NEW YORK (Reuters)—Generic drug makers are turning to mergers and acquisitions to shield themselves against a concerted effort by U.S. regulators to crack down on steep drug prices. Impax Laboratories Inc, Perrigo Company Plc and Alvogen Inc have been talking to advisers about strategic options for their generics businesses, ranging from acquisitions to increase scale…
Search results for: oxycodone
Mallinckrodt Settles U.S. Opioid Drug Probe for $35 million
(Reuters)—Mallinckrodt Plc., one of the largest manufacturers of the generic opioid painkiller oxycodone, will pay $35 million to resolve allegations that it failed to report suspicious drug orders, the U.S. Justice Department said on Tuesday. The deal, in which Mallinckrodt did not admit wrongdoing, marked a record settlement of claims that a drugmaker failed to properly…
FDA Responds to New Drug Application for Baricitinib
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
Pain Management Research Sheds Light on Postsurgical Pain Sensitization, Opioid Risks, Nondrug Interventions
WASHINGTON, D.C.—Successful management of pain remains a challenge for rheumatologists. Five research abstracts presented at the 2016 ACR/ARHP Annual Meeting in a session titled Pain—Basic and Clinical Aspects offered new insights on pain sensitization, and the risks and effects of various pain therapies. Knee Pain After Surgery Can we predict which patients will have longer-term…
Prescription-Drug Monitoring Cuts Doctor-Shopping for Painkillers
(Reuters Health)—State programs that require physicians to check drug registries before writing prescriptions appeared to slash the odds of doctor-shopping for opioid pain relievers, a new study found. “Our study shows that prescription-drug monitoring programs are a promising component of a multifaceted strategy to address the opioid epidemic,” Ryan Mutter, one of the study authors,…
Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar
After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…
A Morphine Alternative with Less Overdose Risk?
(Reuters Health)—Scientists are testing an experimental drug that’s designed to have the painkilling power of morphine without some of the side effects that can lead to overdose deaths. Initial results in mice with the compound known for now as PZM21 suggest it might be less addictive than morphine and other opiate painkillers and avoid respiratory…
Prescription-Drug Monitoring Saves Lives, Could Save More
(Reuters Health)—State programs that monitor narcotic prescriptions help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day, a new study finds. States with the most robust programs—ones that tracked a greater number of potentially addictive medications and updated their databases at least weekly—saw the biggest drops…
Lilly Says New Type of Pain Drug Could Reduce Need for Opioids
(Reuters)—Eli Lilly and Co. on Tuesday said it and partner Pfizer Inc. aim to seek approval by 2018 for a new type of pain drug that could be an alternative to opioids for osteoarthritis, chronic back pain and cancer pain. The Indianapolis drugmaker said tanezumab, given by injection every eight weeks, could be a far…
U.S. Agency Issues New Guidelines to Limit Chronic Use of Opioids
(Reuters)—Addressing a growing “epidemic” of opioid overdoses and abuse of the prescribed painkillers in the U.S., the Centers for Disease Control and Prevention on Tuesday released voluntary guidelines that instruct primary care doctors to sharply deter use of the medicines for chronic pain. “Overprescribing opioids, largely for chronic pain, is a key driver of America’s…