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Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Valeant, AbbVie and..

pic thx to noel pennington on flickr creative commons [1]

pic thx to noel pennington on flickr creative commons

Rise and shine, everyone. Another busy day has arrived. And this is shaping up to be a pleasant one, too. A warm sun is enveloping the Pharmalot campus, where the official mascots are snoozing and we are exercising our new coffee kettle. As usual, there is much to do and we assume you can relate. So time to get cracking. Here are a few items of interest for you to peruse. Have a productive day and keep us in mind when something interesting happens…

Valeant Pharmaceuticals sought to reassure doctors that cutting ties with Philidor Rx Services, a mail-order pharmacy, would not disrupt their ability to prescribe its drugs, according to this letter [2]. The drug maker plans to pay for the cost of its medicines through Nov. 8 and make sure patients can fill their prescriptions without having to pay out-of-pocket expenses. But patients on government-run health plans such as Medicare are not eligible.

The South African government is considering a recommendation by Doctors Without Borders to allow generic versions of the Lopinavir HIV drug after shortages resulted in interruptions to some treatments, Business Day [3] reports. A rise in patient numbers in April and capacity constraints at the European plant where AbbVie makes the drug led to reduced supplies.

AbbVie has vowed to keep biosimilars of its Humira rheumatoid arthritis treatment from reaching the US market before 2022, Biopharma Reporter [4] writes. The drug maker is confident it can do so, thanks to more than 70 formulation, manufacturing and method of treatment patents. But as Evaluate Pharma [5]points out, Wall Street is less certain and forecasts sales to start declining in 2018.

The Food and Drug Administration cancelled an advisory committee meeting scheduled for today that would have discussed a new drug application for a novel testosterone product, MedPage Today [6] says. In a conference call with investors, Joseph Podolski, chief executive of Repros Therapeutics, which is developing the drug, said the FDA told the company of concerns that the method used for measuring testosterone levels hadn’t been properly validated.

GlaxoSmithKline and Merck plan to test a combination of two separate drugs – including Merck’s Keytruda – as a potential cancer treatment, MarketWatch [7] writes. Meanwhile, Keytruda picked up its third breakthrough therapy designation in the US, this time after showing promise as a treatment for a form of metastatic colorectal cancer, according to Pharma Times [8].

An FDA letter raises questions about Biomarin Pharmaceutical’s handling of approval for a Duchenne muscular dystrophy drug, The Street [9]informs us.

Pfizer has partnered with South Africa’s Biovac Institute to produce a potentially life-saving pneumonia vaccine for infants, Reuters [10] reports.

Eli Lilly plans to build a $70 million research facility that will put all 200 of its Indianapolis small-molecule scientists under one roof, The Indianapolis Star [11] writes.

A cocktail of Johnson & Johnson’s HIV compound and an experimental drug from ViiV Healthcare met the main goal of a mid-stage study, becoming the second combination to do so, Reuters [12] tells us.

GlaxoSmithKline reiterated its expectations for earnings growth in the next five years and said it may seek regulatory approval for about 20 new potential medicines to bolster sales in the period, Bloomberg News [13] says.