Drugs
FDA says it is updating the agency Expanded Access Web pages to improve usability through streamlining of content and a more user-friendly organization. A statement from FDA commissioner Scott Gottlieb says the updates include a reduction in duplication and the addition of new pages with commonly requested information such
Drugs
Former Pfizer Global Research and Development president John LaMattina says that while cardiovascular outcome trials for diabetes drugs are expensive and lengthy, they are here to stay. Writing in a Forbes online post, LaMattina says that Type 2 diabetics generally have conditions that make then prone to cardiovascular disease and
Drugs
FDA has granted Revive Therapeutics an orphan drug designation for cannabidiol for preventing ischemia and reperfusion injury (IRI) resulting from solid organ transplantation. IRI can result in a higher incidence of acute and chronic rejection, as well as long-term morbidity and mortality, the company says. Revive believes that cannabidiol’
Drugs
FDA has issued an alert on a Kadesh recall of all lots of Puriton Eye Relief Drops due to non-sterile production conditions at the manufacturing facility. The over-the-counter homeopathic eye drops are marketed for the temporary relief of burning and irritation due to eye dryness and eye
Drugs
FDA has granted SpringWorks Therapeutics a fast track designation for nirogacestat, a selective gamma-secretase inhibitor under development for treating adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. Depending on their size and location, desmoid tumors can cause severe morbidities such as pain, internal bleeding,
Drugs
FDA has cleared an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0. The platform’s new features are designed to improve the clinical workflow and user experience of the company’s ClearPoint Neuro Navigation System, including “enhanced functionality in areas of image fusion, volume of interest
Drugs
FDA has granted Karyopharm Therapeutics a fast track designation for selinexor, the company’s first-in-class, oral Sine compound for treating patients with diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue
Drugs
AstraZeneca says that an FDA draft guidance on considerations for use of placebos and blinding in randomized controlled clinical trials for hematologic malignancy and oncologic disease does not address considerations for sponsor-level blinding of placebo-controlled clinical trials. “It would be helpful if the agency could provide information to
Drugs
FDA has released the FDA-483 issued following the 9/12-9/27 inspection at MedisourceRx, a Los Alamitos, CA, outsourcing facility. The seven specific observations on the document are: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet
Drugs
Attorney Scott Lassman (Goodman) says FDA’s position on transitional biologics, which is approaching a 3/23/20 effective date, is “ripe for litigation.” Appearing with two colleagues on a webinar on biosimilar litigation, Lassman defined transitional biologics as protein products that for historical reasons have been reviewed by regulators
Drugs
FDA has released the FDA-483 issued following a 7/23-8/30 inspection at Akorn, a Somerset, NJ, sterile drug manufacturer. It was the latest in a string of issues the company has faced. The 11 specific observations on the form were: * failing to thoroughly review any unexplained discrepancy
Drugs
FDA has released a 10/17 letter from the Association for Accessible Medicines raising concerns about the U.S.-Mexico-Canada Free Trade Agreement. “The trade agreement, if left in its current form, will decrease competition, inevitably leading to increased drug prices in the United States, harming patients, job creators,
Drugs
CDER biomarker development and regulatory science team science policy analyst Abena Agyemanm says FDA is making available additional resources for drug development programs that want to use surrogate endpoints. She says one such resource is the Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure for
Drugs
FDA has approved Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Ortho’s Vitros 5600 Integrated System. The combination test is designed to detect both HIV-1 and HIV-2 antibodies and the p24 antigen, enabling detection of acute HIV-1 infection earlier
Drugs
FDA has released a guidance on “Hypertension: Developing Fixed-Combination Drug Products for Treatment.” The document focuses on developing two-drug combinations of previously approved drugs, the agency says, adding that the general approach is readily applicable to three or more drugs in combination. It does not address combinations that
Drugs
FDA has published a draft guidance, Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products, to describe the factors FDA intends to consider when evaluating the strength of evidence provided by a meta-analysis studying the safety of drugs. The document includes
Drugs
FDA has accepted a Dova Pharmaceuticals supplemental NDA for Doptelet (avatrombopag) for a new indication — treating chronic immune thrombocytopenia (ITP) in patients who have had an insufficient response to a previous treatment. ITP is an autoimmune bleeding disorder characterized by thrombocytopenia (low platelets level). The second generation, orally administered thrombopoietin
Drugs
A 6/26-7/20 FDA inspection at Vital Rx, doing business as Atlantic Pharmacy and Compounding, Pompano Beach, FL, found “serious deficiencies” in the firm’s practices for producing drug products, which put patients at risk. A just-released 9/26 notice of violation says drug products were prepared,
Drugs
Sandoz has decided not to pursue FDA approval for its proposed biosimilar of rituximab (Genentech’s Rituxan), indicated for treating some non-Hodgkin’s lymphomas. Earlier this year, the agency issued a complete response letter, requesting additional information to complement the submission, the company says. Sandoz says it will focus
Drugs
FDA has issued Lupin a five-item Form 483 after an inspection at the firm’s Madhya Pradesh, India manufacturing plant cited significant GMP violations. For example, FDA said Lupin’s control procedures are not established to monitor the output and validate the performance of those manufacturing processes that may
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 17 to 1 that data support the benefit-risk profile of Sage’s Zulresso (brexanolone) injection for treating postpartum depression (PPD). Panel members recommended that the drug be administered by qualified staff in a
Drugs
FDA has issued a safety alert about labels attached to some Pfizer/Mylan EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, which may block access to the auto-injector and prevent the ability to easily access the product. The alert also applies to authorized generic versions of the