Health News Roundup: FDA says widening probe on generic drug impurities; Possible link between C-section and autism, ADHD
Following is a summary of current health news briefs.
FDA says widening probe on generic drug impurities
The U.S. Food and Drugs Administration said on Wednesday it was expanding its investigation into impurities in U.S. generic drugs beyond a class of medicines for high blood pressure known as angiotensin II receptor blockers (ARBs). The agency did not specify which types of additional drugs it was looking at, but said it was testing samples of other medicines with similar manufacturing processes to those in which concerning impurities have been discovered.
FDA flags risks from AbbVie, Gilead, Merck hepatitis C drugs to certain patients
The U.S. Food and Drug Administration said on Wednesday it had identified 63 cases of worsening liver function in certain patients taking hepatitis C medicines made by drugmakers Merck & Co Inc, Gilead Sciences and AbbVie Inc . The agency said that while the treatments are safe and effective, it had received reports of rare but serious instances of worsening liver function or failure when they were taken by patients with advanced liver disease.
FDA gives fast track status to AstraZeneca's diabetes drug Farxiga
AstraZeneca Plc said on Tuesday that the U.S. Food and Drug Administration has granted fast track status for the development of its diabetes drug Farxiga to prevent heart and kidney failure in patients with chronic kidney disease (CKD). Farxiga, one of AstraZeneca's top 10 drugs by sales, is part of the SGLT2-inhibitor class of antidiabetics that cause the kidneys to expel blood sugar from the body through urine.
U.S. prices for multiple sclerosis drugs are on the rise
Annual costs of disease modifying treatments for multiple sclerosis more than quadrupled from 2006 to 2016 as several new, costly medicines entered the market, a U.S. study suggests. Before 2009, only four drugs were available to reduce symptoms and slow the progression of multiple sclerosIs (MS), a disabling autoimmune disease that damages the central nervous system and can lead to fatigue, pain, vision loss and impaired coordination and motor skills. Since 2009, seven new drugs have entered the U.S. market.
Purdue Pharma in discussion on $10 billion-$12 billion offer to settle opioid lawsuits: sources
OxyContin maker Purdue Pharma LP and its owners, the Sackler family, are in discussion to settle more than 2,000 opioid lawsuits against the company for $10 billion to $12 billion, two people familiar with the matter said on Tuesday. Purdue is among several drugmakers and distributors that have been sued for fueling an opioid addiction crisis in the United States, which claimed 400,000 lives from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention.
AstraZeneca respiratory business gets boost from 3-drug inhaler results
Prospects for AstraZeneca's respiratory treatments business improved on Wednesday as a three-drug inhaler was shown to ease smoker's lung and U.S. regulators granted its injectable asthma drug Fasenra special status for a rare lung condition. AstraZeneca said the late-stage ETHOS trial of triple-drug therapy Breztri Aerosphere, formerly known as PT010, helped patients suffering from chronic obstructive pulmonary disease (COPD), in a challenge to Glaxosmithkline's Trelegy Ellipta.
U.S. judge rules for Regeneron, Sanofi in Amgen cholesterol drug patent fight
A U.S. judge on Wednesday set aside a jury verdict that found Amgen Inc patents on its cholesterol drug Repatha were valid, handing a victory to Regeneron Pharmaceuticals Inc and Sanofi SA, which sells a rival drug. The ruling from U.S. District Judge Richard Andrews in Wilmington, Delaware was the latest reversal of fortune in a long-running lawsuit in which Amgen is seeking to stop French drugmaker Sanofi and U.S. biotech Regeneron from selling their drug Praluent.
Hard to tell how common sesame allergy may be
(Reuters Health) - Roughly half of children and adults who say they're allergic to sesame don't have a history of convincing symptoms, a U.S. study suggests. Researchers examined data on 78,851 children and adults and found that 102 kids and 149 adults had a convincing sesame allergy based on experiencing at least one clear immune reaction in the past.
Possible link between C-section and autism, ADHD
The combined results of 61 studies conducted in 19 countries suggest that when a woman gives birth by cesarean section, autism in the child is 33% more likely and the odds of attention-deficit/hyperactivity disorder (ADHD) increase by 17%. The statistical analysis, published in JAMA Network Open, does not prove that having a C-section directly causes such problems. Other factors that lead doctors to order a surgical delivery of the baby may underlie the link.
J&J liable for $572 million in Oklahoma opioid epidemic trial; shares rise
An Oklahoma judge on Monday ordered Johnson & Johnson to pay $572.1 million to the state for its part in fueling an opioid epidemic by deceptively marketing addictive painkillers, a sum that was substantially less than investors had expected, driving up J&J's shares. The state's attorney general had filed the lawsuit, seeking $17 billion to address the impact of the drug crisis on Oklahoma. It had been considered a bellwether for other litigation nationwide over the opioid epidemic.
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