Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Biotech CEOs discuss the challenges of working with CROs
- NYC sues opioid manufacturers
- U.K. biotechs are thriving, despite Brexit
Mergers & analysis
A flurry of deal activity kicked off the week as both Celgene Corp. and Sanofi SA announced multi-billion dollar deals. Celgene picked up CAR-T company Juno Therapeutics for $9 billion, while the French pharma dropped $11.6 billion to pick up Biogen Inc. spinout Bioverativ Inc. for its hemophilia franchise.
Investors were excited to see that M&A is picking up as predicted, but analysts raised questions about whether the acquirers overpaid for their assets and whether they be will smart deals when all is said and done.
With M&A top of mind, fourth quarter earnings season kicked off this week, with analysts asking when other companies are going to make buys too. Bellwether Johnson & Johnson told investors that the recent changes to the U.S. tax code wouldn't change its M&A strategy, while Biogen CEO Michel Vounatsos said he doesn't expect the influx of cash due to tax reform to create a deal frenzy.
But Biogen didn't disappoint on that front completely; The big biotech inked a small deal for a preclinical neuro asset from Karyopharm Therapeutics Inc., putting up $10 million upfront in the deal. Meanwhile, several hours after announcing its own earnings results, Novartis AG revealed that it has signed up to market Spark Therapeutics Inc.'s gene therapy Luxturna outside the U.S.
Perhaps incoming Novartis CEO Vas Narasimhan exchanged tips on how to make a deal with President Donald Trump. The pair, along with recently-appointed Bayer CEO Werner Baumann and about a dozen other business executives from various industries, had dinner Thursday evening together in Davos, Switzerland.
Clinically relevant
While the failure of Eli Lilly & Co.'s solanezumab is largely old news by now, it seems to be the (bad) gift that keeps on giving. The very expensive Alzheimer's disease drug continues to notch failures, while Lilly continues to insist that treating patients earlier in the evolution of the disease is going to change these bad results.
Lilly finally got around to publishing the last round of data from its EXPEDITION clinical trial program and the ugly truth is Lilly (and may other scientists who have been operating under the assumption that a buildup of amyloid plaque in the brain causes the disease) may have gotten it wrong.
According to the latest trial results published in the New England Journal of Medicine, the EXPEDITION3 results show that the compound just doesn't work. Just not at all.
The debate of the amyloid theory has been raging for years, and there will likely be hold outs who insist that this is the right path. But EXPEDITION3 seems to be the latest nail in a coffin that is already pretty tightly nailed shut.
In other shows of failure, Teva Pharmaceutical Industries Ltd. got its latest bout of bad news when the subcutaneous version of its asthma drug Cinqair failed to deliver in a pair of Phase 3 studies — dashing the Israeli company's hopes of expanding the market.
Astellas Pharma Inc. and partner Vical Inc. also announced a late-stage disappointment. An experimental vaccine failed to protect hematopoietic stem cell transplant recipients from cytomegalovirus (CMV), notching another setback for the drug.
Highly regulated
The short-lived government shutdown did not have widespread ramifications for the Food and Drug Administration, but had it continued, it could've kept the FDA from fulfilling several key functions.
FDA would've been unable to "support the majority of its food safety, nutrition and cosmetics activities" and would have to stop routine establishment inspections and certain compliance and enforcement activities. What's more, the "majority of the laboratory research necessary to inform public health decision-making" would stop.
Commissioner Scott Gottlieb elected to stay home from the World Economic Forum in Davos while the government was closed, but promptly hopped a plane to Switzerland after Congress was able to reach an agreement.