Drugs
FDA has granted Equillium a fast track designation for itolizumab for treating lupus nephritis. In September, Equillium initiated the EQUALISE Phase 1b study of itolizumab in patients with lupus and lupus nephritis. The study will have two cohorts: Type A is an open-label cohort and will treat patients with
Drugs
FDA has released a draft guidance entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.” The document is intended to assist sponsors in the clinical development of locally applied corticosteroid products (including suppositories or products that require an applicator)
Drugs
FDA has approved an Amgen BLA for Avsola (infliximab-axxq), a biosimilar of Janssen’s Remicade, indicated for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The agency says this is the fourth biosimilar of Remicade (infliximab) to gain approval. To view the
Drugs
A New York physician, Gordon Freedman, has been convicted for participating in a scheme to receive bribes and kickbacks through sham educational programs (“speaker programs”) from Insys Therapeutics in exchange for prescribing millions of dollars’ worth of Subsys, a fentanyl-based spray. “As a jury of his peers has now
Drugs
FDA says it is asking manufacturers of ranitidine (Zantac) and nizatidine (Axid) to expand their testing for N-nitrosodimethylamine (NDMA) in all lots of the medications before making them available to consumers. An agency statement says that if testing shows NDMA above the acceptable daily limit of 96 nanograms/day
Drugs
ViiV Healthcare has submitted an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection. The drug is under development for combination use with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive
Drugs
The CDRH Manufacturer and User Facility Device Experience (MAUDE) database does not make public information on the sex of patients involved in a medical device adverse event for reasons of “patient confidentiality.” However, the CDER FDA Adverse Events Reporting System (FAERS) makes such information publicly available. Because the International Consortium
Drugs
FDA has approved three ANDAs for the first generics of Novartis’ Gilenya (fingolimod) capsules for treating relapsing forms of multiple sclerosis in adult patients. Approvals were granted to HEC Pharm Co., Biocon Limited and Sun Pharmaceutical Industries. An FDA release says that fingolimod must be dispensed with a Medication Guide
Drugs
FDA has launched CURE ID, an Internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a Web site, smart phone, or other mobile device. An agency statement says the platform “enables
Drugs
Genus Lifesciences says FDA applied a different and much more lenient standard to an application submitted by Lannett for its cocaine hydrochloride product that Genus says is substantially similar to its Goprelto product. In an 11/27 letter, Genus says that FDA required it to submit results from several studies
Drugs
FDA has published a draft guidance, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment, with recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome. The document incorporates recommendations the agency received at a 12/2017 advisory committee meeting
Drugs
The Justice Department says a deferred prosecution agreement reached with Rising Pharmaceuticals, a New Jersey generic drug company, will resolve charges through the company’s admission that it conspired with a competing generic drug company to fix prices and allocate customers for benazepril HCTZ. A one-count felony charge filed
Drugs
FDA has approved a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Approval is based
Drugs
The White House Council of Economic Advisors (CEA) says that H.R. 3, the Lower Drug Costs Now Act of 2019, could keep as many as 100 new lifesaving drugs off the market. The CEA also estimates that by limiting access to lifesaving drugs, the bill would reduce Americans’ average
Drugs
Aquestive Therapeutics has completed a rolling NDA submission for Libervant (diazepam) Buccal Film for managing seizure clusters. Libervant is administered from inside the cheek in selected, refractory patients with epilepsy on stable regimens who require intermittent use of diazepam to control bouts of increased seizure activity. Aquestive says it is
Drugs
The House Energy and Commerce Oversight and Investigations Subcommittee has planned a 12/10 hearing entitled “Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program.” It will be held at 10 am in the John D. Dingell Hearing Room, 2123 Rayburn House Office Building. “Over
Drugs
FDA has released the FDA-483 issued following a 9/9-9/19 inspection at AnazaoHealth, a Las Vegas, NV, outsourcing facility. The three inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions; * the flow of
Drugs
At the 11/16-11/10 International Council on Harmonization (ICH) meeting in Singapore, the ICH management committee reelected CDER associate director for strategic initiatives Theresa Mullin to a one-year term as the committee chair. A meeting report also indicates that the assembly regulatory members adopted the new ICH
Drugs
FDA has released the FDA-483 issued following an 8/26-9/26 inspection at Nubratori, Inc., a Torrance, CA, outsourcing facility. The inspection observations were: * failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * disinfectant contact time and coverage of the item
Drugs
Immunomedics has resubmitted its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In January, FDA issued a complete response letter on the original submission. “The issues related to approvability in
Drugs
Citing a May Supreme Court ruling outlining the standard for a federal preemption defense in drug warning claims, the 3rd Circuit Court of Appeals has remanded to a New Jersey federal court hundreds of Fosamax bone fracture lawsuits, asking that court to decide whether the failure-to-warn cases are
Drugs
Immunomedics has resubmitted its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In January, FDA issued a complete response letter on the original submission. “The issues related to approvability in