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. We hope it was a useful two-parter! We’re looking forward to the next crop!

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. Posted: November 2020. NEW YORK, Nov.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. 22, 2020– Gilead Sciences, Inc. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS to 1.12).

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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. 15, 2020 (GLOBE NEWSWIRE) — Athenex, Inc., 15, 2020 (GLOBE NEWSWIRE) — Athenex, Inc., The FDA approval of Klisyri is a significant milestone for Athenex. Posted: December 2020. BUFFALO, N.Y.,

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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. 27, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.

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The Pharma Data

OCTOBER 30, 2020

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. NASDAQ: REGN) will host a webcast on Monday, December 7, 2020 at 4:30pm EST. Management will discuss data presented at the American Society of Hematology (ASH) 2020 Annual Meeting as well as provide updates on the Company’s broader oncology and hematology portfolio.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [19] FDA prescribing information for zilucoplan. Xenobiotica, 47:10, 856-869. Oncotarget.

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The Pharma Data

OCTOBER 31, 2020

1, 2020 /PRNewswire/ — TaiGen Biotechnology Company, Limited (“TaiGen”) ( Taiwan : 4157) announced today that U.S. Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. TAIPEI, Taiwan , Nov.

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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

JANUARY 19, 2021

NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2020 financial and operating results on Friday, February 5, 2021 , before the U.S. TARRYTOWN, N.Y. , 19, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. financial markets open.

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The Pharma Data

NOVEMBER 5, 2020

05, 2020 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2020 and provided a corporate update. “In FDA approval, and customary exceptions).

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The Pharma Data

AUGUST 31, 2020

Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Reviewed June 8, 2020. Accessed July, 24 2020. J Clin Virol.

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The Pharma Data

DECEMBER 9, 2020

10, 2020 08:00 UTC. –( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDA approval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. . HOUSTON , Dec. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb.

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The Pharma Data

FEBRUARY 4, 2021

3, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020. AbbVie hosted an Immunology Strategic Update event on December 14, 2020 for members of the investment community. NORTH CHICAGO, Ill., Gonzalez , chairman and chief executive officer, AbbVie.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations. WASHINGTON , Dec.

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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. He is co-inventor of SEED Biosciences’ core technology called DISPENCELL and co-authored several patents and scientific articles that made the cover of SLAS Technology in 2020.

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The Pharma Data

OCTOBER 27, 2020

27, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. EST on Monday, November 9, 2020. Cowen Virtual Presentation Series – 2020 IO Next Summit at 1:15 p.m. EST on Friday, November 13, 2020. GMT ) on Tuesday, November 17, 2020. TARRYTOWN, N.Y. , Jefferies Virtual London Healthcare Conference at 7:20 a.m.

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The Pharma Data

MAY 7, 2021

under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. 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. The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S.

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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. He is co-inventor of SEED Biosciences’ core technology called DISPENCELL and co-authored several patents and scientific articles that made the cover of SLAS Technology in 2020.

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The Pharma Data

JANUARY 18, 2021

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.

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The Pharma Data

DECEMBER 23, 2020

Leronlimab, which is a viral-entry inhibitor against the CCR5 receptor, is originally intended as an HIV drug, though it has yet to receive FDA approval in this disease area. said in a statement.

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New Drug Approvals

DECEMBER 19, 2022

2020 Feb 27;63(4):1612-1623. Epub 2020 Feb 12. 1] Olutasidenib was approved for medical use in the United States in December 2022. [1] 1] Olutasidenib was approved for medical use in the United States in December 2022. [1] Olutasidenib FT-2102 FT2102 C 18 H 15 ClN 4 O 2 354.79 J Med Chem. doi: 10.1021/acs.jmedchem.9b01423.

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The Pharma Data

DECEMBER 1, 2020

2, 2020 11:05 UTC. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. Presentations will be available for registered attendees via the Piper Sandler conference site through December 3.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. FDA-2020-E-1840 (July 13, 2020). FDA-2020-E-1840 (Mar.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 — The first blood test to help diagnose Alzheimer disease is now available in the United States, but some experts have a number of concerns about it. © 2020 HealthDay. Posted: November 2020. MONDAY, Nov. The test from C2N Diagnostics of St. the AP reported. AP News Article. All rights reserved. Source link.

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The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class.

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The Pharma Data

DECEMBER 15, 2020

15, 2020 — The first non-prescription COVID-19 test that enables people to collect samples and get results at home has received emergency use authorization from the U.S. ” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. © 2020 HealthDay.

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The Pharma Data

MAY 17, 2021

“These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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The Pharma Data

DECEMBER 16, 2020

16, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) on Friday, December 11, 2020. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. About Omidubicel.

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The Pharma Data

JANUARY 6, 2021

The announcement, following a $98 million IPO in October 2020, comes as the company advances several programs through its pipeline. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021. Oncorus’ stock opened at $32.45 Monday, up $0.28

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration (FDA) approval of this first-of-its-kind eye pressure lowering treatment for glaucoma patients in March 2020. Presentations will include updated analyses that help further scientific understanding of DURYSTA ® (bimatoprost intracameral implant), as well as new data on the XEN ® Gel Stent.

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The Pharma Data

DECEMBER 30, 2020

Towards the end of March, the FDA approved two new treatments for multiple sclerosis (MS): Mayzent (siponimod) and Mavenclad (cladribine). Posted: December 2020. Consumer News. The Feverish Pricing of MS Treatments. Both represent important breakthroughs for people with certain types of MS. But they come at a cost.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. Posted: November 2020. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

While we now know that REMS patents may be anticompetitive—and the First Circuit told us in 2020 that listing a patent covering only a component of a device constituent is (apparently) anticompetitive—the listing of other device patents remains a judgment call.

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