that reads “paying research subjects in exchange for their participation is a common and, in general, acceptable practice.” Good to know.

Cell phone cancer

I didn’t mean to imply cancer of the cell phone. My bad. According to NBC News, the US government’s National Toxicology Program released its report on the effects of cell phone-like radiation on tumor development. According to one rat participant “it’s not a tumor” (but really it was). Exposure to radiation of the types from 2G and 3G phones led to “cancerous heart tumors” in male mice. “…the totality of the available scientific evidence continues to not support adverse health effects in humans caused by exposures at or under the current radiofrequency energy exposure limits,” said a very dull-sounding Dr. Jeffrey Shuren from the FDA. Ok, but what about that heart tumor thingy? If that’s not confusing enough, the irradiated male rats also lived longer than the non-radiated rats. Must be a Spider Man thing. These results were about as clear as the reception from Straight Talk mobile service. Here’s a list of the best and worst mobile carriers in the US. Spoiler…Straight Talk suuuuuuuuks.

And the winner is…

All of us. Thanks to James Allison and Tasuku Honjo, winners of the 2018 Nobel Prize in Medicine, we now have a much better understanding of cancer, and how to treat it. Allison and Honjo characterized two very important and potent pathways – called “immune checkpoints” – that can shut down the immune response (CTLA-4 and PD-1). Anyone heard of “monoclonal antibodies?” Of course you have, and well, that’s thanks to these two smart people. For a really good article on their discovery and what it has led to go here. Dr. Allison is currently working at MD Anderson and you can see a short video of him here. MD Anderson has a very nice 3-minute video on “What is immunotherapy” that is worth a watch. Everyone together now, say “thanks guys”

The verdict is in (until the next study)

“…results show that the safest level of drinking is none,” reported a team of researchers in a recent study, funded by the Gates Foundation and published in the Lancet Medical Journal. The meta-analysis of more than 1,000 studies found alcohol to be responsible for nearly 3 million deaths per year globally. These deaths include—among other things—heart disease, cancer, and accidents. While studies that demonstrate the beneficial effects of alcohol receive much popular media attention, Robyn Burton of King’s College London believes, “the conclusions of the study are clear and unambiguous: alcohol is a colossal global health issue.” According to the study, in 2016, alcohol consumption was the single largest risk factor for early death in people ages 15 to 49. Party on, Wayne. Party on, Garth. And other Wayne’s World quotes. [Warning: semi-mature, stupid, adolescent humor]

Real-Time Oncology Review

Earlier this week, FDA granted its first approval as a part of two new pilot programs that aim to make the development and review of cancer drugs more efficient. The drug is Novartis’ Kisqali and the two programs are the Real-Time Oncology Review (allows for the FDA to review much of the data earlier, after the clinical trial results become available and the database is locked) and the Assessment Aid Pilot Project (used by sponsors to organize their submission into a structured format to facilitate FDA’s review of the application). FDA Commissioner Gottlieb says, “With today’s approval, FDA used these approaches to allow the review team to start analyzing data before the submission of the application and help guide sponsor’s analysis of the top-line data.” Looking for a heavyweight fight? Watch sales of Pfizer Ibrance vs. Novartis Kisqali.