DrugBank

JUNE 18, 2025

Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review. Drug development is a complex and highly regulated process.

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BioPharma Drive: Drug Pricing

JUNE 11, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival.

Disease 109

Disease Licensing Licensing Therapies 109

New Drug Approvals

APRIL 18, 2025

2] The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track , breakthrough therapy , orphan drug , and priority review designations. [2] New Drug Therapy Approvals 2024 (PDF). 1,1-carbonyldiimidazole), a coupling-step base (e.g., triethylamine), and a coupling-step solvent (e.g., 1 December 2024.

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FDA FDA Approval Drugs Trials 62

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime.

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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. New Drug Therapy Approvals 2024 (PDF). “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al. Yield:144481-98-1 95.9% Retrieved 28 November 2024 via Business Wire. 1 October 2024.

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FDA Clinical Trials Treatment Trials 62

BioPharma Drive: Drug Pricing

JULY 9, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. Alamy Merck & Co.

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Clinical Trials Drugs Therapies Licensing 277

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. says US won’t donate to global vaccine effort View all Events 07 JUL Webinar | 10 a.m.

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Licensing Licensing Therapies Vaccine 117

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. BCMA and CD19 are the protein targets of the seven approved CAR-T therapies. You can unsubscribe at anytime.

Therapies 176

Therapies FDA Treatment Licensing 176

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. An oral solution of fenfluramine is already cleared in the U.S.

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Vaccine FDA Therapies Licensing 130

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Therapies FDA FDA Approval Treatment 119

Drug Target Review

FEBRUARY 1, 2024

Part of the challenge is that patients present with very different kinds of clinical phenotypes, meaning the populations are heterogeneous. This can present challenges when attempting to recruit an enriched patient population for clinical trials. This has been a hot button issue in neuroscience for as long as I can remember.

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Therapies Drug Development Disease Clinical Development 104

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

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Therapies Engineering Molecular Biology Science 105

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.

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Licensing Licensing Therapies Pharmaceutical Companies 52

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.

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Targeted Protein Degradation Computational Chemistry Trials Licensing 130

The Pharma Data

SEPTEMBER 2, 2021

Novartis will present 12 abstracts at the European Respiratory Society (ERS) International Congress 2021 for Enerzair ® Breezhaler ® (IND/GLY/MF*) and Atectura ® Breezhaler ® (IND/MF**) — for patients whose asthma is uncontrolled with LABA/ICS^ and ICS, respectively 1,2. Details: Oral Presentation, 6 September, 9:30-11:00 CEST.

Licensing 52

Licensing Licensing Treatment Therapies 52

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Thus, these drugs best complement, rather than replace, healthy lifestyle interventions.

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Treatment Drugs Therapies FDA 130

The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. An archived version of the webinar will be available following the presentation.

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Licensing Licensing Biosimilars Disease 52

The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. per 100,000).

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Licensing Licensing Disease Small Molecule 52

The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

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Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

DECEMBER 13, 2020

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the U.S. About Omidubicel.

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Licensing Licensing Clinical Trials FDA 52

The Pharma Data

JANUARY 10, 2021

Chief Executive Officer of MorphoSys, will present at the 39 th Annual J.P. EST. Live audio of the presentation can be accessed from the Media and Investors section under Conferences on MorphoSys’ website, www.morphosys.com. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.

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Clinical Trials Clinical Development Clinical Supply Trials 52

The Pharma Data

NOVEMBER 18, 2020

Presentations to highlight the OBI-833 Phase 1 clinical study results in non-small cell lung cancer (NSCLC) and the dose escalation cohort. These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. ” Presentation number: 397P / Poster: ID 680.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

The Pharma Data

OCTOBER 26, 2020

Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. SAN JOSE, Calif. , AR-711 (COVID-19).

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Pharmaceuticals Virus Hospitals Clinical Trials 52

The Pharma Data

JUNE 14, 2023

With our oncology strategy, we are dedicated to accelerating the research and development of novel cancer therapies that have the potential to make a meaningful difference in the lives of patients.” “We look forward to progressing Cedilla’s programs and continuing to focus on assets that allow better patient selection.

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Licensing Licensing Small Molecule Science 40

The Pharma Data

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. CET ( 11:30 a.m. ET ) to discuss the results and next steps in clinical development of BI-1206.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8

Licensing 40

Licensing Licensing Production Engineering 40

The Pharma Data

NOVEMBER 10, 2020

The poster presentation, given by Johan Sandin , CSO at AlzeCure, presents how the mechanisms in the research platform Alzstatin work and shows that the target mechanism within the platform is suitable as a new treatment for Alzheimer’s disease. STOCKHOLM , Nov. About AlzeCure Pharma AB (publ).

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Pharmaceutical Companies Disease Treatment Pharmaceuticals 40

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. However, such acquisitions also entail significant risks for biotech firms.

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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

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Licensing Licensing Pharmaceutical Companies Treatment 52

The Pharma Data

NOVEMBER 4, 2020

5, 2020 /PRNewswire/ — Bactiguard presents updated financial targets for 2025 in connection with the company’s financial report for the third quarter of 2020. We have several interesting licensing projects ongoing and see new, exciting business opportunities. The presentation can be followed at www.bactiguard.com.

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Licensing Licensing Production Marketing 52

The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD).

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Therapies Disease Treatment FDA Approval 40

The Pharma Data

DECEMBER 13, 2020

RLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors and therefore represents an encouraging approach for cancer patients,” said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. About Relay Therapeutics.

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Licensing Licensing Clinical Trials Small Molecule 40

SugarCone Biotech

JUNE 10, 2024

Targeting 4-1BB remained of interest to the immuno-oncology field as cell culture experiments and tumor models in mice suggested that robust anti-tumor immune responses could be triggered by anti-4-1BB antibody therapies. The NIMBY problem I think the “Cancer Immunity Cycle” as originally presented by Chen and Mellman ( 10.1016/j.immuni.2013.07.012

Immune Response 87

Immune Response Production Regulations Clinical Trials 87

The Pharma Data

MARCH 22, 2022

Foundational cell therapy platform builds upon seminal work from co-founders, leveraging a T Cell Receptor (TCR) discovery engine and suite of synthetic biology components intending to develop potentially best-in-class therapies targeting oncogenic driver mutations like KRAS and p53. Aude Chapuis, M.D., and Tom Schmitt, Ph.D.,

Therapies 52

Therapies Engineering Treatment Licensing 52

Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding.

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FDA Pharmacy Drugs Production 40

The Pharma Data

APRIL 20, 2023

These data will be presented at the American Academy of Neurology (AAN) Annual Meeting held in Boston and virtually on April 22-27, 2023. A separate analysis showed that treatment with Kesimpta for up to five years was well-tolerated, with no new or increased safety risks identified 2.

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Treatment Trials Disease Licensing 40