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Good morning, everyone, and welcome to another working week. We hope the weekend respite was enjoyable and refreshing — you were due, yes? — because the usual routine of deadlines, meetings, and the like has now returned. This was inevitable, though. So why not join us as we cope with a few cups of stimulation. And as always, we are here to help you along with some tidbits — and you can also sign up for a newsletter, too. So have a great day and keep in touch …

Valeant Pharmaceuticals is overhauling part of its management team. The beleaguered drug maker hired Novartis veteran Christina Ackermann as general counsel and executive vice president and Scott Hirsch, a portfolio manager at the Citadel Investment Group hedge fund, as senior vice president for business strategy and communications. Several other execs are being promoted, and the longtime investor relations head, Laurie Little, is leaving.


A new asthma pill from Novartis demonstrated significantly decreased symptoms, improved lung function, reduced inflammation, and repaired the lining of airways, PharmaTimes reports. The rate in asthma patients taking the pill, which is called, fevipiprant, fell from an average of 5.4 percent to 1.1 percent over 12 weeks, according to study results that were published in the Lancet Respiratory Medicine.

A tax loophole used by Gilead Sciences facilitated a threefold increase in untaxed offshore profits that reached $28.5 billion in 2015, the Irish Independent writes, citing a submission with the US Securities and Exchange Commission by Americans for Tax Fairness. The consumer group also suggested the drug maker might face a big tax assessment in the event of a European Commission investigation into tax arrangements similar to a probe into Apple.

An obscure federal regulation known as a 10b5-1 plan allows insiders to buy and sell shares as long they set up the trades in advance, but some say execs can still game the system, according to STAT. In theory, the plan prevents an exec from profiting off information not yet made public, but researchers who have examined thousands of such trades have shown they consistently outperform the broader market.


Merck won another indication for its Keytruda immunotherapy as the US Food and Drug Administration approved the drug for treating head and neck cancer, PharmaTimes says.

Chinese regulators issued new proposals to revamp drug registration rules that could stymie or promote innovation, according to BioCentury.

India’s Department of Pharmaceuticals is considering adding the maximum retail price to bar codes to ensure that companies adhere to pricing, the Business Standard reports. 

  • While you can’t make money by planning your trades based on insider information you can at least not lose money. The SEC imposes no penalty for cancelling a planned trade even if it is based on insider information since an actual trade has to be made for the SEC to take action. For example a VP of clinical research may have a planned trade coming up in two weeks but the results of his blockbuster Phase 3 study won’t be known for another month, making him a tad nervous about the trade. I can tell you from experience that I can look at blinded data and tell with 95% certainty if the outcome will be negative, and so can any experienced clinical research executive. It would be perfectly legal for such an individual to look at blinded data prior to the planned trade, make an educated guess that the study will be negative and cancel his planned trade.
    No muss, no fuss.

  • May I observe that I’m not sure which deserves more admiration – Valeants’ ability to recruit Christina Ackermann as GC or the optimism expressed in her embracing the challenge? I hope that she is properly compensated with checks that will actually clear.

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