Hello, everyone, and welcome to the middle of the week. This is an accomplishment worthy of celebration, yes? After all, you made it this far. Just consider the alternatives. So why not grab a cup of stimulation as you prepare for the deluge. Our own flavor, for those keeping track, is Rain Forest Nut. Meanwhile, here are a few tidbits to help you along. Hope you have another smashing day and conquer the world …
The Alabama Department of Corrections says Pfizer’s decision to restrict use of its drugs for capital punishment won’t affect the state’s ability to carry out executions, the Montgomery Advertiser says. Under Alabama’s execution protocol, a condemned inmate is injected with three drugs on Pfizer’s banned list. But the state will not say where it obtains drugs used in executions, and has rejected Freedom of Information Act requests on the subject.
AbbVie suffered a blow as the US Patent and Trademark Office agreed to review a key patent for its Humira rheumatoid arthritis treatment. The move is a boost for Coherus BioSciences, which later this plans to seek approval to sell a biosimilar version of the best-selling drug. The key patent expires in December, but AbbVie has taken dozens of patents in hopes of thwarting competition until 2022. Credit Suisse analyst Vamil Divan notes that this is an “important setback” to AbbVie, but expects a final decision, including appeals, to take one to two years.
Braeburn Pharmaceuticals is proceeding with plans for a $20 million expansion in Durham, N.C., after all, despite the controversial law governing gender and bathroom use, the Triangle Business Journal tells us. While executives at the company insisted they do not support the legislation, they consider “Durham County’s strong record on non-discrimination against the LGBT community” as a reason to move ahead with the expansion.
As AstraZeneca chief executive Pascal Soriot struggles to reinvent the drug maker, he says that keeping employees edgy as part of a reorganization is a good thing. “In the past, we’ve had too much stability,” he tells Reuters. “We had people who never moved and turnover of 1 or 2 percent. That might sound good but it’s actually not, because you don’t have new ideas flowing through the place.” Meanwhile, the company suffered a setback when a late-stage trial showed its recently approved Lynparza ovarian cancer drug failed to increase overall survival significantly.
Short seller Andrew Left of Citron Research is challenging Mallinckrodt to do a clinical trial of its Achtar drug, which is used to treat seizures in infants and costs $23,000 a vial, according to TheStreet. “Mallinckrodt is squeaking by without anyone talking about it. Mallinckrodt makes Valeant look like a bunch of choirboys,” Left said. The company is “robbing from the healthcare system.” If the company runs a trial, he said he would donate $1 million to charity.
Roche is closing a plant in Clarecastle, Ireland, and eliminating 240 jobs on a phased basis between 2018 and 2019 after failing to find a buyer for the facility, Newstalk reports.
The US Food and Drug Administration granted accelerated approval of Bristol-Myers Squibb’s Opdivo to treat patients with classical Hodgkin lymphoma, Pharma Times says.
The cofounders of Capsule want to eliminate the inventory problems and delays in filling prescriptions by offering an app and then delivering meds by bicycle in New York, MedCity News informs us.
A 2014 study by Novartis found that a drug called rapamycin appeared to bolster the immune system in older patients and early results in aging dogs suggest the drug is helping them, too, the New York Times tells us.
Catalyst Pharmaceuticals is reducing its workforce following a refusal by the FDA to accept its application for a rare disease drug, the South Florida Business Journal writes.
A federal appeals court ruled that a Merck KGaA patent — linked to two of Bayer’s oral contraceptives — is invalid because ingredients in the drug were offered for sale before the patent was filed, Regulatory Focus reports..
More drug discovery work will be outsourced this year as drug makers look to reduce the risk of failure and cost-cutting continues, according to Outsourcing Pharma.
Swedish regulators pulled a good manufacturing practices certificate from Bend Research, calling its plans to address deviations at its Oregon plant “partly unacceptable,” InPharma Technologist says.
About the Author Reprints
If the State of Alabama is using non FDA approved drugs a lawyer for the condemned should file a restraining order.
The concept of a double-blind trial to prove the safety and effectiveness of an execution cocktail is more than I can process at the moment.
One could argue that this is a great bit of management wisdom from the head of AZ – “he says that keeping employees edgy as part of a reorganization is a good thing.” It implies that it’s something you should work at doing when in reality it’s included in the process. And it often isn’t a value for the victims, uh ‘the associates,’ but that may be a failure of perspective on my part.
@Observer, when lethal injection was first legalized there were motions filed on behalf of condemned prisoners that lethal injection constituted cruel and unusual punishment because the cocktail was a combination product that had never been specifically approved by FDA for executions. To this day these drugs are still being used “off label”.