Hello, everyone, and how are you this morning? We are just fine, thank you, as we prepare for another busy day. As usual, there is much to be done and, no doubt, you can relate. However, our usual routine will be abbreviated as we prepare to quarterback an interesting panel this afternoon about the FDA. Nonetheless, we have foraged for some tidbits below to keep you going. Hope your day is productive and remember to keep in touch …
A ballot measure to require California to pay no more for prescription drugs than the Department of Veterans Affairs is leading 3-1 with likely voters, the San Jose Mercury News reports. However, a third of those surveyed remain undecided, according to a new statewide poll. The survey shows 50 percent of likely voters are inclined to vote yes, while 16 percent say they are likely to vote no, and 34 percent are not taking sides.
Mylan clarified profits that chief executive officer Heather Bresch last week told Congress the company made from EpiPen, the Wall Street Journal reports. House committee members badgered the drug maker to justify price hikes amid confusion over profits and taxes, which Bresch did not convey clearly. Mylan lowered its calculation on EpiPen profits by applying the statutory US corporate tax rate of 37.5 percent, five times Mylan’s overall tax rate last year. Mylan released a new analysis Monday.
With brokers increasingly unable to subsidize their research with indirect payments, France’s Natixis is pioneering a novel approach: charging clients for coverage, Bloomberg News reports. However, this is a model that has proved fraught with conflicts for debt-rating companies. “I find the whole concept a little odd,” Ian Gordon, head of banks research at Investec, tells the news service. “It would potentially taint the brokerage’s product.”
Patients participating in clinical trials of new cancer drugs have unrealistic expectations that experimental treatments will save them, the Telegraph tells us, citing a new study. Research on more than 300 cancer patients asked about taking part in early-stage research found almost half believed their tumors would shrink, with hopes rising after they discussed the trials with their doctors.
Imprimis Pharmaceuticals, which makes compounded drugs, is closing its Texas facility and reducing headcount by 8 percent in hopes of saving $3 million. The company plans to use a facility in New Jersey to offset production being done in Texas. Imprimis gained attention last year by moving to produce a compounded version of Daraprim, which Martin Shkreli and Turing Pharmaceuticals bought and then raised the price by 5,000 percent.
Amgen’s hopes of boosting disappointing sales of its Kyprolis multiple myeloma drug suffered a setback with the failure of a late-stage trial involving newly diagnosed patients. “This trial failure raises questions about the positive results from earlier head-to-head trials, and is likely to undermine Amgen’s attempts to have the drug included in emerging front-line treatment trials,” Leerink analyst Geoff Porges writes investors.
GW Pharmaceuticals moved a step closer to having its key childhood epilepsy drug approved when it announced promising Phase 3 clinical trial results, CNBC says.
Three weeks after the US Food and Drug Administration warned Pain Therapeutics and Durect about promoting an unapproved painkiller, the agency declined to approve the Remoxy ER opioid.
Bristol-Myers Squibb plans to test its Opidvo cancer immunotherapy in combination with an experimental drug from Nektar Therapeutics to treat multiple cancers, according to Reuters.
The FDA expanded use of Johnson & Johnson’s Stelara, a psoriasis drug, to treat patients with Crohn’s disease, Pharma Times writes.
Kite Pharma released interim data from a mid-stage study showing its novel cancer treatment met its primary endpoints in non-Hodgkin lymphoma patients, Xconomy tells us.
Mylan and Lupin are among the drug makers believed to be considering bids for Bayer’s dermatology business as the German company sells assets ahead of its $66 billion acquisition of Monsanto, Bloomberg News says.
Prices in India may rise by 10 percent for 100 drugs that were dropped from the national list of essential medicines, overturning a previous prohibition by the national pricing authority, the Economic Times reports.
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