Shares in Mallinckrodt Pharmaceuticals (NYSE:MNK) fell today after the company beat earnings estimates but missed on revenue with its second quarter results. The U.K.-based company posted profits of $62.8 million, or 72¢ per share, on sales of $824.5 million for the 3 months ended June 30, for bottom-line loss of -68% on sales loss of -5% […]
Mallinckrodt Pharmaceuticals
DOJ subpoenas Mallinckrodt over opioids
Mallinckrodt Pharmaceuticals (NYSE:MNK) said yesterday that it received a subpoena from the U.S. Dept. of Justice requesting information related to its marketing practices and sales of opioids. The company, which manufactures only generic and non-promoted branded opioids, said that it has worked to prevent misuse and diversion of its products, pointing to efforts like its testimonies […]
Mallinckrodt enrolls first infant in registry for inhaled nitric oxide gas
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that it included the first patient in its Phase IV registry evaluating the use of inhaled Inomax nitric oxide gas for premature neonates compared to term and near-term newborns. Inomax, which has FDA approval, is designed to boost oxygenation and lessen the need for extracorporeal membrane oxygenation in term and near-term […]
FDA grants regenerative medicine advanced therapy status to Mallinckrodt’s StrataGraft
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that its StrataGraft regenerative skin tissue won regenerative medicine advanced therapy status from the FDA. The tissue-based therapy is among the first products to be granted the designation. The 21st Century Cures Act, which was passed in 2016, enabled the FDA to give accelerated review approval to products that meet RMAT criteria. […]
Mallinckrodt wins orphan drug status for long-acting muscular dystrophy therapy
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that the FDA granted orphan drug status to its long-acting cosyntropin acetate formulation, MNK-1411, for the treatment of Duchenne muscular dystrophy. In August last year, the FDA approved the company’s request to fast track its investigational new drug application for the therapy. “We are pleased the FDA has granted orphan drug status to […]
Mallinckrodt responds to probe into pricey injection pain-killer
Mallinckrodt Pharmaceuticals (NYSE:MNK) issued a response today to Sen. Claire McCaskill (D-Mo.) and her probe into the company’s pricing strategies for its injectable pain-killer, Ofirmev. McCaskill wrote to the company at the end of May, suggesting that that the company’s price increases could have cost hospitals millions and may have pushed healthcare practitioners to use cheaper painkillers, including highly […]
Mallinckrodt launches pivotal trial for StrataGraft regenerative skin graft
Mallinckrodt (NYSE:MNK) said today that it enrolled the 1st patient in the pivotal Phase III trial of its StrataGraft skin tissue graft. The study is slated to include patients with 3% to 49% total body surface area of severe thermal burns. Researchers intend to evaluate outcomes including the area of StrataGraft treatment site that requires a subsequent […]
Mallinckrodt mulls sale of generics biz
Mallinckrodt Pharmaceuticals (NYSE:MNK) is reportedly considering a sale of its generic drug unit in an effort to focus its portfolio on high-margin branded drugs, according to a report from Reuters. The divestment comes only months after the company sold its nuclear imaging business to IBA Molecular for $690 million. The sale of its generics business could […]
Mallinckrodt faces probe over price hikes for injectable pain-killer
Sen. Claire McCaskill (D-Mo.) penned a letter to Mallinckrodt Pharmaceuticals (NYSE:MNK) last week, probing for details about the company’s pricing strategies for its injectable pain-killer, Ofirmev. Mallinckrodt acquired Ofirmev in 2014, when it bought Cadence Pharmaceuticals in a $1.4 billion deal. In May of that year, Mallinckrodt hiked the pain-killer’s list price from $14.75 per vial to […]
Amid drug-pricing criticism, industry trade group ousts members
The pharmaceutical industry’s trade group ousted 22 companies earlier this week after it revised membership rules. The move comes as lawmakers in Washington have pressed the pharma industry about U.S. drug prices. The updated membership rules for the Pharmaceutical Research and Manufacturers of America (PhRMA) group mandates that members spend at least $200 million each year […]
