Let’s be honest, 2016 was a mess of year, and one that many of us will be happy to see the back of. It saw the loss of a series of beloved actors, actresses and musicians as well as political earthquakes that have opened gaping divides between American, British and European societies. As if things weren’t weird enough, the Cubs won the World Series (as predicted in the 1980s by the Back to the Future screenwriters), as Leicester City won the Premier League (which will become a film).
For biotech, 2016 has been a mixed bag; perhaps not an annus horribilis for the industry, but there have been problems. The IPO market for biotech has been weak, with a series of downgrades and pulled offerings, with several biotechs (Bind Therapeutics and NephroGenex) also filing for bankruptcy.
But on the flipside, VC funding has been strong, and there have been some major new areas of research that began in earnest this year.
That brings us to our top story for the year, in terms of overall views from you, dear readers, which is CRISPR-Cas9, the great gene editing hope that many are betting can be a next gen, possibly curative tech for a host of conditions from sickle cell disease to cancer.
Our top story was the news that Facebook and Napster billionaire Sean Parker was to help fund what he hoped would be the first ever in-human clinical trial using CRISPR. In the end, it was Chinese researchers who pipped Parker’s funded team, and the host of biotechs working on the tech, to become the first to test the gene editing technique in humans. Parker’s team should start human tests next year.
Our sixth biggest story of the year was also highly pertinent to the future of this tech, namely the ongoing patent battle over who is/are the original creator(s) and owner(s) of CRISPR? Intrigue and emails heated up the fight – a fight which could have major permutations for all of those working on the tech depending on the outcome.
The rest of the list though shows that you love a negative story, or at least read them in your droves. The second biggest story of the year was Roche’s late-stage failure for its B-cell lymphoma test, while the third and fourth biggest stories centered on Pfizer.
No, not the Big Pharma’s buyout of Medivation, but its shock decision to can PCSK9 inhibitor bococizumab after finding that, actually, it didn’t really work in the way it had hoped. Pfizer was also in hot water when it let go of one of its leading cancer experts after a series of science paper retractions by the co, these prompted by allegations of data manipulation.
Outside of CRISPR, its “cousin” tech CAR-T has also proved a major focal point, but again one of our biggest stories focused on the negative side, i.e., the deaths and brief halt coming out of Juno trial of the tech. This was quickly resolved between the FDA and the biotech, but it appeared to give rival Kite the upper hand, as it seeks to be the first to market – which could happen as early as next year. The story hasn't stopped there however, as just this week Juno halted the trial again after two more deaths, leaving its future hanging in the balance and battering its shares.
As biosimilar development and approvals start to really get going in the U.S., it was a shock when Novartis, seemingly on an easy course to approval, was hit in our seventh biggest story when the FDA rejected its biosim application for Amgen’s Neulasta (pegfilgrastim).
Details were thin on the ground, but the FDA’s dreaded complete response letter was not only sent out to Novartis, as AstraZeneca was hit by manufacturing issues (like so many this year) from its ZS Pharma biotech unit, that saw the U.S. regulator deny approval for its Veltassa rival ZS-9. It has however since re-submitted the med for approval.
ASCO was also one of your most read, but again, you wanted to read about the mishaps, and this time it was around AbbVie and its not-as-impressive-as-hoped cancer drug Rova-T.
Our final biggest story of the year was one of our most recent: president-elect Donald Trump. Leaving the politics aside, his victory was a boon for biotech stocks, with the Nasdaq Biotech Index and the S&P Biotech having the best day since 2008 when Trump was elected in November. The rally continued, despite warnings that he, like the defeated presidential hopeful Hillary Clinton had promised, could still go after drug prices.
The rally was partially as a result of the news that he is seeking to “reform the FDA”, which could mean a stripping down of regulation for new meds and, should Congress get it through this session (as it says it wants to), the 21st Century Cures Act could also go some way to further speed up the FDA’s decisions on drugs.
On the negative side, however, he could rip up Obamacare, leaving a looming question mark over what would replace it, and how it would impact the industry, and whether his government is happy to inject billions into the NIH research budget, as well as paying for the FDA.
I have a sneaking supposition that Trump will likely top some of our bigger stories over the next 12 months; keep up to date with us in 2017 to experience what promises to be an interesting year.