Drugs
Incyte says that after discussions with FDA, it has made a business decision to withdraw its NDA for parsaclisib to treat patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. The company says its decision followed discussions with FDA about confirmatory studies needed to support
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is urging the Judicial Conference Committee on Evidence Rules to adopt a proposed amendment to Federal Rule of Evidence 702 that governs courts’ role as gatekeepers deciding whether to allow expert testimony. The PhRMA 1/25 comment letter says its members are interested
Drugs
The CDER Office of Generic Drugs has issued a Manual of Policies and Procedures, Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications, describing how the Office of Generic Drugs and Office of Pharmaceutical Quality will issue such requests and letters under GDUFA 2 commitments.
Devices
Philips Respironics has recalled certain Trilogy Evo ventilators due to potential health risks caused by a polyester-based polyurethane sound abatement foam that a supplier incorrectly used in the muffler assembly of the affected devices. The issue was identified during lab testing, according to a recall notice. The recalled ventilators
Biologics
FDA has approved an Immunocore BLA for Kimmtrak (tebentafusp-tebn) for treating certain adult patients with unresectable or metastatic uveal melanoma (mUM). Approval was based on data from the company’s Phase 3 IMCgp100-202 clinical trial, which evaluated overall survival (OS) of Kimmtrak compared to investigator’s choice (either
Drugs
FDA has placed a partial clinical hold on Gilead Sciences’ studies evaluating the combination of magrolimab plus azacitidine (Celgene’s Vidaza) due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms. “While no clear trend in the adverse reactions or new safety signal has
Drugs
An FDA 8/2-8/12/21 inspection at the Aurobindo Pharmaceutical drug manufacturing facility in Doultabad, Telangana, India, found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/12 Warning Letter says the specific deviations were: * failing to evaluate the potential effect
Biologics
Former CBER Office of Vaccines Research and Review (OVRR) deputy director Philip Krause has joined Adjuvance Technologies as a strategic consultant. The privately-held clinical-stage biopharmaceutical company says it is focused on developing next-generation saponin adjuvants and vaccines for infectious disease and immuno-oncology. Saponin adjuvants are described
Devices
FDA has published a guidance, Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, on the value of patient and caregiver experiences and perspectives to medical device studies. The document is intended to: * help sponsors understand how they can voluntarily use patient engagement to elicit experience, perspectives,
Drugs
Federal Register notice: FDA is announcing a 3/3 Vaccines and Related Biological Products Advisory Committee meeting at which panel members are scheduled to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2022–2023 influenza season. To view the
Biologics
CBER has released a list of 13 guidance topics it is considering for development this calendar year. The 13 guidances are divided into three categories: Blood and Blood Components (six guidances), Tissues and Advanced Therapies (six guidances), and Vaccines (one guidance).
Drugs
FDA has told Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi Syndrome (PWS). Soleno says that recent meeting minutes from a 12/21/2021 Type C meeting with CDER’s
Drugs
Pfizer and BioNTech have begun a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults aged 18 through 55 years. The 1,400-patient study, which will have three cohorts examining different regimens of their current Covid-19 vaccine or an
Devices
FDA has published a guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation, to help facilitate the systematic collection of how patients feel, function, and survive as valid scientific evidence to support the regulatory and healthcare decision-making process. The document
Drugs
An FDA 6/23-7/1/21 inspection at the Health Plus drug manufacturing facility in Chino, CA, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. A just-released 12/29/21 Warning Letter says specific violations were: * failing to ensure that returned drugs meet
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for releasing 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 key principles on the reliability and use of relevant data from
Devices
FDA has announced a 4/5-6 virtual public workshop entitled “Study Design Considerations for Transbronchoscopic Thermal Ablation (TTA) Devices for the Treatment of Oligometastases to the Lung (OML).” The workshop is intended to provide a forum for stakeholders to share information so FDA can develop appropriate regulatory review approaches
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says its concerns about a series of Lilly ads for Emgality (galcanezumab-gnim) injection for subcutaneous use have been satisfactorily answered by the company. OPDP expressed its concerns in a 12/13/21 Notice of Violation that said the TV spots featuring
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR part 866” (OMB Control Number 0910-0584). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Exports Notification and Recordkeeping Requirements — 21 CFR 1.101” (OMB Control Number 0910-0482). The collection applies to exporters who have notified FDA of their intent to export unapproved products that may not be sold or offered
Drugs
FDA has issued Merck a complete response letter on its NDA for gefapixant, an orally administered selective P2X3 receptor antagonist for treating refractory chronic cough or unexplained chronic cough in adults. Without providing specific information on the rejection, the company said FDA requested additional information related to “measurement of efficacy.
Drugs
FDA has placed a clinical hold on a Viking Therapeutics Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD). The agency has requested an additional preclinical study prior to continuing the study, according to the company. “The request is not due to any findings from