Drug Discovery Today

NOVEMBER 11, 2022

Stockholm, Sweden, November 8, 2022 – Swedish biotech company Salipro Biotech AB today announced that it has entered into a research collaboration and license agreement with Sanofi on the discovery of therapeutic biologics against a challenging drug target.

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FDA Law Blog: Biosimilars

JULY 18, 2023

Consistent with that initiative, OPQ recently issued its 2022 Annual Report on the State of Pharmaceutical Quality. Here’s a breakdown of some of the more interesting highlights, statistics and graphics from the FY 2022 report. Recalls Recalls hit a five-year peak in 2022. The PHE also had a dramatic effect on import alerts.

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Top-line results are expected in the first half of 2022. ProQR – Netherlands-based ProQR Therapeutics N.V.

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Drug Channels

FEBRUARY 21, 2023

addresses the Inflation Reduction Act of 2022. There are 241 exhibits in the 2023 edition, compared with 216 in the 2022 edition. If you have any questions before purchasing a license to the report, please email me. A new Section 12.5. In Subsection 12.5.1., In Subsection 12.5.2., Copyright © 2006-2023 Pembroke Consulting, Inc.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

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Drug Hunter

JUNE 25, 2023

This edition includes Maze’s glycogen synthase 1 (GYS1) inhibitors that were recently licensed to Sanofi, allosteric androgen receptor (AR) modulators that may be of interest to targeted protein degradation researchers, and brain-penetrant HER2 and ROCK2 inhibitors.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. The revised plan could support a potential commercial launch of omidubicel in the United States as early as mid-2022.

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The Pharma Data

JUNE 14, 2023

In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. billion euros. R&D expenses before special items amounted to 6.2

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The Pharma Data

MARCH 25, 2022

Food and Drug Administration (FDA) has extended the review of the supplemental biologics license application (sBLA) for Reblozyl® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia to June 27, 2022. Bristol Myers Squibb (NYSE: BMY) today announced that the U.S.

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Drug Target Review

APRIL 4, 2024

Clozapine induced a significantly different brain state and pimavanserin, the only licensed compound for PD-P, turned out to be more similar to Mesdopetam on the global scale. Nicholas served as the CEO of IRLAB Sweden between 2012 and 2022 and for IRLAB therapeutics 2016-2022. In 2013, Nicholas co-founded IRLAB Sweden.

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Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 2022 [cited 2023Feb24].

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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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New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. Results were expected in May 2022. 2022 Oct;31(10):987-993.

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New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] 1 December 2022. 1 December 2022.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

Briefly, on October 11, 2022, FDA issued a letter in response to a new dietary ingredient notification (NDIN) by Inner Mongolia Kingdomway Pharmaceutical Ltd. In a supplemental letter dated November 4, 2022, FDA addressed MKP’s arguments that FDA’s determination was incorrect. What led to NPA’s lawsuit?

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DrugBank

AUGUST 15, 2024

In 2022 alone, global sales of Repatha reached $1.28 This highlighted the importance of defining patent scope and licensing terms in such collaborations. This partnership proved to be a financial benefit for both parties. Repatha quickly achieved blockbuster status, generating billions of dollars in annual revenue for Amgen.

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The Pharma Data

SEPTEMBER 6, 2021

Takeda today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.

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New Drug Approvals

AUGUST 21, 2023

6] It was approved for medical use in Canada in June 2022, [4] and in the United States in August 2023. [5] 4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 24 January 2022. . 24 January 2022. 20 June 2022. Grogan, D.

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Perficient: Drug Development

JULY 24, 2023

SDK Visual Studio 2019/2022 Docker for Windows, with Windows Containers enabled Hyper-v After cloning a SitecoreHeadlessStarterKit repository in my local machine, the next step was to spin a Docker instance. Before running the first command, make sure that the Sitecore license is placed in the correct folder on your local machine.

