The FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J.

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Pharmacy Times

MAY 16, 2023

Since the 2018 guideline’s publication, additional non-statin therapies such as bempedoic acid, evinacumab, and inclisiran, have been approved by the FDA for the management of hypercholesterolemia.

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pharmaphorum

FEBRUARY 23, 2021

Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. Libtayo was first FDA-approved in late 2018 for advanced cutaneous squamous cell carcinoma, followed by advanced basal cell carcinoma last month.

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STAT

NOVEMBER 30, 2023

Even before the Covid pandemic, a 2018 paper reported that new genetic tests, many of them for increasingly rare conditions, were being released at the rate of 10 a day. You can now avail yourself of noninvasive diagnostics that claim to screen for rare birth defects, cancer-associated mutations, and even Alzheimer’s.

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pharmaphorum

SEPTEMBER 13, 2022

The FDA has started a priority review of Chiesi ‘s velmanase alfa, an enzyme replacement therapy for lysosomal storage disease (LSD) alpha-mannosidosis, with a decision expected in the first half of 2023. The post FDA starts review of first drug for alpha-mannosidosis, from Chiesi appeared first on.

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pharmaphorum

AUGUST 4, 2021

The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).

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FDA Chemotherapy Labelling 98

pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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The FDA Law Blog

MARCH 6, 2023

The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda. In the proposed rule, FDA stated that any final rule would become effective one year after the date of publication of the final rule in the Federal Register.

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Trials peaked at 115 in 2018 before declining to 91 last year.

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pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. AstraZeneca wasn’t so fortunate with its anifrolumab candidate, which flunked a pivotal trial in SLE in 2018, but still thinks it has potential.

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pharmaphorum

AUGUST 12, 2020

The FDA has started its review of Israeli biotech Protalix BioTherapeutics and partner Chiesi’s Fabry disease therapy pegunigalsidase alfa, setting up a possible approval by 27 January. The initial application with the FDA is for dosing of 1mg/kg pegunigalsidase alfa every two weeks, the same interval as Fabrazyme and Replagal.

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pharmaphorum

NOVEMBER 18, 2021

A virtual reality system developed by AppliedVR that has been shown in trials to help reduce chronic lower back pain has been approved by the FDA as a prescription digital therapeutic (DTx). The post AppliedVR’s virtual reality therapy for pain cleared by FDA appeared first on. billion in lost productivity in a year.

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STAT

OCTOBER 4, 2023

Samples collected between 2018 and 2022 led researchers to platelet collection products made by the company at a plant in Puerto Rico. Food and Drug Administration cited the company for contamination problems and other quality control issues at the same facility.

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pharmaphorum

JUNE 11, 2021

Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. Sutimlimab, which Sanofi acquired via its $11.6

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pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

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Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. Recently, the FDA granted approval for Milla Pharmaceutical’s generic version of the drug to help with shortages in the US. Dexmedetomidine is commercially available as Precedex, marketed by Pfizer.

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The FDA Law Blog

OCTOBER 30, 2022

Cato — On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.

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FDA Documentation 59

pharmaphorum

JANUARY 17, 2022

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Founded in 2018 as a spin-off of the University of Zurich and Harvard University, EraCal is already using this technology to develop a novel anti-obesity drug, named Era-379.

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STAT

OCTOBER 27, 2022

The investigation began in February and covers 2017, 2018, and 2019. The Italian branch allegedly sent the capital to foreign affiliates linked to a units based in Delaware called Pfizer Production and Pfizer Manufacturing. Continue to STAT+ to read the full story…

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The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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STAT

FEBRUARY 13, 2024

In 2001, Gilead secured FDA approval of tenofovir disoproxil fumarate (TDF), one of first medicines to treat HIV — a product still on the market, despite the potential side effect of causing skeletal and kidney damage. Ultimately, this medicine was shown to have a better side effect profile than TDF.

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FDA 115

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. The post FDA fast-tracks Leap’s gastric cancer immunotherapy appeared first on.

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STAT

MARCH 12, 2024

Delta 8 THC is a quasi-legal psychoactive version of cannabis, which has skyrocketed in popularity after a loophole found in a 2018 federal law allowed it to be sold nationwide without the same restrictions placed on traditional marijuana.

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The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

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The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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The FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The purpose of this program is to reduce the volume of reports that a manufacturer needs to submit to FDA and to “make malfunction event trends more readily apparent.”. By McKenzie E.

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The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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The FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

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FDA Documentation 115

STAT

SEPTEMBER 12, 2022

Food and Drug Administration in 2018 to treat smallpox and was authorized for use in treating monkeypox.  The National Institute of Allergy and Infectious Diseases is sponsoring the trial, which is being led by the AIDS Clinical Trials Group. TPOXX was approved by the U.S. Continue to STAT+ to read the full story…

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FDA 98

STAT

JULY 5, 2024

One night in November 2018, I fell while crossing a street in Subic Bay, a U.S. naval logistics station in The Philippines. My face whacked the asphalt. Lying in the path of oncoming traffic, I couldn’t move a muscle. After 45 seconds of terror, I was able to stand up and haul myself to the other side.

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FDA 110

Pharmacy Times

SEPTEMBER 7, 2022

The FDA initially approved baloxavir marboxil in October 2018 for the treatment of acute, uncomplicated influenza.

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FDA 65

pharmaphorum

NOVEMBER 20, 2022

The FDA subsequently raised serious concerns about the accuracy of testing that Theranos did conduct with its machines, and the company eventually retracted two years of blood tests before folding in 2018. “She knew that it could not successfully compete with the established conventional machines.”

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pharmaphorum

MAY 24, 2022

Shares in US biotech Nymox Pharma have plunged after the company announced the FDA had refused to accept its marketing application for its drug candidate for benign prostatic hyperplasia (BPH), a common condition affecting older men. The post Nymox slumps as FDA rejects filing for prostate drug appeared first on.

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pharmaphorum

APRIL 6, 2021

UK digital health company Oxehealth has claimed FDA approval for software that can be used to remotely measure vital signs like heart and breathing rates from a camera feed. . The post FDA green lights Oxehealth vital signs monitoring software appeared first on.

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STAT

JULY 26, 2023

The device received FDA clearance in May 2022 through the 510(k) process, which allowed Palette to claim the product was equivalent to a rectal radiation protector sold by Boston Scientific. Boston Scientific has sold that device since 2018, when it acquired it by buying the startup Augmenix for $500 million.

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The Checkup by Singlecare

NOVEMBER 30, 2023

Food and Drug Administration (FDA) used to rely heavily on a letter-based rating system for drug safety during pregnancy , with category A drugs being the safest to take, category X drugs being contraindicated because the risks outweigh the benefits, and category B, C, and D drugs varying in safety and adverse effects.

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pharmaphorum

AUGUST 2, 2021

A digital therapeutic for patients with heart failure has been awarded breakthrough device status by the FDA – said by its developer Biofourmis to be the first time the US regulator has given this designation for this type of product. The post FDA gives breakthrough status to Biofourmis’ heart failure DTx appeared first on.

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