New Drug Approvals

APRIL 25, 2025

“An Overview of Bioactive 1,3-Oxazole-Containing Alkaloids from Marine Organisms” Pharmaceuticals. 15 February 2018). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84” WHO Drug Information. PMID 34127844. MDPI AG: 1274. doi : 10.3390/ph14121274.

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Policy Prescription

MARCH 11, 2022

The crux of the Manitoba court’s decision is that CanadaDrugs’ founder and CEO, Kris Thorkelson , gets his pharmacist license back after it was revoked in 2019. The focus of this post is to simply show that the accused parties did not disregard patient safety in the manner that the pharmaceutical industry sought to portray. .

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. Instead, it had everything to do with licensed U.S. Protecting the imperatives of and the progress made under the DSCSA are used as a primary argument of the Pharmaceutical Researchers and Manufacturers of America ( PhRMA ) and the U.S. Fake DSCSA Pedigrees.

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New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 17 September 2018. Clementia Pharmaceuticals. Clementia Pharmaceuticals. 4] [5] It is a highly selective retinoic acid receptor gamma (RARγ) agonist. [6]

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. 2018) PLoS One. About Tonix Pharmaceuticals Holding Corp. Jessica Morris (corporate) Tonix Pharmaceuticals investor.relations@tonixpharma.com (212) 688-9421.

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New Drug Approvals

SEPTEMBER 6, 2024

Retrieved 21 August 2024. ^ World Health Organization (2018). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79” WHO Drug Information. . ^ “Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. 20 August 2024. hdl : 10665/330941.

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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Most have focused on patents specifically licensed to pharmaceutical companies from academic institutions, where the vast majority of basic biological research takes place in America, most of it supported by NIH. 2018 Feb 12. Such studies suggested that 10 percent or less of newly approved drugs were based on academic patents.

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Practical Cheminformatics

DECEMBER 7, 2023

Mark Murcko’s 2018 paper in J Med. It should be noted that not all biotechs skimp on software licenses. On two separate occasions, VP-level medicinal chemists from large pharmaceutical companies told me, “We have a solubility model that is so good, we stopped running the assay.” There are many ways to broaden your skills.

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New Drug Approvals

SEPTEMBER 10, 2024

Servier Pharmaceuticals. April 2018). LC-MS: m/z 415 (M+H) +.Compound Compound 6-(6-Chloropyridin-2-yl)-N 2 ,N 4 -bis(1,1,1-trifluoropropan-2-yl)-1,3,5-triazine-2,4-diamine 1 H NMR (400 MHz, CDCl 3 ) δ 8.29-8.16 8.16 (m, 1H), 7.72 (d, J=7.6 Hz, 1H), 7.41 (d, J=7.9 Hz, 1H), 5.70-5.13 5.13 (m, 2H), 5.09-4.71 4.71 (m, 2H), 1.34 (m, 6H).

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The Pharma Data

NOVEMBER 10, 2020

AlzeCure ® is a Swedish pharmaceutical company that develops new innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer’s disease and pain – indications for which currently available treatment is extremely limited. STOCKHOLM , Nov.

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The Pharma Data

NOVEMBER 2, 2020

2, 2020 /PRNewswire/ — BioMarin Pharmaceutical Inc. Europe, Latin America, the Middle East, and most of Asia Pacific, there are currently no licensed medicines for achondroplasia. This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. 20, 2021. In the U.S.,

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Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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The Pharma Data

JANUARY 24, 2021

On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

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The Pharma Data

DECEMBER 15, 2020

In 2018, approximately 450,000 individuals globally were diagnosed with this condition, 55,000 of them in the US; and the incidence of pancreatic cancer is expected to continue to increase. About Pancreatic Cancer Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. Its incidence rate in the US is estimated at 3.2%

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Molecule Blog

JUNE 11, 2021

We began exploring the combination of IP and NFTs with DeFi in 2018. When interest from potential investors reaches a certain maturity, the IP moves into a new licensing platform built on Web3.0. The legal contract is an IP license with language referencing blockchain transactions, addresses, and signatures.

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New Drug Approvals

SEPTEMBER 29, 2024

2018 ; Ding et al., According to a company press release and a poster presentation at the 2018 CTAD conference, healthy adults received 25, 50, or 100 mg COR388 or placebo every 12 hours for 10 days; AD patients took 50 mg or placebo every 12 hours for 28 days. Epub 2018 Oct 3 PubMed. Epub 2018 Jan 30 PubMed.

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The Pharma Data

JANUARY 25, 2021

patent is part of a patent family, exclusively licensed from Ionis Pharmaceuticals, which covers modulators of DNM2 expression. 2018 Sep;28(9):766-777. Epub 2018 Jul 2. 2018 Oct 23;115(43):11066-11071. Epub 2018 Oct 4. This patent family includes one additional U.S. ” The U.S. About DYN101.

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The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan. About Asieris. For more information, please visit us at www.asieris.com.

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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. Importantly, we were also able to publish the underlying work in high-quality journals.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. 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 What kind of biologic products entered the market?

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Molecule Blog

AUGUST 19, 2021

In a best case scenario, that technology is out-licensed to a pharmaceutical company and the remainder of the development carries on there. Molecule has been exploring a use case for combining IP and NFTs with DeFi in 2018, and this week, that use case was fully realised. And this is the best-case scenario. for patents)?

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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”.

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The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals’ SPN-812 for ADHD. Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). Adamis Pharmaceuticals’ Zimhi for Opioid Overdose. Food and Drug Administration (FDA) in terms of PDUFA dates.

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Toronto, Ontario–(Newsfile Corp. – January 25, 2021) – PharmaDrug Inc. PharmaDrug Inc.

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The Pharma Data

JANUARY 25, 2021

. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. 75% of all bladder cancer cases occur in men. American Cancer Society.

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The Pharma Data

JANUARY 18, 2021

ZTlido ® was approved by the FDA on February 28, 2018. SEMDEXA is a trademark of Semnur Pharmaceuticals, Inc. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients.

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Agency IQ

JANUARY 26, 2024

Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.” And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.”

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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. Inaqovi (cedazuridine/decitabine; Otsuka Pharmaceuticals) is approved in the E.U. for the years 2020 to 2022. Based on the E.U.

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The Pharma Data

OCTOBER 28, 2020

Mesoblast has formally requested a Type A meeting with the FDA to discuss a potential accelerated approval of the Biologics License Application (BLA) for remestemcel-L for the treatment of SR-aGVHD in children, with an additional randomized controlled study in patients 12 years and older as a post-approval requirement. TEMCELL ® HS Inj.

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Broad Institute

MAY 14, 2024

His T7 expression technology can be used to make large quantities of nearly any RNA or protein and has been for decades, and continues to be, a mainstay of biomedical research and pharmaceutical production. When proteins are the desired end result, the E. and around the world.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Holding Corp. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. CHATHAM, N.J., Holding Corp.

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The Pharma Data

JANUARY 14, 2021

Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical development.

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The Pharma Data

NOVEMBER 4, 2020

As with much of the pharmaceutical industry, VASCEPA revenue and prescription growth have been adversely impacted by the COVID-19 pandemic. In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 million and $8.9 million and $5.7 million and $1.1

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The Pharma Data

FEBRUARY 8, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% Pharmaceuticals business operating income. In the fourth quarter, business operating income (BOI) of Pharmaceuticals increased 3.7%

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The Pharma Data

FEBRUARY 4, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% Pharmaceuticals business operating income. In the fourth quarter, business operating income (BOI) of Pharmaceuticals increased 3.7%

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