Agency IQ

SEPTEMBER 15, 2023

For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Without sufficient resources, the FDA is unable to do so.

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The Pharma Data

MAY 7, 2021

Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We Following the successful delivery of more than 170 million doses to the U.S.

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Pharmaceutical Development Group

AUGUST 9, 2021

Since 1982, when the Federal Drug Administration (FDA) approved the first recombinant biotechnology drug, insulin, for human use, biotechnology, particularly biologic entities and biological processes, has provided key inputs for the development of pharmaceutical goods.

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The Pharma Data

MAY 27, 2022

federal government spent an estimated $1.8 The FDA approves around 50 new drugs each year after clinical trials and data analyses demonstrate a drug’s safety and effectiveness. . “Patients and the government are paying a lot for drugs that may not work.”

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The Pharma Data

DECEMBER 30, 2020

The Company aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”. Source: AstraZeneca.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

5,196,404 covering ANGIOMAX (bivalirudin) after the company’s patent counsel untimely filed for a PTE 62 days after the ANGIOMAX NDA 020873 approval at 5:18 PM on Friday, December 15, 2000 (see our summary and “coda” posts here and here ). Usually at this point in a post we would identify the date of approval of the relevant NDA.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C. Jazz also argues that, notwithstanding the language that instructs FDA to promulgate regulations implementing the clinical superiority provisions at 21 U.S.C.

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The Pharma Data

JANUARY 29, 2021

AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional approval during the health crisis. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca. Source link.

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The Pharma Data

JANUARY 29, 2021

AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional approval during the health crisis. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca. Source link.

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The Pharma Data

NOVEMBER 16, 2020

We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an Emergency Use Authorization and/or similar global authorizations. Moderna is working with the U.S.

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The Pharma Data

OCTOBER 25, 2020

SQI intends to submit RALI-dx for EUA to FDA in late Q4 2020. The RALI-dx COVID-19 Severity Triage Test is expected to be used primarily in hospital emergency departments upon FDA approval. SQI intends to submit RALI- fast for EUA to FDA in late Q1 2021. intends to submit its EUA to FDA in early Q1 2021.

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The Pharma Data

OCTOBER 15, 2020

FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, ®, Impella LD®, and Impella 5.5®

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The Pharma Data

JANUARY 13, 2021

A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Source link.

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Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s analysis of the draft guidance here. ]

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The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) .

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The Pharma Data

JULY 21, 2021

Presentations will include new data on AGN-190584 (pilocarpine 1.25%), an investigational presbyopia treatment, and updated analyses on DURYSTA (bimatoprost intracameral implant), the first and only FDA-approved dissolvable implant to reduce eye pressure in people with open angle glaucoma or high eye pressure.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. The result was the addition of Section 503A to the FD&C Act.

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The Pharma Data

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

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The Pharma Data

FEBRUARY 4, 2021

Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). and by AbbVie outside of the U.S. AbbVie announced that the U.S.

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The Pharma Data

OCTOBER 29, 2020

ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. A global Phase 3 study of ULTOMIRIS in children and adolescents with aHUS is underway.

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Policy Prescription

OCTOBER 22, 2024

Overall, the article addresses how to help people with private, government, or no health insurance. The authors cite the FDA’s personal importation policy. The authors state that, “PharmacyChecker is an independent organization that verifies international online pharmacies and allows patients to compare prices across pharmacies.”

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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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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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the U.S.

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The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ). AZ’ Tagrisso first to win MHRA approval under Project Orbis ( PharmaTimes ) ( Pink Sheet ) ( MHRA ).

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FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. That regulation is pretty clear. On April 29, 2022, FDA approved Tap Pharmaceuticals, AG’s (“Tap’s”) NDA 215809 for EMERZA (levothyroxine sodium) Oral Solution. 2d 1220, 1223 (Fed.

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The Pharma Data

JANUARY 6, 2021

The approval in India is an important milestone as it will enable to supply India but also a large number of countries around the world. We would like to thank the regulators for their swift and decisive actions and our partner, Serum Institute of India, for its substantial contribution to this global effort.”. Source: AstraZeneca.

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The Pharma Data

APRIL 27, 2021

3-7 This disease carries a worse prognosis than other EGFR mutations because there are currently no FDA-approved therapies that target EGFR Exon20 insertions, and current EGFR TKIs and chemotherapy provide limited benefit for these patients.

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The Pharma Data

NOVEMBER 9, 2021

The State’s claims violate abecedarian principles of due process by seeking to hold a company liable for conduct permitted under civil law and regulations. Food and Drug Administration (FDA)-approved and since launch, have reckoned for lower than one percent of total opioid conventions in Oklahoma as well as the United States.

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products. The results of this survey were provided in a report to the AMA’s Council on Scientific Affairs.

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The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

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The Pharma Data

JANUARY 29, 2021

The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations. COV2-S (SARS-CoV-2 vaccine) FDA Approval History. i] [link] [ii] The B.1.351 1.351 lineage also known as 501Y.V2 Source: Johnson & Johnson. Source link.

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The Pharma Data

DECEMBER 8, 2020

During the call, Takeda provided a deep dive into TAK-721, which has the potential to be the first FDA-approved agent for the treatment of eosinophilic esophagitis (EoE), and TAK-003, which is a live attenuated tetravalent vaccine for prevention of dengue disease.

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The Pharma Data

OCTOBER 28, 2020

Wave 1 Q2 highlights include: TAK-721 completed the rolling NDA submission and remains on track to be the first FDA-approved agent to treat eosinophilic esophagitis. Takeda Expands COVID-19 Vaccine Supply in Japan Through Partnership with Moderna and Government of Japan.

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The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. Other 2021 Assumptions. FOOTNOTES. (1)

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Agency IQ

JULY 21, 2023

BY RACHEL COE, MSC JUL 18, 2023 11:14 PM CDT Oncology endpoints: The growing pains of an evolving field FDA approval of a drug or biologic relies on whether there is “substantial evidence” of safety and effectiveness derived from “adequate and well-controlled clinical investigations” according to the Federal Food, Drug, and Cosmetic (FD&C) Act.

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