Drugs
FDA has issued Orexo AB a complete response letter on its NDA for OX124, a high-dose naloxone rescue medication being developed for opioid overdose. The letter cites the need for an additional human factors (HF) study, and requests additional technical data on the final commercial product, according to the
Drugs
FDA has released a guidance entitled “Drugs for Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients One Month of Age and Older.” The document provides recommendations to sponsors on the clinical development of drugs for the treating partial onset seizures (POS) in pediatric patients. Specifically,
Drugs
Lexeo Therapeutics says it will explore with FDA the potential to seek accelerated approval for LX2006 and its use in treating Friedreich ataxia (FA) cardiomyopathy based on just-announced “positive interim data” from two early-stage trials. “Across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and
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Pharmaceutical marketer Quintan Cockerell (Palos Verdes Estates, CA) was sentenced 7/12 to two years and five months in prison and ordered to pay over $59 million in restitution for conspiring to defraud the U.S., receiving illegal kickbacks in exchange for compounded medications prescription referrals, and money laundering. According
Drugs
A 3/2023 inspection at a Lonza Visp, Switzerland manufacturing facility has resulted in a one-item Form FDA-483. The inspection found that the company’s laboratory records do not include complete data derived from all tests, examinations and assays necessary to assure compliance with established specifications and standards,
Drugs
FDA has granted Sumitomo Pharma America a fast track designation for DSP-5336 and its use in treating patients with relapsed or refractory acute myeloid leukemia with a KMT2A rearrangement, also known as mixed lineage leukemia rearrangement or nucleophosmin mutation. DSP-5336 is described as a small molecule inhibitor of
Drugs
Indivior says it is discontinuing sales and marketing of schizophrenia drug Perseris (risperidone) due to “expected adverse impacts from increased payor management of the category that crystalized in [the second quarter] and that are expected to make the product no longer financially viable.” The once-monthly subcutaneous risperidone-containing, long-
Drugs
AbbVie has filed a supplemental NDA for Rinvoq and its use in treating adult patients with giant cell arteritis (GCA), an autoimmune disease involving medium and large arteries that can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision. The submission is based on
Drugs
FDA has released the form FDA-483 issued following a 5/29-6/12 inspection at the Hikma Pharmaceuticals USA outsourcing facility in Cherry Hill, NJ. The three inspection observations were: * failure to establish and follow procedures designed to prevent objectionable microorganisms in drug products not required to be sterile;
Drugs
The Duke-Margolis Institute for Health Policy has released its summary of a 3/19-3/20 public meeting held with FDA on enhancing the adoption of innovative clinical trial approaches. The workshop discussion aimed to better understand shared opportunities for communication and cooperation to enhance the development and adoption
Drugs
Pfizer says it has selected its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist it is developing for treating obesity. The company plans to conduct dose optimization studies later this year that will assess multiple doses of the selected modified-
Drugs
Researchers from FDA and the University of Pennsylvania say payers can be crucial allies in improving evidence generation to inform clinical practice because better data would better inform coverage decisions. Writing in JAMA, the researchers say increasing payer involvement in evidence generation “can benefit all participants in the medical innovation
Drugs
FDA has approved an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream, 0.15%, for treating mild to moderate atopic dermatitis in adult and pediatric patients six years of age and older. The once-daily, steroid-free cream is designed to provide rapid disease clearance and significant reduction in itch,
Drugs
FDA has granted Longeveron a Regenerative Medicine Advanced Therapy (RMAT) designation for Lomecel-B and its use for treating mild Alzheimer’s Disease. The allogeneic cellular investigational therapy is currently being evaluated across multiple indications, including Alzheimer’s (Phase 2a completed), aging-related frailty (Phase 2b completed) and hypoplastic left
Drugs
Kazia Therapeutics says a Phase 2/3 trial evaluating its paxalisib versus standard of care for patients with glioblastoma demonstrated the drug’s effectiveness in extending overall survival. A company statement says the trial showed a 3.8-month improvement in overall survival for newly diagnosed unmethylated patients with glioblastoma
Drugs
CBER has published a standard operating policy and procedure (SOPP), Administrative Processing and Review Management Procedures for Investigational New Drug Applications, as a guide to Center staff. The SOPP applies to INDs received by CBER, including those for expanded access, except for individual emergency use requests. It does not address
Drugs
FDA has granted PharmassêtX an orphan drug designation for epigallocatechin gallate (EGCG), described by the company as a well-characterized component of green tea for treating inflammatory bowel disease (IBD) pouchitis, which is experienced by a number of patients who have undergone surgery to remove their large intestine. There is
Drugs
FDA has published the January-March potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System. FDA says it is evaluating the need for regulatory action for 23 of the 30 listings. The post shows the labeling changes and other actions taken for the
Drugs
FDA’s review of records supplied at its request by ReBom Co., Ltd., a Sejong, South Korea, manufacturer of over-the-counter drug products, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/26 Warning Letter says the specific violations were: * failure to establish
Drugs
A 1/17-1/26 FDA inspection at the Optikem International drug manufacturing facility in Denver, CO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/20 Warning Letter says specific violations were: * failure to perform operations within specifically defined areas of adequate size
Drugs
Elevar Therapeutics says it will soon resubmit its NDA for rivoceranib in combination with camrelizumab as a first-line treatment option for unresectable hepatocellular carcinoma. A company statement says the resubmission follows a 7/2 Type A meeting with FDA that addressed items in the agency’s 5/16 complete
Drugs
FDA has granted Obsidian Therapeutics a fast track designation for OBX-115, an engineered tumor-derived autologous T cell immunotherapy in combination with a pharmacologically regulatable membrane-bound IL15 for treating patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1–