Drugs
Merck says Phase 3 data from the KEYNOTE-598 study evaluating its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab) compared with Keytruda monotherapy did not show improved overall survival (OS) or progression-free survival in patients with metastatic non-small cell lung
Biologics
FDA has approved a Biogen supplemental BLA for an intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a), indicated for treating relapsing forms of multiple sclerosis. A subcutaneous (SC) formulation of Plegridy was originally approved in 2014. Plegridy uses pegylated interferon beta-1a to extend its half-life
Drugs
Concert Pharmaceuticals is discontinuing development of schizophrenia drug CTP-692 after reporting disappointing data from a Phase 2 clinical trial evaluating it as an adjunctive treatment. According to the company, the study failed to meet the primary endpoint or other secondary endpoints. CTP-692 is described as a deuterated form
Devices
FDA has cleared a Soliton 510(k) for its Rapid Acoustic Pulse (RAP) device and technology for the short-term improvement in the appearance of cellulite. The company says that its rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite in
Drugs
Fresenius Kabi was issued a six-item FDA Form-483 after an inspection in May 2020 documented GMP deficiencies at its Melrose Park, IL manufacturing facility. For example, Fresenius’ responsibilities and procedures applicable to the quality control unit were not in writing and fully followed, the inspection form said. The
Devices
Wahl Clipper Corp. has recalled all Deluxe Heat Therapy Massagers, Model 4212, due to overheating concerns. A recall notice says users should discontinue use immediately, adding that the connection between the massager and heat attachment can overheat causing smoke or spark, which may pose a fire hazard. To view the
FDA Policy/General
Tobacco Product Substantial Equivalence Rule Withdrawn 1/25 Federal Register notice: FDA has withdrawn a 1/21-posted final rule that provided additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also established general procedures FDA intends
Biologics
Janssen and Novavax have both reported positive data from Phase 3 clinical trials involving each of their investigational Covid-19 vaccines. Janssen says 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 also
Biologics
FDA has extended by three months the review of a Biogen BLA for aducanumab, indicated for treating Alzheimer’s disease. The updated user fee review action target date is 6/7. The extension was triggered by a Biogen-submitted “information request” response that included FDA-requested analyses and clinical data,
Devices
FDA has approved a Medtronic PMA for the DiamondTemp Ablation (DTA) system for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) who have been unresponsive to drug therapy. The device is a temperature-controlled open-irrigated radiofrequency (RF) ablation system designed to deliver RF energy during ablations, Medtronic says,
Devices
FDA has classified as Class 1 a Penumbra recall of its Jet 7 Xtra Flex catheter due to its potentially becoming susceptible to distal tip damage during use. As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the Jet 7 Xtra Flex catheter
Drugs
FDA has cleared a Vertex Pharmaceuticals IND to proceed with a clinical trial for VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell therapy to treat Type 1 diabetes. VX-880 has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic
Drugs
FDA has granted Ascentage Pharma an orphan drug designation for its novel Bcl-2 inhibitor, APG-2575, for treating patients with follicular lymphoma (FL). The company says FL is a heterogeneous disease and the second most common subtype of non-Hodgkin lymphoma (NHL) among adult patients in the U.S.
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) has released charts showing program metrics for the first quarter of the 2021 Fiscal Year. The post shows statistics on the number and percentage of core initial promotional material reviews completed in 45 days in each of the three months, percentage of
Devices
FDA has cleared a Perspectum 510(k) for Hepatica, a precision oncology decision support tool for liver cancer. The device a quantitative multiparametric MRI to provide a liver health assessment based on artificial intelligence (AI)-driven liver segmentation together with proprietary biomarkers for hepatic fibro-inflammation and fat, according to
Drugs
FDA has cleared a Passage Bio IND application for PBFT02, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for treating patients with frontotemporal dementia (FTD) with granulin (GRN) mutations. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies,
FDA Policy/General
Some 29 advocacy groups, led by Public Citizen and Physicians for Responsible Opioid Prescribing, are urging the Biden administration not to appoint acting commissioner Janet Woodcock as commissioner of FDA. In a 1/27 letter to incoming HHS officials, the groups say that in her role as CDER director for
Drugs
FDA says Meitheal Pharmaceuticals is recalling one lot of cisatracurium besylate 10mg per 5 mL injection due to mislabeling. A company statement says the recall decision was made after a product complaint found that some cartons in the lot were mislabeled as phenylephrine HCl injection 100mg per mL. The company
Drugs
FDA has cleared an Organicell Regenerative Medicine IND for Zofin and its use in treating patients diagnosed with chronic obstructive pulmonary disease (COPD). The company has planned an upcoming double blinded, placebo-controlled, Phase 1-2 trial assessing the safety and potential efficacy of intravenous infusion of Zofin in COPD
Biologics
Cardiac surgeon Hooman Noorchashm, known to FDA for his opposition to power morcellation, has contacted the agency and vaccine makers Pfizer and Moderna about the immunological danger he says could be posed by the Covid-19 vaccine to the recently convalescent or asymptomatic carriers of SARS-CoV-2, and especially
Biologics
FDA has resumed conducting “prioritized” inspections by investigator staff in China and they will begin shortly in India too, according to CDER acting director Patrizia Cavazzoni. In a recent Twitter posting, Cavazzoni noted that inspections deemed “mission critical” are still being conducted. “We’re prioritizing inspections so the agency will
Drugs
FDA has accepted for review a Bio-Thera Solutions BLA for BAT1706, a proposed biosimilar to Genentech’s Avastin (bevacizumab). The submission seeks approval for the following indications: (1) treating patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, (2) first-line treatment for patients with non-squamous