2017, Licensing and Pharmacokinetics

Gepirone

New Drug Approvals

JUNE 11, 2025

5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. Archived from the original on 24 September 2017. 1] It is taken orally. [1] 1] Side effects of gepirone include dizziness , nausea , insomnia , abdominal pain , and dyspepsia (indigestion). [1] 17 March 2016.

FDA

FDA FDA Approval Treatment Clinical Trials

Landiolol

New Drug Approvals

APRIL 19, 2025

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. Dean L (2017). July 2017). 32 (2): 828. doi : 10.1016/j.joa.2015.09.002. 2015.09.002. PMC 4823575. PMID 27092187. August 2000). 68 (2): 14350. 2000.108733.

FDA

FDA Clinical Trials Treatment Trials

VALILTRAMIPROSATE

New Drug Approvals

OCTOBER 12, 2024

Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. 2007 ; Kocis et al., 2016 ; Abushakra et al., 2018; 32(9): 849–861. [2].

Pharmacokinetics

Pharmacokinetics Small Molecule Disease Licensing

Merck Strikes $1B+ Deal to Leverage Janux’s T Cell Engager Program Against Cancer

The Pharma Data

DECEMBER 17, 2020

Previous technologies have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s proprietary TRACTr technology is designed to integrate tumor-specific activation with crossover pharmacokinetics to produce best-in-class T cell engager therapeutics. It’s a big bet for Merck.

Immune Response

Immune Response Pharmacokinetics Engineering Licensing

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

The 2017 Predictive Toxicology Roadmap laid out some of the FDA’s thinking around the need for new toxicology methods driven in part by a desire to find alternatives to animal testing. 42 U.S.C. § 262(k)(2)(A)(i)(I). However, there are signs that FDA is receptive from a policy perspective to alternative methods.

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

Roche provides update on tominersen programme in manifest Huntington’s disease

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.

Disease

Disease Clinical Trials Pharmacokinetics Treatment

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). Retrieved 13 October 2023. ^ [link] ^ World Health Organization (2017). . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . 16 (5): 495–503. doi : 10.1016/j.autrev.2017.03.007. 2017.03.007. PMID 28279838.

FDA

FDA FDA Approval International Pharmacokinetics

Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development. Demetrios Braddock, M.D.,

Clinical Trials

Clinical Trials Trials Treatment FDA

Advances in the Battle Against Autoimmune Disease

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.

Disease

Disease Clinical Trials Small Molecule Trials

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. At that time, FDA flagged concerns with functional unblinding and inherent expectation bias.

FDA

FDA Trials Therapies Regulations

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). Medtronic), the premarket approval application (PMA) for the ISR was approved by the FDA in December 2017. Three Months Ended September 30, . 2020.

FDA

FDA Production Licensing Licensing

ATUZAGINSTAT

New Drug Approvals

SEPTEMBER 29, 2024

2017 ; Ilievski et al., 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 ). Epub 2017 Nov 6 PubMed. In preclinical work from other labs, infection with P.

Small Molecule

Small Molecule DNA Disease Trials

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

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.

Disease

Disease FDA Clinical Trials Licensing

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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.

FDA

FDA Science Biosimilars Clinical Trials

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. A Phase 2 proof-of-concept study of Pfizer’s potential first-in-class pentavalent meningococcal vaccine candidate (Penta; MenABCWY).

Vaccine

Vaccine Therapies Trials Clinical Trials

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AUGUST 22, 2021

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(7) and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. 2017; 61(3): e01714-16. About AstraZeneca.

Trials

Trials Virus Vaccine Pharmacokinetics

Lotilaner

New Drug Approvals

MAY 30, 2025

Kuntz EA, Kammanadiminti S (November 2017). gmol 1 3D model ( JSmol ) Interactive image show SMILES show InChI Toutain CE, Seewald W, Jung M: Pharmacokinetics of lotilaner following a single oral or intravenous administration in cats. 2017 Nov 1;10(1):530. Retrieved 17 March 2024. 29 April 2024. Retrieved 17 June 2024.

FDA Approval

FDA Approval FDA Production International

Acoramidis

New Drug Approvals

APRIL 21, 2025

“First-in-Human Study of AG10, a Novel, Oral, Specific, Selective, and Potent Transthyretin Stabilizer for the Treatment of Transthyretin Amyloidosis: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Adult Volunteers” Clinical Pharmacology in Drug Development. It is taken by mouth. [1]

FDA Approval

FDA Approval FDA Production Treatment

Drug Discovery Digest

Gepirone

Landiolol

Trending Sources

VALILTRAMIPROSATE

Merck Strikes $1B+ Deal to Leverage Janux’s T Cell Engager Program Against Cancer

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

Roche provides update on tominersen programme in manifest Huntington’s disease

Etrasimod

Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency

Advances in the Battle Against Autoimmune Disease

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

ATUZAGINSTAT

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

Lotilaner

Acoramidis

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