pharmaphorum

OCTOBER 12, 2021

A data-mining study conducted by researchers in the US has found that an already-approved diuretic drug could have potential as a treatment for some patients with Alzheimer’s disease. The post Data dive finds cheap diuretic could be Alzheimer’s drug appeared first on.

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Camargo

OCTOBER 14, 2021

The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation.

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Camargo

DECEMBER 9, 2020

If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Evergreening Orphan Drugs May Be Over. This effectively “evergreens” the product, preventing generic competition.

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Pharmaceutical Technology

DECEMBER 20, 2022

The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. The FDA also awarded priority review for Eli Lilly’s donanemab, a monoclonal antibody for Alzheimer’s disease, in August 2022, and the company expects approval by February 2023.

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FDA Law Blog

SEPTEMBER 6, 2023

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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pharmaphorum

JULY 29, 2021

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus.

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Pharmaceutical Technology

NOVEMBER 29, 2022

On November 17, VistaGen Therapeutics announced the publication of data with its drug AV-101, which has ketamine-like effects, in a non-human primate model of Parkinson’s disease. In 1970, the FDA approved ketamine as an anesthetic. In 1970, the FDA approved ketamine as an anesthetic.

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pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.

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Pharmaceutical Technology

MAY 16, 2023

during Q1 2023 largely due to the advancement of a pair of Phase III trials, Oceanic-AF and Oceanic-Stroke, for their blood-thinning drug, Asundexian. According to GlobalData’s drugs database pharma intelligence centre, Wegovy is expected to generate an analyst consensus global forecast sales of $9.4 Novo Nordisk reported an 18.2%

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Pharmacy Checkers

SEPTEMBER 10, 2020

online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. When people go online or to their local Walgreens to buy prescription drugs domestically, they are largely relying on the regulatory strength of the U.S.

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Pharmacy Checkers

FEBRUARY 14, 2020

Years ago, they took on the Food and Drug Administration in regards to Budeprion XL distributed by Teva Pharmaceuticals, the supposed generic equivalent to the popular antidepressant, Wellbutrin XL. Finally, I put it together that this was related to the drug because when I wouldn’t take it I would begin to feel better.

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pharmaphorum

DECEMBER 1, 2021

Current treatments are dominated by generic drugs, and include topical antiseptics, retinoids which work by removing dead skin cells from the surface of the skin but can cause pain and inflammation, and topical antibiotics, as well as hormonal therapies including oral androgen inhibitors like spironolactone or cyproterone.

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FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

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XTalks

JANUARY 20, 2025

Key benefits included the addition of Celgenes blockbuster drug Revlimid (lenalidomide), a cornerstone of its oncology portfolio, and access to innovative CAR-T therapies such as Abecma (idecabtagene vicleucel). This strategic acquisition significantly strengthened Gileads oncology portfolio and provided access to Immunomedics ADC technology.

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FDA Law Blog

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

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pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry.

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pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. The post FDA hands Cassiopea its first approval, for acne drug Winlevi appeared first on. Cassiopea spun out of Ireland-domiciled Cosmo Pharma in 2015.

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John’s doctor was skeptical of drugs bought online from other countries. Is the drug safe?

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The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . Posted 17 May 2021 | By Jeff Craven .

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FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

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pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now.

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Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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FDA Law Blog

AUGUST 7, 2024

In other words, the case asks how “same” a generic drug’s labeling must be as compared to its Reference Listed Drug. That modification to the labeling, Novartis argues, “represents a sharp departure from FDA’s statutory and regulatory mandate to require that a generic drug be the ‘same’ as its reference listed drug.”

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FDA Law Blog

OCTOBER 1, 2024

Or consider Vanda’s challenge that FDA’s approval of a generic version of one of the company’s drugs violated the Appointments Clause of the Constitution (U.S. 2) because the FDA employees who approved the application were not “Officers of the United States.” II, § 2, cl. VANDA PHARMACEUTICALS, INC.

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FDA Law Blog

MAY 11, 2023

Agreeing with Judge Prost’s dissents in the Federal Circuit’s initial and rehearing decisions in this case, the Government argues that a generic’s labeling should not be treated as evidence of intent to induce infringement where that generic “plays by the rules of the section viii pathway” (internal citations omitted).

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FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S.

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FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S.

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FDA Law Blog

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form. Teva’s patents do not meet that criterion.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § 355(j)(2)(A)(v).

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FDA Law Blog

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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The Pharma Data

MARCH 9, 2021

NYSE and TASE: TEVA), today announced its launch of the first available generic version of AZOPT ® (brinzolamide ophthalmic suspension) 1%, approved by the US Food and Drug Administration to treat high pressure inside the eye due to ocular hypertension and open-angle glaucoma. Teva Pharmaceuticals USA, Inc.,

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FDA Law Blog

AUGUST 16, 2021

Koblitz — Meet the newest category of drug applications: the PANDA. Nonetheless, FDA has been calling them ANDAs and listing them in the Orange Book as ANDAs for years, but recent changes to the Orange Book have spurred some confusion.

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The Pharma Data

DECEMBER 28, 2020

Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. Jack Zhang, commented: “This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon.

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FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v. The procedural background of Amarin v.

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FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v. The procedural background of Amarin v.

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