A little more than 5 months ago, Arsalan Arif and I launched the main edition of Endpoints News. We hit the ground running and gunning for a daily industry report that would provide some real insights on the deals, data and drama flowing around the biopharma world every day.
We’re all about the latest news in context, guided by 13+ years of daily coverage. And we recently passed issue #100, with about a quarter million words of searchable content.
We’re using the Thanksgiving break to highlight what you, our readers, have voted as the most popular content we’ve put up in that time. The top 10 links, ranked by web traffic, starts with a scoop and ends with two stories about back-to-back disasters that occurred earlier this week and immediately went semi-viral.
So without more ado, here’s the most clicked stories of 2016, so far.
We got a tip early on August 31 that Novartis was dissolving its 400-person cell and stem cell unit and laying off a bunch of the staffers. When I first heard it, I thought it had to be wrong. Why now? Just as the first cell therapies in CAR-T were heading for regulators? And with competition breathing down its neck? It didn’t make any sense. The company, though, confirmed the story, and our news break triggered a seismic reaction in the industry, which also wasn’t expecting it. The moral of this story is that we are all ears. If you send us a good tip, we’ll check it out. (You can securely send us things using PGP.)
This is one of several big changes we’ve tracked at Novartis in recent months. Also among our top stories: Novartis unveils a new global R&D structure, creating centers in Cambridge, MA and Basel. And there was this: Novartis’ retreat on CAR-T includes axing most of its senior execs on the team.
There are few industries where data is more highly regarded than in biotech. So it’s no surprise that a detailed list of the top VC outfits operating in the US — ranked by the numbers — was a hit just as we started the new online news source. And it continues to attract a steady stream of traffic from an industry which is fueled by billions in venture cash each year. California, with a big Bay Area cluster and a sizable hub in San Diego, clearly attracted most of the cash. And Boston/Cambridge is clearly the second big US hub. Keep an eye on this site: We’ll be back in 2017 with more detailed numbers.
More numbers, this time breaking our the top 15 research spenders in the industry. This is the life blood of innovation, as we know it. And the continued investment in R&D is at the heart of the growing debate over drug pricing in America. The top 15 spenders account for the lion’s share of research spending in biopharma, and I’ve been following the changing structures and strategies behind each of these companies for more than a decade. Each year we see more R&D group overhauls, but underlying everything has been a big commitment to seeking out and partnering with external collaborators. That’s been rewarded with mixed results.
It’s always a bit of a struggle to come up with my latest set of top pipeline blowups. Not because they’re rare. Quite the opposite. Limiting myself to 10 can be difficult. At the top of this first list for Endpoints is Clovis, which has never fully explained the mysterious switch-up in the data it presented on rociletinib. The company stopped responding to my queries months ago as it hunkered down to weather a tsunami of lawsuits and a federal investigation. Meanwhile, it’s been focused on its PARP inhibitor rucaparib, which looks to be squaring off against some tough competition. Some of the top 10 are the unfortunate consequence of a simple biologic mistake. Some are cautionary tales that offer a glimpse of how not to go about drug development. Sometimes, that can be hard to distinguish. But it’s always interesting.
5. Merck triggers a new round of layoffs in R&D reorganization, pushing more jobs into Cambridge, San Francisco
One of the biggest single trends over the past few years has been the migration of biopharma R&D into the big hubs. And Merck demonstrated its commitment to that hub strategy back in July as it set off a new round of layoffs while moving more of its research operations into Boston and the Bay Area, the two giant clusters in the US. In just the last few months we’ve seen new overhauls — both big and small — at Novartis, AstraZeneca, Pfizer and GlaxoSmithKline as well, continuing a years-long process. It may never end. Constant change is the rule in R&D, whether you push it or it pushes you.
This is not your typical pipeline catastrophe. Juno already experienced an extraordinarily short clinical hold for its lead CAR-T back in the summer, following the deaths of 4 patients in two studies. At the time, they managed to convince the FDA that they were quite certain that dropping one of the drugs used to condition patients would solve that nasty neurotoxicity issue. The FDA agreed in a matter of days, and now two more patients have been killed. I suspect that Juno’s next move will be to drop JCAR015 and instantly shift focus to JCAR017, their next top pipeline hopeful. But we need a much, much better accounting of what happened here, from the company as well as the FDA. A call with analysts by the company and a long-winded ‘no comment’ from the FDA isn’t going to cut it.
I’ll admit that we don’t have a whole lot of detailed insight into what Donald Trump is thinking about when it comes to biopharma. Maybe that’s one reason why this story about his enthusiastic, though completely unexplained, position supporting a reformed FDA and faster drug approvals attracted so much attention. We want to know what he’s thinking, but for now we’ll have to settle for what we can get. Based on several surveys we did during the campaign, it’s clear that the big majority of execs in the industry were opposed to a Trump presidency. But a stock rally after the election and an upbeat attitude about a supportive policy — without any new hints about Medicare negotiations on drug prices or reimportation — has started to turn the tide in his favor. Biopharma may never love Trump, but the industry is starting to like what little it’s seen so far.
Anytime a prominent company gets hit with an unexpected disaster, like this one at Alnylam, it tends to raise bigger questions. Did the failure of one drug have implications for the pipeline? How about rivals? How did it get this far? Alnylam tried mightily to put the collapse of its late-stage effort into a more comforting context, but the decision to halt the program clearly rattled investors. Now any new hint of trouble is likely to get the spotlight of careful attention, along with a blizzard of mixed comments on Twitter.
9. It’s over: Eli Lilly shares tank after its huge gamble on Alzheimer’s drug solanezumab ends in failure
Give Eli Lilly points for trying. But be sure to deduct a few for refusing to admit defeat. When you run a huge Phase III study and your drug flops, maybe it’s time to walk away. For Eli Lilly, though, there was enough clinical evidence of success to warrant another monumentally expensive effort. CEO John Lechleiter has already timed his departure, so you can’t say he resigned over this mess. But this is one black eye that will cause more execs to be more careful about how they spend their investors’ money. Sola at best may have turned into a weak but marketable drug. Its loss shouldn’t be mourned. We’re better off looking at better alternatives in the pipeline. And maybe now companies will stop touting their prospects to the press. Patients don’t need to be given false hope. This is a terrible, tough disease. And for the past decade, all investigators have experienced when it comes to actually slowing this disease is defeat.
Credit where it’s due. Endpoints News‘ Shehla Shakoor really got into searching the WikiLeaks collection of emails from the Clinton campaign, and she found a real eye-opener in this one. It turns out that Clinton’s carefully aimed barb at Martin Shkreli was part of a carefully calibrated plan to spotlight her pledge to rein in drug prices and bad actors like Shkreli. And senior staffers were ready to do a high-five as the markets made quite a to-do over the Twitter affair. Interestingly, absolutely nothing came out of the hubbub. No one reined in Turing or its big price hike. Shkreli was indicted on unrelated charges and Clinton lost. But the political war with pharma goes on.
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