Drugs
FDA has granted Altor BioScience a fast track designation for its investigational interleukin-15 (IL-15) agonist complex, ALT-803, in combination with bacillus Calmette-Guérin (BCG), for treating patients with non-muscle invasive bladder cancer (NMIBC). ALT-803 is currently being studied in a Phase 1b/2 clinical trial
Drugs
The Biosimilars Forum has urged FDA to be more flexible with its approach in determining a proposed biosimilar product’s interchangeability with an innovator’s product. In comments addressing the agency’s recent draft guidance on Considerations for Demonstrating Interchangeability with a Reference Product, the organization urges FDA to consider,
Drugs
India’s LiveMint online media reports that Wockhardt posted a bigger loss in the first quarter of this year due to expenses for remedial measures at plants facing regulatory issues. “Wockhardt has been grappling with quality control issues raised by the U.S. FDA for the past four years,” the
Drugs
FDA has granted rare pediatric disease designation for Sangamo Therapeutics’ SB-913 in vivo genome editing treatment for mucopolysaccharidosis type 2 (MPS 2). It also gave orphan drug designation to the company’s SB-525 cDNA therapy for hemophilia A, and fast-track designation for SB-FIX in vivo genome
Drugs
Apotex is petitioning FDA to issue specified requirements for biosimilar applicants referencing Amgen’s Neulasta (pegfilgrastim). Specifically, the petition asks that FDA: * require all biosimilar applicants referencing Neulasta demonstrate “no clinical meaningful differences” by conducting a comparative clinical efficacy study in at least one of Neulasta’s indicated patient populations;
Drugs
FDA has given Soligenix the green light to advance a pivotal Phase 3 clinical trial evaluating SGX942 (dusquetide) for treating oral mucositis in head and neck cancer patients being treated with chemoradiation (CRT). The company plans to begin the trial in the second quarter. Based on positive Phase 2 results
Drugs
FDA has approved an investigator-initiated IND to begin a Phase 1 trial involving ZioPharm Oncology’s CD33-specific CAR-T therapy for relapsed or refractory acute myeloid leukemia (AML). The first patient is expected to be enrolled in the study in the third quarter. The CD33-specific CAR-T
Drugs
Seven patient advocacy groups — Alliance for Aging Research, American Cancer Society Action Network, Friends of Cancer Research, Leukemia and Lymphoma Society, National Organization for Rare Disorders, Parent Project Muscular Dystrophy, and St. Baldrick’s Foundation — say it is “imperative that patients seeking expanded access to unapproved therapies be treated with
Drugs
FDA has released the FDA-483 issued following a 4/10-4/18 agency inspection at Aurobindo Pharma, Hyderabad, Telangana, India. Inspection observations included: * failing to have laboratory controls include establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform
Drugs
FDA has told Intra-Cellular Therapies that it has concerns with certain findings observed in nonclinical animal toxicology studies involving ITI-007 (lumateperone), an investigational therapy for schizophrenia. During a company-requested feedback meeting, the agency requested additional information to confirm that the nonclinical findings are not indicative of a
Drugs
Medical ethicist Arthur Caplan and two other Health Affairs bloggers warn that “right-to-try” legislation that purports to give terminally ill patients the right to try experimental drugs outside of a clinical trial “will do nothing to make companies more likely to grant patients access to their experimental drugs
Drugs
FDA has released the FDA-483 issued at the conclusion of a 4/17-4/21 inspection at Nephron Pharamceuticals, West Columbia, SC. Specific violations noted on the form include: * failing to include adequate validation of the sterilization process in procedures designed to prevent microbiological contamination of a drug product
Drugs
Implementation of policies at academic medical centers that restricted pharmaceutical detailing between 2006 and 2012 was associated with modest but significant reductions in prescribing of detailed drugs across six of eight drug classes, according to research published (subscription or purchase required) online in the Journal of the American Medical Association.
Drugs
A Health Affairs blog post outlines three complex challenges facing FDA commissioner nominee Scott Gottlieb and ways in which he could address them. The post says that critics and supporters who seek to judge what Gottlieb would do as commissioner are trying to discern the answer to a question that
Drugs
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Criticare Technologies North Kingstown, RI (4/21): FDA inspected the firm in March and cited it for GMP violations related to its patient vital sign monitors. For example, FDA
Drugs
Dr. Reddy’s Laboratories tells stock analysts in India that FDA completed its inspection of the firm’s formulation manufacturing plant at Bachupally, Hyderabad, India, and issued an FDA-483 containing 11 observations. “These observations are mostly procedural in nature,” the firm says, “reflecting the need to improve people capabilities
Drugs
A 6/27-7/1/16 FDA inspection at Sal Pharma, Hyderabad, Andhra Pradesh, India, found significant deviations from current good manufacturing practices for active pharmaceutical ingredients (API), according to a 4/30 Warning Letter. Specific deviations included: * failing to transfer all quality or regulatory information received from the API
Drugs
The Esophageal Cancer Action Network is asking FDA to require a stronger warning about the risk of esophageal cancer for all OTC drug products labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion, and sour stomach. “The warnings should note that these OTC drug products do not
Drugs
CBER director Peter Marks says FDA and the National Institutes of Health have released a finalized template for investigators to use when organizing clinical trial protocols. Writing in an FDA Voice blog post, Marks says issuance of the template “is likely to contribute important efficiencies to the process of protocol
Drugs
FDA has approved a Takeda Pharmaceutical Co. NDA for Alunbrig (brigatinib) for treating patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. The accelerated approval was based on tumor response rate and duration of response shown in a
Drugs
FDA has granted accelerated approval to AstraZeneca for Imfinzi (durvalumab) for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The agency also
Drugs
Sanofi and Regeneron Pharmaceuticals have resubmitted their BLA for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients with moderately to severely active rheumatoid arthritis. In 10/2016, FDA sent the companies a Complete Response Letter on their BLA, citing certain deficiencies identified during a routine good manufacturing