New Drug Approvals

JULY 25, 2025

79 (2022) 1005–1014. [71] 79 (2022)1005–1014 Bioorg. Shale, U.J. Hoffman, Efficacy and safety of vamorolone vs placebo and prednisone among boys with duchenne muscular dystrophy: a randomized clinical trial, JAMA Neurol. Reeves, E.P. Hoffman, K. Nagaraju, J.M. Damsker, J.M. 2020, 117,24285−24293. Alliance 2019, 2,No. e201800186.

FDA

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. The company scrapped its initial drug program in 2022 and changed course two years later when a second prospect disappointed.

FDA

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.

FDA Approval

New Drug Approvals

JULY 10, 2025

October 2022). World Health Organization (2022). . ^ “KalVista Pharmaceuticals Announces FDA Approval of Ekterly (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema” (Press release). 7 July 2025. Retrieved 9 July 2025 – via Business Wire. 65 (20): 13629–13644. doi : 10.1021/acs.jmedchem.2c00921.

FDA

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.

FDA

New Drug Approvals

APRIL 18, 2025

1 November 2022). 17 February 2022). . “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82” WHO Drug Information. hdl : 10665/330879. Further reading Auchus, Richard; Chan, Jean; Farber, Robert; Fechner, Patricia; Giri, Nagdeep; Nokoff, Natalie; et al. (1 6 (Supplement_1): A618.

FDA

New Drug Approvals

JULY 7, 2025

History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] s,3H)。 PATENTS EP3643715 WO2018233527 US20200140431 US11180495 WO2018233527 US20200140431 References ^ Vaynrub A, Healey JH, Tap W, Vaynrub M (2022). 6] The U.S. s,1H),8.37(d,J＝5.7Hz,1H),8.27(s,1H),8.01–7.85(m,2H),7.67(d,J＝8.8Hz,1H),7.19(d,J＝2.4Hz,1H),6.62(dd,J＝5.7,2.4Hz,1H),5.89(s,1H),3.86(s,3H),3.83–3.76(m,1H),3.67–3.61(m,1H),2

Small Molecule

New Drug Approvals

APRIL 19, 2025

21 December 2022. 24 August 2022. Further reading Shiga T (June 2022). . ^ “Details for: Sibboran” Health Canada. 20 November 2023. Retrieved 3 March 2024. ^ “Regulatory Decision Summary for Sibboran” Drug and Health Products Portal. Retrieved 2 April 2024. Procedure no.: 20 (Suppl A): A10 A14.

FDA

Perficient: Drug Development

JULY 23, 2025

In addition, you must set your license key to activate these features properly. Basic grid including sorting, filtering, and pagination Inbuilt themes and custom styling Custom cell rendering Enterprise consists of a paid version of ag-grid which has ag-grid-enterprise package. Creating Basic Grid In your app.module.ts

Packaging

Drug Hunter

APRIL 20, 2023

We asked the global drug discovery community to nominate and vote on their favorite molecule from 2022, and the results are in. The 2022 winner, with the most overall votes across the ten finalist molecules , is BMS’ oral, deuterated allosteric TYK2 inhibitor, deucravacitinib, the first new treatment for plaque psoriasis in nearly a decade.

Small Molecule

Drug Discovery Today

JANUARY 26, 2022

Saffron Walden, 26th January 2022 / Domainex Ltd., a leading provider of integrated drug discovery services to life science organisations globally, is delighted that Professors Daniel Longley, Tim Harrison and colleagues at Queen’s University Belfast have entered into a collaboration and licensing agreement with Ipsen.

Licensing

Drug Channels

MARCH 15, 2022

I am pleased to announce our new 2022 Economic Report on U.S. Prescription Market (press release) We’re offering special discounted pricing if you order before March 28, 2022. The 2022 Economic Report on U.S. The chart below illustrates the depth and breadth of the 2022 edition. Click to Enlarge].

Pharmacy

Science Daily: Pharmacology News

AUGUST 9, 2023

The drug tecovirimat is currently in use for the treatment of mpox -- the disease caused by monkeypox virus -- that spread worldwide in 2022. Tecovirimat is an anti-poxviral drug, and its use is driving the emergence of drug-resistant variants of the monkeypox virus.

Licensing

Drug Channels

OCTOBER 11, 2022

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022!

Pharmaceuticals

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.

Licensing

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.

FDA

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

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

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

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

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

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

Perficient: Drug Development

JULY 24, 2025

Furthermore, platforms offer different payment schemes for licensing and use. 2022, February 21). Acquiring AI Solutions is very expensive There is a wide variety of AI tool offerings on the market, which allows for greater price competitiveness. Sources: Myths and Truths about Artificial Intelligence. Samsung.com.

Licensing

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.

Therapies

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.

FDA Approval

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

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.

FDA

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

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

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

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

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

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.

Biosimilars

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

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

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

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