Health News Roundup: Europe's clampdown on faulty medical devices; late-stage amyloidosis study

Unsubstantiated claims Muslim doctor sterilized women raise tensions in Sri Lanka

On May 23 Sri Lankan newspaper Divaina, known for its nationalist stance, published a front page article alleging a Muslim doctor had secretly sterilized 4,000 Sinhala Buddhist women after caesarean deliveries. The doctor, who was not identified in the article, was also described as a member of the National Thowheed Jamath, one of two local Islamist groups blamed for bombings that killed more than 250 people in hotels and churches on Easter Sunday.

Mallinckrodt to settle U.S. drug marketing probe, fight kickback case

Mallinckrodt Plc on Wednesday said it had tentatively agreed to pay $15.4 million to resolve a U.S. Justice Department probe into how a drugmaker it now owns marketed an expensive treatment for a rare infant seizure disorder and multiple sclerosis. But Mallinckrodt said it would fight new claims by the department contained in complaint filed on Tuesday in federal court in Philadelphia that it improperly used a charity to pay kickbacks aimed at encouraging Medicare patients to use the drug.

Insys to pay $225 million, plead guilty in U.S. over opioid kickbacks

Insys Therapeutics Inc agreed to pay $225 million and an operating unit will plead guilty to fraud to settle probes into their payment of kickbacks to induce doctors to prescribe highly addictive opioids, the U.S. Department of Justice said on Wednesday. Prosecutors said Insys used kickbacks and other illegal marketing practices to boost sales of Subsys, an under-the-tongue spray meant to treat pain in adult cancer patients and which contains fentanyl, an opioid 100 times stronger than morphine.

Fresenius says tighter EU rules could trigger antibiotic shortage

German drugmaker Fresenius warned that stricter production norms being considered by Europe's drug regulator could compound shortages of a life-saving antibiotic that is used by about 25 million patients globally each year. The market for piperacillin-tazobactam is highly concentrated with Fresenius and Chinese rival Qilu supplying almost the entire European market between them. Production outages at Qilu have already caused repeated stock shortages over the past three years.

AstraZeneca's blood cancer drug meets main goal in late-stage trial

AstraZeneca Plc said on Thursday its blood cancer drug met the main goal of a final stage trial, taking the treatment one step closer to a marketing approval as the drugmaker seeks to bolster its oncology portfolio. In its second late-stage trial success in a month, the drug showed meaningful improvement in patients with chronic lymphocytic leukemia when compared with a chemotherapy-based treatment, the company said.

Takeda scraps late-stage amyloidosis study

Takeda Pharmaceutical Co Ltd said on Wednesday it would discontinue a late-stage study testing its experimental treatment for amyloidosis, as it did not meet the first of two main goals. Amyloidosis is a rare disease caused by an abnormal build up of a substance called amyloid in organs.

Will Europe's clampdown on faulty medical devices hurt patients?

When a Californian company founded by a U.S. veteran wounded in Afghanistan sought to register a new medical device this year, it turned to Europe before the United States. The European approvals system had long been quicker, the company said, but the introduction of new rules is changing all that. "Now it has flipped," said Bill Colone, CEO of San Clemente-based Spinal Singularity, which hopes to launch a 'smart' catheter for men with spinal injuries or disease early next year after squeezing in its application under the old European rules.

Wildfire smoke worse for kids' health than prescribed burns

Children who are exposed to smoke from wildfires may experience a greater health impact than those exposed to smoke from prescribed controlled burns, according to a small study in northern California. "Prescribed burns have been done for thousands of years to maintain the health of the forest, but there is public opposition to them due to the smoke exposure," said lead study author Dr. Mary Prunicki of the Stanford University School of Medicine.

U.S. records 1,000th case of measles, officials blame misinformation for outbreak

The United States has recorded 1,001 measles cases so far this year in the worst outbreak of the highly contagious disease in more than a quarter-century, federal health officials said on Wednesday as they issued a new plea for parents to vaccinate their children. The U.S. Centers for Disease Control and Prevention said 61 new cases have been reported since May 27 of the sometimes deadly disease. It is the highest number of cases since 1992 when the CDC recorded 2,126 cases.

Trump administration moves to end U.S. research using fetal tissue from abortions

The Trump administration on Wednesday said it would end scientific research at the National Institutes of Health that relies on fetal tissue from elective abortions and would accelerate efforts to find alternatives for such research, a move welcomed by anti-abortion groups. Scientists say fetal tissue is critical for research into many complex diseases, including HIV, Alzheimer's and cancer.

(With inputs from agencies.)