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Regulatory

Latest Headlines

Latest Headlines

Shkreli's 5th Amendment hall pass rejected for congressional drug pricing hearing

Pharma bro Martin Shkreli is requesting a hall pass to get out of testifying at a congressional hearing on drug pricing next week after receiving a subpoena ordering him to appear. But principals leading the price-fighting crusade including ringleader Rep. Elijah Cummings (D-MD) aren't letting Shkreli off the hook that easily.

With most sanctions lifted, Novo ahead of the pack in Iran

International pharma giants looking to make inroads into the Iranian market are going to find at least two drug companies standing in their way--Novo and Cipla--which have maintained a presence in the country while Western sanctions ate away at the rest of the economy.

Key Southeast Asia markets show strong potential punch in 2016

Outside of the main markets in China, Japan and India in Asia are closely followed plays in Indonesia, Thailand, Malaysia and Vietnam with the last two among 11 nations that signed the Trans-Pacific Partnership trade pact.

FDA nod for synchronized motion table for Intuitive Surgical robotic surgical system

Robotic surgery adherents will soon have a novel option--a table that can move with an Intuitive Surgical robot during a surgical procedure. The idea is to enable surgeons to use gravity to their advantage by moving the table in tandem with a surgical robot to manipulate the patient's body for better surgical access or to remove some of the physical pressure from a certain bodily location.

U.S. pivotal trial starts for Senseonics glucose monitor implant with data due in June

Upstart Senseonics expects to be the first to introduce a long-term implant to continuously monitor glucose levels in diabetics. It's already under review for a CE mark after disclosing pivotal European data in October. Now, it's detailed the plans for the pivotal U.S. study of its Eversense Continuous Glucose Monitoring System.

U.K. competition watchdog targets pharma for 'substantial fines'

The U.K.'s Competition and Markets Authority (CMA) is planning to levy "substantial fines" this year, marking a "big step up in the scale and impact" of its enforcement activity, Alex Chisholm, head of the agency, told The Financial Times. And one of those fines will likely be directed at a pharma company, Chisholm said, as the CMA probes drugmakers including GlaxoSmithKline and Pfizer for alleged wrongdoing.

Levaquin users slap J&J with $800M RICO suit, claiming pharma giant hid serious side effects

Johnson & Johnson is facing yet another lawsuit over its antibiotic Levaquin from people who claim that the company hid serious side effects tied to the drug. The latest legal action comes a couple of months after an FDA panel flagged serious problems associated with the entire class of antibiotics and voted to change the meds' labels.

FDA snow day delays review of Sarepta's Duchenne drug

The FDA is taking a snow day this Friday, abandoning scheduled plans to submit Sarepta's Duchenne muscular dystrophy drug to a review by outside experts.

FDA bans products from another Chinese plant

On Wednesday, the FDA added Zhejiang Hisoar Pharmaceutical to its import alert list, Bloomberg reports. According to the notice, all of the company's antibiotics and drugs for human or animal use manufactured at a plant in Taizhou have been banned from being brought into the U.S.

FDA says microbial contamination found at Montana Compounding

Being able to take your dogs to the office may be a perk at some workplaces, but the FDA doesn't think it is such a great idea for a compounding pharmacy. So says an FDA warning letter posted this week for a compounder, another action in the FDA's effort to bring up the standards of that industry.
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