DrugBank

JUNE 18, 2025

The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

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Drug Development Clinical Trials Compliance Drugs 52

New Drug Approvals

APRIL 11, 2025

2] History The efficacy and safety of fitusiran were assessed in two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male participants with either hemophilia A or hemophilia B. [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1] Fitusiran 1711.0g/mol,

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Clinical Trials FDA FDA Approval Trials 107

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. 5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. 1] It is taken orally. [1]

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FDA FDA Approval Treatment Clinical Trials 62

New Drug Approvals

APRIL 2, 2025

The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo. ESI-MS m/z calc.475.0922,

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FDA Therapies Trials Treatment 62

New Drug Approvals

JUNE 29, 2025

1] [2] Adverse effects The FDA prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. [1] Food and Drug Administration.

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International FDA Clinical Trials Treatment 62

New Drug Approvals

JUNE 15, 2025

Retrieved 11 December 2023. ^ “Zilbrysq Product information” Union Register of medicinal products. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80” WHO Drug Information. 6] [9] [10] It is a complement inhibitor that is injected subcutaneously (under the skin). [6]

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FDA Treatment Production Clinical Trials 57

New Drug Approvals

JULY 10, 2025

. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87” WHO Drug Information. hdl : 10665/352794. External links “Sebetralstat (Code – C184930)” EVS Explore. amcrasto@gmail.com

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FDA Treatment Small Molecule International 57

New Drug Approvals

MAY 8, 2025

13] Efficacy was evaluated in BRUIN (NCT03740529), an open-label, multicenter, single-arm trial of pirtobrutinib monotherapy that included 120 participants with mantle cell lymphoma previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. [4] 6] The same trial was used to assess safety and efficacy. [6] 12 (5): 80.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease.

Disease 109

Disease Licensing Licensing Therapies 109

New Drug Approvals

MAY 15, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76” WHO Drug Information. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77” WHO Drug Information. 2] [5] It is a kinase inhibitor [2] [6] that is taken by mouth. [2]

FDA Approval 62

FDA Approval FDA Treatment International 62

New Drug Approvals

APRIL 18, 2025

2] History Crinecerfont’s approval is based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic congenital adrenal hyperplasia. [2] 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2] 1 December 2024.

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FDA FDA Approval Drugs Trials 62

BioPharma Drive: Drug Pricing

JULY 10, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. You can unsubscribe at anytime. Kennedy Jr., who has pushed for policy changes around mRNA vaccines in particular. Recommended Reading Medical groups, pregnant doctor sue RFK Jr.

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Vaccine FDA Therapies Licensing 226

BioPharma Drive: Drug Pricing

JULY 10, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. You can unsubscribe at anytime.

Drugs 215

Drugs Licensing Licensing Therapies 215

New Drug Approvals

APRIL 19, 2025

elimination half-life (min) cardio-selectivity (1/2) metabilization Landiolol 4 250 pseudocholinesterases Esmolol 9 30 ery-esterases Metoprolol 420 3 cytochrom P2D6 (Leber) History The beneficial effects of landiolol have been demonstrated in over sixty clinical trials (pubmed search -August 2018). IV -Blocker max. Medical Genetics Summaries.

FDA 62

FDA Clinical Trials Treatment Trials 62

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. You can unsubscribe at anytime. Both programs are in early human studies.

RNA 219

RNA Drugs Therapies Licensing 219

BioPharma Drive: Drug Pricing

JULY 14, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.

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Production Drugs Therapies Clinical Trials 152

BioPharma Drive: Drug Pricing

JULY 2, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published July 2, 2025 By Kristin Jensen post share post print email license Endometriosis involves the outgrowth of womb lining tissue in the pelvis or abdomen.

Clinical Trials 240

Clinical Trials Drugs Licensing Licensing 240

BioPharma Drive: Drug Pricing

JULY 9, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. By Jonathan Gardner • Sept. Sign up A valid email address is required.

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Clinical Trials Drugs Therapies Licensing 277

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. You can unsubscribe at anytime.

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Licensing Licensing Therapies Vaccine 117

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer.

Therapies 176

Therapies FDA Treatment Licensing 176

Drug Patent Watch

JANUARY 8, 2025

It typically begins with the filing of a patent application and extends through various stages: Discovery and initial patent filing Clinical trials and regulatory approval Market exclusivity period Patent expiration and generic competition Understanding this lifecycle is crucial for developing a strategy that maximizes protection at every stage.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceuticals Licensing Licensing 52

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. In the trial, 59% of people who got a 1.2 You can unsubscribe at anytime. Kennedy Jr. milligram shot, the company said.

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Vaccine FDA Therapies Licensing 130

Conversations in Drug Development Trends

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

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Trials Clinical Trials Licensing Licensing 97

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

Drug Hunter

JUNE 25, 2023

This edition includes Maze’s glycogen synthase 1 (GYS1) inhibitors that were recently licensed to Sanofi, allosteric androgen receptor (AR) modulators that may be of interest to targeted protein degradation researchers, and brain-penetrant HER2 and ROCK2 inhibitors. Get ahead now by requesting a trial. already a member?

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Targeted Protein Degradation Computational Chemistry Licensing Trials 130

The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc. Source link.

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Licensing Licensing Therapies Pharmaceutical Companies 52

Perficient: Drug Development

OCTOBER 20, 2023

While it proved to be tricky to find an opening for an infant, we endeavored to compare in-home daycares and licensed facilities. Through this blog, I aim to offer insights based on our personal experience, hoping to assist new parents in making informed choices that were not apparent to me when we welcomed our first child to the family.

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Licensing Licensing Doctors Regulations 52

The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan. About ImaginAb.

Licensing 52

Licensing Licensing Clinical Trials Pharmaceutical Companies 52

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov. chief executive officer of Gamida Cell.

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Licensing Licensing Clinical Trials FDA 52

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. “We are pleased to work with U.S.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Skip to main content Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Cookie Preferences / Do Not Sell This website is owned and operated by Informa TechTarget, part of a global network that informs, influences and connects the worlds technology buyers and sellers.

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Treatment Drugs Therapies FDA 130

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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Licensing Licensing Vaccine FDA 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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Therapies FDA FDA Approval Treatment 119

The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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Vaccine Trials Clinical Trials Small Molecule 52

LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? Human and mouse genetics can inform not only efficacy but also safety. What tends to be unifying is investors’ desire to fund through key de-risking milestones in a given financing.

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Production Small Molecule Regulations Trials 131

The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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Licensing Licensing Pharmaceuticals Pharmaceutical Companies 40

The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram. Dragonfly received U.S. About Dragonfly. Source link.

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Licensing Licensing Production Clinical Trials 52