Drugs
FDA has released 15 Fiscal Year 2022 GDUFA science and research priority initiatives. The agency says the initiatives are organized according to the categories of complex generic drug products described in the GDUFA 2 commitment letter, followed by a category addressing tools and methodologies for evaluating bioequivalence and therapeutic equivalence
Drugs
FDA has extended by three months its review of a CTI BioPharma NDA for treating adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. The new user fee review action target date is 2/28/2022. “In the course of product
Drugs
FDA has lifted its clinical hold on Statera Biopharma’s entolimod research and development activity in acute radiation syndrome. The company says that based on its response to the agency, FDA has acknowledged that Statera satisfactorily addressed historical regulatory matters. The company says that on the basis of data demonstrating
Drugs
FDA has cleared an Immunexpress 510(k) for its SeptiCyte Rapid, a diagnostic aid for use in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis. The device contains all the reagents needed for “quantification of gene expression using a reverse transcription polymerase chain reaction (PCR)
Drugs
Stakeholders are contacting FDA to express opposition to or concerns about the agency’s recent reclassification of drug products as drug-led combinations whose components require additional regulatory review. The Association for Accessible Medicines (AAM), representing the generic drug industry, is calling on the agency to rescind its reclassification decision.
Drugs
AdvaMed says it supports FDA efforts to provide up-to-date guidance to help clinical investigators comply with IDE studies. In an 11/19 comment on an agency draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices, AdvaMed makes both general and specific comments. It says that while
Drugs
FDA’s Antimicrobial Drugs Advisory Committee 11/30 narrowly voted 13-10 to recommend an emergency use authorization for Merck’s oral antiviral molnupiravir (MOV) for treating Covid-19 patients. An FDA advisory committee briefing document released in advance of the meeting said data show that MOV was associated with
Drugs
FDA has issued Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for preventing ototoxicity (hearing loss) associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic, solid tumors. The letter again cited “manufacturing deficiencies,” which the company says need to be satisfactorily
Drugs
Amgen says it supports FDA issuance of a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products, that gives sponsors, researchers, and other stakeholders considerations when proposing to use electronic health records or medical claims data
Drugs
Teleflex has recalled its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device (PTD) Kit, 7FR, after receiving reports about the inner lumen becoming detached from the device’s basket. The PTD catheter is used with the Arrow Rotator Drive Unit to permit mechanical declotting of native arterio-venous fistulae and
Drugs
FDA has accepted for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. The
Drugs
An FDA advisory committee briefing document says data show that Merck’s oral antiviral molnupiravir (MOV) was associated with a relative risk reduction of 52% in hospitalization or death compared to placebo in adults with mild-to-moderate Covid-19 and at high risk for progression to severe disease. Committee
Drugs
FDA has issued a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. The document provides sponsors with considerations about designing a registry or proposing to use an existing registry to support a regulatory decision about a drug’s effectiveness or
Drugs
FDA has approved an On Target Laboratories NDA for Cytalux (pafolacianine), an imaging drug to assist surgeons in identifying ovarian cancer lesions. “The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery,” FDA says in a news release.
Drugs
The Department of Justice says Alain Bouaziz, a French national who lives in the United Arab Emirates, has been charged with making false statements to FDA to fraudulently obtain control of Sanorex, a weight-loss drug owned by an unidentified major pharmaceutical company. A department statement says Bouaziz was arrested
Drugs
FDA has approved Takeda’s Livtencity (maribavir), the first treatment approved by the agency for adults and pediatric patients with post-transplant cytomegalovirus infection that does not respond to available antiviral treatment for the infection. The approval was announced by the Brand Institute, which partnered with Takeda in naming the
Drugs
FDA has approved an Aadi Bioscience NDA for Fyarro (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for treating adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Approval was based on efficacy data from the AMPECT multicenter, single-arm clinical trial in 31
Biologics
Pfizer has asked a California federal court for an injunction against former employee Chun Xiao (Sherry) Li, claiming she uploaded over 12,000 files from her company laptop to a personal account and/or device. In its court filing, Pfizer says Li resigned effective 11/24 and reportedly accepted a
Drugs
FDA has placed on partial clinical hold a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). The hold is the result of the company’s recent report to the agency about a Grade 5 serious adverse event (patient
Drugs
Sagent Pharmaceuticals has recalled four lots of levetiracetam injection due to container closure integrity concerns. “Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening,” a recall notice says. To date, Sagent says it has not
Drugs
The Sedgwick Recall Index for the third quarter of 2021 says both medical device and pharmaceutical recalls “surged.” The index says medical device recalls rose 35.8% from 173 in the previous quarter to 235. And drug recalls surged by 45.8% from 59 last quarter to 86. Software issues
Drugs
FDA has extended for three months to 2/28/2022 the PDUFA action date for Amryt’s NDA for Oleogel-S10 to treat cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB). FDA said the extension was needed to give it time to review additional analyses of data previously submitted