FDA moves to prevent Pharma from ‘gaming’ generic drug system

Reuters, 21 June 2017
Author: Toni Clarke
“The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals. FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules to place obstacles in the way of generic competition. The move comes as the President and lawmakers in Congress search for ways to lower the cost of prescription drugs.”
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Legislature passes bill to rein in drug company perks for doctors

Press Herald, 20 June 2017
Author: Joe Lawlor
“A bill that would curtail gifts, speaking and consulting fees and expensive food flowing from pharmaceutical companies to doctors has passed the Legislature and awaits the signature of Gov. Paul LePage. the goal of the bill is to ensure doctors do not have conflicting interests when prescribing drugs – especially opioids – since Maine is in the midst of an opioid crisis. Maine had 376 drug overdose deaths in 2016 – an average of about one per day – an all-time high and 40 percent higher than in 2015.”
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No evidence that $40,000 ‘miracle’ drug cures hepatitis C

Daily Mail, 9 June 2017
Author: Cheyenne Roundtree
“A medicine hailed as a ‘miracle’ drug that could eliminate hepatitis C may not actually cure the disease, a study claims. Sick patients were offered hope with a new $40,000 direct-acting antiviral drug, which boasted it could clear the virus from the blood within 12 weeks.
The staggering price of the medicine was worth it to some because the contagious liver disease can lead to cancer and death. Now researchers claim that although the drug may rid the blood of the virus there is no valid evidence that it completely rids the body of the infection.”
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Breast cancer drug that can extend lives approved for NHS use

The Guardian, 15 June 2017
Source: Press Association
“A drug that can extend the lives of women with advanced breast cancer has been approved for routine use on the NHS. A deal has been struck between NHS England and the manufacturer Roche, backed by Nice, to make the drug available to around 1,200 women a year in England. Until now, the drug has been funded only through the cancer drugs fund. In clinical trials, Kadcyla, which has a full list price of £90,000 a year per patient, was shown to extend the lives of people with terminal cancer by an average of six months. It also dramatically improves quality of life and reduces side effects.”
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Aspirin increases bleeding risk in older stroke patients: study

MedicalXpress, 14 June 2017
Source: The Lancet
“Long-term, daily use of aspirin to prevent blood clots in very elderly patients leads to an increased risk of serious or fatal internal bleeding, researchers said Wednesday. Heartburn medication would allows people 75 years and older to keep the preventative benefits of aspirin while avoiding its dangerous side-effects. Even among people with no history of heart problems or stroke, the risk of gastrointestinal bleeding goes up with age for aspirin users.”
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Pfizer, Roche and Aspen face South African probe into cancer drug prices

Reuters, 14 June 2017
Authors: Paul Arnold, Tiisetso Motsoeneng
“South Africa’s competition watchdog has launched an investigation into three drug companies accused of over-charging for cancer medicines, the agency’s chief said on Tuesday. The Commission, which investigates cases before bringing them to the Competition Tribunal for adjudication, said it suspected the lung cancer treatment xalkori crizotinib sold by Pfizer had been excessively priced as has the breast cancer drugs Herceptin and Herclon sold by Roche. It Commission also would look into whether Aspen might have over-charged for Leukeran, Alkeran and Myleran cancer treatments in South Africa.”
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Merck & Co. Halts Enrollment in Two Keytruda Trials, Citing Deaths

GEN, 13 June 2017
Source: Genetic Engineering & Biotechnology News
“Merck & Co. said it has stopped enrollment in two Phase III trials assessing its cancer immunotherapy Keytruda® (pembrolizumab) in combination with other therapies to treat multiple myeloma, following reports of patient deaths. Patients currently enrolled in the two studies will continue to receive treatment, Merck said, adding that its other clinical studies of Keytruda will continue unchanged.”
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Our so-called ‘universal’ healthcare: the well waste money and the poor get sicker

The Guardian, 11 June 2017
Author: Amy Corderoy
“The waste of wellness dollars is an ethical issue when health inequality in Australia is a life-or-death issue. While the worried well shell out great amounts stockpiling placebos, the poor get sicker. What if all those billions of dollars were poured into some real wellness? Perhaps along with our tobacco tax, we need to introduce a snake-oil tax as well. We need to start thinking of this waste of wellness dollars as an ethical issue. Because the money is needed elsewhere. And desperately.”
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Women urged to speak up on painful transvaginal mesh implant side effects

ABC, 31 May 2017
Author: Sophie Scott and Alison Branley
“The number of women who have experienced catastrophic side effects from a medical device used to treat prolapse after childbirth is likely to be higher than expected, experts fear. A Victorian health consumer group has conducted the first comprehensive survey of Australian women who have been treated with transvaginal mesh implants and they have received more than 1,850 responses in just six weeks, with more than 750 women saying they have had adverse effects. Reported problems from the device include incontinence, severe chronic pain, problems walking, painful intercourse and even marital breakdown.The Australian Commission on Safety and Quality in Health Care is now reviewing the use of the implants.”
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Valium recall: Worker sacked over Roche diazepam tampering

ABC News, 31 May 2017
Source: ABC News
“A worker has been sacked after the TGA issued a nation-wide recall of Roche Products’ diazepam, because the relaxant had been swapped out for different drugs at a Sydney distribution centre. Roche said the incident occurred at a distribution centre, and this afternoon, Symbion Contract Logistics released a statement saying they had sacked a worker at its Sydney-based distribution facility.”
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