Pharmalot, Pharmalittle: Sarepta stock jumps after critic of DMD drug leaves the FDA

Hello, everyone, and welcome to the middle of the week. Congratulations on making it this far. It is an accomplishment, after all. The next step is to forge ahead. And why not? Just consider the alternatives. On that optimistic note, please join us for a needed cup or three of stimulation. Meanwhile, here are some items of interest to get you going. Have a wonderful day and do drop us a line when you hear something juicy …

Sarepta Therapeutics stock jumped this morning on the news that an FDA official, Dr. Ronald Farkas, who had been critical of its drug for Duchenne muscular dystrophy drug, has left the agency, TheStreet writes. Farkas was one of the FDA officials who, at an advisory committee meeting earlier this year, maintained that the drug maker had not submitted sufficient evidence for the drug to be approved. As STAT noted, the panel voted against approval.

Mylan Pharmaceuticals had the second-highest executive compensation among all US drug and biotech companies over the past five years, paying its top five managers a total of nearly $300 million, according to the Wall Street Journal. The combined total of $292.1 million in pay for its top five execs over the five years ending in 2015 outpaced much bigger rivals.

Since 2013, there have been more than 19,000 reports of complications from ADHD drugs made to the US Food and Drug Administration, according to an analysis by the Milwaukee Journal Sentinel and MedPage Today. Of those, adults were far more likely than children to suffer severe complications, such as death and hospitalization. Among those 26 and older, recreational use of Adderall, an amphetamine, rose fourfold from 2006 to 1.4 million in 2014.

For more than a decade, members of Pain Care Forum blanketed Washington with messages touting the vital role of prescription painkillers, quietly working to derail efforts to curb escalating use of the drugs, the Associated Press and the Center for Public Integrity report. The group is actually a loose coalition of drug makers, trade groups, and dozens of nonprofits supported by industry funding that has flown under the radar.

Meanwhile, health insurers increased spending more than 1,300 percent between 2011 and 2015 on patients diagnosed with opioid dependence or abuse, Kaiser Health News writes, citing a new study. Insurer payments to hospitals, laboratories, treatment centers, and other medical providers for these patients grew from $32 million to $446 million. On average, insurers spent $19,333 on an individual patient with an opioid dependence or abuse diagnosis.

Takeda Pharmaceuticals wants to buy US companies developing drugs for cancer, gastrointestinal conditions, and diseases of the central nervous system, such as Alzheimer’s, the Financial Times reports. The Japanese drug maker has set aside between $10 billion to $15 billion for acquisitions, which could go towards one large deal or several smaller ones, although the company may be willing to spend up to $20 billion.

An advisory group for UK drug makers is urging the government to help the industry preserve access to the European Union’s market and researchers after Brexit, Bloomberg News informs us.

Roche says its Ocrevus multiple sclerosis drug controlled the most common form of the disease better than a Merck medicine and worked against another form of MS for which there is no approved treatment, Reuters says.

Indoco Remedies says problems that US regulators identified at a drug plant in Goa, India, last month are “correctable,” InPharma Technologist writes.

Takeda Pharmaceuticals struck deal with PHA Health Services to manage its clinical trial development and regulatory affairs work, Outsourcing Pharma tells us.

Novo Nordisk is voluntarily recalling six batches of its GlucaGen HypoKit in the US due to two customer complaints from Europe about detached needles, InPharma Technologist reports.