March 25 (Reuters) - Vanda Pharmaceuticals Inc :
* Reports successful completion of pre-NDA meeting with FDA on tasimelteon for
the treatment of non-24-hour disorder in the totally blind
* FDA confirmed that efficacy and safety data to be submitted in tasimelteon
NDA for non-24 is adequate to support filing
* Says is targeting an NDA submission for tasimelteon in mid-2013.
* Source text * Further company coverage
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Witty's predicting mid-single-digit declines in 2013, with that already factored into Glaxo's forecast for earnings per share growth of 3 to 4 percent.
Glaxo is also accelerating its "change program" to cut costs. "There are really two major areas of focus of this change program," the CEO said. "One is to make sure we right size our European pharmaceutical business in response to the pricing pressure we've seen from European governments."
The other, Witty said, is to change the company's technology platforms to reduce manufacturing costs, improve the the carbon footprint, cut inventories, and improve cycle time.
The drug company's product pipeline is also filling up, with six new products under regulatory review. Glaxo expects to launch around 15 new products globally over the next three years, according to the company's earnings report. It is also aiming to improve its research and development returns to around 14 percent over the long term.
(Read More: Drug Pipelines Begin to Fill for Big Pharma)
Glaxo is considering selling its sports drinks business as well, but told CNBC that it has no plans to follow some rivals like Pfizer and transform into a less-diversified company. Last week, Pfizer's animal health subsidiary Zoetis raised $2.2 billion in its initial public offering.
Witty said there are strong synergies binding Glaxo's three key divisions — pharmaceuticals, vaccines, and consumer health.
The company's emerging market pharma and consumer business are also strong, Witty said, and now account for about 40 percent of the entire group.
"We are a big believer in bound together synergistic businesses," the CEO said, "We are against diversification for the sake of it."
Archbishop Mario ContiNot expecting to be outdone by the many other bishops who’ve attacked same-sex couples already this month, Scottish Archbishop Emeritus Mario Conti penned a letter this week to the Catholic journal The Tablet expressing his own opposition to marriage equality. In fact, he believes the Catholic Church’s stance must “surely be worthy of consideration” by the government because it helps “promote the moral well-being of society.” Here’s how Conti framed that position:
While it is true, certainly within Catholic social teaching, that governments are not required to make all immoral actions illegal, to many it is unhelpful, unnecessary and indeed profoundly unwise for political action to do quite the opposite, namely to attempt through the law, by equating homosexual unions with heterosexual marriage, to render moral what is in itself morally defective.
So far in 2013, members of the Catholic hierarchy have already referred to same-sex marriage as “morally defective” and an “immoral activity,” and claimed that gay people don’t really exist, but if they claim to, then God obliges them to a life of chastity. And Conti’s implication here isn’t just that he wants to prevent same-sex marriage, but that his preference would be to make homosexuality itself “illegal.”
Combined with Pope Benedict’s multiple malignant statements in December, the Catholic Church’s hierarchy has established itself as the archenemy of loving same-sex families in 2013. These religious leaders provide no argument against marriage equality except their own moral judgment, but then expect the governments of the world to cater to their whims when even their own followers largely do not agree. They imagine a universe where there is no such thing as gay people or same-sex marriage, but with each passing day that false reality becomes more delusional.
