Shares in Endo Pharmaceuticals (NSDQ:ENDP ) have risen nearly 20% so far today after the medical giant beat expectations on Wall Street with its second quarter results. The Dublin, Ireland-based company posted losses of $60.9 million, or 27¢ per share, on sales of $714.7 million for the three months ended June 30, seeing losses shrink 95.6% […]
Endo Pharmaceuticals hit with subpoena over opioid products
Endo Pharmaceuticals (NSDQ:ENDP) was hit by a grand jury subpoena yesterday from the U.S. Attorney’s Office for the Southern District of Florida over its oxymorphone products. The subpoena requests an array of documents, including those derived from past or pending lawsuits, product safety and efficacy, overdoses, diversion, theft, abuse and misuse, withdrawal and addictiveness. The attorney’s […]
FDA wants to improve access to generic abuse-deterrent opioids: here’s how
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse. To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in […]
Trump’s opioid public health emergency highlights differences with FDA
President Donald Trump yesterday declared the opioid epidemic a national public health emergency – a move that he said will help “liberate our communities from this scourge of drug addiction.” The president, surrounded by lawmakers and advocates, said that the government’s plan to fight the opioid epidemic would include “really tough, really big, really great […]
Study: Abuse-deterrent opioids are costly and unproven
In an attempt to curb the harrowing opioid crisis in America, drugmakers have developed what they tout as “abuse-deterrent” pain-killers – opioid formulations that are designed to prevent users from injecting the drugs. But a report published this week by the Institute of Clinical and Economic Review found that there isn’t enough evidence to claim […]
Endo swings to Q2 loss on $775m pelvic mesh set-aside
Endo International (NSDQ:ENDP) posted a net loss in the second quarter of this year, citing charges like the $775 million it has set aside to resolve 22,000 remaining lawsuits relating to the company’s vaginal-mesh implants. The generic drugmaker faced other setbacks this quarter, including the FDA asking that Endo pull its painkiller, Opana ER, from the […]
Endo shutters manufacturing facilities in Huntsville
Endo (NSDQ:ENDP) said today that it plans to close its manufacturing and distribution plants in Huntsville, Alabama, slashing 875 jobs from its workforce. The closing, which is slated to happen over the next 12 to 18 months, is due to declining volumes of commoditized products, according to Endo. “Endo’s key priorities include building our product portfolio and […]
Endo pulls painkiller from the market following FDA request
Endo Pharmaceuticals (NSDQ:ENDP) said today that it will voluntarily pull its Opana ER painkiller from the market. The move comes just weeks after the FDA asked the company to pull the plug on its opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks. To write off the remaining net book value […]
FDA asks Endo to pull Opana from the market over concerns of abuse
The FDA asked Endo Pharmaceuticals (NSDQ:ENDP) to pull its opioid pain med, Opana ER, from the market, saying that the benefits of the abuse-deterrent drug no longer outweigh the risks. The move marks the 1st time the federal regulatory watchdog has urged a company to remove an opioid painkiller due to concerns of abuse. “We are facing […]
Critics allege misleading campaigns, poorly-cited data fueled opioid addiction crisis
The state of Ohio filed a lawsuit against opioid-makers this week, alleging that the companies produced misleading marketing schemes to convince doctors and patients that opioids were not addictive. Ohio isn’t alone – Mississippi and West Virginia have filed similar cases against major players in the pharmaceutical industry. Purdue Pharma, Johnson & Johnson (NYSE:JNJ), Endo […]
