Drugs
FDA has granted Takeda Pharmaceutical Co. a priority review for a supplemental NDA that seeks to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Alunbrig
Drugs
Three industry stakeholders say further information and clarification is needed in an FDA draft guidance on the implementation of pediatric studies of molecularly targeted oncology drugs under the FDA Reauthorization Act. The Biotechnology Innovation Organization (BIO) says that while the law contemplates only one molecularly targeted pediatric investigation, the draft
Drugs
A 9/9-9/13/19 FDA inspection at the Essnd Global drug manufacturing facility in Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/14 Warning Letter says specific violations were: · failing to perform, for each batch of drug product, appropriate
Drugs
A 4/9-4/16/19 FDA inspection at KVK-Tech, Newtown, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/11 Warning Letter said specific violations were: * failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods;
Drugs
FDA has approved a Perrigo Pharmaceutical ANDA for the first generic of Teva’s ProAir HFA (albuterol sulfate) inhalation aerosol for treating or preventing bronchospasm in patients four years of age and older with reversible obstructive airway disease. It is also indicated for preventing exercise-induced bronchospasm in patients four
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biomedix, Bloomington, IN (2/12): FDA inspected the firm 10/2019 and cited GMP violations with its medical device operations. For example, the company failed to establish and maintain
Drugs
FDA has approved Eli Lilly’s Trulicity (dulaglutide) for reducing major adverse cardiovascular events (MACE) in adults with Type 2 diabetes who have established cardiovascular (CV) disease or multiple CV factors. The company says Trulicity is the only Type 2 diabetes drug approved to reduce the risk of MACE for
Drugs
As part of its efforts to deal with impacts from the global spread of the coronavirus, FDA has identified about 150 prescription drugs (antibiotics, generics and some brand drugs) that could be in short supply if plants in China that make the active pharmaceutical ingredients are restricted from manufacturing or
Drugs
In a new post on FDA’s Web site, two senior CDER officials discuss how real world data (RWD) and real world evidence (RWE) can be used in making regulatory decisions. “RWD, according to the FDA’s definition, are data that are routinely collected about a patient's health
Drugs
Taro Pharmaceuticals has recalled two lots of phenytoin oral suspension USP, 125 mg/5 mL in 237 mL bottles because it may not re-suspend when shaken, which could result in under- or over-dosing, according to a recall notice. Phenytoin is indicated for treating tonic-clonic (grand mal) and
Drugs
FDA has accepted for review a GlaxoSmithKline supplemental NDA for Zejula (niraparib) as a first-line maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The submission is supported by data from the Phase 3 PRIMA study, which the company says
Drugs
FDA has approved a Teva Respiratory supplemental NDA for ArmonAir Digihaler (fluticasone propionate) Inhalation Powder, an inhaled corticosteroid delivered by Teva’s Digihaler device for asthma maintenance treatment. The inhaler contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with
Drugs
FDA has launched a new resource for external and agency researchers collecting historical information about FDA’s drug approvals. The compilation of new molecular entity drug and new biologic approvals is provided in a .CSV file that goes back to 1985. The agency says that it will continue to provide
Drugs
FDA has released a revised guidance on “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically for all submission types. It also references
Drugs
A drug supply chain security pilot program, which was approved by FDA in 2019, is endorsing blockchain technology to meet Drug Supply Chain and Security Act (DSCSA) requirements for an interoperable, confidential change-of-ownership system for the U.S. pharmaceutical supply chain. Last year, FDA began accepting pilot project
Drugs
FDA has issued a final rule and question and answers for patients and healthcare providers to ensure a smooth 3/23 regulatory transition that the agency says is aimed at increasing patient access to insulin products. As of 3/23, an online statement says, an application for a biological product
Drugs
FDA has granted priority review to a BioMarin BLA for its investigational AAV5 gene therapy (valoctocogene roxaparvovec) for adults with hemophilia A. This is the first time FDA has accepted a marketing application for gene therapy for any type of hemophilia. The PDUFA action date for the BLA is 8/
Drugs
FDA has approved a Baudax Bio NDA for Anjeso (meloxicam injection), indicated for managing moderate to severe pain, alone or in combination with other analgesics. The product is intended to be administered as a once-a-day intravenous bolus push. The active ingredient meloxicam is a long-acting, preferential COX-
Drugs
Bristol-Myers Squibb says that a Phase 2 trial testing the combination of Five Prime Therapeutics’ cabiralizumab and Opdivo (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint. A Five Prime statement says that the trial enrolled some 160 patients with locally
Drugs
CDRH and CDER say they are collaborating on an effort to provide FDA’s view of the state of the current science in pharmacogenetics. They are launching a Web-based resource that includes a table describing “some of the gene-drug interactions for which the agency believes there is sufficient
Drugs
Sen. Charles Grassley (R-IA) has predicted that his bipartisan Prescription Drug Pricing Reduction Act of 2019 will pass by 5/20. The Daily Iowan reports that Grassley addressed a healthcare summit in Coralville, IA, 2/14 and predicted the 5/20 passage. “The reason that’s an important date
Drugs
FDA has published a draft guidance, Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics, to assist sponsors by supplementing the recommendations on nonclinical immune system assessments provided across a number of International Council for Harmonization and FDA guidances. The document covers the evaluation of functional, histomorphologic, and