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.

Pharmacy 97

Pharmacy Specialty Pharmacies Licensing Licensing 97

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.

Licensing 52

Licensing Licensing Vaccine FDA 52

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.

Targeted Protein Degradation 130

Targeted Protein Degradation Computational Chemistry Licensing Licensing 130

Drug Target Review

JUNE 11, 2025

Carlos specialises in helping pharmaceutical and biotechnology companies develop their in- and out-licensing strategies, with additional expertise and experience in portfolio assessment and prioritisation, drug candidate valuation, valuation and related services. Nature Medicine, 28, 1656–1661 (2022) [link]

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Drugs Clinical Trials Drug Development Pharmaceuticals 64

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.

Licensing 52

Licensing Licensing Clinical Trials FDA 52

New Drug Approvals

MAY 17, 2025

January 2022). It is administered as an intrathecal injection. [3] 3] The most common side effects include fatigue, arthralgia (joint pain), increased cerebrospinal (brain and spinal cord) fluid white blood cells, and myalgia (muscle pain). [3] 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7]

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FDA Approval FDA Treatment Clinical Trials 62

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

Licensing 40

Licensing Licensing Small Molecule Science 40

New Drug Approvals

JUNE 15, 2025

Archived from the original on 22 February 2022. 24 September 2024. . “RA101495, a subcutaneously administered peptide inhibitor of complement component 5 (C5) for the treatment of generalized myasthenia gravis (gMG): Phase 1 results and phase 2 design (S31. 006)” Neurology. 90 (15 Supplement). doi : 10.1212/WNL.90.15_supplement.S31.006.

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FDA Treatment Drugs Production 57

New Drug Approvals

MAY 8, 2025

2022 Jun 16;13:20406207221101697. eCollection 2022. 2022 Jun 16;13:20406207221101697. eCollection 2022. 2022 May 20;12(5):80. 2022 Oct 1;15(1):138. 2022 Feb 24;386(8):735-743. Retrieved 28 January 2023. This article incorporates text from this source, which is in the public domain. 12 (5): 80.

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FDA Approval FDA Therapies Trials 52

New Drug Approvals

MAY 9, 2025

Lloyd MR, Wander SA, Hamilton E, Razavi P, Bardia A (2022). . ^ “EC approves Menarini Group’s Orserdu for advanced or metastatic breast cancer” PMLive. 21 September 2023. Retrieved 22 September 2023. 14 : 17588359221113694. doi : 10.1177/17588359221113694. . 26 (9): 948956. doi : 10.1097/CAD.0000000000000271. PMC 4560273.

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FDA Pharmacokinetics Therapies Treatment 62

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.

Disease 105

Disease Treatment Licensing Licensing 105

New Drug Approvals

APRIL 25, 2025

2022 Dec 22;65(24):16589-16621. Epub 2022 Dec 1. December 2022). Mente M, Karakuzulu BB, Uar GB, Yandm C (August 2022). January 2022). Vanhaesebroeck B, Burke JE, Madsen RR (January 2022). American Association for Cancer Research (AACR): 2022. J Med Chem. doi: 10.1021/acs.jmedchem.2c01422. 2c01422.

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FDA FDA Approval Therapies Trials 57

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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Therapies FDA FDA Approval Treatment 119

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 Approval FDA Treatment Pharmaceuticals 52

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?

Production 59

Production FDA Licensing Licensing 59

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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FDA Clinical Trials Treatment Pharmaceuticals 52

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.

Licensing 52

Licensing Licensing 52

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.”

Licensing 96

Licensing Licensing Production Regulations 96

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.

Trials 52

Trials FDA Clinical Trials Pharma Companies 52

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

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

Policy Prescription

OCTOBER 3, 2023

That’s why, according to Salant, drug companies “[blur] the distinction between dangerous counterfeit drugs and safe drugs sold by pharmacies licensed in other high-income countries.” In the summer of 2022, a policy debate in the Senate HELP committee ensued with Sens. but negotiate higher prices in foreign markets.

Pharmacy 84

Pharmacy International Government FDA Approval 84

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.

Pharmaceuticals 52

Pharmaceuticals Licensing Licensing Drugs 52

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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Biosimilars Production FDA Licensing 59

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.

Small Molecule 143

Small Molecule Trials Therapies Disease 143

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.

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

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.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

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.

Research 78

Research Production Licensing Licensing 78

The Pharma Data

MARCH 27, 2022

In February 2022, the U.S. European Union and Japan in 2022. “In 2022, OLUMIANT could become the first medicine ever approved to treat adults with alopecia areata. OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Lilly expects regulatory decisions in the U.S.,

Licensing 40

Licensing Licensing Disease FDA Approval 40

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The statutory Accelerated Approval provisions were amended in 2023 as part of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) to, among other things, give FDA greater authority to expedite the withdrawal of approval of an Accelerated Approval product if clinical benefit is not confirmed post-NDA or -BLA approval. FDA-2022-E-3124 ).

FDA 59

FDA Production FDA Approval Licensing 59

The Pharma Data

OCTOBER 14, 2021

Novartis moment blazoned that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Operation (sBLA) and that the European Medicines Agency (EMA) has validated the type-II variation operation for Beovu ® (brolucizumab) 6 mg for the treatment of diabetic macular edema (DME).

FDA 52

FDA Treatment Trials Licensing 52

Drug Target Review

FEBRUARY 28, 2024

Normality sensing licenses local T cells for innate-like tissue surveillance. Nat Immunol 23:411-422 (2022). Cancer immunotherapy with γδ T cells: many paths ahead of us. Cell Mol Immunol 17:925-939 (2020). McKenzie D, Hart R, Bah N, et al. Lamb L Jr, Henslee-Downey P, Parrish R, et al.

Therapies 105

Therapies Engineering Molecular Biology Science 105

The Pharma Data

JUNE 7, 2022

With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lebrikizumab in AD in the second half of 2022, followed by submissions to other regulatory agencies around the world. Almirall S.A.’s ’s Chief Scientific Officer.

Trials 40

Trials Clinical Trials Licensing Licensing 40

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. 11] In fact, in Fiscal Years 2018 – 2022, fewer than 100 510(k)s went through the Third-Party Review Program annually. [12] of 510(k) decisions, respectively. [13]

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FDA Laboratories Regulations Production 69

FDA Law Blog: Biosimilars

JUNE 17, 2024

Instead, the State of Pharmaceutical Quality Report provides more detailed statistics and data from FY2023 (October 1, 2022—September 30, 2023), and a clearer window into enforcement priorities. This report is not to be confused with OPQ’s Annual Report , a shorter and gauzier look into OPQ’s operations.

Pharmaceuticals 59

Pharmaceuticals FDA Production Drugs 59

The Pharma Data

JANUARY 18, 2021

The European sales and marketing infrastructure is being put in place to be ready for commercial launch as early as the beginning of 2022. At the same time, we continue to prepare for the filing of the Biologics License Application with the U.S. Temporary Authorization for Use (ATU) of LUMEVOQ ®.

Treatment 40

Treatment Therapies Clinical Trials Marketing 40

The Pharma Data

JULY 23, 2021

These doses are expected to be delivered from October 2021 through April 2022. The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccine 52

Vaccine Government Immune Response FDA 52

Agency IQ

JANUARY 4, 2024

The Swiss Federal Council confirmed its intention to continue to follow European device regulations in mid-2022, even in the face of rising concern around the implementation of the European MDR. Swissmedic reported a cash reserve of CHF 100 million, or about $118 million, at the end of 2022. What does this mean for manufacturers?

Marketing 40

Marketing Regulations Clinical Trials International 40