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Prescribed Reading: ASCO dominates, Icahn BMS interest just a rumor

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.

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Clinically relevant

Despite all the distractions that have been going on this week with the Trump Administration and investigations into Russia ties, the pharmaceutical industry has been moving along largely unaffected for the moment. All eyes have instead been on the upcoming American Society of Clinical Oncology (ASCO) conference that will be taking place at the beginning of June. Sort of like Christmas in May, the release of the ASCO abstracts this week is highly anticipated and has many a reporter and industry insider up all night. 

ASCO wil likely be the most closely watched industry meeting of the year. We will get updates from Incyte on its IDO1 inhibitor with both Merck & Co.'s Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab). The two market-leading checkpoint inhibitors have been creating quite a bit of buzz on their own, but combination therapies are the future of the space. While there are plenty of combinations in development, little is known just yet about how they will read out. 

You can get more highlights from the ASCO abstracts here.

Mergers & analysis

While deals amongst the pharma and biotech players continue to be scarce, consolidation in the contract research and development space has ramped up, with three deals announced in the space of two weeks. Thermo Fisher is buying Patheon for $7.2 billion, while Inventiv Health and INC Research will merge to create a top three CRO in an all-stock transaction worth $7.4 billion. It will be interesting to see how consolidation in the R&D, as well as contract manufacturing space, will impact how pharma conducts its business. 

Meanwhile, other deal speculation may be overblown. Earlier this year, rumors started swirling that Bristol-Myers Squibb was rapidly becoming a takeout target as infamous activist investor Carl Icahn, who is known for his shake-ups at biotechs including ImClone and Biogen, was reported to take a stake in the big pharma. 

As is protocol, Icahn's investments from the first quarter became available on the Securities and Exchange Commission's website 45 days after the close of the quarter (this week). The filing showed no evidence that Icahn invested in Bristol-Myers. With that in mind, it might be a long time before we see any deal action there. 

Highly regulated

Scott Gottlieb began his tenure as Food and Drug Administration Commissioner this week, kicking things off by telling employees that rising drug prices will be a focus for the agency. The FDA has typically remained out of the pricing debate and impartial to that part of drug development, but Gottlieb seems to be taking the agency into a new direction. 

Elsewhere, Concert Pharma took a hit this week when the FDA put its hair loss drug on hold ahead of dosing in its mid-stage study. The clinical hold changes the race between Concert and Aclaris, which is also trying to bring a baldness drug to market. 

J&J also got some unwelcome news from the agency; the FDA slapped a black box warning on its blockbuster diabetes drug Invokana (canagliflozin). The drug has shown an increased risk of causing the need for amputation in patients. 

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Filed Under: Clinical Trials Mergers and Acquisitions / Deals Regulatory / Compliance