Biologics
Janssen Biotech has filed an emergency use authorization (EUA) application for its single-dose Covid-19 vaccine candidate. Last week, the company reported that its vaccine was 72% effective in the U.S. and 66% effective overall at preventing moderate to severe Covid-19. The vaccine’s Phase 3 data
Drugs
The 4th Circuit Court of Appeals has affirmed a federal district court’s summary judgment in favor of Greer Laboratories in a case in which whistleblowers said the company had sold custom mixes of allergenic extracts to doctors under an FDA general license rather than a required separate license for
Drugs
FDA’s Oncology Center of Excellence (OCE) annual report for 2020 describes OCE’s work on behalf of cancer patients affected by the Covid-19 pandemic. “OCE participated in writing a guidance emphasizing the flexibility that FDA would exercise with regard to conduct of clinical trials with decentralized trial procedures
Devices
FDA has cleared a B-Secur 510(k) for its HeartKey software library, which was developed to enable scalability of medical grade EKG/ECG across “Internet of Things” devices. The company says its suite of powerful EKG/ECG algorithms combine user identification, health and wellness to generate accurate data encrypted
Drugs
A decade-old, FDA-investigated case involving the unlicensed wholesale distribution of prescription drugs by Israeli citizen Boaz BenMoshe is finally coming to a close with his extradition to the U.S. and a sentencing date now scheduled for 4/1. According to the government, in 2009 BenMoshe pled guilty
Drugs
FDA says that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Pfizer’s arthritis and ulcerative colitis drug Xeljanz (tofacitinib) and Xeljanz XR, compared to tumor necrosis factor (TNF) inhibitors. An agency drug safety communication says FDA required the
Drugs
FDA has approved a Durect NDA for Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Approval was based on clinical trial data in patients undergoing arthroscopic
Drugs
FDA has announced a 3/29-30 public workshop on “Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation.” The agency says the workshop will include presentations on nitrosamines chemistry and toxicology, and on the findings of nitrosamines as impurities in drugs. It will also include an open discussion
Drugs
FDA has approved safety-related labeling changes for Adamas Pharmaceuticals Parkinson’s drug Gocovri (amantadine HCl). The changes involve adding a postmarketing experience subsection to the Adverse Reactions section of the label and revising the Patient Counseling Information/Patient Information/Medication Guide.
Drugs
FDA has approved a BioCryst Pharmaceuticals supplemental NDA for Rapivab (peramivir injection) expanding the patient population for treating acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, Rapivab was indicated for patients two years and
FDA Policy/General
Pharmaceutical consulting firm Indegene says doctors are expressing discontent with elements of the virtual drug detailing forced by the pandemic, although they also are not very pleased with in-person detailing. In an online white paper, Indegene reports that one in three healthcare professionals is dissatisfied with contacts with drug
Drugs
FDA has released an FDA-483 with two observations issued following an 8/25-11/2/20 inspection at Hopkinton Drug, a Hopkinton, MA, producer of non-sterile drug products. The two observations were: * non-microbial contamination observed in the production area; and * failing to provide adequate segregation, cleaning of
Drugs
FDA has approved a BioCryst Pharmaceuticals supplemental NDA for Rapivab (peramivir injection) expanding the patient population for treating acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, Rapivab was indicated for patients two years and
Biologics
CBER says it plans to issue 14 guidances in three categories during calendar year 2021. The Center’s guidance agenda anticipates six guidances under Blood and Blood Components, seven guidances under Tissues and Advanced Therapies, and one guidance under Other.
Devices
FDA has approved Galderma’s Restylan Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21. The hyaluronic acid dermal filler was first approved in 2016 for mid-to-deep injection into the facial tissue for the correction of moderate to
Devices
FDA has cleared an NGMedical 510(k) for its 3D-manufactured titanium cervical interbody BEE cage implant. The device is designed to reduce the risk of subsidence while allowing fusion, the company says. Its honeycomb structure allows for bony ingrowth and it demonstrates the reduced use of titanium to minimize
Drugs
FDA has released notes from three workgroup and subgroup meetings as part of PDUFA 7 reauthorization discussions between the agency and industry representatives: * Manufacturing and Inspections Workgroup, 11/18/20. The meeting focused on finalizing discussions at the subgroup level for industry proposals relating to pre-approval/pre-licensure inspections
Drugs
FDA says its review of the Web site and Facebook page maintained by American Global Health Products, Bellevue, WA, indicated the company takes order for several AloeCure brand products. A 1/22 Warning Letter says the company makes claims for the products that establish that they are intended for use
Drugs
FDA has given the green light to NeurMedix to begin a pivotal Phase 3 clinical trial to evaluate its lead drug candidate, NE3107 in Alzheimer’s disease patients. The planned 316-patient placebo-controlled trial (NCT04669028) of the small molecule, orally administered, anti-inflammatory, insulin-sensitizing agent with a novel
Drugs
FDA has issued a complete response letter to Eagle Pharmaceuticals for its ANDA for vasopressin. The company says it has had two conversations with the agency about the letter and will have an additional meeting with FDA within 30 days. Eagle says it believes it can respond to questions FDA
Devices
FDA has denied a Public Citizen 7/7/15 petition asking that the agency withdraw its premarket approval of Genzyme’s Seprafilm and also start a mandatory recall of all remaining unused Seprafilm devices. The agency response says that while it denied the petition, it has requested additional Warnings and
Drugs
FDA has lifted a clinical hold on Mustang Bio’s lentiviral gene therapy MB-107 and a pivotal Phase 2 clinical trial after reviewing a “comprehensive” CMC package that the company says was submitted in late December. Mustang says it will proceed with its plans to initiate the pivotal Phase