Enforcement Report - Week of February 22, 2023
The shuttering of Teva’s long troubled manufacturing facility in Irvine, California, may create shortages of up to 24 generic sterile injectable drugs, including five essential medications of which the company supplied more than 15% of the market last year, according to an industry group.
The oral hearing on the anti-dumping investigation related to the imports of the key raw material used in antiretroviral drugs like valaliclovir and amikacin, is scheduled to be held on August 20, 2021. The Directorate General of Trade Remedies (DGTR) has initiated the investigation through a notification on February 25, 2021.
BRIDGEWATER, N.J., Jan. 4, 2021 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the first patient was dosed in late December, 2020, in the frontline clinical trial program of ARIKAYCE® (amikacin liposome inhalation suspension) in patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). The program consists of ARISE, an interventional study designed to validate cross-sectional and longitudinal characteristics of patient-reported outcome (PRO) tools in MAC lung disease, and ENCORE, a pivotal trial designed to establish, using the PRO tools validated in the ARISE trial, the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed MAC lung disease.
NEW YORK, Nov. 12, 2020 /PRNewswire/ -- Bridge Medicines, a pioneering drug discovery company focused on advancing promising early technologies from concept to clinic, announced today the additional funding of $10 million to advance its current pipeline of products as well as expand with additional in-licensed technologies.
At its June 2020 meeting, the human medicines committee of the European Medicines Agency (EMA’s CHMP) recommended that 11 new medicines be approved for use in the European Union (EU); one of these, Dapirivine Vaginal Ring, was recommended under EU Medicines for All, a mechanism for medicines that are also to be used outside the EU.
BRIDGEWATER, N.J., July 7, 2020 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that ARIKAYCE® (amikacin liposome inhalation suspension) has been included in the new international treatment guidelines for nontuberculous mycobacterial (NTM) lung disease, a chronic, debilitating condition that can cause severe, permanent damage to the lungs. The evidence-based guidelines, issued by the American Thoracic Society (ATS), European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and Infectious Diseases Society of America (IDSA), recommend the use of ARIKAYCE for the treatment of patients with refractory NTM lung disease caused by Mycobacterium avium complex (MAC) as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options.
The Pharmacovigilance Programme of India (PvPI) has come out with previously unknown adverse events for nine popular drugs including opioid pain medication Tramadol; three antibacterial drugs Cefepime, Ofloxacin and Amikacin; and multidrug- resistant tuberculosis medication Bedaquiline, etc.
The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).
PITTSBURGH, Dec. 18, 2018 /PRNewswire/ -- PANTHERx® Specialty Pharmacy, THE Rare Disease Specialty Pharmacy®, announced that it has been selected by Insmed Incorporated to distribute ARIKAYCE® (amikacin liposome inhalation suspension), the first and only therapy specifically indicated for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. PANTHERx® is one of a select few specialty pharmacies providing nationwide access to the medication.