Drugs
AstraZeneca says a need remains to develop additional medical products with alternate methods of action to address the burden of chronic sinusitis with nasal polyps. The company commented in response to an FDA draft guidance, Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment. It says the draft “serves as
Drugs
FDA has approved several safety-related labeling changes for Allergan’s Celexa (citalopram hydrobromide), a selective serotonin reuptake inhibitor indicated for treating depression. Psychiatric Times reports the changes include new dosage recommendations and Warnings for a higher risk of adverse reactions in pediatric and geriatric populations. The labeling also includes
Drugs
A 5/11-5/27/21 FDA inspection at Innoveix Pharmaceuticals, Addison, TX, found serious deficiencies in the production of sterile drug products that put patients at risk. A 1/26 Warning Letter says the agency investigator found that drug products intended or expected to be sterile were prepared, packed,
Drugs
FDA has published an immediately-in-effect guidance, Covid-19 Public Health Emergency: Policy on Covid-19 Related Sanitation Tunnels, to discourage sponsors from developing or seeking approval or authorization for the use of sanitation tunnels. The document says sanitation tunnels are tunnels, walkways, chambers, and similar systems that spray
Drugs
FDA appears poised to be putting its foot down on drug sponsors conducting drug development programs that exclusively rely on foreign clinical trial data conducted in a single country. FDA Oncology Center of Excellence director Richard Pazdur tipped his hand (see story) late last week when he co-authored a
Drugs
FDA says CDER researchers are developing new methods and understandings to bridge the critical gap between the in vitro measurements and the in vivo performance of injectable suspensions. An agency online post says researchers developed new methods to understand the impact of flocculation (forming weakly bound agglomerates) state on drug
Drugs
The Oklahoma Firefighters Pension and Retirement System has filed a securities class action suit in Massachusetts federal court against Biogen and several of its top executives over the approval and marketing of its Aduhelm (aducanumab) to treat Alzheimer’s disease. The suit details Biogen’s declining profits from its multiple
Drugs
The Biotechnology Innovation Organization (BIO) has submitted comments on an FDA draft guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, listing four “overarching recommendations to improve the draft guidance.” The recommendations are: * considerations for prospective and retrospective real-world data (RWD); * considerations for mapping and
Drugs
Five King & Spaulding lawyers say a 12/2021 FDA draft guidance on digital health technologies (DHTs) is a “pandemic silver lining.” In an online post, the lawyers say the draft describes the agency’s thinking about how sponsors, study investigators, and others can use DHTs to gather health-related
Drugs
The Parenteral Drug Association (PDA) says it supports the concept of remote interactive evaluations (RIEs) of drug manufacturing and bioresearch monitoring facilities during the Covid-19 public health emergency. It thanks FDA for providing more information on its thinking on the subject in a guidance. The PDA letter says the
Drugs
The Department of Justice (DoJ) says it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2021. A department statement says it is the second-largest annual total in False Claims Act history and the largest
Drugs
FDA has released a draft guidance entitled “Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC).” The document discusses clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions. FDA says that selecting
Drugs
FDA Oncology Center of Excellence director Richard Pazdur has taken the unusual step of calling into question the development of dozens of oncology drug development programs that rely almost exclusively on clinical data from China. Writing in a 2/4 The Lancet comment piece, Pazdur and oncology divsion director Harpreet
Drugs
A just-released Government Accountability Office report has offered recommendations on an FDA planned pilot program to test unannounced foreign inspections. The pilot will look at bringing foreign inspections on equal footing with domestic inspections, which traditionally have been unannounced. The agency is also looking at eliminating the option of
Drugs
FDA says it is lifting its domestic inspection pause and will resume conducting inspections in the U.S beginning 2/7 across all commodities now that Covid-19 cases are dramatically declining. “In addition to the resumption of planning and conducting domestic surveillance inspections on 2/7, the FDA continues
Drugs
FDA has issued Wells Pharma (Houston, TX) a one-item Form FDA-483 after a 6/2021 inspection at the drug outsourcing facility. The inspection cited the firm’s procedures designed to prevent microbiological contamination of sterile drug products because they are not established, written and followed, according to the
Drugs
FDA has posted a final guidance entitled “Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the Covid-19 Pandemic.” The document is intended to help sponsors mitigate the challenges related to the constrained supply of nonhuman primates available for conducting nonclinical toxicity assessments. It is intended to remain
Drugs
FDA has accepted for review a Cytokinetics NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator for treating heart failure with reduced ejection fraction (HFrEF). The agency set a user fee review action target date of 11/30. The submission is based on data from the 8,
Drugs
FDA commissioner nominee Robert Califf is promising, if confirmed by the Senate, to crack down on drug companies that gain accelerated approval and then fail to adequately pursue confirmatory evidence as required by the agency in postmarketing commitments. In a bid to gain the backing of Senator Ron Wyden (D-
Drugs
Reps. Anna Eshoo (D-CA), Brian Fitzpatrick (R-PA), and Robin Kelly (D-IL) have introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. They say (includes a link to the bill text) the measure is intended to boost diversity in clinical trials by requiring enhanced data reporting
Drugs
Pfizer and Ionis Pharmaceuticals are discontinuing the Pfizer-led clinical development program for vupanorsen, an investigational antisense therapy that was being evaluated for potential indications in cardiovascular risk reduction and severe hypertriglyceridemia. An announcement says Pfizer decided after a thorough review of data from a global Phase 2b study of
Drugs
The FDA Office of Clinical Pharmacology (OCP) has issued its 2021 annual report that highlights its efforts to “improve public health by building and translating knowledge of drug-response into patient-centered regulatory decisions of the highest quality.” The report says that in 2021 OCP addressed multiple public health issues,