XTalks

NOVEMBER 10, 2023

cTTP is a very rare, inherited and life-threatening blood clotting disorder caused by a disease-causing mutation in the ADAMTS13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) gene, which encodes the ADAMTS13 enzyme that regulates blood clotting by cleaving the von Willebrand factor (VWF) protease.

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XTalks

JULY 27, 2022

He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility. FDA-Approved? Shaw was recently fielding questions live on TikTok when someone asked her whether Pink Sauce was FDA-approved.

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Pharmaceutical Technology

FEBRUARY 8, 2023

Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks. One such example is Hemgenix (etranacogene dezaparvovec), the first gene therapy to treat adults with haemophilia B, which was approved in November.

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XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. Omaveloxolone Clinical Trials Skyclarys is an oral medication that contains omaveloxolone, an activator of the nuclear factor-erythroid 2 related factor 2 (Nrf2) pathway.

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XTalks

NOVEMBER 22, 2021

Virtual reality pain therapy company AppliedVR bagged de novo clearance from the US Food and Drug Administration (FDA) this week for its virtual reality EaseVRx system indicated as an adjunct treatment for chronic lower back pain for patients 18 years of age and older. Clinical Evidence for Virtual Reality Pain Treatment.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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Camargo

MAY 19, 2021

According to the FDA guidance document on HUD : “The scientific rationale supporting use of the device for the rare disease or condition, or orphan subset of a non-rare disease or condition (see Section III.C) Note: An HUD designation and the subsequent submission of an HDE application do not guarantee FDA approval.

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The Pharma Data

NOVEMBER 29, 2021

The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux. The FDA previously granted Cytalux orphan-drug , priority and fast track designations. The FDA granted the approval to On Target Laboratories, LLC. The FDA, an agency within the U.S.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).

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XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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pharmaphorum

MARCH 4, 2021

billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche. Sylentis, part of PharmaMar Group, has just announced FDA approval of a phase 3 trial for eye drops containing tivanisiran, in dry eye disease associated with Sjogren’s Syndrome.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Mounjaro and Ozempic are both FDA approved for glycemic control in adults with type 2 diabetes, in combination with diet and exercise.

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Camargo

NOVEMBER 15, 2021

In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”. The guidance also contains some useful information, despite the limitations described above.

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The Pharma Data

MARCH 15, 2022

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). Source link: [link] ov/.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Janssen Biotech, Inc.

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Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. The export regulations were later incorporated into the Food and Drug Regulations ( FDR ) in 2021.

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XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It is injected into a patient’s muscle tissue.

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XTalks

SEPTEMBER 5, 2024

” Opzelura (ruxolitinib), which contains 1.5 percent ruxolitinib, a topical Janus kinase (JAK) inhibitor, is US Food and Drug Administration (FDA)-approved for the treatment of mild to moderate atopic dermatitis in patients 12 years and older.

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Camargo

JUNE 4, 2021

Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod. Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. Since two-thirds of the more than 50 million U.S.

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FDA Law Blog

NOVEMBER 30, 2022

In addition, Grifols’s eligibility for government contracts is conditioned on FDA approval of Gamunex and FDA approval is conditioned on compliance with GMPs. Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) ( 21 U.S.C

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XTalks

JUNE 13, 2024

The US Food and Drug Administration (FDA) plays a crucial role in regulating hemp products, particularly those intended for consumption. The FDA’s stance has been cautious, focusing on ensuring that hemp beverages and other products are safe for consumers.

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XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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FDA Law Blog

JUNE 13, 2024

FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R.

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Camargo

MARCH 25, 2021

Its purpose is to stimulate the development of new drugs for rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products beyond the incentives offered by the ODD program. Sources: CFR – Code of Federal Regulations Title 21. FDA’s Orphan Drug Modernization Plan.

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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The Pharma Data

JANUARY 21, 2021

Hypersensitivity Reactions: Hypersensitivity reactions, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. .

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XTalks

AUGUST 28, 2020

And to ensure that the user is breathing clean, filtered air, the mask contains FDA-approved HEPA filters that provide up to 99 percent protection against particles including dust, aerosols and droplets. The parts contain magnets that allow for optimal adjustment of the mask to the user’s face.

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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Delveinsight

OCTOBER 1, 2021

Myasthenia Gravis Approved Therapies. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis. Some of the approved drugs are: Prograf (Tacrolimus). Prograf is available for oral administration in the form of capsules (tacrolimus capsules USP) containing 0.5

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XTalks

JUNE 5, 2024

The FDA’s assessment comes over two years after Daily Harvest’s French Lentil + Leek Crumbles product containing tara flour sickened nearly 400 people. Manufacturers can notify the FDA of a GRAS determination but are not required to do so. This decision could expose involved manufacturers to criminal liability.

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FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. FDA, Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act, 3.

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XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

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