A Premature Death? KV Pharma And Makena Make An Unexpected Comeback
Ever since the scandal erupted over compounding pharmacies and a national outbreak of fungal meningitis, KV Pharmaceuticals has been telling the FDA ‘we told you so.’ Now, the drugmaker, which landed in bankruptcy after a pricing controversy over its Makena treatment for premature births caused a ruckus and dramatically slashed sales, is finally experiencing a degree of vindication.
For months, KV has been complaining about the quality of some compounded versions of Makena (back story). Specifically, KV has pointed to the troubles at the New England Compounding Center, which was blamed for 741 cases of meningitis, incl...
Source: Pharmalot - June 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Ve haf vays of making you guinea pigs!
Leading Western pharmaceutical companies paid millions of pounds to former Communist East Germany to use more that 50,000 patients in state-run hospitals as unwitting guinea pigs for drug tests in which several people died, it was revealed today.An investigation by the German magazine Der Spiegel said international conglomerates such as Bayer, Hoechst, Roche, Schering and Sandoz carried out more than 600 tests on patients, mostly without their knowledge, at hospitals and clinics in the former Communist state.The companies were said to have paid the regime the equivalent of €400,000 (£338,000) per test. Schering, a conce...
Source: PharmaGossip - May 13, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Don't Put All The Blame On Hormones - Gluten Can Shorten Your Sex Life, Too
Even though it is believed that with menopause and andropause comes a loss of libido, fertility and sex drive, it has been always assumed that the reason is due to a change in hormones.
However, a recent study is claiming that it may not be the only reason, and that gluten, once again, is the culprit for our failing health! (1,2).
Moreover, the problem starts long time before menopause hits. This problem affects the whole reproductive life of a woman, leading to miscarriages and premature birth. This problem makes menopause more severe than in healthy women. But what is it? What is this unknown enemy that can make su...
Source: Doctor Kalitenko antiaging blog - January 10, 2013 Category: Physicians With Health Advice Authors: admin Source Type: blogs
A long gestation!
Settlement reached in pregnancy drug cancer lawsuit
BOSTON -- Eli Lilly and Co. has settled a lawsuit brought by four sisters who contended their breast cancer was caused by a drug their mother took during pregnancy in the 1950s, a move some believe could trigger financial settlements in scores of other claims brought by women around the country.
A total of 51 women, including the Melnick sisters, filed lawsuits in Boston against more than a dozen companies that made or marketed a synthetic estrogen known as DES.
The Melnick sisters' case was the first to go to trial. The settlement was announced Wednesday on the secon...
Source: PharmaGossip - January 10, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
KV Pharma Loses Another Battle Over Makena
KV Pharmaceutical may have emerged from bankruptcy in hopes of marketing still more of its Makena treatment for reducing the risk of premature births. But the troubled little drugmaker, which has consistently locked horns with the FDA, last week lost another battle with the agency over its efforts to fend off competition to its controversial drug.
This time, the FDA rejected a petition KV had filed in hopes of preventing agency approval of a generic version of Delalutin, an older version of Makena, or hydroxyprogesterone caproate. KV argued that the FDA should not approve a generic because this would violate its exclusive ...
Source: Pharmalot - January 4, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Compounding Pharmacy FDA Fungal Meningitis KV Pharmaceutical Makena Orphan Drugs Premature Birth Source Type: blogs
The pain of the fetus
In France, the new studies demonstrate that the fetus can suffer. The question is to find the treatment to fight this pain.On June 5th in Paris, Palais du Luxembourg, the PremUp foundation organizes a colloquium to discuss it. This Fondation works on prematurity, average prematurity and extreme prematurity.The premature births increased by 15 % these last ten years in France. The fetus perceives the pain from the second quarter of the pregnancy, it is important to treat her.What is the best means to avoid the suffering of the foetus?Besides the contact with the mother, the environment of the fetus is essential. Some medica...
Source: Women's Bioethics Blog - June 6, 2010 Category: Medical Ethics Tags: fetal pain fetus prematurity Source Type: blogs
