2016, 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. 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review. [13] 17 March 2016. ^ “Gepirone” Drugs and Lactation Database. 17 March 2016. PMID 37856644.

FDA

FDA FDA Approval Treatment Clinical Trials

Navigating Regulatory Hurdles in Drug Development

DrugBank

JUNE 18, 2025

Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring. Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review.

Drug Development

Drug Development Clinical Trials Compliance Drugs

Landiolol

New Drug Approvals

APRIL 19, 2025

April 2016). “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. 2016 Apr 25;80(5):1106-7 ^ “Rapibloc Summary of Product Characteristics” (PDF). October 2016). 22 (4): 3616. PMID 19011773.

FDA

FDA Clinical Trials Treatment Trials

VALILTRAMIPROSATE

New Drug Approvals

OCTOBER 12, 2024

2016 ; Abushakra et al., 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. 2018; 32(9): 849–861. [2]. Hey JA, et al.

Pharmacokinetics

Pharmacokinetics Small Molecule Disease Licensing

Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

Under the terms of the amended agreement , originally executed in 2016 with Bristol Myers’ Celgene, an undisclosed fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors.

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. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

FDA

FDA Trials Therapies Regulations

ATUZAGINSTAT

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. Examples Example 1. mmol, 1.00

Small Molecule

Small Molecule DNA Disease Trials

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development

Clinical Development Disease Treatment Licensing

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Regulations

Regulations FDA Drugs Treatment

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. 2016; 61 (1): e01020-16. About AstraZeneca.

Trials

Trials Virus Vaccine Pharmacokinetics

Rezafungin

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] 7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] 23 March 2023. 64 (1): 2752. PMC 11762474.

Pharmacokinetics

Pharmacokinetics FDA FDA Approval Treatment

Trospium chloride

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] Retrieved 13 May 2016. billion in 2004. [23] billion in 2004. [23] January 2011.

FDA Approval

FDA Approval FDA Pharmacokinetics Licensing

BENZGALANTAMINE

New Drug Approvals

APRIL 2, 2025

2016 Jan 20;2(1):13-22. eCollection 2016 Jan. 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. Alzheimers Dement (N Y). doi: 10.1016/j.trci.2015.12.003. 2015.12.003. eCollection 2020.

FDA

FDA FDA Approval Treatment Disease

Drug Discovery Digest

Gepirone

Navigating Regulatory Hurdles in Drug Development

Trending Sources

Landiolol

VALILTRAMIPROSATE

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

ATUZAGINSTAT

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

Rezafungin

Trospium chloride

BENZGALANTAMINE

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