FDA lashes out at Mylan for dismal quality control at HIV drug facility

Mylan—the pharmaceutical company infamous for raising the price of EpiPens—is in hot water with the Food and Drug Administration. This time, the dust-up is related to the quality control practices at one of the company’s drug facilities making antiretroviral therapies (ARVs) used to treat HIV, Reuters reports.

In a letter to Mylan, the FDA outlined several violations at the facility, based in Maharashtra, India, and warned Mylan to shape up. Specifically, the FDA said that investigators found that facility employees inexplicably invalidated quality control data that showed that drug batches didn’t meet standards. The agency also claimed that employees didn’t bother trying to investigate those failures or prevent them from reoccurring.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the FDA wrote. The letter was dated April 3, but it was released by the agency Tuesday.

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U.S. House lawmaker to release revamped Dodd-Frank overhaul bill

WASHINGTON (Reuters) – The head of the U.S. House of Representatives committee that polices Wall Street plans to unveil a new draft of sweeping legislation by month’s end that would give the 2010 Dodd-Frank Wall Street reform law a major facelift.

Chevron executive pay rises in 2016 on value of pensions

HOUSTON (Reuters) – Compensation for three of Chevron Corp’s senior leaders, including Chief Executive John Watson, rose last year due to a change in how the value of pensions are calculated.

Five Reasons Why Delta Beat United This Week

Yes, Delta’s disruption inconvenienced far more people than United’s. But in terms of brand value, United was the loser this week, by far.

There is an important lesson here for any enterprise as it struggles to reinvent its brand for the digital age: always keep your eye on the customer.

Pembina Pipeline relocates planned liquefied propane gas project from Oregon to Prince Rupert

CALGARY – Pembina Pipeline Corp. plans to build a propane export terminal in Prince Rupert, B.C. where major liquefied natural gas export projects have stalled in recent years.

Pembina announced Tuesday it would conduct a feasibility study and begin engineering and design work on a $125 million to $175 million liquefied petroleum gas terminal on the site of an old pulp mill near on the West Coast near Prince Rupert, scrapping previously announced plans to build the terminal in Portland, Ore.

If built, the project would become the second LPG export terminal in the Prince Rupert area, which is also home to four LNG export terminal proposals — though none of those LNG projects have been sanctioned or built years after being announced.

BG Group’s LNG project has been suspended after the company’s merger with Shell; Petronas Bhd is reportedly looking for a new site for its LNG project; and both Nexen and Imperial have yet to announce sanctioning decisions for their projects.

The area’s LPG projects, which would be built to send propane to Asia and other overseas markets, could be more near-term developments as the global LPG market is set to grow to US$147 billion by 2024, according to San Francisco’s Grand View Research.

Pembina senior vice-president, natural gas liquids and natural gas facilities Stuart Taylor said the company would work on engineering and consulting with local communities over the next six to 12 months before bringing a proposal to its board. He said the terminal could be built within two years of a sanctioning decision.

“One of the things that we’re excited about is the cost,” Taylor said, noting that the project would be built on an existing but abandoned industrial site with an existing unused shipping berth. He said the site is also connected to a CN rail line, which would allow Pembina to ship in propane for processing and export.

The City of Prince Rupert took possession of the site on Watson Island years ago when the local pulp mill closed and successive municipal governments have looked for ways to remediate and reuse the land. The pulp mill had also been a major employer in the city, whose population declined after it closed.

“We are looking forward to a new beginning for our community as we work towards putting Watson Island back on the tax roll,” Prince Rupert Mayor Lee Brain said in a press release. “We are happy to have the opportunity to potentially partner with (Pembina) to create new local jobs and revenue that will significantly improve the quality of life for everyone in Prince Rupert.”

Calgary-based AltaGas Ltd. announced in January that it would build the West Coast’s first LPG export terminal nearby, on Ridley Island, at a cost of between $450 million to $500 million to send Canadian propane to Asia.

Propane production has increased rapidly in Canada and the United States in recent years as natural gas producers have tapped into more shale formations.

Propane is a byproduct of shale natural gas production and domestic producers have been looking for new markets for it since Canadian propane has lost market share to growing U.S. supplies in key petrochemical markets.

Taylor said gas producers were looking for new export markets — including in Mexico, South America and Asia — to send their propane. He also said Pembina continues working on a major petrochemical plant in Alberta that would process propane, further soaking up the glut of supply out of the Western Canadian energy sector.

Financial Post



Western push at U.N. to boost backing for Syria gas attack inquiry

UNITED NATIONS (Reuters) – The U.N. Security Council could vote as early as Wednesday on a push by the United States, Britain and France to bolster support for international inquiries into a deadly toxic gas attack in Syria, diplomats said, a move Russia had deemed unacceptable and unwarranted.

The battle for fair game prices—and Gearbox’s attempt to ruin it

Bulletstorm Full Clip Edition launched on modern consoles and PCs last week. In a different universe, maybe the remaster of this 2011 first-person shooter would have had some obvious, significant care poured into it. Maybe it would come with new modes or twists, or maybe it would be paired with an event, an anniversary, or a beloved character in a way that reestablished its context as a quality, one-of-a-kind shooter. Any of those things might have given the game a decent shot both critically and commercially.

Instead, the game launched as both a bad product and a clueless answer to the ongoing question of how we should value video game purchases.

Kill really stupid enemies, but with skill

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