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FDA announces policy shift to encourage new opioid addiction treatments

The US Food and Drug Administration (FDA) have announced that it is altering the way it evaluates a drug’s ability to treat opioid addiction as part of a move to encourage the development and approval of new opioid addiction treatments.

While currently the effectiveness of a potential treatment for opioid addiction is measured through its ability to reduce drug use, the shift in policy will mean that other factors will now be considered.

Eleven babies dead after Dutch viagra trial

Test tubes being used in a clinical trial

A trial of the drug sildenafil, commonly sold under the brand name Viagra, has been halted immediately after the death of 11 babies.

The trial, which had been carried out in 10 hospitals across the Netherlands, was stopped on Monday after 17 babies were born with lung conditions and 11 had died. In comparison, of those 90 babies in the control group, three were born with lung conditions while none died from conditions that have been linked to the use of sildenafil.

26 die after attempting to replace Abbott's blood pump controller themselves

At least 26 advanced heart failure patients have died and 19 have been injured by attempting to change the controller on Abbott Laboratories’ HeartMate II blood pumps themselves at home. The manufacturer released new software and alarm guides concerning almost 29,000 devices to doctors on 30 March, after 70 reports of malfunctions following an unsuccessful controller replacement.

Alnylam’s shares plunge by 42% after deaths in clinical trials

Alnylam Pharmaceuticals’ shares lost close to half of their value as it was forced to end a trial of its late-stage experimental drug because it was causing more deaths compared with the placebo. The treatment, revusiran, was being tested to treat a condition named hereditary ATTR amyloidosis with cardiomyopathy, which can potentially cause nerve and heart damage.

Bayer terminates clinical trial for hypertension due to safety concerns

Bayer has terminated a Phase II trial evaluating riociguat in patients with pulmonary hypertension due to fears raised by an independent data monitoring committee (DMC) after fears were raised about a possible increased risk of death and other serious adverse events.

GSK faces fine over Argentina clinical trial

A court in Argentina says GSK should be fined for irregularities in recruitment during a trial in which children died.

GSK said it “respectfully disagrees” with the ruling in favour of ANMAT (National Administration of Medicines, Food and Medical Technology).

The firm says it will appeal against the ruling to the country’s Supreme Court after a judge upheld the £60,000 penalty against it.

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