Drugs
FDA’s Antimicrobial Drugs Advisory Committee 6/8 voted 21 to 0 that AstraZeneca and Sanofi’s nirsevimab has a favorable benefit-risk assessment for preventing respiratory syncytial virus (RSV) lower respiratory disease in neonates and infants born during or entering their first RSV season. Panel members also voted 19
Devices
FDA has cleared a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire – a bipolar temporary device designed specifically for use during transcatheter aortic valve replacement and bicuspid aortic valve procedures. It offers dual functionality, supporting both valve delivery and ventricular bipolar pacing during procedures, the company says. “From its
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “E6(R3) Guideline for Good Clinical Practice.” The agency says the International Council for Harmonization document outlines modernized good clinical practice considerations for designing and conducting clinical trials in a manner that ensures participant safety and the reliability of
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of an emergency use authorization issued to B. Braun Melsungen AG for propofol-lipuro 1% injectable emulsion. The company notified the agency that the product’s inventory has been depleted and that it does not intend to offer this product in the
Biologics
CBER has released a 6/6 letter to sponsors, applicants, and regulated entities with updated information to assist the recipients to transition back to normal operations in this calendar year following the expiration of the Covid-19 public health emergency. The letter covers information about CBER meetings; FDA guidance; the
Biologics
Legend Biotech has submitted a supplemental BLA seeking to expand the label for Carvykti (ciltacabtagene autoleucel) to include the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The submission
Drugs
FDA medical reviewers say data from the Phase 3 CLARITY AD trial support the benefits of Eisai/Biogen’s Leqembi (lecanemab) in the early treatment of Alzheimer’s disease. In a briefing document released in advance of the 6/9 meeting of the Peripheral and Central Nervous Systems Drugs Advisory
Drugs
A 3/22-4/28/22 FDA inspection of three clinical trials conducted by Dr. Mobeen Mazhar in Houston, TX, undertaken as part of the agency’s bioresearch monitoring program, identified objectionable conditions. A 5/31 Warning Letter says it appears that Mazhar did not adhere to the applicable statutory
Drugs
Five Hogan Lovells attorneys say that if the FDA proposed Patient Medication Information (PMI) is finalized, it would represent “a major change in Rx drug labeling.” Writing in an online post, the attorneys say that manufacturers have struggled to translate approved instructions for healthcare providers into patient-friendly language for
Drugs
FDA has approved Merck’s Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients. The antiviral agent was originally approved in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. It is administered once daily
Drugs
FibroGen says its pamrevlumab did not meet the primary endpoint in the Phase 3 LELANTOS-1 trial in treating non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids. A company statement says pamrevlumab was generally safe and well tolerated and the majority of treatment-emergent events were mild
Devices
AdvaMed says it agrees with five questions FDA proposes adding to a proposed future revision of a guidance on voluntary submission of patient preference information (PPI) in PMAs, HDEs, and de novo requests. The association’s comment letter also recommends adding an additional question about the characteristics of the respondents
Drugs
Sen. Ron Wyden (D-OR) says FDA and the Drug Enforcement Agency (DEA) need to issue a joint statement on the attention deficit/hyperactivity disorder medication Adderall and its generics “to clarify the role and management of quotas, as well as the conflicting reports from agencies, manufacturers, and pharmacies that
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.” The document is intended to assist ANDA sponsors with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, and amendments and supplements. To
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Vintage Pharmaceuticals ANDA for pemoline tablets in response to the sponsor’s request. All pemoline product sponsors stopped marketing their products in 2005 due to an FDA safety alert that concluded the overall liver toxicity risk of Cylert (pemoline) and associated
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of a priority review voucher to Krystal Biotech in response to an approved rare pediatric disease product application. The qualifying product is Vyjuvek (beremagene geperpavec-svdt) for treating patients six months of age or older with dystrophic epidermolysis bullosa. To view the
Drugs
FDA has published the International Council for Harmonization (ICH) E6(R3) draft guidance Good Clinical Practice (GCP) with updated recommendations for good clinical practices aimed at modernizing the design and conduct of clinical trials. An agency notice (contains a link to the guidance) says the draft was developed to enable
Devices
An 8/15-8/19/22 and 11/3-11/8/22 FDA inspection at Steiner Biotechnology in Henderson, NV, found multiple violations in the firm’s manufacturing and labeling of several dental bone grafting products. A just-released 5/19 Warning Letter says specific Quality System Regulation violations were:
Biologics
FDA has accepted for review a GSK supplemental BLA for Jemperli (dostarlimab) in combination with chemotherapy for treating adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high primary advanced or recurrent endometrial cancer. “If approved in this patient population, dostarlimab plus chemotherapy could represent the first meaningful frontline treatment
Devices
A 7/25-8/12/22 FDA inspection at iRhythm Technologies in Cypress, CA, determined that the company manufactures the ZIO AT system, which it says is an unapproved medical device. A 5/25 Warning Letter says the system is intended to continuously record and report patient symptomatic and asymptomatic
Devices
FDA has granted a de novo marketing authorization for Cue Health’s Cue Covid-19 Molecular Test, the first at-home Covid test granted a traditional marketing authorization outside of the agency’s emergency use authorities. The molecular nucleic acid amplification test (NAAT) is intended to detect genetic material from
Drugs
Norwich Pharmaceuticals is suing FDA in the DC federal court over its “arbitrary, capricious, and unlawful refusal to grant Norwich’s amended ANDA final approval” for the 550 mg strength of rifaximin (Salix’ Xifaxan) to treat irritable bowel syndrome with diarrhea. The suit says that in an 8/2022 decision,