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Perficient: Drug Development

JANUARY 24, 2024

There was debate on whether an IP address was identifiable until HHS made it clear that it was in a memo about how website visitor tracking data is to be handled was published in late 2022. The other part of the definition is what constitutes “health information.”

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The Pharma Data

APRIL 26, 2022

These data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022). In January 2022, the FDA approved a sNDA to expand the indication to non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death.

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The Premier Consulting Blog

OCTOBER 21, 2024

A report by the Office of Inspector General (OIG) in September 2022 revealed that over one-third of drugs granted accelerated approval had incomplete confirmatory trials, with 34% delayed beyond their original completion dates. This approach ensures timely completion of confirmatory trials in closer proximity to the initial approval.

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FDA Law Blog: Biosimilars

APRIL 25, 2024

The Revised Draft Guidance emphasizes that where multiple products are licensed as biosimilar to and interchangeable with or biosimilar to but not interchangeable with the same reference product, promotional communications should avoid suggesting that any of the products are less safe or effective than each other for their approved uses.

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Drug Channels

OCTOBER 10, 2023

addresses the Inflation Reduction Act of 2022. There are 163 exhibits in this 2023-24 edition, compared with 150 in the 2022-23 edition. The exhibits appear in all license versions. The PowerPoint file option is available only with the purchase of a corporate license.) A new Section 6.3.2. In Subsection 6.5.1.,

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The Pharma Data

NOVEMBER 25, 2020

The majority of the work will be completed in 2021 to start clinical trials as early as possible during 2022. Cantargia, which specializes in the development of antibody-based therapeutics for various types of cancer and inflammatory diseases, is a new manufacturing customer for BioInvent. The Company’s validated, proprietary F.I.R.S.T

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products. As a reminder, the U.S. See AgencyIQ’s analysis of these changes here.

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The Pharma Data

APRIL 29, 2022

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data. About SK bioscience.

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The Pharma Data

DECEMBER 2, 2020

GENFIT – France’s GENFIT announced the conclusion of the partial buyback of GENFIT’s 6,081,081 convertible bonds maturing in October 2022. Vivlion holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries. Horizon Discovery Group – U.K.-based

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Drug Channels

SEPTEMBER 17, 2024

Review pricing/license options and place a preorder Download a free pre-publication report overview (including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits) You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal.

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The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. The financial impact of the vaccine on the full year consolidated financials for the fiscal year ending March 31, 2023 (Fiscal Year 2022) will depend on the specific distribution schedule.

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The Pharma Data

MARCH 22, 2022

Pfizer expects supply to be available to support orders in April 2022, and supply will continue throughout 2022, pending regulatory authorization or approval and according to country needs. Financial details of the agreement were not disclosed.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., had Part D expenditures on or before August 16, 2022).

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. GlaxoSmithKline's spin-off of its consumer healthcare division , Haleon, in 2022 is a case in point.

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LifeSciVC

JANUARY 16, 2024

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots. Join the club.

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New Drug Approvals

DECEMBER 24, 2023

December 2022). . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL. “Eplontersen for Hereditary Transthyretin Amyloidosis With Polyneuropathy” The Journal of the American Medical Association. 330 (15): 1448–1458. doi : 10.1001/jama.2023.18688. 2023.18688.

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LifeSciVC

JANUARY 25, 2024

Getting funding and publishing papers in these two controversial fields was difficult, but the research teams I led there persevered for 15 years and succeeded in discovering new drugs that were licensed to pharma and biotech companies. We have never seen the number of layoffs in biotech that happened in 2022 and 2023… ever.

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National Institute on Drug Abuse: Nora's Blog

JANUARY 3, 2025

The National Survey on Drug Use and Health reported that between 2012 and 2019, past-year use of cannabis among people 12 and older rose from 11 percent to over 17 percent, and although trend comparisons arent possible because of changes in the surveys methodology, in 2022, nearly 22 percent of people had used the drug in the past year.

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