Licensing, Pharmacokinetics and Presentation

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

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. 1] It is taken orally. [1] 1] Side effects of gepirone include dizziness , nausea , insomnia , abdominal pain , and dyspepsia (indigestion). [1] 1] Gepirone acts as a partial agonist of the serotonin 5-HT 1A receptor. [1]

FDA

FDA FDA Approval Treatment Clinical Trials

Vamorolone

New Drug Approvals

JULY 25, 2025

Example 2: Synthesis of the present invention Scheme C: Route of Synthesis of Vamorolone from 8-DM Vamorolone was synthesized in three synthetic steps from commercially available 8-DM. “Population Pharmacokinetics of Vamorolone (VBP15) in Healthy Men and Boys With Duchenne Muscular Dystrophy” Journal of Clinical Pharmacology.

FDA

FDA FDA Approval Treatment Clinical Trials

Crinecerfont

New Drug Approvals

APRIL 18, 2025

A representative Coupling-Step of 2-cyclopropylacetic acid ( Compound 1A) with N,O-dimethylhydroxylamine or a salt thereof in the presence of a coupling-step reagent (e.g., 1,1-carbonyldiimidazole), a coupling-step base (e.g., triethylamine), and a coupling-step solvent (e.g., Br), in the presence of an alkylating-step solvent (e.g.,

FDA

FDA FDA Approval Drugs Trials

Landiolol

New Drug Approvals

APRIL 19, 2025

Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. Yield:144481-98-1 95.9% 32 (2): 828. doi : 10.1016/j.joa.2015.09.002.

FDA

FDA Clinical Trials Treatment Trials

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

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. These changes can impact staffing requirements throughout the study.

Trials

Trials Clinical Trials Regulations FDA

Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

The Pharma Data

NOVEMBER 11, 2020

A (spike) protein present on the viral envelope must bind to a receptor on the surface of the host cell and be activated in order to enter the cell. SLV213 was developed based on research from UC San Diego and the university exclusively licensed it to Selva Therapeutics. Cofounder and Chief Scientific Officer of Selva Therapeutics.

Treatment

Treatment Small Molecule Virus Pharmacokinetics

Donanemab data that demonstrated relationship between reduction of amyloid plaque and slowing of cognitive decline

The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. Lilly plans to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year.

Disease

Disease Treatment Pharmacokinetics Trials

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

Treatment

Treatment FDA Approval Pharmacokinetics FDA

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

AUGUST 8, 2024

As outlined in the table below, application fee rates, such as for a New Drug Application (NDA) or Biologics License Application (BLA), will increase by almost $300,000 in FY2025 (effective October 1, 2024). For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g.,

Drugs

Drugs Pharmacokinetics FDA Production

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

1 Therefore, S1P receptor modulators like etrasimod were investigated in treating immune-mediated diseases like ulcerative colitis where a high level of inflammatory T cells is present in the gastrointestinal tract, thus causing diffuse mucosal inflammation. twitter +919321316780 call whatsaapp EMAIL.

FDA

FDA FDA Approval International Pharmacokinetics

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

JANUARY 10, 2021

The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. Presentation at J.P. ?.

Clinical Trials

Clinical Trials Clinical Development Small Molecule Trials

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

NOVEMBER 4, 2020

New CTP-543 Data Presented in Late-Breaking News Session at EADV 2020. Initial data from an ongoing long-term, open label extension study with CTP-543 were presented in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Virtual Congress on October 29, 2020. 2019.

Pharmaceuticals

Pharmaceuticals Clinical Trials Trials Treatment

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

JULY 26, 2024

These protocols are used to describe the change and present all the tests and studies to be performed along with the acceptance criteria to ensure the continued safety and efficacy of the product. The new draft guidance is fairly short, clocking in at 13 pages total, about seven of which are the Q&A – with four individual questions.

Biosimilars

Biosimilars Science FDA Production

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

The Pharma Data

JULY 27, 2021

. “Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

Production

Production Clinical Trials Government Disease

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

The Pharma Data

OCTOBER 27, 2020

A reconciliation of net income to non-GAAP earnings is presented below (in millions, except per share data): . License-related fees (5). License-related fees (5). Three Months Ended September 30, .

