Licensing, Pharmacokinetics and Small Molecule

Immunotherapy for solid tumours progresses to human trials

Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. HTL0039732 works by blocking signalling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4).

Trials

Trials Small Molecule Pharmacokinetics Clinical Trials

Vertex Bags Experimental Drug for Rare Liver Disease after Disappointing Phase 2 Results | 2020-10-15

The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. James Miessler.

Disease

Disease Small Molecule Pharmacokinetics Licensing

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.,

Pharmacokinetics

Pharmacokinetics FDA Production Drugs

Highs and lows of drug repurposing

Drug Discovery World

SEPTEMBER 26, 2022

To do this, the Drug Repurposing Hub has developed an open-access library of over 6,000 compounds, which are being tested against disease models in an effort to find new treatments using small molecules – many of which have already been approved by the FDA. . Diving into data . Volume 23 – Issue 4, Fall 2022. References .

Pharmaceutical Companies

Pharmaceutical Companies Drugs Pharmaceuticals Clinical Trials

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Sygnature Discovery

NOVEMBER 29, 2023

Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

Clinical Trials

Clinical Trials Treatment Trials Small Molecule

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Sygnature Discovery

NOVEMBER 29, 2023

Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

Clinical Trials

Clinical Trials Treatment Trials Small Molecule

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). Pfizer Inc. NYSE: PFE) today announced that the U.S.

Building collaborations to fight a pandemic

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.

Virus

Virus Small Molecule Licensing Licensing

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

The Pharma Data

NOVEMBER 4, 2020

License and research and development revenue. Concert Pharmaceuticals is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform® (deuterated chemical entity platform). . 2019. .

Pharmaceuticals

Pharmaceuticals Clinical Trials Trials Small Molecule

Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

LifeSciVC

APRIL 24, 2024

and whether a molecule’s pharmacology can help to mitigate safety risk. Especially for oligo or small molecule discovery and development, it’s important to understand whether there are highly homologous sequences or proteins that may be impacted by a given therapeutic approach. in liver, in CNS)?

Production

Production Small Molecule Regulations Trials

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

in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products. Any CMC changes (e.g.,

Biosimilars

Biosimilars Science FDA Licensing

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

As an orally bioavailable small molecule with broad antiviral activity, SLV213 could be a valuable treatment to meet today’s urgent need to fight COVID-19 as well other life-threatening infectious diseases, such as Chagas disease, Ebola virus disease, and Nipah virus infection.”. About SLV213. About Selva Therapeutics.

Treatment

Treatment Small Molecule Virus Pharmacokinetics

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. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

DNA

DNA RNA Engineering Licensing

Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. The secondary outcome involves pharmacokinetic endpoints. Oral, Small Molecules. The primary outcome includes safety and tolerability endpoints.

Disease

Disease Clinical Trials Small Molecule Trials

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. ?. .

Clinical Trials

Clinical Trials Clinical Development Small Molecule 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

Drug Discovery Digest

Immunotherapy for solid tumours progresses to human trials

Vertex Bags Experimental Drug for Rare Liver Disease after Disappointing Phase 2 Results | 2020-10-15

Trending Sources

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

Highs and lows of drug repurposing

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

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

Building collaborations to fight a pandemic

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

Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

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

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

Codon Digest: Injected Gene Editors

Advances in the Battle Against Autoimmune Disease

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

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

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