Drugs
FDA has denied a request in a 5/9/19 petition submitted by Dr. William Williams of the Contraceptive Study Group asking that a Boxed Warning be added to prescribing information and patient-related materials for all combined hormonal contraceptives (CHC) on an increased risk of breast cancer. The agency
Drugs
CDER Office of Surveillance and Epidemiology director Gerald Dal Pan and deputy director Robert Ball say there is considerable interest in applying artificial intelligence (AI) to pharmacovigilance (PV), and one way to start could be through individual case study reports (ICSRs). Writing in the journal Drug Safety, Dal Pan and
Drugs
FDA has published a guidance, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, to help human prescription drug and biological product sponsors, application holders, and applicants minimize medication errors associated with their products. The document provides a set of principles and recommendations for ensuring that
Drugs
An 11/8-11/17/21 FDA inspection at the Colorful Products drug manufacturing facility, Newbury Park, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter topical drug products and hand sanitizers. A 5/10 Warning
Drugs
An 11/8-11/10/21 FDA inspection at Specialty Process Labs, a Phoenix, AZ, drug manufacturing facility, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 5/3 Warning Letter lists specific deviations as: * failing to demonstrate that the firm’s manufacturing
Drugs
FDA has accepted an scPharmaceuticals NDA for Furoscix (furosemide) delivered through an on-body infusor for treating congestion in patients with worsening heart failure. The agency has set a user fee review action target date of 10/8. The company describes Furoscix as a proprietary solution formulated to a neutral
Drugs
The National Academies of Science, Engineering, and Medicine has published Improving Representation in Clinical Trials, with recommendations for building research equity for women and underrepresented groups. The report (free PDF or purchase) says there is no doubt that past investments in clinical research to improve the health and well-being
Drugs
FDA has released the FDA-483 issued following an 8/16-9/8/21 inspection at Appollo Care, a Columbia, MO, outsourcing facility. The inspection observations were: * failing to put in writing and fully follow the responsibilities and procedures applicable to the quality control unit; * failing to establish, write, and
Drugs
Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) have introduced bipartisan legislation entitled the Retaining Access and Restoring Exclusivity (RARE) Act, which addresses a 2021 court decision that adversely impacts how FDA handles orphan drug exclusivity (see earlier story). A House Energy and Commerce Committee bill (see story)
Drugs
FDA has accepted for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy (IgAN). The company says it is seeking accelerated approval, and, if approved, sparsentan would be the first FDA-approved non-immunosuppressive treatment option for IgA nephropathy. The agency has set an
Drugs
FDA has released a revised final guidance entitled “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” The document discusses how to investigate OOS test results, including the roles/responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the
Drugs
FDA has removed a clinical hold on Gilead Sciences’ injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis. The company previously announced that the agency hold was placed on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. “FDA removed the clinical hold following
Drugs
A March FDA inspection of Novel Laboratories (dba Lupin Somerset) has resulted in a 13-item FDA Form-483. A 2020 agency inspection at the Novel facility led to a 6/11/21 Warning Letter citing three significant violations of current good manufacturing practice regulations for finished drugs. In the
Drugs
FDA has rejected an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician David Boulware and other researchers to allow the use of generic drug fluvoxamine maleate for outpatient treatment of Covid-infected adults to prevent progression to severe disease or hospitalization. Fluvoxamine is currently
Drugs
Ethicon has acquired Torax Medical, which manufactures and markets the LINX Reflux Management System for treating gastro-esophageal reflux disease. The device is based on magnetic sphincter augmentation (MSA) technology and the procedure is currently available in the U.S. and European medical centers. BioLineRx Ltd. has acquired Agalimmune Ltd.
Drugs
A just-published article in the journal Nature examines the problems with FDA’s accelerated approval program and potential reforms to reduce any gaming by the pharmaceutical industry. “Part of the problem is that drug companies aren’t upholding their end of the bargain with timely post-market studies confirming
Drugs
BridgeBio Pharma has entered into a definitive agreement with an undisclosed purchaser to sell its priority review voucher for $110 million. The voucher was awarded by FDA in 2/2021 after it approved the company’s Nulibry (fosdenopterin), for treating an ultra-rare disease called molybdenum cofactor deficiency (MoCD) Type
Drugs
FDA has issued UCB a complete response letter on its BLA for bimekizumab for treating adults with moderate to severe plaque psoriasis. The letter says preapproval inspection observations must be resolved before the submission can be approved. In 8/2021, bimekizumab received marketing authorization in the European Union and Great
Drugs
A scathing 23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries’ Halol manufacturing facility (Gujarat, India). The company announced earlier in the week that the inspectional observation form was issued 5/9 at the conclusion of its inspection, and the agency has now released the redacted
Drugs
FDA has approved an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Type 2 diabetes, as an addition to diet and exercise. “Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which
Drugs
Bristol Myers Squibb has detailed two-year results from its POETYK PSO long-term extension (LTE) trial showing durable efficacy and a consistent safety profile with deucravacitinib treatment in adult patients with moderate to severe plaque psoriasis. A deucravacitinib NDA is under review at FDA, with a user fee review
Drugs
FDA says an 11th Circuit Court of Appeals 9/30/21 decision in Catalyst Pharms v. Becerra will adversely affect the incentives for research and development of medical products for rare diseases. In an online review of the decision, the agency says the court addressed the scope of orphan drug