FDA

FDA Production Licensing Licensing

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

The results were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

Production

Production Trials Treatment Disease

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. This study is planned to start in late 2024 and conclude in late 2025.

FDA

FDA Trials Therapies Regulations

HIV prevention and treatment, alongside pipeline advances at CROI 2021

The Pharma Data

MARCH 2, 2021

and Shionogi Limited as shareholders, today announced the presentation of 16 sponsored abstracts from its diverse portfolio of innovative pipeline and licensed HIV treatment and prevention options at the Conference on Retroviruses and Opportunistic Infections (CROI 2021), being held virtually 6-10 March. Kimberly Smith, M.D.,

Treatment

Treatment Pharmacokinetics Licensing Licensing

ATUZAGINSTAT

New Drug Approvals

SEPTEMBER 29, 2024

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. The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar.

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

and 5 yes, 0 no and 6 uncertain on the question, “Has the Applicant presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology?”. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. About Aducanumab. About Alzheimer’s Disease.

Disease

Disease FDA Clinical Trials Licensing

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Ricciardi M.J. Science Translational Medicine. Nature Plants. Will Bedingfield.

DNA

DNA RNA Engineering Licensing

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The company anticipates submitting study results for presentation at an upcoming medical congress.

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Global Head, Janssen Research & Development, Johnson & Johnson. Use in Specific Populations.

FDA Approval

FDA Approval Treatment RNA FDA

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

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

The Pharma Data

DECEMBER 23, 2020

Vocabria is intended for adults who are virologically suppressed on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. Elsewhere around the world: Avacta Group – U.K.-based

Licensing

Licensing Licensing Vaccine Drugs

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

The Pharma Data

SEPTEMBER 15, 2020

New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology.

Vaccine

Vaccine Therapies Trials Clinical Trials

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.” The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration.

Regulations

Regulations FDA Drugs Treatment

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

APRIL 16, 2021

variant, present in these other countries and remain an important treatment option. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Treatment

Treatment Hospitals Long-Term Care Facilities Virus

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AUGUST 22, 2021

Full results from PROVENT will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. About PROVENT. About AstraZeneca. Griffin MP, et al. Yu XQ, et al.

Trials

Trials Virus Vaccine Pharmacokinetics

BENZGALANTAMINE

New Drug Approvals

APRIL 2, 2025

The compounds of the present invention can either interact as such with their target molecules, or they can act as pro-drugs, in the sense that after reaching their target regions in the body, they are converted by hydrolysis or enzymatic attack to the original parent compound and react as such with their target molecules, or both.

FDA

FDA FDA Approval Treatment Disease

TREOSULFAN

New Drug Approvals

APRIL 5, 2025

WO2019043587A2 EXAMPLES Detailed experimental parameters suitable for the preparation of Treosulfan or intermediates according to the present invention are provided by the following examples, which are intended to be illustrative and not limiting. The following examples are meant to be illustrative of the present invention.

FDA

FDA FDA Approval Production Treatment

Iomeprol

New Drug Approvals

APRIL 18, 2025

PATENT [link] The process for preparing iopromide of formula (1) according to the present invention is shown in the following reaction scheme 5. The present invention will be explained more specifically by the following examples. However, the examples are not intended to limit the scope of the present invention thereto.

FDA

FDA Production FDA Approval Clinical Pharmacology

Drug Discovery Digest

Navigating Regulatory Hurdles in Drug Development

Gepirone

Trending Sources

Vamorolone

Crinecerfont

Landiolol

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

Donanemab data that demonstrated relationship between reduction of amyloid plaque and slowing of cognitive decline

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

Etrasimod

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

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

HIV prevention and treatment, alongside pipeline advances at CROI 2021

ATUZAGINSTAT

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

Codon Digest: Injected Gene Editors

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

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

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

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

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

BENZGALANTAMINE

TREOSULFAN

Iomeprol

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