Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval. Spanogle, Ph.D.

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Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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The Premier Consulting Blog

DECEMBER 28, 2023

Under section §812.10, a sponsor may request a waiver of any requirement of the IDE regulations through an application with supporting documentation. The FDA may grant a waiver if the requirement is not stipulated by the Federal Food, Drug, and Cosmetic (FD&C Act) or if it is not necessary for the protection of human subjects. [3]

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

The ramifications of the Federal Claims case and some of the other lawsuits brought by Vanda could be significant to regulated industry and to the food and drug bar. FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending 1:2023cv00629 (COFC) VANDA PHARMACEUTICALS, INC.

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DrugBank

MAY 6, 2024

A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals. In the first quarter alone, the FDA approved 9 new biologics, a substantial rise from the 5 approvals during the same period in 2023.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

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The Pharma Data

OCTOBER 15, 2020

The findings were presented at TCT Connect , the 32nd annual scientific symposium of the Cardiovascular Research Foundation. In the first study, presented by Hemindermeet Singh, MD, of Ascension St. This press release features multimedia. View the full release here: [link]. Figure 1 (Graphic: Business Wire). The Impella 2.5,

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The Pharma Data

JULY 21, 2021

– Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new data from its leading portfolio of eye care medicines at the 2021 ASCRS (American Society for Cataract and Refractive Surgery) Annual Meeting being held July 23-27 in Las Vegas, NV. Details about Allergan’s presentations are as follows: .

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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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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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

FDA explained that its bioequivalence regulations at 21 C.F.R. Those regulations break “concentration” out from strength but only in certain contexts. solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.” It was not too long ago that FDA punted on BI’s petition.

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The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement. The agency requested that data be further standardized and presented by primary functional endpoint. The FDA also granted a second meeting for review.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

The company asserts that carbadox residues fall below dangerous levels before the products hit consumers’ plates, and that the Agency’s anti-carbadox bias and failure to follow the mandated regulatory procedures violated the “the FDCA, FDA’s regulations, the APA, and due process.” Carbadox has had a tortured approval history.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ).

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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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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

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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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Codon

AUGUST 26, 2024

For this reason, developing broad-spectrum antivirals presents an enormous scientific challenge. Broad-spectrum antiviral drugs often have trouble finding pre-existing markets because regulators and consumers favor drugs that treat specific diseases, rather than drugs that have broad applicability. A look inside Panoplia Laboratories.

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The Pharma Data

JUNE 18, 2021

1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. NORTH CHICAGO, Ill.

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Drug Target Review

JULY 5, 2024

Secondly, organoids lack a functional blood-brain barrier (BBB) and so a drug showing a response in the organoid might not be active in vivo where a BBB is present. Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. NORTH CHICAGO, Ill. 1 Additionally, a separate integrated safety analysis found the safety profile of RINVOQ was consistent over 4.5 years, with no new safety risks observed.

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Agency IQ

NOVEMBER 3, 2023

Best practice is for this CFU to indicate the number of living organisms present at the time of expiration. In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP. The regulation of dietary supplements in the U.S.

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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. For more information, visit [link]. Important Notice.

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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

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

AUGUST 3, 2021

References in this release to “non-GAAP” measures, measures presented “on a non-GAAP basis” and to “free cash flow” (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757).

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Agency IQ

JANUARY 4, 2024

For regulators, there are two primary concerns associated with impurities – that they may cause a drug substance to degrade (thereby reducing its efficacy or safety) and that the impurities (or their effects on the drug substance) may be harmful to patients. Read AgencyIQ’s analysis of the ICH guideline here ].

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The Anticancer Fund

JUNE 23, 2023

Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ). They screened 20 FDA approved AEDs against a panel of six patient-derived IDHmut glioma stem-like cells. All articles need to be critically assessed and viewed in their broader research context.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Oxidation of adagrasib occurs on the methylpyrrolidine group 4. Gut 1996; 38: 439-446.

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The Pharma Data

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Today, the U.S. Source link: [link].

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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

SEPTEMBER 9, 2020

Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. ENSPRYNG is approved in Canada, Japan, Switzerland and the U.S.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019.

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Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. The meeting featured presentations from four of the program’s awardees from FY22 and FY23, which included both internal and external researcher projects.

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