ANI Pharmaceuticals ventured into new territory last November with its first-ever branded product in Purified Cortrophin Gel and is tapping cloud software company Veeva Systems to help it identify best practices for reaching patients and doctors. Under the aegis of a new business unit focused on rare diseases, the Minnesota-based specialty drug company is throwing down the gauntlet against Mallinckrodt Pharmaceuticals’ Acthar Gel, which since 1954 has been the established purified corticotropin injection for refractory symptoms of autoimmune disorders like rheumatoid (RA), multiple sclerosis (MS) and nephrotic syndrome.
The United States sued a unit of the drugmaker Mallinckrodt Plc on Tuesday, accusing it of defrauding Medicaid out of hundreds of millions of dollars as a result of “meteoric” price increases for its biggest-selling drug, Acthar Gel.
Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced findings from a large retrospective study of Acthar® Gel (repository corticotropin injection) in the treatment of the respiratory disease symptomatic sarcoidosis that assessed patient characteristics, treatment patterns, concomitant medication use and physicians' assessments of treatment response. The study examined medical records from 302 patients with advanced symptomatic sarcoidosis, the majority of whom had comorbidities and had previously been treated with corticosteroids. The analysis showed that the use of Acthar Gel was associated with improved overall health status in 95 percent of patients as reported by physicians' assessments, with more than half of patients (54 percent) seeing improvements in two or more symptoms. In addition, there was an association observed between the use of Acthar Gel therapy and reduced overall use of other medications. Results of the study were recently published online in Therapeutic Advances in Respiratory Disease, an online, open-access peer-reviewed journal.
Mallinckrodt Plc said on Tuesday it has received a subpoena from the U.S. Securities and Exchange Commission for documents related to the drugmaker’s lawsuit against the U.S. Department of Health and Human Services (HHS).
Mallinckrodt is selling its CDMO unit for up to $250 million to a private equity firm, but that is a drop in the bucket of what it may need as it faces growing exposure to opioid and other litigation and as reports of bankruptcy circulate.
Every day seems like a new test for Mallinckrodt investors: Consider last month, when Humana took the company to court for $700 million in fraudulent billing. But now, with Mallinckrodt reportedly talking bankruptcy if federal opioid penalties balloon out of control, it could be the last straw.
Mallinckrodt has announced that it is permanently discontinuing its Phase IIb study designed to assess the efficacy and safety of Acthar Gel as an investigational treatment for amyotrophic lateral sclerosis (ALS). ALS is a progressive neurodegenerative disease that affects motor neuron cells in the brain and the spinal cord.
More than 80% of doctors who filed Medicare claims in 2016 for H.P. Acthar Gel -- a drug best known for treating a rare infant seizure disorder -- received money or other perks from the drugmakers, according to a CNN analysis of publicly identified prescribers.
Mallinckrodt plc , a leading global specialty pharmaceutical company, announced it will conduct a new phase 4, multi-center, randomized, double blind, placebo-controlled study to further assess the efficacy of H.P. Acthar gel as a therapy option in patients with symptomatic sarcoidosis, one of 19 indications approved by the US Food and Drug Administration (FDA).
Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed enrollment of the first patient in the company's Phase 2B study designed to assess the efficacy and safety of H.P. Acthar® Gel (repository corticotropin injection) as a treatment for amyotrophic lateral sclerosis (ALS).