The Pharma Data

JANUARY 17, 2021

Spero plans to initiate additional Phase 1 studies to assess the penetration of SPR206 into the pulmonary compartment and pharmacokinetics in subjects with renal impairment in 2021. SHANGHAI , Jan. In addition, no evidence of nephrotoxicity was observed in the study. About Everest Medicines.

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Practical Cheminformatics

DECEMBER 7, 2023

It is rare for graduate students to be exposed to tasks like optimizing pharmacokinetics or off-target binding. In these cases, broadening your skillset into other areas like medicinal chemistry, pharmacology, biophysics, pharmacokinetics, and disease biology is important. There are many ways to broaden your skills.

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Computational Chemistry Pharmacokinetics Drugs Pharmaceutical Companies 86

Conversations in Drug Development Trends

AUGUST 9, 2024

The team must present data to the IDSMB accurately and promptly, especially when multiple trial arms progress at different rates, demanding comprehensive data management, including safety, pharmacokinetic (PK), or pharmacodynamic (PD) data, and statistical inputs.

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The Pharma Data

AUGUST 21, 2020

Fortunately, as a member of the Novartis Business Development & Licensing (BD&L) department, she was in a position to try to help. Jennifer Leeds , Head of West Coast Search and Evaluation, NIBR Business Development & Licensing. We are also supporting the consortium’s preclinical safety and pharmacokinetics workstreams.

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The Pharma Data

MARCH 22, 2021

In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT.

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Disease Clinical Trials Pharmacokinetics Treatment 52

New Drug Approvals

OCTOBER 24, 2023

1] Etrasimod was discovered by Arena Pharmaceuticals , with subsequent development by Pfizer. [2] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 78” WHO Drug Information. 1] It is taken by mouth. [1] twitter +919321316780 call whatsaapp EMAIL. Click here to purchase.

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The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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New Drug Approvals

APRIL 18, 2025

potassium hydroxide), and water to prepare 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-prop-2-ynyl-1,3-thiazol-2-amine (Compound 1) or a pharmaceutically acceptable salt thereof is provided below in Scheme VII. Br), in the presence of an alkylating-step solvent (e.g.,

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The Pharma Data

DECEMBER 29, 2020

” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Protalix has licensed to Pfizer Inc.

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Clinical Trials Disease Treatment Trials 52

New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics.

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The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

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The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells.

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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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Agency IQ

JULY 26, 2024

The guidance “is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.” Any CMC changes (e.g.,

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The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. About Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. View original content: [link].

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Production Trials Treatment Disease 40

The Pharma Data

JANUARY 10, 2021

Development of TransCon CNP is progressing as planned with the recent initiation by VISEN Pharmaceuticals of a second phase 2 trial in patients with achondroplasia, the ACcomplisH China Trial, which provides for dose expansion at an effective dose determined from the ACcomplisH Trial. . ?. .

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Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

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DrugBank

JUNE 18, 2025

While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations. The extensive data requirements for regulatory submissions further complicate the process.

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. CABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression. cp-51575v4.

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New Drug Approvals

SEPTEMBER 29, 2024

The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. In August 2022, Cortexyme discontinued the gingipain inhibitor program, and offered it for external licensing ( press release ). All volunteers with AD had P. gingivalis DNA fragments in their CSF at baseline.

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Small Molecule DNA Disease Trials 62

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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FDA Biosimilars Clinical Trials Licensing 52

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

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

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Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Astrea is a leading provider of affinity separation solutions to the pharmaceutical and biomanufacturing industries. It is a division of Gamma Biosciences.

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Licensing Licensing Vaccine Drugs 52

The Pharma Data

SEPTEMBER 15, 2020

Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS. BNT162 mRNA-based Vaccine Program. and -50.4%

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. About Roche.

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The Pharma Data

MAY 4, 2021

About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology , Chinese Academy of Science (IMCAS). It is approved in the U.S.

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New Drug Approvals

MAY 14, 2025

7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79” WHO Drug Information. 23 March 2023. Albanell-Fernndez M (January 2025).

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New Drug Approvals

APRIL 27, 2025

9] [10] [11] Pharmacokinetics After oral administration, less than 10% of the dose is absorbed. 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] “Clinical pharmacokinetics of trospium chloride” Clin Pharmacokinet.

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FDA Approval FDA Pharmacokinetics Licensing 57

New Drug Approvals

APRIL 21, 2025

Syndax Pharmaceuticals. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88” WHO Drug Information. 15 November 2024. Retrieved 20 November 2024 via PR Newswire. World Health Organization (2022). hdl : 10665/363551. Haematologica. 2024 Nov 1;109(11):3488-3495. 2022.282621.

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New Drug Approvals

APRIL 2, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88” WHO Drug Information. Article ] Bakker C, van der Aart J, Hart EP, Klaassen ES, Bergmann KR, van Esdonk MJ, Kay DG, Groeneveld GJ: Safety, pharmacokinetics, and pharmacodynamics of Gln-1062, a prodrug of galantamine.

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FDA FDA Approval Treatment Disease 57

New Drug Approvals

MAY 11, 2025

11] History Omaveloxolone is a second generation member of the synthetic oleanane triterpenoid compounds and in clinical development by Reata Pharmaceuticals. 2] [5] It is taken by mouth. [2] 5] Omaveloxolone was approved for medical use in the United States in February 2023, [2] [5] [6] [7] [8] and in the European Union in February 2024. [3]

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New Drug Approvals

MAY 30, 2025

hashtag#Lotilaner For more information blog: [link] Research Tarsus Pharmaceuticals has conducted phase II studies of lotilaner as a remedy to prevent tick bites in humans. [16] Tarsus Pharmaceuticals. 16] [11] References ^ Jump up to: a b c d e “Xdemvy- lotilaner ophthalmic solution solution/ drops” DailyMed. 26 July 2023.

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New Drug Approvals

APRIL 5, 2025

Retrieved 2 January 2023. ^ “Trecondi (Link Medical Products Pty Ltd T/A Link Pharmaceuticals)” Therapeutic Goods Administration (TGA). Medexus Pharmaceuticals. “International nonproprietary names for pharmaceutical substances (INN). 21 December 2022. Archived from the original on 3 April 2022. 14 January 2025.

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New Drug Approvals

APRIL 21, 2025

under reduced pressure to afford a solid residue of Formula IX.Example 7Preparation of a Pharmaceutically Acceptable Salt of Formula I The solid residue of Formula IX was dissolved in water (57 mL) and stirred for 10 min and cooled to 05 C. The aqueous solution was acidified with conc. 25 November 2024. Retrieved 25 November 2024. ^

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