Prescribed Reading: Rumors, blood and history in the making
A weekly guide to the goings-on in the biopharma industry.
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
- Lilly defends Cialis franchise
- Ocular Therapeutix handed latest rejection
- Allergan's Saunders highlights growing concerns
Mergers & analysis
Some of the biggest news this week was not news at all, but rumor and speculation that AstraZeneca CEO Pascal Soriot is jumping ship to beleaguered generic drugmaker Teva Pharmaceuticals. The "news" was all based on a little report out of an Israeli news website, and neither company will comment on it. Yet, it has major implications for both companies.
For Teva, it could mean acquiring a high-profile CEO who knows nothing about generics and may or may not be able to do any better than his four most recent predecessors at the company. For AstraZeneca, well, it might mean its leader doesn't want to go down with the ship if the MYSTIC trial results turn out to be unfavorable.
While the Teva Board of Directors has has previously insisted on an Israeli-borne CEO, the drugmaker replaced several board members yesterday, potentially setting up the company to welcome a new French-borne CEO.
Or not. We'll have to wait and see how this bizarre not-so-news plays out.
Hemophilia treatments dominated this week, as new data poured out of the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress in Berlin. Specifically, two treatments that are close to market from Roche and Alnylam Pharmaceuticals could be game-changing. At least for a little while.
Those treatments could become largely irrelevant if some exciting gene therapies that are in development eventually succeed. The data for the drugs from the likes of Spark Therapeutics and BioMarin, amongst others, is still very early, but has shown some astounding results in a very small number of patients. Some companies are even throwing around that word 'cure.' It seems gene therapies have the potential to do for hemophilia what drugs like Sovaldi did for hepatitis C.
Elsewhere, Arena Pharmaceuticals may be making a comeback. The once-failing obesity company has switched gears to focus on a hypertension drug that has some recently strong results in Phase 2. If it can reach the market, it won't be as hard a sell as its last attempt.
We might be seeing history in the making as a new class of cancer therapies is ushered onto the U.S. market. The first step toward that happened this week when a panel of experts gave a unanimously positive vote for approval at an advisory committee meeting. While the Food and Drug Administration is not required to follow their recommendation, it's likely we'll see the approval of the first CAR-T treatment in September.
While these drugs have shown astounding efficacy, there have been some safety issues, and manufacturing isn't exactly easy. It will be interesting to watch and see if CAR-Ts are the next big thing or the next big never-was.
A day earlier, an FDA advisory panel gave a positive vote for another drug. In a moment of deja vu, Pfizer's Mylotarg is once again up for approval. The almost 20-year saga of the drug has reached its latest twist and turn. Mylotarg was the first drug approved under the accelerated approval process to be pulled from the market due to safety issues and lack of efficacy. After ten years of new research, Mylotarg might get a comeback.
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