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Pharmalot… Pharmalittle… As the weekend nears

pic thx to jake cook on flickr creative commons [1]

pic thx to jake cook on flickr creative commons

And so, another working  week will soon draw to a close. This is, you may recall, our treasured signal to daydream about weekend plans. Once again, our agenda is rather modest. We plan to manicure the Pharmalot campus, catch up on sundry chores and escort Mrs. Pharmalot to another installment in our ‘let’s-see-them-before-they-die’ concert [2]series. And what about you? In some parts, this is a lovely time of year to enjoy the fall scenery. Perhaps you can catch up on your reading or reach out to someone special. Or simply plan the future. Whatever you do, have a lovely time. But remember, be safe. See you soon…

Bernie Sanders will oppose Califf as the next FDA commish, citing his ties to drug makers. “At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr. Califf is not that person,” Sanders said.

Will this simply amount to another public relations dodge? Pfizer representatives will meet with Gloucester, Mass., police chief Leonard Campanello, who called out the pharmaceutical industry and its highest-paid CEOs by posting their email addresses and phone numbers and urging people to contact them in the fight against opioid addiction, The Gloucester Times [3] writes.

Generic drug makers in India are engineering hepatitis C combination pills that are impossible in western nations due to patent protections, Bloomberg News [4] says. In particular, some are working on combining a one-pill cocktail that includes Sovaldi, the Gilead Sciences pill, and Daklinza, which is made by Bristol-Myers Squibb. Those two companies never collaborated to make such a combination.

So is the FDA definitely holding advisory committee meetings late next month to review a pair of drugs for Duchenne muscular dystrophy? Investors and patient advocates are uncertain, since the agency has not yet posted definitive information and a deadline for doing so is approaching. Sarepta Therapeutics ceo Ed Kaye told us he is unsure himself: “We still do not know. We keep on pestering FDA, but we have no confirmation about that as of yet.”

Genentech says its experimental drug ocrelizumab proved effective in three late-stage studies against multiple sclerosis, potentially heralding an important new treatment option for the debilitating disease, The Wall Street Journal [5] reports. Separately, Genzyme says five-year investigational data from an extension study Lemtrada showed positive results for patients with relapsing remitting multiple sclerosis, Reuters [6] writes.

AstraZeneca is temporarily halting two trials that combine cancer drugs due to reports of lung disease, according to Bloomberg News [7].

The National Institute for Health and Care Excellence has given its blessing for the use of Merck’s Keytruda early on in the treatment pathway for patients with advanced skin cancer, Pharma Times [8] says.

The Court of Justice of the European Union issued a ruling that essentially adds up to a couple days’ worth of patent protection to medicinal products, but could mean millions of Euros for drug makers, Regulatory Focus [9] writes.

The Clinical Trials Transformation Initiative, a public-private partnership, published a set of “best practices [10]” for industry, academia and patient groups to ensure patients are handled correctly.

India’s Department of Pharmaceuticals has once again extended voluntarily implementation of a new code for marketing practices, this time until December, PharmaBiz [11] reports.

Recipharm will cut about 100 jobs in the greater Stockholm area to reduce costs after lower customer demand, Outsourcing Pharma [12] tells us.

Sanofi is seeking a deal with unions to boost productivity by 20 percent to 25 percent at French plants over three years, according to Reuters [13].

Glenmark Pharmaceuticals may appeal a court ruling preventing it from selling a version of Januvia, a Merck diabetes drug, The Economic Times [14] writes.

Johnson & Johnson has begun clinical trials for an Ebola vaccine in Sierra Leone, according to the Associated Press [15].