Drugs
FDA has placed a clinical hold on a Sarepta Therapeutics Phase 1/2 Duchenne muscular dystrophy micro-dystrophin gene therapy trial due to the presence of a trace amount of DNA fragment in research-grade third-party supplied plasmid. “Preliminary in-vivo testing performed by the research institute indicates that
Drugs
Four drug companies have submitted their answers to an FDA docket seeking input to assist with development of a policy or guidance document on assessment of pH-dependent absorption and potential drug-drug interactions (DDI) with pH modulating agents such as proton-pump inhibitors (PPIs) or acid reducing agents (ARAs)
Drugs
Rep. John Sarbanes (D-MD) has introduced the Biosimilars Competition Act of 2018 to require biologic and biosimilar drug manufacturers to report anticompetitive “pay-for-delay” agreements that keep lower-cost drugs off the market. “We must take every step possible to prevent Big Pharma from continuing to raise drug
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA not to approve any pending or future application for a section 505(b) or 505(j) opioid product with a proposed indication or any other labeling that suggests that the product is appropriate for chronic use. PMRS asks that its requests be
Drugs
FDA has approved an AbbVie NDA for Orilissa (elagolix), the first oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. Approval is supported by data from two replicate Phase 3 studies involving nearly 1,700 women with moderate to severe endometriosis pain. Clinical
Drugs
FDA has published a draft guidance, Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments, addressing the approaches recommended for suitability determination of vehicles intended for use with specific drug products. The document provides: * consideration
Drugs
On the same day Public Citizen filed a lawsuit against it, FDA 7/23 partially granted the activist group’s objective: a ban on cesium chloride use in drug compounding sought in a 12/2017 petition. The group’s lawsuit was in response to the agency’s inaction on the
Drugs
FDA has released a draft guidance on “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” The document describes the current recommendations about how to optimize and standardize dietary management in such trials where dietary management is a
Drugs
FDA has granted Allergan a fast track designation for AGN-241751, an investigational new treatment for major depressive disorder. AGN-241751 is a novel, orally bioavailable, small molecule N-methyl-D-aspartate receptor modulator that recently entered Phase 2 development, the company says. Allergan acquired AGN-241751 as part of
Drugs
FDA has accepted for review an Aerie Pharmaceuticals 505(b)(2) NDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a once-daily eye drop designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension. It is a fixed dose combination of Aerie’s Rhopressa (netarsudil
Drugs
FDA has posted 43 product-specific guidances (26 new guidances and 17 revised guidances) that describe the agency’s current thinking and expectations on how to develop generic drug products. The new batch of documents is part of FDA’s strategy to promote generic drug development to address rising drug
Drugs
FDA has approved an Agios Pharmaceuticals NDA for Tibsovo (ivosidenib) tablets for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first isocitrate dehydrogenase-1 inhibitor approved for use with an FDA-approved companion diagnostic (Abbott’s RealTime IDH1
Drugs
FDA has approved a Pfizer BLA for Nivestym (filgrastim-aafi), a biosimilar product referencing Amgen’s Neupogen, indicated for treating neutropenia. Filgrastim is a short acting granulocyte-colony stimulating factor that increases the body’s production of white blood cells. The BLA submission is supported by similarity data from analytical,
Drugs
FDA has granted Sellas Life Sciences Group a fast track designation for its galinpepimut-S and its use in treating multiple myeloma. The therapy is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 protein, which is present in an array of tumor types. The designation
Drugs
FDA commissioner Scott Gottlieb and two top CDER officials say the agency is investing in a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used. Writing in the
Drugs
In a break from past practices, FDA commissioner Scott Gottlieb says he is forming a work group to explore policy frameworks that could lead to short-term importation of drugs to help resolve specific drug shortage situations. In a statement, Gottlieb says the group will “consider whether and how the
Drugs
CDER director Janet Woodcock says that an FDA reorganization plan submitted to HHS for approval before going to Congress for concurrence will affect nearly one-third of CDER offices. “The changes within CDER offices will enable us to respond to new priorities more efficiently with a stronger organizational framework and
Drugs
FDA has released the FDA-483 issued following a 2/26-3/2 inspection at Hetero Drugs, a Sangareddy District, India, active pharmaceutical ingredient producer. The form says specific inspection observations were: * failing to thoroughly review any unexplained discrepancy and failure of a batch or any of its components to
Drugs
FDA has released the FDA-483 issued following a 4/9-5/18 inspection at Akorn, a sterile drug manufacturer in Decatur, IL. Specific observations in the document were: * failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including
Drugs
Ocular Therapeutix has resubmitted its NDA for Dextenza (dexamethasone insert) 0.4mg, indicated for treating ocular pain following ophthalmic surgery. The submission responds to concerns raised in a 7/2017 complete response letter (see earlier story). The agency set a user fee review action target date of 12/28. The
Drugs
FDA has approved Terumo BCT’s sodium citrate 4% solution USP, indicated for anticoagulating whole blood during automated apheresis procedures. The product has been on the agency’s shortage list for over a year and is manufactured at Terumo BCT's facility in Larne, UK, which supplies parts of
Drugs
FDA has placed a clinical hold on a Mersana Therapeutics Phase 1 study of XMT-1522 after the company reported a Grade 5 Serious Adverse Event (patient death) in dose level seven of the therapy. “While the partial clinical hold remains in effect, no new patients will be enrolled in