Drugs
While praising FDA efforts to develop guidances and standards to implement the Drug Supply Chain Security Act, four industry stakeholders are seeking changes to a draft guidance on the interoperable exchange of information for tracing of certain human, finished prescription drugs. The American Pharmacists Association (APhA) says the information guidance
Drugs
Pacira BioSciences says it will submit a supplemental NDA early next year to broaden the label for its post-surgical pain drug Exparel (bupivacaine extended-release liposome injection) for use as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee
Drugs
FDA has lifted its clinical hold on Sarepta’s SRP-5051 (vesleteplirsen), an investigational, next-generation peptide conjugated phosphorodiamidate morpholino oligomer indicated to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping. The company says that as part of the lift, it will adjust the Phase
Drugs
FDA says its review of a Web site maintained by Leaf of Life, St. Louis, MO, determined that the company takes orders for several dietary supplements that are legally considered to be drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. A just-
Drugs
CDER scientists are working on ways to improve the bioavailability of drugs that do not dissolve well in water on their own. An Impact post describes research exploring the potential for using amorphous solid dispersions to formulate generic drug products that may include poorly water-soluble ingredients. “Understanding the supersaturation
Drugs
FDA has denied all but two requests in a 2/15/21 petition submitted by Salix Pharmaceuticals asking that the agency not approve any 505(j) ANDA referencing any strength of Xifaxin (rifaximin) tablets as the reference-listed drug unless one of five specified bioequivalence and pharmaceutical equivalence criteria is
Drugs
The Department of Justice (DoJ) says Bayer has agreed to pay $40 million to resolve two whistleblower suits alleging violations of the False Claims Act in connection with the drugs Trasylol, Avelox, and Baycol. The whistleblower suits were filed and pursued for almost two decades by former Bayer marketing employee
Drugs
FDA has accepted a Bausch & Lomb and Novaliq NDA for NOV03 (perfluorohexyloctane), an eye drop therapy for treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Perfluorohexyloctane is described as a water-free, non-steroidal, single-component preservative-free eye drop. The
Drugs
FDA has approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company says the approval was based on “a review of a comprehensive
Drugs
FDA reviewers appear pessimistic that new analyses and data from Amylyx can push its amyotrophic lateral sclerosis (ALS) drug AMX0035 (sodium phenylbutyrate and taurursodiol) across the approval finish line as the submission heads to a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting. Earlier this year, the
Drugs
FDA has approved a Boehringer Ingelheim NDA for Spevigo (spesolimab) as a treatment option for generalized pustular psoriasis (GPP) flares in adults. The novel, selective antibody is said to work by blocking the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to
Drugs
FDA has approved an Azurity Pharmaceuticals NDA for Konvomep (omeprazole and sodium bicarbonate for oral suspension), a proton pump inhibitor for treating active benign gastric ulcer and reducing risk of upper gastrointestinal bleeding in critically ill patients. Omeprazole and sodium bicarbonate are the active ingredients in Santarus’ Zegerid. “We are
Drugs
FDA has approved an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for combination use with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. Approval was based on overall survival (OS) and other data from the TOPAZ-1 trial that enrolled 685 patients. “A statistically significant
Drugs
FDA has issued a form FDA-483 to India’s Biocon Biologics following three on-site August inspections at the company’s seven manufacturing sites in Bengaluru, India, and Johor, Malaysia. In a stock exchange notice, Biocon says the inspections were triggered by three preapproval inspections for biosimilar bevacizumab, rh-
Drugs
The FY 2021 GDUFA Science and Research Outcomes Report demonstrates that research outcomes have played an increasing role over four years in supporting the development of generic drug products. A chart in the report shows the number of: * pre-ANDA meetings affected by research increased from 62 in FY 2018
Drugs
FDA says it is partnering with the Critical Path Institute (C-Path) to explore the feasibility of launching a Lysosomal Diseases Consortium. An agency post says the consortium would be a public/private partnership among FDA, leading academic institutions, pharmaceutical industries, patient groups, and non-government organizations to address unmet
Drugs
A Florida federal judge has sentenced former Pharmatech CEO Raidel Figueroa to 37 months in federal prison for lying to FDA and allowing contaminated products to be shipped to pediatric hospitals. A Department of Justice (DoJ) news release says Pharmatech manufactured and distributed the laxative Diocto Liquid between 2016 and
Drugs
Ascendis Pharma has submitted an NDA for TransCon PTH, an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism. The submission is based on data from the global Phase 3 PaTHway Trial, the Phase 2 PaTH Forward Trial,
Drugs
FDA has approved Genzyme’s Xenpozyme (olipudase alfa) for intravenous infusion in pediatric and adult patients with acid sphingomyelinase deficiency (ASMD). The agency says Xenpozyme is the first approved medication to treat symptoms that are not related to the central nervous system in patients with ASMD. Xenpozyme is described as
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on risk management plans to mitigate the potential for drug shortages “would benefit from a number of changes to enhance clarity for stakeholders developing and implementing risk management plans to mitigate drug shortages.” The comment letter makes eight
Drugs
Amneal Pharmaceuticals has submitted an NDA for IPX203, a company-described novel formulation of carbidopa/levodopa (CD/LD) extended-release capsules for treating Parkinson’s disease (PD). The submission is based on data from the pivotal Phase 3 RISE-PD clinical trial that Amneal says demonstrated more “good on” time
Drugs
Three advocacy groups representing HIV, hepatitis, and diabetes patients are suing HHS and its Centers for Medicare and Medicaid Services over payment requirements under the 2010 Patient Protection and Affordable Care Act (Obamacare) that the groups say make it impossible for many people, even with insurance, to afford the drugs