Drugs
FDA has approved an oral suspension formulation of Mitsubishi Tanabe Pharma America’s Radicava (edaravone) for treating adults with amyotrophic lateral sclerosis (ALS). Radicava was originally approved in 2017 as an intravenous (IV) infusion to treat ALS (Lou Gehrig’s disease). Radicava ORS is self-administered and can be taken
Drugs
India’s troubled Aurobindo Pharma says a 5/2-5/10 FDA inspection at its Unit VII oral drug manufacturing facility in Jedcherla, Hyderabad, resulted in an FDA-483 with six observations.In a submission to the National Stock Exchange of India, Aurobindo says it will respond to FDA within
Drugs
The U.S. now has a sufficient supply of molybdenum-99 (Mo-99) produced without highly enriched uranium, thanks to efforts by FDA and other government and private organizations. In a CDER From Our Perspective online post, Division of Imaging and Radiation Medicine medical officer Joseph Rajendran says the Center
Drugs
FDA has extended by 90 days its review period for an Amicus Therapeutics BLA for cipaglucosidase alfa and its NDA for miglustat, the two components in the company’s AT-GAA, intended for late-onset Pompe disease. The new PDUFA action dates for the BLA and NDA are 8/29
Drugs
Sanofi and AstraZeneca say a pre-specified pooled analysis of Phase 3 and Phase 2b data demonstrates efficacy of 79.5% for their nirsevimab against medically attended lower respiratory tract infections, including hospitalizations, caused by the respiratory syncytial virus (RSV). A Sanofi media statement says the safety profile across the
Drugs
Veru Inc. says it will submit an emergency use authorization (EUA) application in the second quarter of 2022 for its sabizabulin for use in hospitalized moderate-to-severe Covid-19 patients at high risk for acute respiratory distress syndrome. A company statement says a 5/10 pre-EUA conference with
Drugs
A 5/9-concluded FDA inspection of Sun Pharmaceutical Industries’ Halol manufacturing facility (Gujarat, India) resulted in a 10-item Form FDA-483, according to a company release. Sun says it is preparing a response to the observations, which will be submitted to the agency within 15 business days. The
Drugs
Eisai has completed a rolling BLA submission under the accelerated approval pathway for its investigational anti-amyloid beta protofibril antibody lecanemab (BAN2401) for treating mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD with a confirmed presence of amyloid pathology in the brain. Eisai has requested a
Drugs
An 8/5-9/16/21 FDA inspection at Brigham and Women’s Hospital, Boston, MA, found significant violations of current good manufacturing practice regulations for positron emission tomography drugs. A 4/11 Warning Letter says specific violations were: * the facilities are not adequate to ensure the prevention of equipment
Drugs
CDER says it has launched its new Accelerating Rare disease Cures (ARC) program to speed and increase the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. An online announcement says developing drugs for some 7,000 rare diseases and conditions can be
Drugs
Mesa Biotech has recalled (Class 1) its Accula SARS-CoV-2 Test because certain lots of the device have an increased risk of giving false positive results due to contamination at the manufacturing facility. False positive results could lead to further exposure of uninfected individuals to Covid-19, according to
Drugs
FDA says its review of a Web site maintained by inhousepharmacy.vu indicates the site introduces into interstate commerce domperidone drug products that are unapproved new drugs. A 5/4 Warning Letter says domperidone is not currently a legally marketed human drug and is not approved for sale in the
Drugs
FDA has approved a new indication for Eli Lilly’s Olumiant (baricitinib) for treating Covid-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for Covid-19 to receive FDA approval, according to an agency
Drugs
FDA has released a draft guidance entitled “Benefit-Risk Considerations for Product Quality Assessments,” which describes the agency’s benefit-risk principles used when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted in NDAs/BLAs, in addition to other information (e.g., inspection findings) available
Drugs
FDA has lifted a clinical hold on LogicBio Therapeutics’ Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia (MMA), a mutation in a gene called methylmalonyl-CoA mutase that prevents the body from properly processing certain fats and proteins. According to the company, four
Drugs
Mustang Bio has entered into a lease agreement with the UMass Medicine Science Park in Worcester, MA for a manufacturing facility to support the clinical development and commercialization of the company’s chimeric antigen receptor engineered T cell technology. The facility is expected to be operational for the production of
Drugs
FDA has extended by three months its review of a Myovant Sciences and Pfizer supplemental NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pain associated with endometriosis. FDA told the companies that it requires additional time to review
Drugs
Robert Califf admits that his return to the FDA top post gives him an opportunity to address “unfinished business from the first time around,” when he served as commissioner during the final year of the Obama administration (2016 to 2017). In an JAMA online interview with deputy editor Greg Curfman,
Drugs
A CDER self-audit of continuous manufacturing regulatory submissions and outcomes identified no substantial barriers associated with common regulatory interactions related to the implementation of continuous manufacturing as compared to batch manufacturing. A study report in the International Journal of Pharmaceutics, also says there are potential regulatory and clear economic
Drugs
FDA has approved Daiichi Sankyo’s Enhertu (fam-tastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant setting and have developed disease recurrence during or within six
Drugs
An FDA-sponsored study found that for patients undergoing properly monitored levothyroxine treatment over time, those who switched among generic drug products maintained the same level of thyroid function as those who consistently used a single levothyroxine product. As reported in Spotlight on CDER Science, the study was not designed
Drugs
FDA has released the FDA-483 with 15 observations issued following a 4/29-6/15/21 inspection at Qualgen, an Edmond, OK, outsourcing facility. The observations were: * failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers,